EnglishAll4 1.2.3.4-2009-Versao-Corrigida-2010 Pt.br en HFS (9)

Freely available Standard through an ABNT-ABIQUIM AgreementM

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STANDARDABNT NBR

14725-1

First Edition08.26.2009

Valid from:09.26.2009

Corrected copy01.26.2010

Chemicals — Information about safety, health and environment

Part 1: Terminology

Chemicals – Information about safety, health and environmentPart 1: Terminology

ICS 71.100.01 ISBN 978-85-07-01703-5


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ABNT NBR 14725-1:2009

BRAZILIAN ASSOCIATION OF TECHNICAL STANDARDS

Reference numberABNT NBR 14725-1:2009

9 pages

© ABNT 2009

ii © ABNT 2009 – All rights reserved.


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© ABNT 2009All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without prior written permission from ABNT.

ABNTAv.Treze de Maio, 13 - 28° andar20031-901 - Rio de Janeiro – RJTel.: + 55 21 3974-2300Fax: + 55 21 [email protected]

© ABNT 2009 – All rights reserved. iii

http://www.abnt.org.br/

mailto:[email protected]


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Contents Page

Foreword................................................................................................................................................................... iv

Introduction............................................................................................................................................................... v

1 Scope.......................................................................................................................................................... 1

2 Terms and Definitions............................................................................................................................... 1

Bibliography.............................................................................................................................................................. 9

iv © ABNT 2009 – All rights reserved.


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ABNT NBR 14725-1:2009

Foreword

The Brazilian Association of Technical Standards − ABNT (Associação Brasileira de Normas Técnicas) is the National Forum of Standardization. The Brazilian Standards, whose content is under the responsibility of the Brazilian Committees (ABNT/CB), Sectorial Standardization Organisms (ABNT/ONS) and Special Study Committees (ABNT/CEE), are worked out by Study Committees (CE) composed of representatives from the involved sectors, such as: Producers, consumers and neutral entities (universities, laboratories and others).

The ABNT technical documentation is made according to the rules set forth in the ABNT Guidelines, Part 2.

The Brazilian Association of Technical Standards (ABNT) emphasizes that some elements of this document may have patent protection. ABNT should not be held responsible to point out any patent rights.

The Standard ABNT NBR 14725-1 has been worked out within the Brazilian Committee of Chemistry (ABNT/CB-10) by members of the Committee for Information Studies on Safety, Health and Environment related to Chemicals (CE-10:101.05). Their 1st Project was sent to a Nationwide Query according to the Invitation to Bid no. 12, carried out from 12/21/2007 until 02/18/2008, with the Project number 10:101.05-004, whereas the 2nd. Project was also sent to Nationwide Query through the Invitation to Bid no 09, carried out from 09/02/2008 until 10.01.2008 named 2nd for Project 10:101.05-004.

The ABNT NBR 14725 standard entitled Chemical Products - Information on Safety, Health and Environment ("Produtos químicos - Informações sobre segurança, saúde e meio ambiente") is expected to approach the following:

— Part 1: Terminology;

— Part 2: Hazard Rating System;

— Part 3: Labeling;

— Part 4: Material Safety Data Sheet (MSDS).

This ABNT NBR 14725-1 first edition, jointly with Parts 2, 3 and 4, supersedes and cancel the ABNT NBR 14725:2005 print, which has been technically revised and dismembered in parts.

This ABNT NBR 14725-1:2009 corrected print includes Errata 1 dated 01/26/2010.

© ABNT 2009 – All rights reserved. v


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Introduction

This ABNT NBR 14725 part was meant to set forth the terms used in ABNT NBR 14725-2, ABNT NBR 14725-3 and ABNT NBR 14725-4.

ABNT NBR 14725 is part of the effort to implement the Globally Harmonized System (GHS) of information security on hazardous chemicals.

Decree 2657 of July, 3rd, 1998, which issued the Convention No.170 of the International Labor Organization (ILO), establishes some responsibilities for the implementation of the ABNT NBR 14725 standard.

ABNT NBR 14725 was based on the following GHS basic assumptions:

— The need to provide information on hazardous chemicals related to safety, health and environment issues;

— The right of the target public become familiar and able to identify the dangerous chemicals commonly used and their associated risks;

— The utilization of a simple identification system, which could be easily understood and applied in the different sites where dangerous chemicals are used;

— The need to make this consistent system compatible with the classification criteria for all anticipated hazards by GHS;

— The need to facilitate international agreements and to protect industrial secrets and confidential information;

— The workers' training and skill building, and

— The development of consumers' education and awareness.

vi © ABNT 2009 – All rights reserved.


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© ABNT 2009 – All rights reserved. vii


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BRAZILIAN STANDARD ABNT NBR 14725-1:2009

Chemicals — Information about safety, health and environment Part 1: Terminology

1 Scope

This ABNT NBR 14725 part defines the terms used in the chemical products Hazard Rating System, in the labeling of hazardous chemicals, and in Material Safety Data Sheets (MSDS).

2 Terms and Definitions

The following terms and definitions are relevant for this part of ABNT NBR 14725.

2.1aerosolcontainer made of metal, glass or plastic, non-reusable, containing a liquefied or dissolved compressed gas with or without liquid in paste or powder form, and fitted with a discharge device to expel its contents in a gas suspended solid or liquid particle mixture as foam, paste or powder, or in liquid or gaseous state.

2.2explosive articlearticle with one or more substances or explosive mixtures

2.3aspirationadmission of liquid or solid chemical directly through oral or nasal routes, or indirectly by vomiting, through the trachea or lower respiratory tract

2.4bioaccumulationorganism absorption, transformation and elimination output of substance through all exposure routes, such as, air, water, sediment / soil and food

2.5bioconcentrationorganism absorption, transformation and elimination output of substance after being exposed to water

2.6bioavailabilityindicates the extent to which a substance is absorbed and distributed to an area of such organism

NOTE The bioavailability depends on the physical-chemical properties of the substance, on the anatomy and physiology of the organism, on pharmacokinetics and on the exposure route

2.7carcinogenicitydevelopment of malignancies, e.g., the process of forming a malignant tumor (cancer) in an organism, as a resulting effect of the action of a carcinogen

© ABNT 2009 – All rights reserved. 1


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2.8carcinogenictoxic chemical substance, inert solid body or ionizing radiation able to induce carcinogenicity

2.9danger categorysubdivision of a danger class

EXAMPLE The 'oral acute toxic' class has four danger categories.

2.10EC50

effective concentration of substance causing 50% of maximum response

2.11ECr50

effective concentration in terms of reducing the growth rate

2.12LC50

concentration of chemical in air or water that kills 50% of a group of animals undergoing assays

2.13danger classkind of physical danger either to health or to the environment EXAMPLE Carcinogenic, flammable, acute oral toxicity

2.14exposure controlpreventative measures for human protection against the effects of chemical exposure

2.15cutaneous corrosive, skin corrosivetest material capable to produce the destruction of skin tissue, called visible necrosis through the epidermis into the dermis, in at least one of three tested animals after 4-h exposure

2.16corrosive to metalssubstance or mixture that can damage or even destroy metals through its chemical action

2.17 damagephysical lesion and/or injury to the health, environment or property

2.18degradabilityability of a substance or mixture to degrade itself in the environment through the biodegradation process or other processes

2.19degradationdecomposition of organic molecules in smaller molecules, and finally, in carbon dioxide, water and salts.

2.20additive effecteffect quantitatively equal to the sum of the individual effects produced by two or more toxic agents

2 © ABNT 2009 – All rights reserved.


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2.21potentiation effecteffect that happens when a toxic agent, acting simultaneously with non-toxic agent, has its effect increased.

2.22synergic effecteffect quantitatively greater than the sum of the individual effects produced from two or more toxic agents

NOTE The synergic effect is greater than the additive effect

2.23external packagingpackaging intended to pack inner packings

2.24inner packingpacking containing the product directly and contained within an outer packaging

2.25final packagingpackage intended to sell the product

2.26simple packagepackaging consisting of one single container box which does not require an outer packaging to be transported

2.27specialistperson who has the knowledge, ability or special practice in a certain subject

2.28personal protection equipmentPPEany single-user device or product the worker uses for protection against health and safety threatening risks at work

2.29mass explosionpractically instantaneous explosion of almost the entire mass quantity

2.30unstable explosivesthermally unstable and / or highly sensitive explosives to be handled, transported and for the normal use

2.31supplierresponsible party to make a hazardous chemical available to the target public

2.32flammable gasgas which becomes flammable in air at 20o C and at a reference pressure of 101.3 kPa

2.33oxidant gasgas causing or contributing more than air for the combustion of another material, generally because it provides oxygen



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2.34gas under pressuregas contained in recipient either under no less than 280 kPa at 20 °C or as a refrigerated liquid

2.35biological indicator of exposurechemical parameter used to identify an occupational exposure which may be hazardous to health

2.36in vitroeverything produced or occurred in a laboratory environment outside the organism

NOTA In vitro production or execution may be accomplished, for instance, either in a culture medium or into a test tube.

2.37in vivowhatever is produced or done with a living organism

2.38confidential informationevery information that potentially may jeopardize a supplier activity if disclosed to his/her competitor

2.39componentingredient of a chemical product or pertaining to a residue

2.40skin irritationgrowth of a reversible skin lesion as a consequence of the application of a product during a 4-hr long test

2.41ocular irritationocular lesions brought about as a consequence of some product applied into the anterior eye surface, which can be totally reversible within the following 21 days after the application

2.42irritantproduct capable to provoke eye or cutaneous irritation

2.43Kow

partition coefficient n-octanol/water

2.44serious eye lesiondamage to the eye tissue or serious vision impairment as a consequence of some product applied into the anterior eye surface which does not show to be totally reversible within the 21 days following its application

2.45concentration limitcutoff valuereference value which sets forth the category of danger of a particular product



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2.46occupational exposure limitconcentration of an agent, or maximum/minimum intensity of such agent, related to the nature and exposure period to the said agent, which will cause no harm to the worker throughout his/her working life. It has the same meaning of "tolerance limit".

2.47mixtureproduct consisting of two or more substances that not react together

2.48mobility into the soilability of a substance or mixture to reach the water table if released into the environment or to be carried over towards other places through natural environmental conditions

2.49mutationpermanent alteration in the quantity or in the structure of a cell genetic material

2.50mutagenicityassessing the ability of chemicals to induce genetic changes in the nuclei of cells that are transmitted during cell division

2.51mutagenicagent that increases the frequency of mutation in cellular tissues, or in organisms, or in both

2.52commercial namename that identifies a product without having to associate it with its chemical name

2.53chemical namescientific namename describing the atomic or molecular structure of a substance and being the official name followed by the structural and terminology rules of the International Union of Pure and Applied Chemistry, (IUPAC)

EXAMPLE Dimetilbenzene.

2.54technical namefree name for general-purpose use to identify a chemical substance which does not require the use of its chemical name

EXAMPLE Xilol, xylene

2.55signal wordword used in labeling a hazardous chemical intended to point out the relative level of danger severity and/or to warn the target public about a potential danger of that chemical

2.56dangerpotential injury source and intrinsic characteristic of a product

2.57persistenceability of a substance or mixture to remain detectable over time and not self-degrade through biodegradation or other processes in the environment



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2.58pertinentimportant information related to the security, health, environment, and/or uses related to chemicalss

2.59pictogramgraphical composition intended to transmit a particular information concerning danger or safety situations

NOTE Every danger pictogram includes a symbol inserted in a square supported by one of its vertices. The safety pictogram does not have an established pattern.

2.60hazardous chemical

a chemical which is classified as hazardous to the safety, health and/or environment according to the classification criteria adopted.

2.61chemical productsubstance or mixture

2.62program for safety, health and environmentset of actions aimed at to minimize risks in the workplace improving the safety and protection of health and environment

2.63target publicworkers, consumers and professionals of emergency services and transport services

2.64chemical residuesubstance, mixture or material leftover from industrial activities, health, agricultural or commercial services to be disposed of according to the environment regulations in force, such as those ruling the use in another process, or in reprocessing / recovery, recycling, co-processing, thermal destruction and landfill operations

2.65riskprobability of dangerous situations capable to cause damages

2.66labelingidentification through printing, lithography, painting, fire engraving, pressure, trace engraving or printed legend

NOTE Labeling can be applied in any unitary package of chemicals or on any other kind of protective package

2.67safetyabsence of unacceptable damage risks

2.68skin sensitizersubstance that will induce an allergic response following skin contact

2.69respiratory sensitizersubstance that induces hypersensitivity of the upper airways following inhalation of the substance



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2.70symbolgraphical element with conventional meaning used to express graphically through a quickly and easily identifiable way a danger alert, warning, recommendation or instruction

2.71globally harmonized systemGHSset of rules, among other rules, for classification and labeling of chemicals aiming at the establishment of a common and consistent basis for classification and communication of dangers related to dangerous chemicals

2.72overwrappinga way to group simple or external packages of compatible hazardous chemicals to facilitate their handling and transport

2.73flammable solidsolid substance easily combustible or that may cause or feed the fire through friction

2.74substancechemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the product and any impurity deriving from the production process used, but excluding any solvent that might be separated without affecting the stability of the substance or change its composition

2.75emergency telephonecommunication mean able to provide information concerning measures of safety, health and environment related to chemical products should an emergency occur

2.76make FISPQ (MSDS) documents availablemake the FISPQ available in electronic format and / or in a physical location suitable to the user, such as a web site and / or sectors of customer services and / or phone / fax and / or other means

2.77acute toxicityadverse effects after single or multiple doses of a substance by oral or dermal route at 24-h intervals, or resulting of one inhalation exposure period to such substance during a 4-h period

2.78acute aquatic toxicityproperty of a substance to cause adverse effects to an aquatic organism after a short period of exposure

2.79chronic aquatic toxicityproperty of a substance to cause adverse effects to an aquatic organism during predetermined exposures related to the life cycle of the organism

2.80toxicity to reproductionwell-known substance able to produce adverse effects on the sexual function or in the fertility of adult male and female species, and also in the development of their offspring



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2.81undue useuse of a product or process under conditions or for purposes not specified by the supplier, albeit occurring induced by the appearance and characteristics of the product, combined with or resulting from predictable human behavior

2.82userrecipientparty who receives a chemical product from a supplier for industrial or professional purposes such as storage, handling, processing, packaging, or distribution



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Bibliography

[1] Decree 2657, of 03 of July of 1998, which publishes the Convention No 170 of the International Labour Organization (ILO).

[2] GHS book, Globally Harmonized System of Classification and Labeling of Chemicals (GHS) — Purple Book.

[3] NR 6 (Norma Regulamentadora, or Regulatory Standard), Equipamento de Proteção Individual — EPI (Personal Protection Equipment − PPE)

[4] NR 7 (Norma Regulamentadora, or Regulatory Standard) Programas de Controle Médico de Saúde Ocupacional ─ PCMSO (Medical Control of Occupational Health Program)

[5] NR 15 (Norma Regulamentadora, or Regulatory Standard), Atividades e Operações Insalubres (Unhealthy Activities and Operations)



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STANDARDABNT NBR

14725-2


Valid from09.26.2009

Chemicals — Information about safety, health and environmentPart 2: Hazard Classification System

Chemicals – Information about safety, health and environmentPart 2: hazard classification system

ICS 71.100.01 ISBN 978-85-07-01704-2



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98 pages

© ABNT 2009

2 © ABNT 2009 – All rights reserved


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© ABNT 2009 – All rights reserved 3



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www.abnt.org.br




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ContentsPage

Foreword....................................................................................................................................................................viii

Introduction................................................................................................................................................................ ix

1 Scope.......................................................................................................................................................... 1

2 Normative references.................................................................................................................................. 1

3 Terms and definitions.................................................................................................................................. 1

4 Criteria for hazard classification of a chemical product - Mixtures and substances.....................................1

4.1 Mixtures....................................................................................................................................................... 14.2 Test methods and data reliability.................................................................................................................24.3 Previously classified chemicals................................................................................................................... 24.4 Substances/Mixtures posing special problems............................................................................................24.5 Use of animals............................................................................................................................................. 24.6 Specialists judgment.................................................................................................................................... 24.7 Evidence from humans................................................................................................................................ 34.8 Weight of evidence...................................................................................................................................... 34.9 Use of cut-off values/concentration limits....................................................................................................34.10 Synergistic or antagonistic effects...............................................................................................................34.11 Knowing the properties of substances and mixtures...................................................................................44.12 Registration................................................................................................................................................. 44.13 Symbols for danger and warning words......................................................................................................45 Hazard classification to the human health...................................................................................................4

5.1 General consideration................................................................................................................................. 45.2 Acute toxicity............................................................................................................................................... 45.2.1 Classification categories.............................................................................................................................. 45.2.2 Classification of mixtures where acute toxicity test data are available for the complete mixture.................55.2.3 Classification of mixtures where acute toxicity test data are not available for the complete mixture:

Bridging principles....................................................................................................................................... 75.2.4 Classification of mixtures based on its components - Additive Formula......................................................85.2.5 Decision logic Diagrams.............................................................................................................................. 95.3 Skin irritation and corrosion....................................................................................................................... 135.3.1 Classification categories............................................................................................................................ 135.3.2 Substance - Corrosion............................................................................................................................... 135.3.3 Substance - irritation.................................................................................................................................. 145.3.4 Classification criteria for mixtures..............................................................................................................145.3.5 Decision logic Diagrams............................................................................................................................ 175.4 Serious eye damage / eye irritation...........................................................................................................215.4.1 Classification criteria for ingredients..........................................................................................................215.4.2 Classification criteria for mixtures..............................................................................................................235.4.3 Decision logic Diagrams............................................................................................................................ 265.5 Respiratory or skin sensitization................................................................................................................295.5.1 Classification criteria for substances.........................................................................................................295.5.2 Classification criteria for mixtures..............................................................................................................295.5.3 Decision logic Diagram.............................................................................................................................. 305.6 Germ cell mutagenicity.............................................................................................................................. 335.6.1 Classification criteria.................................................................................................................................. 335.6.2 Classification criteria for mixtures..............................................................................................................345.6.3 Decision logic Diagrams............................................................................................................................ 355.7 Carcinogenicity.......................................................................................................................................... 375.7.1 Classification criteria.................................................................................................................................. 37



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5.7.2 Classification criteria for mixtures..............................................................................................................385.7.3 Decision logic Diagrams............................................................................................................................ 395.8 Toxicity to reproduction and lactation........................................................................................................415.8.1 Classification criteria - Effects on reproductivity........................................................................................415.8.2 Classification categories - Effects on or via lactation.................................................................................415.8.3 Classification categories............................................................................................................................ 425.8.4 Decision logic Diagrams............................................................................................................................ 435.9 Specific target organ systemic toxicity single exposure.............................................................................475.9.1 Classification categories............................................................................................................................ 475.9.2 Classification criteria for mixtures..............................................................................................................485.9.3 Decision logic Diagrams............................................................................................................................ 495.10 Specific target organ systemic toxicity repeated exposure........................................................................525.10.1 Classification criteria.................................................................................................................................. 525.10.2 Classification criteria for mixtures..............................................................................................................545.10.3 Decision logic Diagrams............................................................................................................................ 555.11 Aspiration hazard....................................................................................................................................... 585.11.1 Classification criteria.................................................................................................................................. 585.11.2 Classification criteria for mixtures..............................................................................................................585.11.3 Decision logic diagrams............................................................................................................................. 606 Hazardous to the aquatic environment......................................................................................................61

6.1 General considerations.............................................................................................................................. 616.2 Classification criteria for substances.........................................................................................................616.3 Classification criteria for mixtures..............................................................................................................636.3.1 Flow diagram for classification................................................................................................................... 636.3.2 Classification of mixtures when data are available for toxicity of aquatic organisms.................................646.3.3 Classification of mixtures when aquatic data assays are not available for the mixture: Bridging

principles................................................................................................................................................... 646.3.4 Classification of mixtures when data are available for all components or only for some components of

the mixture................................................................................................................................................. 656.3.5 Classification procedure............................................................................................................................ 656.3.6 Classification for the acute categories 1, 2 and 3......................................................................................666.3.7 Classification for the chronic categories 1, 2, 3 and 4...............................................................................666.3.8 Mixtures with highly toxic components......................................................................................................676.3.9 Classification of mixtures with components without any useable information............................................676.4 Decision logic diagrams............................................................................................................................. 677 Physical hazards....................................................................................................................................... 73

7.1 General considerations.............................................................................................................................. 737.2 Classification criteria for substances, mixtures and explosive articles.......................................................737.3 Classification criteria for flammable gases.................................................................................................747.4 Classification criteria for flammable aerosols.............................................................................................757.5 Criteria for classification of oxidizing gaseses...........................................................................................787.6 Criteria for classification of gases under pressure.....................................................................................797.7 Criteria classification for flammable liquids................................................................................................817.8 Criteria classification for flammable solids.................................................................................................827.9 Classification criteria for self-reactive substances and mixtures - Substances liable

to spontaneous combustion....................................................................................................................... 847.10 Criteria classification for pyrophoric liquids................................................................................................857.11 Criteria classification for pyrophoric solids.................................................................................................867.12 Classification criteria for self-heating substances and mixtures.................................................................867.13 Classification criteria for substances and mixtures which, in contact with water,

emit flammable gases................................................................................................................................ 887.14 Criteria classification for oxidizing liquids..................................................................................................907.15 Criteria classification for oxidizing solids...................................................................................................927.16 Classification criteria for organic peroxides...............................................................................................947.17 Classification criteria for substances and mixtures corrosive to metals.....................................................95Annex A (informative) Test methods......................................................................................................................... 96

Bibliography.............................................................................................................................................................. 98



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Foreword







— Part 2: Hazard Classification System;


— Part 4: Material Safety Data Sheet - MSDS

WARNING - Other classification systems, besides those described in this part of ABNT NBR 14725, may be used until 02.26.2011. After 02/27/2011, all chemicals should be classified only in accordance with this part of ABNT NBR 14725 (ABNT NBR 14725-2:2009).




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Introduction

The production and use of chemical products are essential in global economic development; however, such products may pose a risk to the human health and to the environment if not used responsibly. Therefore, the primary objective of the Hazard Classification System for Chemicals is to provide information to protect the human health and the environment.

An essential step for the safe use of chemicals is the identification of specific hazards jointly with the organization of such information as well, so that they can be clearly transmitted and easily understood by the users. Consequently, security measures can be taken to minimize and manage potential risks in circumstances where an exposure might occur.

The United Nations (UN) Conference on Environment and Sustainable Development (UNCED) identified in 1992 that the classification of chemicals should be unified so that the associate risks could be communicate through Safety Data Sheets for chemicals, and easily identifiable labels and symbols.

For this purpose, the Globally Harmonized System (GHS) was created in order to increase the protection of the human health and environment, to provide an internationally comprehensible system for risk communication, and to facilitate the international trade of chemicals as well, whose hazards were properly assessed and identified on international basis.

The Decree 2657 of July, 3rd, 1998, which issued the Convention No.170 of the International Labor Organization (ILO), sets forth in article 6th that: "the competent authority, body or bodies approved or recognized by the competent authority in accordance with national or international standards, should establish systems and specific criteria appropriate to classify all chemicals according to the type and degree of physical risks and health risks they pose, and to assess the relevance of the information required to determine their dangerousness".


The unified Chemicals Hazard Classification System intends to be simple and transparent, aiming at allowing a clear distinction between the different categories of risk, thus facilitating the classification procedure. For several categories, the criteria are either qualitative or nearly quantitative, and an expert opinion is needed to interpret the data for purposes of classification.

The labeling criteria for substances and mixtures according to the classification criteria as defined in this part of ABNT NBR 14725 is specified in ABNT NBR 14725-3. The diagrams included in this part of ABNT NBR 14725 are provided only as general guidance.

This part of the ABNT NBR 14725 was based on the following GHS basic assumptions:

— There is a need to provide information on hazardous chemicals concerning safety, health and environment;

— The target public has the right to know and identify the hazardous chemicals they use and the dangers they offer;

— A simple and easy to understand system of identification should be applied in the different locations where the hazardous chemicals are used;



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— Such system should be compatible with the classification criteria for all hazards that might be anticipated by GHS;

— International agreements should be facilitated and industrial secrets and confidential information should be protected;

— There is a need to train workers and to improve their capability and,

— It is required to foster users' education and awareness.



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Chemicals — Information about safety, health and environmentPart 2: Hazard Classification System

1 Scope

This part of ABNT NBR 14725 establishes the criteria for the Chemicals Hazard Classification System, whether they are substances or mixtures in order to provide the user with information related to security, human health and environment.

This part of ABNT NBR 14725 applies to all chemicals (pure chemical substances and their mixtures thereof).

NOTE It is necessary to check the mandatory application of this part of ABNT NBR 14725 if the chemical substance must be in compliance with the provisions of specific legislation.

2 Normative references

The following documents are indispensable to the application of this Standard. Dated references are applicable only to the mentioned editions. For undated references, the latest reference should be applied (including amendments).

ABNT NBR 14725-1, Chemicals — Information about safety, health and environment Part 1: Terminology

ABNT NBR 14725-3, Products chemical - Information about safety, health and environment Part 3: Labeling

ABNT NBR 14725-4, Chemicals — Information about safety, health and environment Part 4: Material Safety Data Sheet - MSDS (Ficha de Informações de Segurança de Produtos Químicos ─ FISPQ Brazil).

GHS book, Globally Harmonized System of Classification and Labeling of Chemicals (GHS) - Purple Book, 2005.

Recommendation on the transports of dangerous goods, Manual of Tests and Criteria, United Nations

3 Terms and definitions

This part of ABNT NBR 14725 uses the terms and definitions of ABNT NBR 14725-1.

4 Criteria for hazard classification of a chemical product - Mixtures and substances

4.1 Mixtures

Where test data are available for the mixture, the classification of the mixture will always be based on that data. The established criteria for classification of mixtures allow the use of the available data for the mixture itself and/or mixtures substantially similar (see 5.2.3.5) and/or data of the mixture ingredients.



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Where test data are not available for the mixture itself, then bridging principles included and explained in each specific chapter should be considered to see whether they permit classification of the mixture.

If test data are not available for the mixture, and the available information is not sufficient to allow application of the bridging principles, then the method(s) described in Annex A f will be applied to estimate the hazard classify the mixture.

4.2 Test methods and data reliability

The classification of a chemical substance or mixture depends both on the criteria and on the reliability of the test methods underpinning the criteria. In some cases the classification is determined by a pass or fail of a specific test, (e.g. the ready biodegradation test for substances or ingredients of mixtures), while in other cases, interpretations are made from dose/response curves and observations during testing. In all cases, the test conditions need to be standardized so that the results are reproducible with a given chemical substance and the standardized test yields “valid” data for defining the hazard class of concern. In this context, validation is the process by which the reliability and the relevance of a procedure are established for a particular purpose.

Tests that determine hazardous properties should be carry out following the GLP (Good Laboratory Practices) , according to internationally validated recognized scientific principles, and can be used for hazard determination to the health and to the environment.

4.3 Previously classified chemicals

One of the general principles established by GHS states that test data already generated and internationally recognized for classification of chemicals in other systems, should be accepted to avoid duplicative testing and the unnecessary use of test animals.

4.4 Substances/Mixtures posing special problems

The effect of a substance or mixture on biological and environmental systems is influenced, among other factors, by the physico-chemical properties of the substance or mixture and/or ingredients of the mixture and the way in which ingredient substances are biologically available. Some groups of substances may present special problems in this respect, for example, some polymers and metals. A substance or mixture need not be classified when it can be shown by conclusive experimental data from internationally acceptable test methods that the substance or mixture is not biologically available. Similarly, bioavailability data on ingredients of a mixture should be used where appropriate in conjunction with the harmonized classification criteria when classifying mixtures.

4.5 Use of animals

Where possible and appropriate, tests and experiments that do not require the use of live animals are preferred to those using sentient live experimental animals. To that end, for certain hazards (skin irritation/corrosion and eye irritation/serious eye damage) testing schemes starting with non-animal observations/measurements are included as part of the classification system. For other hazards, such as acute toxicity, alternative animal tests, using fewer animals or causing less suffering are internationally accepted and should be preferred to the conventional LD50 test.

4.6 Specialists judgment

The approach to classifying mixtures includes the application of expert judgment in a number of areas in order to ensure existing information can be used for as many mixtures as possible to provide protection for human health and the environment.

4.7 Evidence from humans

For classification purposes, reliable epidemiological data and experience on the effects of chemicals on humans (e.g. occupational data, data from accident databases) should be taken into account in the evaluation of human health hazards of a chemical. Testing on humans solely for hazard identification purposes is generally not acceptable.

4.8 Weight of evidence

For some hazard classes, classification results directly when the data satisfy the criteria in this ABNT NBR 14725 section. For others, classification of a substance or a mixture is made based on data consistency and weight of evidence. This means that all available information bearing on the determination of toxicity is considered together,



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including the results of studies on sites, mechanisms and courses of action. Both positive and negative results are assembled together in a single weight of evidence determination.

Positive effects that are consistent with the criteria for classification outlined in 5.2 a 5.11, whether seen in humans or animals, will normally justify classification. Where evidence is available from both sources and there is a conflict between the findings, the quality and reliability of the evidence from both sources must be assessed in order to resolve the question of classification. Generally, data of good quality and reliability in humans will have precedence over other data.

A single positive study performed according to GLP and with statistically and biologically significant positive results may justify the classification of a product or mixture.

4.9 Use of cut-off values/concentration limits

When classifying an untested mixture based on the hazards of its ingredients, cut-off values or concentration limits already established are used in GHS.

While the adopted cut-off values/concentration limits adequately identify the hazard for most mixtures, there may be some that contain hazardous ingredients at lower concentrations than those included in this part of ABNT NBR 14725 standard, but that still pose an identifiable hazard. There may also be cases where the established cut-off value/concentration limit is lower than could be expected based in an established non-hazardous level for an ingredient.

If the available information indicates that the hazard posed by certain ingredient is evident even below the cut-off values/concentration limit, the mixture containing that ingredient should be classified accordingly.

Occasionally, conclusive data may show that the hazard of an ingredient will not be evident when present at a level above the GHS cut-off values/concentration limit(s). In these cases, the mixture could be classified according to those data. The data should exclude the possibility that the ingredient would behave in the mixture in a manner that would increase the hazard over that of the pure substance. Furthermore, the mixture should not contain ingredients that would affect that determination.

Adequate documentation supporting the use of any values other than the generic cut-off values/concentration limits should be retained and made available for review on request.

4.10 Synergistic or antagonistic effects

When performing an assessment in accordance with the ABNT NBR 14725 Standard requirements, the evaluator must take into account all available information about the potential occurrence of synergistic effects among the ingredients of the mixture.

Lowering classification of a mixture to a less hazardous category because of antagonistic effects may be done only if the determination is supported by sufficient data.

4.11 Knowing the properties of substances and mixtures

The evaluation of the hazard of pure substances and their mixtures is accomplished based on the properties indicating effects on health, environment and considering their physical and chemical properties.

4.12 Registration

All procedures and records used and generated during the classification must be filed and made available when required.

4.13 Symbols for danger and warning words

The use of hazard symbols and words of warning are illustrated in Figures in this part of ABNT NBR 14725 and detailed presented in ABNT NBR 14725-3.



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5 Hazard classification to the human health

5.1 General considerations

The hazards of substances and mixtures on health are determined by evaluation of their toxicological properties, in accordance with the criteria described in this part of ABNT NBR 14725 and methodologies described in the UN Manual of Tests and Criteria (see Annex A).

Besides that, the hazards of substances and mixtures can be demonstrated through:

Epidemiological studies from scientifically valid case or by statistically supported experience, such as evaluations from centers of intoxication or information concerning occupational diseases databases;

Toxicological effects in humans that differ from those suggested by experimental laboratory methods are referenced in Appendix A and should be classified according to the symptoms observed in humans

Synergistic, potentiation, or added effects that should be considered in classifying a mixture when a conventional assessment leads to an underestimation of the toxicological hazard. The same applies to antagonistic effects that might have been overestimated.

When the formula is modified from a mixture, with a variation in mass or volume, a new evaluation and classification of its hazard should be performed. Therefore, such new assessment only is not applicable if scientific evidence is pointing out for the need of a reassessment of the hazards will not result in changing the classification.

Regarding the classification of mixtures, one can estimate its toxicity based on the toxicological knowledge of the ingredients present. This estimate can also be done using several well-known national and international models, such as the OSHA of the European Community Directive, among others.

5.2 Acute toxicity

5.2.1 Classification categories

The hazard classification of substances and mixtures is based on cut-off values / concentration limits of the values of acute oral, dermal and inhalation, the LD50 and LC50, which are obtained by testing with mammals, according to the methods described in Annex A. These limits substances and mixtures are classified into categories of hazards.



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5.2.2 Classification of mixtures where acute toxicity test data are available for the complete mixture Chemical products and mixtures may be classified in one out of five categories of acute toxicity by oral, dermal or inhalation routes according to Table 1.

Table 1 — Categorias de toxicidade aguda e valores aproximados de DL50/CL50

Exposure routesApproximate Upper limits of LD50/LC50

Category 1 Category 2 Category 3 Category 4 Category 5

Oral a

mg/kg bodyweight 5 50 300 2 000

5 000 f

Dermal a

mg/kg bodyweight 50 200 1 000 2 000

Gases a b µL/L (ppm)

100 500 2 500 5 000

Vapors a b c d

mg/L0.5 2.0 10 20

Dust and mist a b e

mg/L0.05 0.5 1.0 5

a The acute toxicity estimate (ATE) for the classification of a substance or ingredient in a mixture is derived using:— the LD50/LC50 where available,— the appropriate conversion value from Table 2, which relates to the results of a range test, or— the appropriate conversion value from Table 2 that relates to a classification category.b Inhalation cut-off values in the Table is based on 4 hour testing exposures. If the existing inhalation toxicity data have been generated according to 1-hour exposures, the values of LC50 should be divided by a factor of 2 for gases and vapors, and 4 for dusts and mists.c It is recognized that saturated vapor concentration may be used as an additional element by some regulatory systems to provide for specific health and safety protection. (e.g. UN Recommendations for the Transport of Dangerous Goods).d For some chemicals the test atmosphere will not just be a vapor but will consist of a mixture of liquid and vapor phases. In these cases, classification should be based on microliter per liter (ppm) as follows: category 1, 100 µL/L (ppm); category 2, 500 µL/L (ppm); category 3, 2500 µL/L (ppm); category 4, 5000 µL/L (ppm). Methods from Annex A are performed aiming at a better definition of such terms as dusts, mists and vapors, regarding the toxicity tests by respiratory route.e The values for dusts and mists should be reviewed to adapt to any future changes to the ones in Annex A with respect to technical limitation in generating, maintaining and measuring dust and mist concentrations in respirable form.f Criteria for Category 5 are intended to enable the identification of substances which are of relatively low acute toxicity hazard but which under certain circumstances may present a danger to vulnerable populations. These substances are anticipated to have an oral or dermal LD50 in the range of 2000-5000 mg/kg bodyweight and equivalent doses for inhalation.The specific criteria for Category 5 are:a) The substance is classified in this Category if reliable evidence is already available that indicates the

LD50 (or LC50) to be in the range of Category 5 values or other animal studies or toxic effects in humans indicate a concern for human health of an acute nature;

b) The substance is classified in this Category, through extrapolation, estimation or measurement of data, if assignment to a more hazardous category is not warranted, and:1) reliable information is available indicating significant toxic effects in humans; or2) any mortality is observed when tested up to Category 4 values by the oral, inhalation, or dermal

routes; or 3) where expert judgment confirms significant clinical signs of toxicity, when tested up to Category 4

values, except for diarrhea, piloerection or an ungroomed appearance; or4) where expert judgment confirms reliable information indicating the potential for significant acute

effects from other animal studies.



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When the mixture itself is tested for acute toxicity it may be classified according to criteria set for substances in Table 2.

Table 2 — Conversion from experimentally obtained acute toxicity range values to acute toxicity category, for the different routes of exposure

Exposure routes Experimentally obtained acute toxicity ranges

Classification category a

Converted Acute Toxicity point estimate b

OralLD50

mg/kg bodyweight

0 < Category 1 ≤ 5 0.55 < Category 2 ≤ 50 550 < Category 3 ≤ 300 100300 < Category 4 ≤ 2 000 5002 000 < Category 5 ≤ 5 000 2 500

DermalLD50

mg/kg bodyweight

0 < Category 1 ≤ 50 550 < Category 2 ≤ 200 50200 < Category 3 ≤ 1 000 3001 000 < Category 4 ≤ 2 000 11002 000 < Category 5 ≤ 5 000 2 500

GasesLC50

µL/L (ppm)

0 < Category 1 ≤ 100 10100 < Category 2 ≤ 500 100500 < Category 3 ≤ 2 500 7002 500 < Category 4 ≤ 5 000 3 000Category 5 a -

VaporsLC50

mg/L

0 < Category 1 ≤ 0,5 0.050,5 < Category 2 ≤ 2,0 0.52,0 < Category 3 ≤ 10,0 310,0 < Category 4 ≤ 20,0 11Category 5 a -

Dust/mistLC50

mg/L

0 < Category 1 ≤ 0,05 0.0050,05 < Category 2 ≤ 0,5 0.050,5 < Category 3 ≤ 1,0 0.51,0 < Category 4 ≤ 5,0 1.5Category 5 a -

a Category 5 is for mixtures which are of relatively low acute toxicity but which under certain circumstances may pose a hazard to vulnerable populations. These mixtures are anticipated to have an oral or dermal LD50 value in the range of 2000-5000 mg/kg bodyweight or equivalent dose for other routes of exposure. In light of animal welfare considerations, testing in animals in Category 5 ranges is discouraged and should only be considered when there is a strong likelihood that results of such testing would have a direct relevance for protecting human health.b These values are designed to be used in the calculation of the ATE for classification of a mixture based on its components (see Formulas 1 and 2) and do not represent test results. The values are conservatively set at the lower end of the range of Categories 1 and 2, and at a point approximately 1/10th from the lower end of the range for Categories 3 – 5.

Recognizing the need to protect animal welfare, testing in animals in Category 5 ranges is discouraged and should only be considered when there is a strong likelihood that results of such a test would have a direct relevance for protecting human health.



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If test data for the mixture are not available, the procedures pointed out in 5.2.3 should be followed.

5.2.3 Classification of mixtures where acute toxicity test data are not available for the complete mixture: Bridging principles

NOTE Where the mixture itself has not been tested to determine its acute toxicity, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data will be used in accordance with the following agreed bridging rules. This ensures that the classification process uses the available data to the greatest extent possible in characterizing the hazards of the mixture without the necessity for additional testing in animals.

5.2.3.1 Dilution

If a mixture is diluted with a substance that has an equivalent or lower toxicity classification than the least toxic original ingredient, and which is not expected to affect the toxicity of other ingredients, then the new mixture may be classified as equivalent to the original mixture. Alternatively, the formula (1) (see Figure 2) could be applied.

If a mixture is diluted with water or other totally non-toxic material, the toxicity of the mixture can be calculated from test data on the undiluted mixture. For example, if a mixture with an LD50 of 1000 mg/kg bodyweight were diluted with an equal volume of water, the LD50 of the diluted mixture would be 2000 mg/kg bodyweight.

5.2.3.2 Batching

The toxicity of one production batch of a complex mixture can be assumed equivalent to that of another production batch of the same commercial product, and produced by or under the control of the same manufacturer, unless there is reason to believe there is significant variation such that the toxicity of the batch has changed. If the latter occurs, new classification is necessary.

5.2.3.3 Concentration of highly toxic mixtures

If a mixture is classified in Category 1, and the concentration of the ingredients of the mixture that are in Category 1 is increased, the new mixture should be classified in Category 1 without additional testing.

5.2.3.4 Interpolation within one toxicity category

For three mixtures with identical ingredients, where A and B are in the same toxicity category and mixture C has the same toxicologically active ingredients with concentrations intermediate to the concentrations of those ingredients in mixtures A and B, then mixture C is assumed to be in the same toxicity category as A and B.

5.2.3.5 Substantially similar mixtures

Given the following:

a) Two mixtures:

1) A + B;

2) C + B;

b) The concentration of component B is the same in both mixtures;

c) The concentration of component A in mixture (1) equals that of component C in mixture (2);

d) Classification for A and C for toxicity are available and are the same, i.e. they are in the same hazard category and are not expected to affect the toxicity of B.

Then there is no need to test mixture (2) if mixture (1) is already characterized by testing and both mixtures would be classified in the same category.

5.2.3.6 Aerosols

An aerosol form of a mixture may be classified in the same hazard category as the tested, non-aerosolized form of the mixture for oral and dermal toxicity provided the added propellant does not affect the toxicity of the mixture on spraying. Classification of aerosolized mixtures for inhalation toxicity should be considered separately.



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5.2.4 Classification of mixtures based on its components - Additive Formula

5.2.4.1 Data are available for all components

To ensure that the classification of the mixture is accurate and that the calculations will be perform only once for all systems, sectors and categories, the estimated acute toxicity (ETA) of the components should be considered as follows:

— Include ingredients with a known acute toxicity, which fall into any of the known toxicity categories;

— Ignore ingredients that are presumed not acutely toxic (e.g. water, sugar);

— Ignore ingredients if the oral limit test does not show acute toxicity at 2000 mg/kg bodyweight.

Ingredients that fall within the scope of this paragraph are considered ingredients with a known acute toxicity estimate.

The ETA of the mixture is determined by calculation from the ETA values for all relevant ingredients according to the following formula (1) below for oral, dermal or inhalation toxicity:

Formula (1)

where:

n number of components, and i is running from 1 to n;

ETAi Acute Toxicity Estimate of ingredient i;

ETAm Acute Toxicity Estimate of mixture m;

Ci concentration of component i .

5.2.4.2 Data are not available for one or more ingredients of the mixture

5.2.4.2.1 Where an ATE is not available for an individual ingredient of the mixture, but available information such as listed below can provide a derived conversion value, the formula in (1) may be applied. This may include evaluation of:

— Analogies among estimates for oral, dermal and inhalation acute toxicity. Such evaluation may require appropriate data from pharmacodynamics and farmacokinetics. For ingredients with acute toxicity estimates available for other than the most appropriate exposure route, values may be extrapolated from the available exposure route to the most relevant route. Dermal and inhalation route data are not always required for ingredients. However, in case data requirements for specific ingredients include acute toxicity estimates for the dermal and inhalation route, the values to be used in the formula need to be from the required exposure route;

— Evidence from human exposure that indicates toxic effects but does not provide lethal dose data;

— Evidence from any other toxicity tests/assays available on the substance that indicates toxic acute effects but does not necessarily provide lethal dose data; or

— Data from closely analogous substances using structure/activity relationships.

5.2.4.2.2 This approach generally requires substantial supplemental technical information, and a highly trained and experienced expert, to reliably estimate acute toxicity. If such information is not available, proceed to the provisions of 5.2.4.2.4.

5.2.4.2.3 In the event that an ingredient without any useable information at all is used in a mixture at a concentration of 1% or greater, it is concluded that the mixture cannot be attributed a definitive ETA. In this situation, the mixture should be classified based on the known ingredients only, with the additional statement that x percent of the mixture consists of ingredient(s) of unknown toxicity.

5.2.4.2.4 If the total concentration of the ingredient(s) with unknown acute toxicity is ≤ 10% then the formula (1) should be used. If the total concentration of the ingredient(s) with unknown toxicity is >10%, the formula (1) should be corrected to adjust for the total percentage of the unknown ingredient(s) as follows in formula (2):



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Formula (2)

Where

Cd is the concentration of ingredients of unknown acute toxicity;

ETAm is the Acute Toxicity Estimate of mixture m;

n number of components, and i is running from 1 to n;

Ci concentration of component i.

ETAi is the Acute Toxicity Estimate of ingredient i.

5.2.5 Decision logic Diagrams

Figures 1 and 2 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic.



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Figure 1 — Decision logic for acute toxicity


Substance: Are there data and/or information to evaluate acute toxicity?

Mixture: Does the mixture as a whole have data/information to evaluate acute toxicity?

Classification not possible

Mixture: Does the mixture as a whole have data/information to evaluate acute toxicity?

Calcule ETA for mixture (see Figure 2)

ETA (from Figure 2)

Oral LD50 ≤ 5 mg/kg bodyweight, orDermal LD50 ≤ 50 mg/kg bodyweight, orInhalation (gas) LC50 ≤ 100 µL/L (ppm), orInhalation (vapor) LC50 ≤ 0.5 mg/L, orInhalation (dust/mist) LC50 ≤ 0.05 mg/L?

Oral LD50 > 5 but < 50 mg/kg bodyweight, orDermal LD50 > 50 but ≤ 200 mg/kg bodyweight, orInhalation (gas) LC50>100 µL/L (ppm) but ≤ 500 µL/L (ppm); orInhalation (vapor) LC50 > 0.5 mg/L but ≤ 2.0 mg/L; orInhalation (dust/mist) LC50 > 0.05 mg/L e ≤ 0.5 mg/L?

Category 1

Danger

Oral LD50 > 5 mg/kg but ≤ 300 mg/kg bodyweight; orDermal LD50 > 200 mg/kg but ≤ 1 000 mg/Kg bodyweight; orInhalation (gas) LC50 > 500 µL/L (ppm) but ≤ 2 500 µL/L (ppm); orInhalation (vapor) LC50 > 2 mg/L but ≤ 10 mg/L; orInhalation (dust/mist) LC50 > 0.5 mg/L but ≤ 1.0 mg/L?

Yes

Yes

Yes

Yes

Yes

Yes

No

No

No

No

No


Category 2

Category 3

Danger

Danger


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Figura 1 (continuing)


Yes

No

Category 4

Warning

Yes

No

Category 5

Warning

Yes

No

Category 5if assignment to

a more hazardous class is not warranted

No

Not classified

Oral LD50 > 300 mg/kg but ≤ 2000 mg/Kg bodyweight, orDermal LD50 > 1000 mg/kg but 2000 mg/Kg bodyweight, orInhalation (gas) LC50 > 2500 µL/L (ppm) but ≤ 5000 µL/L (ppm),

orInhalation (vapor) LC50 > 10 mg/L but ≤ 20 mg/L, orInhalation (dust/mist) LC50 > 1 mg/L but ≤ 5 mg/L?

Oral LD50 > 2 000 but ≤ 5 000 mg/kg bodyweight, orDermal LD50 > 2 000 mg/kg but ≤ 5 000 mg/kg

bodyweight, orInhalation (gas and/or vapor and/or dust/mist) LC50 in

the equivalent range of the oral and dermal LD50

( i.e., 2 000-5 000 mg/kg bodyweight?

Is there reliable information available indicating significant toxicity effects in humans?; or

Was any mortality observed when tested up to Category 4 values by the oral, inhalation or dermal routes?; or

•Is there expert judgment that confirms significant clinical signs of toxicity, when tested up to Category 4 values, except for diarrhea, piloerection or an ungroomed appearance?; or

•Is there expert judgment that confirms reliable information indicating the potential for significant acute effects by the product?


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a In the event that an ingredient without any useable information is used in a mixture at a concentration > 1%, the classification should be based on the ingredients with the known acute toxicity only, and an additional statement on the label should identify the fact that the acute toxicity of x percent of the mixture is unknown.

Figure 2 — Decision logic for acute toxicity - ETA mixtures


No

No

No

No

Yes

Yes

Yes

Yes a

Classify in appropriate

categoryCan bridging principles be applied?

Is acute toxicity data available for all ingredients of mixture?

Is it possible to estimate a missing ETA(s) of the ingredients? Meaning, can conversion value(s) be derived?

Is the total concentration of the ingredient(s) with unknown acute toxicity >10 %?

Go to Formula 2

Go to Formula 1

Apply Formula (1), Acute Toxicity Estimate, to

calculate the ETA of the mixture

Apply formula (2) to calculate the ETA


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5.3 Skin irritation and corrosion

5.3.1 Classification categoriesThe classification of substances and mixtures in the various categories related to skin irritation and corrosion is shown in Tables 3 and 4. Category 1 has 3 subcategories (see Table 3).

Table 3— Skin corrosive category and subcategories

Category 1Corrosive

subcategories

Corrosive in ≥ 1 of 3 animals

Exposure Observation

Skin corrosive effect

1A t ≤ 3 minutes t ≤ 1 hour

1Bt > 3 minutes t ≤ 1 hour

t ≤ 14 days

1C t > 1 hour ≤ 4 hours t ≤ 14 days

NOTE t is the exposure or observation time

Table 4 — Skin irritation categories

Categories Criteria

Irritant (Category 2)

— Mean value of ≥ 2.3 < 4.0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

— Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals; or

— In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

Mild irritant(Category 3)

Mean value of ≥ 1.5 < 2.3 for erythema/eschar or for oedema from gradings in at least 2 of 3 tested animals from grades at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions (when not included in the irritant category above).

NOTE Animals can be tested using methods outlined in Annex A.

5.3.2 Substance - Corrosion

A single harmonized corrosion category is provided in Table 3, using the results of animal testing.

Category 1 has three subcategories according to Table 3:

— 1A: where responses are noted following up to 3 minutes exposure and up to 1 hour observation;

— 1B: where responses are described following exposure between 3 minutes and 1 hour and observations up to 14 days; and

— 1C: where responses occur after exposures between 1 hour and 4 hours and observations up to 14 days.



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5.3.3 Substance - irritation

Irritant and mild irritant categories are pointed out in Table 4, which:

— describes the criteria for both categories of skin irritation (2 and 3) differentiated primarily by the severity of skin reactions;

— represents an average of the values used in the existing classifications;

— represents an average of all scores;

— recognizes that some test materials may lead to effects which persist throughout the length of the test; and

— acknowledges that animal responses in a test may be quite variable. An additional category for mild skin irritant (Category 3) may be used.

Reversibility of skin lesions is another consideration in evaluating irritant responses. When inflammation persists to the end of the observation period in 2 or more test animals, taking into consideration alopecia (limited area), hyperkeratosis, hyperplasia and scaling, then a material should be considered to be an irritant.

Animal irritant responses within a test can be quite variable, as they are with corrosion. A separate irritant criterion accommodates cases when there is a significant irritant response but less than the mean score criterion for a positive test. For example, a test material might be designated as an irritant if at least 1 of 3 tested animals shows a very elevated mean score throughout the study, including lesions persisting at the end of an observation period of normally 14 days. Other responses could also fulfill this criterion. However, it should be ascertained that the responses are the result of chemical exposure. Addition of this criterion increases the sensitivity of the classification system.

5.3.4 Classification criteria for mixtures

5.3.4.1 Classification of a mixture as corrosive or irritant

The classification of mixtures according to their ingredients concentration, classification categories and chemical/toxicological properties is shown in Tables 5 and 6.

Table 5 — Concentration of ingredients of a mixture classified as skin Category 1, 2 or 3 that would trigger classification of the mixture as hazardous to skin (Category 1, 2 or 3)

Sum of ingredients classifications aConcentration for mixture classification

Skin corrosive Skin irritant Category 1 Category 2 Category 3

Category 1 c ≥ 5 % c ≥ 1% but c < 5% -Category 2 - c ≥ 10 % c ≥ 1% but c <

10%Category 3 - - c ≥ 10 %(10 x Category 1) + Category 2 - c ≥ 10 % c ≥ 1% but c <

10%(10 x Category 1) + Category 2 + Category 3

- - c ≥ 10 %

For subcategories of Skin Category 1 the sum of all ingredients of a mixture classified as Skin Category 1A, 1B or 1C respectively, should each be ≥ 5% in order to classify the mixture as either Skin Category 1A, 1B or 1C. In case the sum of the Skin Category 1A ingredients is < 5% but the sum of Skin Category ingredients 1A+1B is ≥ 5%, the mixture should be classified as Skin Category 1B. Similarly, in case the sum of Skin Category 1A + 1B is < 5%, but the sum of Category 1A + 1B + 1C is ≥ 5% the mixture would be classified as Category 1C.NOTE c is the sum of ingredients classification.a Categories according to Tables 3 and 4.



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Table 6 — Concentration of ingredients of a mixture for which the additivity approach which would trigger the classification of the mixture as hazardous to skin is not applicable

Ingredients Concentration Mixture classificationAcid with pH ≤ 2 ≥ 1 % Category 1Base with pH ≥ 11.5 ≥ 1 % Category 1Other corrosive (Category 1) ingredients for which additivity does not apply

≥ 1 % Category 1

Other irritant (Category 2 and 3) ingredients for which additivity does not apply, including acids and bases

≥ 3 % Category 2

5.3.4.2 Classification of mixtures when data are available

5.3.4.2.1 The mixture will be classified using the criteria for substances, and taking into account the testing and evaluation strategies to develop data for these hazard classes.

5.3.4.2.2 Unlike other hazard classes, there are alternative tests available for skin corrosivity of certain types of chemicals that can give an accurate result for classification purposes, as well as being simple and relatively inexpensive to perform. When considering testing of the mixture classifiers are encouraged to use a tiered weight of evidence strategy as included in the criteria for classification of substances for skin corrosion and irritation to help ensure an accurate classification, as well as avoid unnecessary animal testing. A mixture is considered corrosive (Skin Category 1) if it has a pH of 2 or less or a pH of 11.5 or greater. If consideration of alkali/acid reserve suggests the substance or preparation may not be corrosive despite the low or high pH value, then further testing needs to be carried out to confirm this, preferably by use of an appropriate validated in vitro test.

5.3.4.3 Classification of mixtures when data are not available for the complete mixture: Bridging principles

NOTE Where the mixture itself has not been tested to determine its skin irritation/corrosion, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data will be used in accordance with the following agreed bridging rules. This ensures that the classification process uses the available data to the greatest extent possible in characterizing the hazards of the mixture without the necessity for additional testing in animals.

5.3.4.3.1 Dilution

f a mixture is diluted with a diluent which has an equivalent or lower corrosivity/irritancy classification than the least corrosive/irritant original ingredient and which is not expected to affect the corrosivity/irritancy of other ingredients, then the new mixture may be classified as equivalent to the original mixture. Alternatively, the method explained in 5.3.4.4 could be applied.

5.3.4.3.2 Batching

The irritation/corrosion potential of one production batch of a complex mixture can be assumed equivalent to that of another production batch of the same commercial product and produced by or under the control of the same manufacturer, unless there is reason to believe there is significant variation such that the toxicity of the batch has changed. If the latter occurs, new classification is necessary.



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5.3.4.3.3 Concentration of mixtures of the highest corrosion/ irritation category

If a tested mixture classified in the highest subcategory for corrosion is concentrated, a more concentrated mixture should be classified in the highest corrosion subcategory without additional testing. If a tested mixture classified in the highest category for skin irritation is concentrated and does not contain corrosive ingredients, a more concentrated mixture should be classified in the highest irritation category without additional testing.

5.3.4.3.4 Interpolation within one toxicity category

For three mixtures with identical ingredients, where A and B are in the same irritation/ corrosion toxicity category and mixture C has the same toxicologically active ingredients with concentrations intermediate to the concentrations of those ingredients in mixtures A and B, then mixture C is assumed to be in the same irritation/corrosion category as A and B.

5.3.4.3.5 Substantially similar mixtures


a) Two mixtures:

1) A + B;

2) C + B;



d) Classification for A and C for corrosivity / irritability are available and are the same, i.e. they are in the same hazard category and are not expected to affect the carcinogenicity of B.


5.3.4.3.6 Aerosols

An aerosol form of a mixture may be classified in the same hazard category as the tested non-aerosolized form of mixture if the added propellant does not affect the irritation or corrosive properties of the mixture upon spraying.

5.3.4.4 Classification of mixtures when data are available for all components or only for some components of the mixture

5.3.4.4.1 In order to make use of all available data for purposes of classifying the skin irritation/corrosion hazards of mixtures, the following assumption has been made and is applied where appropriate in the tiered approach: The relevant ingredients of a mixture are those which are present in concentrations of 1% (weight/weight for solids, liquids, dusts, mists and vapors and volume/volume for gases) or greater, unless there is a presumption (e.g. in the case of corrosive ingredients) that an ingredient present at a concentration of less than 1% can still be relevant for classifying the mixture for skin irritation/corrosion. .

5.3.4.4.2 In general, the approach to classification of mixtures as irritant or corrosive to skin when data are available on the components, but not on the mixture as a whole, is based on the theory of additivity, such that each corrosive or irritant component contributes to the overall irritant or corrosive properties of the mixture in proportion to its potency and concentration. A weighting factor of 10 is used for corrosive components when they are present at a concentration below the concentration limit for classification with Category 1, but are at a concentration that will contribute to the classification of the mixture as an irritant. The mixture is classified as corrosive or irritant when the sum of the concentrations of such components exceeds a cut-off value/concentration limit.



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5.3.4.4.3 Table 5 below provides the cut-off value/concentration limits to be used to determine if the mixture is considered to be an irritant or a corrosive to the skin.

5.3.4.4.4 Particular care must be taken when classifying certain types of chemicals such as acids and bases, inorganic salts, aldehydes, phenols, and surfactants. The approach explained in 5.3.4.4.1 and 5.3.4.4.2 might not work given that many of such substances are corrosive or irritant at concentrations < 1%. For mixtures containing strong acids or bases the pH should be used as classification criteria (see 5.3.4.2.2), since pH will be a better indicator of corrosion than the concentration limits of Table 5. A mixture containing corrosive or irritant ingredients that cannot be classified based on the additivity approach shown in Table 5 due to chemical characteristics that make this approach unworkable, should be classified as Skin Category 1 if it contains ≥ 1% of a corrosive ingredient and as Skin Category 2 or 3 when it contains ≥ 3% an irritant ingredient. Classification of mixtures with ingredients for which the approach in Table 5 does not apply is summarized in Table 6.

5.3.4.4.5 On occasion, reliable data may show that the skin corrosion/irritation of an ingredient will not be evident when present at a level above the generic concentration cut-off levels mentioned in Tables 5 e 6. In these cases the mixture could be classified according to those information (see 4.9). On occasion, when it is expected that the skin corrosion/irritation of an ingredient will not be evident when present at a level above the generic concentration cut-off levels mentioned in Tables 5 e 6, testing of the mixture may be considered.

5.3.4.4.6 If there are data showing that (an) ingredient(s) may be corrosive or irritant at a concentration of < 1% (corrosive) or < 3% (irritant), the mixture should be classified accordingly (see 4.9).


Figures 3 e 4 an be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic.



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Figure 3 — Decision logic for acute toxicity skin irritation or corrosion


No

No

No

No

Yes

Yes

Yes

Yes



See Figure 4

Category 1

Danger

Is the substance or mixture corrosive considering:Existing human experience showing irreversible damage to skin, Existing animal observations indicating skin corrosion after single or repeated exposure, In vitro data, Information available from structurally related compounds, pH extremes of ≤ 2 or ≥ 11.53, Destruction of skin in 1 or more test animals?

Mixture: Does the mixture as a whole have data/information to evaluate skin corrosion/irritation?

Mixture: Does the mixture as whole or its ingredients have data/information to evaluate skin corrosion/irritation?

Substance: Are there data/information to evaluate skin corrosion/irritation?


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Figura 3 (continuing)


No

No

Category 3

Warning

Is the substance or mixture a mild irritant considering criteria in Table 4?

Is the substance or mixture an irritant considering: Existing human experience and data, single or

repeated exposure, Existing animal observations including single or

repeated exposure, In vitro data, Information available from structurally related

compounds, Skin irritation data from an animal study ?

Category 2

Warning

Yes

Yes

No

Not classified


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Figure 4 — Decision logic for acute toxicity skin irritation or corrosion - Classification of mixtures when data are available for components


No

No

Category 3

Warning

Yes

Not classified

Yes

Yes

Yes

Yes

Yes

No

No

No

No

Category 2

Warning

Category 1

Danger

Category 2

Warning

Category 1

Danger


category

Can bridging principles be applied?

Does the mixture contain ≥ 1% of an ingredient 4,5 which is corrosive (see 3.2.1, 3.2.2.2 to 3.2.2.4) and for which the additivity principle may not apply, such as:

Acids and bases with extreme pH ≤ 2 or ≥ 11.5, or Inorganic salts, or Aldehydes, or Phenols, or Surfactants, or Other ingredients?

Does the mixture contain ≥ 3% of an ingredient which is irritant and for which additivity principle may not apply, including acids and bases?

Does the mixture contain one or more corrosive ingredients for which additivity applies and where the sum of concentrations of Ingredient classification Skin Category 1 ≥ 5%?

Does the mixture contain one or more corrosive or irritant ingredients for which additivity applies and where the sum of concentrations of Ingredient classification

Skin Category 1 ≥ 1% but ≤ 5%, or Skin Category 2 ≥ 10%, or (10 × Skin Category 1) + Skin Category 2 ≥ 10%?

Does the mixture contain one or more corrosive or irritant ingredients for which additivity applies, and where the sum of concentrations of Ingredients classification is

Skin Category 2 ≥ 1% but < 10%, or Skin Category 3 ≥ 10%, or (10 × Skin Category 1) + Skin Category 2 ≥ 1% but < 10%, or (10 × Skin Category 1) + Skin Category 2 + Skin Category 3 ≥

10%?


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5.4 Serious eye damage / eye irritation

5.4.1 Classification criteria for ingredients

5.4.1.1 General considerations

Several factors should be considered in determining the serious eye damage or irritation potential of chemicals before testing is undertaken. Accumulated human and animal experience should be the first line of analysis. In some cases, sufficient information may be available on the ingredients of a chemical structure related to the classification of the mixture. Likewise, pH extremes like ≤ 2 and ≥ 11.5 may produce serious eye damage.

Possible skin corrosion has to be evaluated prior to consideration of serious eye damage/eye irritation in order to avoid testing for local effects on eyes with skin corrosive substances. In vitro alternatives that have been validated and accepted may be used to make classification decisions.

The classification criteria for substances and mixtures causing eye damage and eye irritation are shown in Table 7.

Table 7 — Testing and evaluation strategy for serious eye damage and eye irritation for chemicals classification

Step Parameter Findings Conclusions

1a

Data relating to historical human or animal experience

↓

Serious eye damage Category 1

Eye irritant Category 2

No or unknown↓

- -

1b


↓Skin corrosive Category 1

No or unknown↓

- -

1c


↓Skin irritant

No evaluation of effects on eyes; deemed to be Category 2

No or unknown↓

- -

2a

Structure activity relationships / Structure property relationships (SAR/SPR)

↓Severe damage to eyes Category 1

No or unknown- -

2b


↓Eye irritant

No evaluation of effects on eyes; deemed to be Category 2

No or unknown↓

- -

2c


↓ Skin corrosiveNo evaluation of effects on eyes;

deemed to be Category 1No or unknown

↓



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Table 7 (continuing)

Step Parameter Findings Conclusions3a pH/acid or alkaline reserve

↓pH ≥ 11.5 or pH ≤ 2 (considering

acid or alkaline)Category 1

3b 2 < pH < 11.5(no buffering potential)

↓

- -

4 Other information indicating the material is a skin corrosive

↓

Yes No evaluation of effects on eyes; deemed to be Category 1

No↓

5 Is a valid in vitro test available to assess severe damage to eyes

No Go to step 6

5a In vitro test for severe eye irritation↓

Severe damage to eyes Category 1

Not a severe eye irritant↓

6 Is there a valid in vitro test for eye irritation available?

↓

- -

No↓

No, but an in vitro test for severe eye irritancy was negative

Go to step 8

In the absence of any in vitro test Go to step 7Yes

↓- -

6a In vitro eye irritation test?↓

Eye irritant Category 2

No indication of eye irritant properties↓

- -

7 Experimentally assess skin corrosion potential4

Skin corrosive No evaluation of effects on eyes; deemed to be Category 1

Not corrosive↓

- -

8 Eye test in 1 rabbit Severe damage to eyes Category 1No severe eye damage 4 - -

9 Eye test in more than 1 or 2 rabbits Eye irritant Category 2Not an eye irritant Not classified



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5.4.1.2 Eye irritant Category 1 - Irreversible effects on the eye

An eye irritant Category 1 (irreversible effects on the eye) is a test material that produces:

a) at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/or

b) at least in 2 of 3 tested animals, a positive response of

1) corneal opacity ≥ 3 and/or

2) iritis > 1.5

calculated as the mean scores following grading at 24, 48 and 72 hours after application of the test material.

5.4.1.3 Eye irritant Category 2A and 2B - Reversible effects on the eye

An eye irritant Category 2A (eye irritant) is a test material that produces at least in two or three animals, a positive response to:

a) corneal opacity ≥ 1; and/or

b) iris irritation (irite) ≥ 1; and/or

c) conjunctival redness ≥ 2, and/or

d) conjunctival oedema (chemosis) ≥ 2

calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of normally 21 days.

Within this category, an eye irritant is considered mildly irritating to eyes (Category 2B) when the effects listed above are fully reversible within 7 days of observation.


5.4.2.1 Classification of mixtures when data are available for the complete mixture

5.4.2.1.1 The mixture will be classified using the criteria for substances, and taking into account the testing and evaluation strategies used to develop data for these hazard classes.

5.4.2.1.2 Unlike other hazard classes, there are alternative tests available for skin corrosivity of certain types of chemicals that can give an accurate result for classification purposes, as well as being simple and relatively inexpensive to perform. When considering testing of the mixture manufacturers are encouraged to use a tiered weight of evidence strategy as included in the criteria for classification of substances for skin corrosion and serious eye damage and eye irritation to help ensure an accurate classification, as well as avoid unnecessary animal testing.

5.4.2.1.3 A mixture is considered to cause serious eye damage (Eye Category 1) if it has a pH of 2 or less or 11.5 or greater. If consideration of alkali/acid reserve suggests the substance or preparation may not have the potential to cause serious eye damage despite the low or high pH value, then further testing needs to be carried out to confirm this, preferably by use of an appropriate validated in vitro test.



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NOTE Where the mixture itself has not been tested to determine its skin corrosivity or potential to cause serious eye damage or irritation, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data will be used in accordance with the following agreed bridging rules. This ensures that the classification process uses the available data to the greatest extent possible in characterizing the hazards of the mixture without the necessity for additional testing in animals.

5.4.2.2.1 Dilution

If a mixture is diluted with a diluent that has an equivalent or lower classification for serious eye damage/irritancy classification than the least damaging/irritant original ingredient and which is not expected to affect the corrosivity/irritancy of other ingredients, then the new mixture may be classified as equivalent to the original mixture. Alternatively, the method explained in 5.4.2.3 could be applied.

5.4.2.2.2 Batching

The irritation/serious eye damage potential of one production batch of a complex mixture can be assumed equivalent to that of another production batch of the same commercial product and produced by or under the control of the same manufacturer, unless there is reason to believe there is significant variation such that the toxicity of the batch has changed. If the latter occurs, new classification is necessary

5.4.2.2.3 Concentration of mixtures of the highest serious eye damage/ irritation category

If a tested mixture classified in the highest category for serious eye damage is concentrated, a more concentrated mixture should be classified in the highest serious eye damage category without additional testing. If a tested mixture classified in the highest subcategory for skin/eye irritation is concentrated and does not contain serious eye damage ingredients, a more concentrated mixture should be classified in the highest irritation category without additional testing.


For three mixtures with identical ingredients, where A and B are in the same irritation/ serious eye damage toxicity category and mixture C has the same toxicologically active ingredients with concentrations intermediate to the concentrations of those ingredients in mixtures A and B, then mixture C is assumed to be in the same irritation/serious eye damage category as A and B.



a) Two mixtures:

1) A + B;

2) C + B;



d) Classification for A and C for eye irritation or eye lesion are available and are the same.




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5.4.2.2.6 Aerosols

An aerosol form of a mixture may be classified in the same hazard category as the tested non-aerosolized form of mixture provided that the added propellant does not affect the irritation or corrosive properties of the mixture upon spraying. Bridging principles apply for the intrinsic hazard classification of aerosols, however, the need to evaluate the potential for “mechanical” eye damage from the physical force of the spray is recognized.


5.4.2.3.1 In order to make use of all available data for purposes of classifying the eye irritation/serious eye damaging properties of the mixtures, the following assumption has been made and is applied where appropriate in the tiered approach, the relevant ingredients of a mixture are those which are present in concentrations of 1% (w/w for solids, liquids, dusts, mists and vapors and v/v for gases) or greater, unless there is a presumption (e.g. in the case of corrosive ingredients) that an ingredient present at a concentration of less than 1% can still be relevant for classifying the mixture for eye irritation/serious eye damage.

5.4.2.3.2 In general, the approach to classification of mixtures as eye irritant or seriously damaging to the eye when data are available on the components, but not on the mixture as a whole, is based on the theory of additivity, such that each corrosive or irritant component contributes to the overall irritant or corrosive properties of the mixture in proportion to its potency and concentration. A weighting factor of 10 is used for corrosive components when they are present at a concentration below the concentration limit for classification with Category 1, but are at a concentration that will contribute to the classification of the mixture as an irritant. The mixture is classified as seriously damaging to the eye or eye irritant when the sum of the concentrations of such components exceeds a threshold cut-off value/concentration limit.

5.4.2.3.3 Table 8 provides the cut-off value/concentration limits to be used to determine if the mixture should be classified an irritant or a seriously damaging to the eye.

Table 8 — Concentration of ingredients of a mixture classified as skin Category 1 and/or eye Category 1 or 2 that would trigger classification of the mixtures as hazardous to the eye (Category 1 or 2)

Sum of ingredients classifications

Concentration classification of the mixture Irreversible eye

effects - Category 1

Reversible eye effects -

Category 2Eye or Skin Category 1 c ≥ 3 % 1 % ≤ c < 3 %Eye Category 2/2A - c ≥ 10 %10 × Eye Category 1) + Eye Category 2/2A - c ≥ 10 %Skin Category 1 + Eye Category 1 c ≥ 3 % 1 % ≤ c < 3 %10 × (Skin Category 1 + Eye Category 1) + Eye Category 2A/2B - c ≥ 10 %NOTE c is the sum of ingredients concentrations.

5.4.2.3.4 Particular care must be taken when classifying certain types of chemicals such as acids and bases, inorganic salts, aldehydes, phenols, and surfactants. The approach explained in 5.4.2.3.1 and 5.4.2.3.2 might not work given that many of such substances are corrosive or irritant at concentrations < 1%. For mixtures containing strong acids or bases the pH should be used as classification criteria (see 5.4.2.1.3), since pH will be a better indicator of severe eye damage than the concentration limits of Table 8. A mixture containing corrosive or irritant ingredients that cannot be classified based on the additivity approach shown in Table 8, due to chemical characteristics that make this approach unworkable, should be classified as eye Category 1 if it contains ≥ 1% of a corrosive ingredient and as eye Category 2 when it contains ≥ 3% an irritant ingredient. Classification of mixtures with ingredients for which the approach in Table 8 does not apply is summarized in Table 9.



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Table 9 —Concentration of ingredients of a mixture for which the additivity approach does not apply, that would trigger classification of the mixture as hazardous to the eye

Ingredient ConcentrationMixture

classificationAcid with pH < 2 ≥ 1 % Category 1Base with pH > 11.5 ≥ 1 % Category 1Other corrosive (Category 1) ingredients for which additivity does not apply

≥ 1 % Category 1

Other irritant (Category 2) ingredients for which additivity does not apply, including acids and bases

≥ 3 % Category 2

5.4.2.3.5 On occasion, reliable data may show that the reversible/irreversible eye effects of an ingredient will not be evident when present at a level above the generic cut-off values / concentration limits mentioned in Tables 8 and 9. In these cases, the mixture could be classified according to those data (see 4.9). On occasion, when it is expected that the skin corrosion/irritation or the reversible/irreversible eye effects of an ingredient will not be evident when present at a level above the generic concentration/cut-off levels mentioned in Tables 8 and 9, testing of the mixture may be considered. In those cases, the tiered weight of evidence strategy should be applied as referred to in section 5.4.1 and in Table 7.

5.4.2.3.6 If there are data showing that (an) ingredient(s) may be corrosive or irritant at a concentration of < 1% (corrosive) or < 3% (irritant), the mixture should be classified accordingly (see also 4.9). The percentages of ingredients in mixture classifying the mixture in categories 1 and 2 are shown in Tables 8 and 9.


Figures 5 and 6, can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic.



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Figure 5 — Decision logic for serious eye damage and eye irritation


No

No

No

No

Yes

Yes

Yes

Yes



See Figure 6

Category 1

Danger

Does the substance or mixture have potential to cause irreversible eye damage considering: Existing human experience, Existing animal observations including single or


compounds, pH extremes of ≤ 2 or ≥ 11.5, Irreversible eye damage in 1 or more test animals?

(see 5.4.1.1) ?

Mixture: Does the mixture as a whole have data/information to evaluate serious eye damage/eye irritation?

Mixture: Does the mixture as a whole or its ingredients have data/information to evaluate serious eye damage/eye irritation?

Substance: Are there data/information to evaluate serious eye damage/eye irritation?

No

No

Yes

Yes

Category 2A

Category 2B

Warning

Warning

Not classified

Is the substance or mixture a mild irritant Category 2B?

Is the substance or mixture an eye irritant considering: Existing human experience and data, single or

repeated exposure Existing animal observations including single or


compounds, Eye irritation data from an animal study?


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Figure 6 — Decision logic for serious eye damage and eye irritations / Classification of mixtures based on information /data of ingredients


No

Not classified

Yes

Yes

Yes

Yes

Yes

No

No

No

No

Category 2A

Warning

Category1

Danger

Category 2

Warning

Category 1

Danger


category


Does the mixture contain ≥ 1 % of an ingredient which causes irreversible eye damage and for which additivity principle may not apply, such as:

Acids and bases with extreme pH's ≤ 2 or ≥ 11,5, or Inorganic salts, or Aldehydes, or Phenols, or Surfactants, or Other ingredients?

Does the mixture contain ≥ 3% of an ingredient which is irritant and for which additivity principle may not apply, including acids and bases?

Does the mixture contain one or more corrosive or irritant ingredients for which additivity applies, and where the sum of concentrations of ingredients classified as7: Eye or Skin Category 1 ≥ 3% or Skin category 1 + eye category 1 ≥ 3%?

Does the mixture contain one or more corrosive or irritant ingredients for which additivity applies, and where the sum of concentrations of Ingredient classification Eye or Skin Category 1 ≥ 1% but < 3%, or Eye Category 2/2A ≥ 10%, or (10 x Eye Category 1) + Eye Category 2A/2B ≥ 10%, or Skin Category 1 + Eye Category 1 ≥ 1% but < 3%, or 10 x (Skin Category 1 + Eye Category 1) + Eye Category 2A/2B ≥ 10%? ?


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5.5 Respiratory or skin sensitization

5.5.1 Classification criteria for substancesIf there is evidence in humans that the substance can induce respiratory sensitization or if there are positive results from animal tests, these substances shall be classified as respiratory sensitizers (Category 1). Evidence in humans means that the substance can induce specific respiratory hypersensitivity such as asthma, rhinitis, conjunctivitis and alveolitis. The symptom will have the clinical character of an allergic reaction (see GHS Book, subsection 3.4.2).



When reliable and good quality evidence from human experience or appropriate studies in experimental animals, as described in the criteria for substances, is available for the mixture, then the mixture can be classified by weight of evidence evaluation of these data.

5.5.2.2 Classification of mixtures when data are not available for the complete mixture: Bridging Principles

NOTE Where the mixture itself has not been tested to determine its sensitizing properties, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data will be used in accordance with the following agreed bridging rules. This ensures that the classification process uses the available data to the greatest extent possible in characterizing the hazards of the mixture without the necessity for additional testing in animals.

5.5.2.2.1 Dilution

If a mixture is diluted with a diluent which is not a sensitizer and which is not expected to affect the sensitization of other ingredients, then the new mixture may be classified as equivalent to the original mixture.

5.5.2.2.2 Batching

The sensitizing properties of one production batch of a complex mixture can be assumed equivalent to that of another production batch of the same commercial product and produced by or under the control of the same manufacturer, unless there is reason to believe there is significant variation such that the sensitization of the batch has changed. If the latter occurs, new classification is necessary.



a) Two mixtures:

1) A + B;

2) C + B;



d) Ingredient B is a sensitizer and ingredients A and C are not sensitizers;

e) A and C are not expected to affect the sensitizing properties of B.

If mixture (1) is already classified by testing, then mixture (2i) can be assigned the same hazard category.



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5.5.2.2.4 Aerosols

An aerosol form of the mixture may be classified in the same hazard category as the tested non-aerosolized form of the mixture provided that the added propellant does not affect the sensitizing properties of the mixture upon spraying (pulverized, sprinkled over)


The mixture should be classified as a respiratory or skin sensitizer when at least one ingredient has been classified as a respiratory or skin sensitizer and is present at or above the appropriate cutoff value/concentration limit for the specific endpoint as shown in Table 10.

Table 10 — Cut-off values/concentration limits of ingredients of a mixture classified as either skin sensitizers or respiratory sensitizers that would trigger classification of the mixture

Ingredient Classified as:

Cut-off values/concentration limits used for classify the mixture as Category 1

Skin sensitizer Respiratory sensitizerAll physical states Solid/Liquid Gas

Skin sensitizer ≥ 0,1 % - -Respiratory sensitizer - ≥ 0,1 % ≥ 0,1 %

5.5.3 Decision logic Diagram

Figures 7 and 8 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logics.



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Figure 7 — Decision logic classification for respiratory sensitization


No

No

No

Yes

Yes

Yes

Yes



Category 1

Danger

Is there evidence in humans that the substance/mixture can induce specific respiratory hypersensitivity, and/or

are there positive results from an appropriate animal test?

Mixture: Does the mixture as a whole have respiratory sensitization data?

Mixture: Does the mixture as a whole or its ingredients have respiratory sensitization data?

Substance: Does the substance have respiratory sensitization data?

No

No

Yes

Yes


category

Category 1

No

Danger

Notclassified

Does the mixture contain one or more ingredients classified as a respiratory sensitizer ?

Notclassified



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Figure 8 — Decision logic for classification of skin sensitization


No

No

No

Yes

Yes

Yes

Yes



Category 1

Warning

Is there evidence in humans that the substance/mixture can induce sensitization by skin contact in a substantial number of persons, or

are there positive results from an appropriate animal test?

Mixture: Does the mixture as a whole have skin sensitization data?

Mixture: Does the mixture as a whole or its ingredients have skin sensitization data?

Substance: Does the substance have skin sensitization data?

No

No

Yes

Yes


category

Category 1

No

Warning

Not classified

Does the mixture contain one or more ingredients classified as a skin sensitizer?

Not classified



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5.6 Germ cell mutagenicity

5.6.1 Classification criteria

Table 11 has the criteria for classification of substances and mixtures related to their mutagenic potential. Table 12 has the criteria for classification of mixtures according to the concentration of the ingredients in the mixture.

Table 11 —Hazard categories for germ cell mutagens

Category Critérios

1Chemicals known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans

-

1AChemicals known to induce heritable mutations in germ cells of humans

Positive evidence from human epidemiological studies.

1BChemicals which should be regarded as inducing heritable mutations in the germ cells of humans

Positive result(s) from in vivo heritable germ cell mutagenicity tests in mammals; or— Positive result(s) from in vivo somatic cell

mutagenicity tests in mammals, in combination with some evidence that the substance has potential to cause mutations to germ cells. This supporting evidence may, for example, be derived from mutagenicity/genotoxic tests in germ cells in vivo, or by demonstrating the ability of the substance or its metabolite(s) to interact with the genetic material of germ cells; or

— Positive results from tests showing mutagenic effects in the germ cells of humans, without demonstration of transmission to progeny; for example, an increase in the frequency of aneuploidy in sperm cells of exposed people.

2 a Chemicals which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans

Positive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments, obtained from:— Somatic cell mutagenicity tests in vivo,

in mammals; or

— Other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.

a Chemicals which are positive in vitro mammalian mutagenicity assays, and which also show chemical structure activity relationship to known germ cell mutagens, should be considered for classification as Category 2 mutagens.



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Table 12 — The cut-off values/concentration limits in the table above apply to solids and liquids (w/w units) as well as gases (v/v units)

Ingredient classified as: Cut-off/concentration limits Category 1 mutagen

Category 2 mutagen

Category 1 mutagen ≥ 0.1 % -Category 2 mutagen - ≥ 0.1 %NOTE The cut-off values/concentration limits in the table above apply to solids and liquids (w/w units) as well as gases (v/v units).



Classification of mixtures will be based on the available test data for the individual ingredients of the mixture using cut-off values/concentration limits for the ingredients classified as germ cell mutagens. The classification may be modified on a case-by-case basis based on the available test data for the mixture as a whole.

In such cases, the test results for the mixture as a whole must be shown to be conclusive taking into account dose and other factors such as duration, observations and analysis (e.g. statistical analysis, test sensitivity) of germ cell mutagenicity test systems. Adequate documentation supporting the classification should be retained and made available for review upon request.


NOTE Where the mixture itself has not been tested to determine its germ cell mutagenicity hazard, but there are sufficient data on the individual ingredients and similar tested mixtures to characterize the hazards of the mixture, these data will be used in accordance with the following agreed bridging rules. This ensures that the classification process uses the available data to the greatest extent possible in characterizing the hazards of the mixture without the necessity for additional testing in animals.

5.6.2.2.1 Dilution

If a mixture is diluted with a diluent which is not expected to affect the germ cell mutagenicity of other ingredients, then the new mixture may be classified as equivalent to the original mixture.

5.6.2.2.2 Batching

The germ cell mutagenic potential of one production batch of a complex mixture can be assumed equivalent to that of another production batch of the same commercial product produced by and under the control of the same manufacturer unless there is reason to believe there is significant variation in composition such that the germ cell mutagenic potential of the batch has changed. If the latter occurs, a new classification is necessary.



a) Two mixtures:

1) A + B;

2) C + B;



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d) Classification for A and C for toxicity are available and are the same, i.e. they are in the same hazard category and are not expected to affect the mutagenicity of B.



The mixture will be classified as a mutagen when at least one ingredient has been classified as a Category 1 or Category 2 mutagen and is present at or above the appropriate cut-off value/concentration limit as shown in Table 3.5.1 below for Category 1 and 2 respectively.


Figures 9 and 10 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logics.

Figure 9 — Decision logic for classification of mutagenic substances in germ cells


No

No

No

Yes

Yes

Yes

Not classified


Category 2

Warning

According to the criteria, does the substance cause concern for humans owing to the possibility that it may induce heritable mutations in the germ cells of humans? Application of the criteria needs expert judgment in a weight of evidence approach. .

According to the criteria, is the substance: Known to induce heritable mutations in germ cells of

humans, or Should it be regarded as if it induces heritable

mutations in the germ cells of humans?Application of the criteria needs expert judgment in a weight of evidence approach.

Substance: Does the substance have data on mutagenicity?

Category 1

Danger


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Classification modified on a case-by-case basis

Figure 10 — Decision logic for classification of germ cell mutagenicity on mixtures


No

No

No

Yes

Yes

Yes

Not classified

Classification based on individual ingredients of the mixture.

Category 2

Danger

Does the mixture contain one or more ingredients classified as a Category 1 mutagen at concentration ≥ 0.1%?

Does the mixture contain one or more ingredients classified as a Category 2 mutagen at concentration ≥ 1.0 %?

Mixture: Classification of mixtures will be based on the available test data for the individual ingredients of the mixture, using cut-off values/concentration limits for those ingredients. The classification may be modified on a case-by-case basis based on the available test data for the mixture as a whole or based on bridging principles. See Modified classification on a case-by-case basis.

Category 1

Danger

No

Yes


category

No

Yes

Are test data available for the complete mixture?


Are the test results on the mixture conclusive taking into account dose and other factors such as duration, observations and analysis (e.g. statistical analysis, test sensitivity) of germ cell mutagenicity test systems?

Danger or Warning or

No classification

Classification based on the mixture ingredients


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5.7 Carcinogenicity


Carcinogen substances and mixtures should be classified according to the criteria and elements set forth in Tables 13 and 14.

Table 13 — Hazard categories for carcinogens

Category Criteria a

1 Known or presumed human carcinogens The placing of a chemical in Category 1 is done based on epidemiological and/or animal data.

1AKnown to have carcinogenic potential for humans; the placing of a chemical is largely based on human evidence.

-

1BPresumed to have carcinogenic potential for humans; the placing of a chemical is largely based on animal evidence.

Based on strength of evidence together with additional considerations, such evidence may be derived from human studies that establish a causal relationship between human exposure to a chemical and the development of cancer (known human carcinogen). Alternatively, evidence may be derived from animal experiments for which there is sufficient evidence to demonstrate animal carcinogenicity (presumed human carcinogen). In addition, on a case by case basis, scientific judgment may warrant a decision of presumed human carcinogenicity derived from studies showing limited evidence of carcinogenicity in humans together with limited evidence of carcinogenicity in experimental animals. Classification: Category 1 (A and B) Carcinogen

2 Suspected human carcinogens

The placing of a chemical in Category 2 is done based on evidence obtained from human and/or animal studies not sufficiently convincing to place the chemical in Category 1.

Classification: Category 2 carcinogena See GHS book, subsection 3.6.2.

Table 14 — Cut-off values/concentration limits of ingredients of a mixture classified as carcinogen that would trigger classification of the mixture

Ingredient classification Cut-off/concentration limits which trigger mixture classification

Category 1carcinogen

Category 2 carcinogen

Category 1 carcinogen ≥ 0,1 % -

Category 2 carcinogen - ≥ 0,1 %



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Classification of mixtures will be based on the available test data of the individual ingredients of the mixture using cut-off values/concentration limits for those ingredients. The classification may be modified on a case-by case basis based on the available test data for the mixture as a whole.

In such cases, the test results for the mixture as a whole must be shown to be conclusive taking into account dose and other factors such as duration, observations and analysis (e.g. statistical analysis, test sensitivity) of carcinogenicity test systems.


NOTE Where the mixture itself has not been tested to determine its carcinogenic hazard, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data will be used in accordance with the following agreed bridging rules. This ensures that the classification process uses the available data to the greatest extent possible in characterizing the hazards of the mixture without the necessity for additional testing in animals.

5.7.2.2.1 Dilution

If a mixture is diluted with a diluent that is not expected to affect the carcinogenicity of other ingredients, then the new mixture may be classified as equivalent to the original mixture.

5.7.2.2.2 Batching

The carcinogenic potential of one production batch of a complex mixture can be assumed equivalent to that of another production batch of the same commercial product produced by and under the control of the same manufacturer unless there is reason to believe there is significant variation in composition such that the carcinogenic potential of the batch has changed. If the latter occurs, a new classification is necessary.



a) Two mixtures:

1) A + B;

2) C + B;



d) Classification for A and C for toxicity are available and are the same, i.e. they are in the same hazard category and are not expected to affect the carcinogenicity of B.




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The mixture will be classified as a carcinogen when at least one ingredient has been classified as a Category 1 or Category 2 carcinogen and is present at or above the appropriate cut-off value/concentration limit as shown in Table 14, for Category 1 and 2 respectively.


Figures 11 e 12 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logics.

Figure 11 — Decision logic for classification of germ cell mutagenicity on substances


No

Yes

No

Yes

No

Yes


Substance: Does the substance have carcinogenicity data?

Not classified

Category 2

Warning

Category 1

Danger

According to the criteria, is the substance:

Known to have carcinogenic potential for humans, or

Presumed to have carcinogenic potential for humans?

Application of the criteria needs expert judgment in a strength and weight of evidence approach.

According to the criteria, is the substance a suspected human carcinogen?

Application of the criteria needs expert judgment in a strength and weight of evidence approach.


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Figure 12 — Decision logic for classification of carcinogen mixtures


No

No

No

Yes

Yes

Yes

Not classified

Classification based on individual ingredients of the mixture.

Category 2

Warning

Does the mixture contain one or more ingredients classified as a Category 1 carcinogen at: ≥ 0.1 %?

Does the mixture contain one or more ingredients classified as a Category 2 carcinogen at ≥ 0.1 %?

Mixtures

Classification of mixtures will be based on the available test data for the individual ingredients of the mixture, using cut-off values/concentration limits for those ingredients. The classification may be modified on a case-by-case basis based on the available test data for the mixture as a whole or based on bridging principles.

Category 1

Danger

No

Yes


category

No

Yes



Are the test results on the mixture conclusive taking into account dose and other factors such as duration, observations and analysis (e.g. statistical analysis, test sensitivity) of carcinogenicity test systems?

Danger or

Warning or

No classification

Classification based on individual ingredients of the mixture



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5.8 Toxicity to reproduction and lactation

5.8.1 Classification criteria - Effects on reproductivity

Table 15 establishes classification criteria for substances and toxic mixtures to reproduction.

Table15 — Hazard categories for reproductive toxicants

Category Criteria a

1Known or presumed known human reproductive or development toxicant

This category includes substances which are known to have produced an adverse effect on sexual function and fertility or on development in humans or for which there is evidence from animal studies, possibly supplemented with other information, to provide a strong presumption that the substance has the capacity to interfere with reproduction in humans. For regulatory purposes, a substance can be further distinguished on the basis of whether the evidence for classification is primarily from human data (Category 1A) or from animal data (Category 1B).

1AKnown human reproductive or development toxicant

The placing of the substance in this category is largely based on evidence from humans.

1BPresumed human reproductive or development toxicant

The placing of the substance in this category is largely based on evidence from experimental animals. Data from animal studies should provide clear evidence of an adverse effect on sexual function and fertility or on development in the absence of other toxic effects, or if occurring together with other toxic effects the adverse effect on reproduction is considered not to be a secondary non-specific consequence of other toxic effects. However, when there is mechanistic information that raises doubt about the relevance of the effect for humans, classification in Category 2 may be more appropriate.

2Suspect human reproductive or development toxicant

This category includes substances for which there is some evidence from humans or experimental animals, possibly supplemented with other information, of an adverse effect on sexual function and fertility, or on development, in the absence of other toxic effects. If occurring together with other toxic effects, the adverse effect on reproduction is not considered a secondary non-specific consequence of others toxic effects when such evidence is not sufficiently convincing to place the substance in Category 1. For instance, deficiencies in the study may turn the quality of evidence less convincing; considering this, Category 2 could be a more appropriate classification.

a See GHS book, subsection 3.7.2.

5.8.2 Classification categories - Effects on or via lactation Effects on or via lactation are allocated to a separate single category. It is appreciated that for many substances there is no information on the potential to cause adverse effects on the offspring via lactation. However, substances which are absorbed by women and have been shown to interfere with lactation, or which may be present (including metabolites) in breast milk in amounts sufficient to cause concern for the health of a breastfed child, should be classified to indicate this property hazardous to breastfed babies. This classification can be assigned on the basis of:

— studies of absorption, metabolism, distribution and excretion indicating the likelihood of the substance to be present in potentially toxic levels in breast milk; and/or

— results of one or two generation studies in animals providing clear evidence of adverse effect in the offspring due to transfer in the milk or adverse effect on the quality of the milk; and/or

— human evidence indicating a hazard to babies during the lactation period.



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Classification of mixtures will be based on the available test data of the individual constituents of the mixture using cut-off values/concentration limits for the components of the mixture. The classification may be modified on a case-by case basis based on the available test data for the mixture as a whole.

In such cases, the test results for the mixture as a whole must be shown to be conclusive taking into account dose and other factors such as duration, observations and analysis (e.g. statistical analysis, test sensitivity) of reproduction test systems. Adequate documentation supporting the classification should be retained and made available for review upon request.


NOTE Where the mixture itself has not been tested to determine its reproductive toxicity, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data will be used in accordance with the following agreed bridging rules. This ensures that the classification process uses the available data to the greatest extent possible in characterizing the hazards of the mixture without the necessity for additional testing in animals.

5.8.3.2.1 Dilution

If a mixture is diluted with a diluent which is not expected to affect the reproductive toxicity of other ingredients, then the new mixture may be classified as equivalent to the original mixture.

5.8.3.2.2 Batching

The reproductive toxicity potential of one production batch of a complex mixture can be assumed to be substantially equivalent to that of another production batch of the same commercial product produced by and under the control of the same manufacturer unless there is reason to believe there is significant variation in composition such that the reproductive toxicity potential of the batch has changed. If the latter occurs, a new classification is necessary.



a) Two mixtures:

1) A + B;

2) C + B;



d) Classification for A and C for toxicity are available and are the same, i.e. they are in the same hazard category and are not expected to affect the toxicity to reproduction of B.




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The mixture will be classified as a reproductive toxicant when at least one ingredient has been classified as a Category 1 or Category 2 reproductive toxicant and is present at or above the appropriate cut-off value/concentration limit as shown in Table 16 for Category 1 and 2, respectively.

Table 16 — Cut-off values/concentration limits of ingredients of a mixture classified as toxicant to reproduction which trigger the classification

Ingredient classification

Cut-off/concentration limits Category 1

reproductive toxicant

Category 2 reproductive

toxicant

Additional category for

effects on or via lactation

Category 1 reproductive toxicant

≥ 0,1 % - -

Category 2 reproductive toxicant

- ≥ 0,1 % -

Additional category for effects on or via lactation

- - ≥ 0,1 %

5.8.4 Decision logic DiagramsFigures 13, 14, and 15 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic.



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Figure 13 — Decision logic for classification of substances and mixtures as to their toxic effect on reproduction


No

Yes

No

Yes

No

Yes


Substance: Does the substance have data on reproductive toxicity?

Not classified

Category 2

Warning

Category 1

Danger

According to the criteria, is the substance:

a known toxicant to reproduction or development of human beings; or

a presumed toxicant to aptitude, reproduction capability, or development of human beings?

Application of the criteria needs expert judgment in a weight of evidence approach.

According to criteria is the substance a suspect toxicant to produce adverse effects on sexual function, fertility, or development of human beings? Application of the criteria needs expert judgment in a weight of evidence approach.


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Figure 14 — Decision logic for mixtures


No

No

No

Yes

Yes

Yes

Not classified

Classification based on individual ingredients of the

mixture

Category 2

Warning

Does the mixture contain one or more ingredients classified as a Category 1 reproductive toxicant at a concentration ≥ 0,1 %?

Does the mixture contain one or more ingredients classified as a Category 2 reproductive toxicant at a concentration ≥ 1.0 %?

Mixtures


Category 1

Danger

No

Yes


category

No

Yes



Are the test results on the mixture conclusive taking into account dose and other factors such as duration, observations and analysis (e.g. statistical analysis, test sensitivity) of reproduction test systems?

Danger or

Warning or

No classification




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Figure 15 — Decision logic for classification of substances and mixtures of effects on or via lactation


No

No

Not classified

Yes

Yes

Yes

Not classified

Classification based on individual ingredients of the

mixture.


Does the mixture contain one or more ingredients classified as Category 1 for effects on or via lactation at a concentration ≥ 0,1 %?

Are the test results on the mixture conclusive taking into account dose and other factors such as duration, observations and analysis (e.g. statistical analysis, test sensitivity) of reproduction test systems?

Mixtures


Additional category for


or

No classification

No

YesDoes the substance according to the criteria cause concern for the health of breastfed? children ?

No

No




Yes

Modified classification on a case-by-case basis



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5.9 Specific target organ systemic toxicity single exposure

5.9.1 Classification categories

Substances should be classified according to Table 17 criteria.

Table 17 — Categories for specific target organ systemic toxicity - single exposure

Categoria Critérios

1

Substances that have produced significant toxicity in humans, or that, on the basis of evidence from studies in experimental animals can be presumed to have the potential to produce significant toxicity in humans following single exposure

Placing a substance in Category 1 is done on the basis of: reliable and good quality evidence from human cases or

epidemiological studies; or. observations from appropriate studies in experimental

animals in which significant and/or severe toxic effects of relevance to human health were produced at generally low exposure concentrations. Guidance dose/concentration values are provided below to be used as part of weight-of-evidence evaluation.

2

Substances that, on the basis of evidence from studies in experimental animals can be presumed to have the potential to be harmful to human health following single exposure

Placing a substance in Category 2 is done on the basis of observations from appropriate studies in experimental animals in which significant toxic effects, of relevance to human health, were produced at generally moderate exposure concentrations. Guidance dose/concentration values are provided below in order to help in classification. In exceptional cases, human evidence can also be used to place a substance in Category 2.

3There are target organ effects for which a substance/mixture may not meet the criteria to be classified in Categories 1 or 2 indicated above. These are effects which adversely alter human function for a short duration after exposure. This category only includes narcotic effects and respiratory tract irritation.

For these categories, the specific target organ/system that has been primarily affected by the classified substance may be identified, or the substance may be identified as a general systemic toxicant. Attempts should be made to determine the primary target organ of toxicity and classify for that purpose, e.g. hepatoxicants, neurotoxicants. One should carefully evaluate the data and, where possible, not include secondary effects, e.g. a hepatotoxicant can produce secondary effects in the nervous or gastro-intestinal systems.NOTE In exceptional cases, evidence in human beings may also being used to include a substance in Category 2.

Table 18 shows results from experimental test using animals that are reference values to subsidize the classification on categories 1 and 2.

Table 18 — Guidance value ranges for single-dose exposures

Exposure routeGuidance value ranges a

Category 1 Category 2 Category 3

Oral (rat)mg/kg bodyweight

c ≤ 300 2 000 ≥ c > 300

Guidance values do not

apply

Dermal (rat or rabbit)mg/kg peso corpóreo

c ≤ 1 000 2 000 ≥ c > 1 000

Inhalation (rat) gasµL/L (ppm)

c ≤ 2 500 5 000 ≥ c > 2 500

Inhalation (rat) vapormg/L

c ≤10 20 > c > 10

Inhalation (rat) dust/mist/fumemg/L/4 h

c ≤ 1.0 5.0 ≥ c > 1.0

a See GHS book sub-section 3.8.2. NOTE c is dosage or concentration.



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When reliable and good quality evidence from human experience or appropriate studies in experimental animals, as described in the criteria for substances, is available for the mixture, then the mixture can be classified by weight of evidence evaluation of this data. Care should be exercised in evaluating data on mixtures, that the dose, duration, observation or analysis, do not render the results inconclusive.


NOTE Where the mixture itself has not been tested to determine its specific target organ/systemic toxicity, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data can be used in accordance with the following bridging principles. This ensures that the classification process uses the available data to the greatest extent possible in characterizing the hazards of the mixture without the necessity of additional testing in animals.

5.9.2.2.1 Dilution

If a mixture is diluted with a substance that has an equivalent or lower toxicity classification than the least toxic original ingredient, and which is not expected to affect the toxicity of other ingredients, then the new mixture may be classified as equivalent to the original mixture.

5.9.2.2.2 Batching


5.9.2.2.3 Concentration of highly toxic mixtures

If a mixture is classified in Category 1, and the concentration of the ingredients of the mixture that are in Category 1 is increased, the new mixture should be classified in Category 1 without additional testing.


If mixtures A and B are in the same classification category and mixture C is made in which the toxicologically active components have concentrations intermediate to those in mixtures A and B, then mixture C is assumed to be in the same category as A and B.



a) Two mixtures:

1) A + B;

2) C + B;





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Then there is no need to test mixture (2) if mixture (1) is already characterized by testing and both mixtures would be classified in the same danger category.

5.9.2.2.6 Aerosols

An aerosol form of a mixture may be classified in the same hazard category as the tested, non-aerosolized form of the mixture for oral and dermal toxicity provided the added propellant does not affect the toxicity of the mixture on spraying. Classification of aerosolized mixtures for inhalation toxicity should be considered separately.


Where there is no reliable evidence or test data for the specific mixture itself, and the bridging principles cannot be used to enable classification, then classification of the mixture is based on the classification of the ingredient substances. In this case, the mixture will be classified as a specific target organ/systemic toxicant (specific organ specified), following single exposure, repeated exposure, or both when at least one ingredient has been classified as a Category 1 or Category 2 specific target organ/systemic toxicant and is present at or above the appropriate cut-off value/concentration limit as mentioned in Table 19 for Category 1 and 2 respectively.

Table 19 — Cut-off values/concentration limits of ingredients of a mixture classified as toxicant to reproduction which trigger the classification

Ingredient classificationCut-off/concentration limits

Category 1 Category 2Category 1Specific target organ toxicant

≥ 1,0 % -

Category 2Specific target organ toxicant

- ≥ 1,0 %


Figures 16 e 17 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic.



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Figure 16 — Decision logic for classification of target organ systemic toxicity from single exposure


No

No

No

No

Yes

Yes

Yes

Yes



See Figure 17

Category 1

Danger

Following single exposure: Can the substance or mixture produce significant toxicity in

humans, or Can it be presumed to have the potential to produce

significant toxicity in humans on the basis of evidence from studies in experimental animals?

See Table 19 for criteria and guidance values. Application of the criteria needs expert judgment in a weight of evidence approach.

Mixture: Does the mixture as a whole have data/information to evaluate specific target organ systemic toxicity following single exposure?

Mixture: Does the mixture as a whole or its ingredients have data/information to evaluate specific target organ systemic toxicity following single exposure?

Substance: Does the substance have data and/or information to evaluate specific target organ systemic toxicity following single exposure?

No

No

Yes

Yes

Category 2

Category 3

Warning

Warning


Following single exposure, can the substance or mixture produce narcotic effects or respiratory tract irritation?See Table 19 for criteria. Application of the criteria needs expert judgment in a weight of evidence approach.

Following single exposure, can the substance or mixture, be presumed to have the potential to be harmful to human health on the basis of evidence from studies in experimental animals?

See Table 19 for criteria and guidance values. Application of the criteria needs expert judgment in a weight of evidence approach.


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Figure 17 — Decision logic for classification of target organ systemic toxicity from single exposure - Classification of mixtures based on ingredients information


Warning

No

Yes

Yes

Not classified

Does the mixture contain one or more ingredients classified as a Category 1 specific target organ systemic toxicant at a concentration ≥ 1,0 %?See Table 19 for explanation of cut-off values/concentration limits.


category No

Can bridging principles be applied? Yes

No

Danger

Category 2

Category 1



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5.10 Specific target organ systemic toxicity repeated exposure


Substances and mixtures should be classified according to Table 20 criteria.

Table 20 — Categories for specific target organ systemic toxicity - repeated exposure

Categoria a Critérios

1

Substances that have produced significant toxicity in humans, or that, on thebasis of evidence from studies in experimental animals can be presumed tohave the potential to produce significant toxicity in humans following repeatedexposure

Placing a substance in category1 is based on:

reliable and good quality evidence from human cases or epidemiological studies; or

observations from appropriate studies in experimental animals in which significant and/or severe toxic effects of relevance to human health were produced at generally low exposure concentrations. Guidance dose/concentration values are provided below (see Table 21) to be used as part of weight-of-evidence evaluation.

2

Substances that, on the basis of evidence from studies in experimental animals can be presumed to have the potential to be harmful to human health following repeated exposure

Placing a substance in Category 2 is done on the basis of observations from appropriate studies in experimental animals in which significant toxic effects, of relevance to human health, were produced at generally moderate exposure concentrations. Guidance dose/concentration values are provided below (see Table 22) in order to help in classification. In exceptional cases human evidence can also be used to place a substance in Category 2.

a For both categories the specific target organ/system that has been primarily affected by the classified substance may be identified, or the substance may be identified as a general systemic toxicant. Attempts should be made to determine the primary target organ of toxicity and classify for that purpose, e.g. hepatoxicants, neurotoxicants. One should carefully evaluate the data and, where possible, not include secondary effects, e.g. a hepatotoxicant can produce secondary effects in the nervous or gastrointestinal systems. See GHS book, sub-section 3.9.2.

Tables 21 and 22 show guidance values to facilitate the classification of a substance or mixture on categories 1 or 2.



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Table 21 — Guidance values to assist in Category 1 classification

Route of exposureGuidance values

(dose/concentration)Oral (rats)mg/kg bodyweight/day

10

Dermal (rat or rabbit)mg/kg bodyweight/day

20

Inhalation (rat) gasµL/L (ppm)/6 h/day

50

Inhalation (rat) vapormg/L/6 h/day

0.2

Inhalation (rat) dust/mist/fume (rats)mg/L/6 h/day

0.02

Table 22 — Guidance values to assist in Category 2 classification

Route of exposure Guidance Value Ranges a

Oral (rats)mg/kg bodyweight/day

10 ≤ c < 100

Dermal (rat or rabbit)mg/kg bodyweight/day

20 ≤ c < 200

Inhalation (rat) gasµL/L (ppm)/6 h/day

50 ≤ c < 250

Inhalation (rat) vapormg/L/6 h/day

0.2 ≤ c < 1.0

Inhalation (rat) dust/mist/fume (rats)mg/L/6 h/day

0.02 ≤ c < 0.2

a Guidance proposed values are referred to toxic effects observed in a 90-day standard toxicity studies with rats.NOTE c is the concentration of ingredients/substances



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When reliable and good quality evidence from human experience or appropriate studies in experimental animals, as described in the criteria for substances, is available for the mixture, then the mixture can be classified by weight of evidence evaluation of these data. Care should be exercised in evaluating data on mixtures that the dose used does not render the results inconclusive.


NOTE Where the mixture itself has not been tested to determine its specific target organ/systemic toxicity, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data will be used in accordance with the following agreed bridging rules. This ensures that the classification process uses the available data to the greatest extent possible in characterizing the hazards of the mixture without the necessity for additional testing in animals.

5.10.2.2.1 Dilution

If a mixture is diluted with a substance that has an equivalent or lower toxicity classification than the least toxic original ingredient, and which is not expected to affect the toxicity of other ingredients, then the new mixture may be classified as equivalent to the original mixture.

5.10.2.2.2 Baching


5.10.2.2.3 Concentration of highly toxic mixtures

If a mixture is classified in Category 1, and the concentration of one of the toxic ingredients of the mixture that are in Category 1 within one category




a) Two mixtures:

1) A + B;

2) C + B;





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5.10.2.2.6 Aerosols

An aerosol form of a mixture may be classified in the same hazard category as the tested, non-aerosolized form of the mixture for oral and dermal toxicity provided the added propellant does not affect the toxicity of the mixture on spraying. Classification of aerosolized mixtures for inhalation toxicity should be considered separately


Where there is no reliable evidence or test data for the specific mixture itself, and the bridging principles cannot be used to enable classification, then classification of the mixture is based on the classification of the ingredient substances. In this case, the mixture will be classified as a specific target organ/systemic toxicant (specific organ specified), following single exposure, repeated exposure, or both when at least one ingredient has been classified as a Category 1 or Category 2 specific target organ/systemic toxicant and is present at or above the appropriate cut-off value/concentration limit as mentioned in Table 23 for Category 1 and 2 respectively.

Table 23 shows the ingredient concentrations in a mixture that triggers its classification in hazard categories.

Table 23 — Cut-off values/concentration limits of ingredients of a mixture classified as specific target organ/systemic toxicant that trigger the classification

Ingredient classificationCut-off/concentration limits

Category 1 Category 2Category 1Specific target organ systemic toxicant

≥ 1,0 % -

Category 2Specific target organ systemic toxicant

- ≥ 1,0 %


Figures 18 e 19 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic.



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Figure 18 — Decision logic for classification of target organ systemic toxicity from repeated exposure


No

No

No

No

Yes

Yes

Yes

Yes



See Figure 19

Category 1

Danger

Following repeated exposure, Can the substance or mixture produce

significant toxicity in humans, or Can it be presumed to have the potential to

produce significant toxicity in humans on the basis of evidence from studies in experimental animals?

Check criteria and guidance values. Application of the criteria needs expert judgment in a weight of evidence approach.

Mixture: Does the mixture as a whole have data/information to evaluate specific target organ systemic toxicity following repeated exposure?

Mixture: Does the mixture as a whole or its ingredients have data/information to evaluate specific target organ systemic toxicity following repeated exposure?

Substance: Does the substance have data and/or information to evaluate specific target organ systemic toxicity following repeated exposure?

No

Yes

Not classified

Categoria 2

Warning

Following repeated exposure, can the substance or mixture be presumed, to have the potential on the basis of evidence from studies in experimental animals, to be harmful to human health? Check criteria and guidance values. Application of the criteria needs expert judgment in a weight of evidence approach.


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Figure 19 — Decision logic for classification of target organ systemic toxicity from single exposure - Classification of mixtures based on ingredients information


Warning

No

Yes

Yes

Not classified



categoryNo


No

Danger

Category 2

Category 1



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5.11 Aspiration hazard


Aspiration toxicity includes severe acute effects such as chemical pneumonia, varying degrees of pulmonary injury or death following aspiration.

Table 24 has the criteria parameters for classification of toxicity aspiration hazards .

Table 24 — Hazard categories for aspiration toxicity

Categories Criteria

1Chemicals known to cause human aspiration toxicity hazards or to be regarded as if they cause human aspiration toxicity hazard

A substance is classified in Category 1 based on reliable and good quality human evidence (a) or, if it is a hydrocarbon and has a kinematic viscosity of 20.5 mm2/s or less, measured at 40° C.

2Chemicals that probably cause human aspiration toxicity hazard.

A substance is classify in Category 2 on the basis of existing animal studies and expert judgment that takes into account surface tension, water solubility, boiling point, and volatility, substances, other than those classified in Category 1, which have a kinematic viscosity of 14 mm2/s or less, measured at 40º C

a Examples of substances included in Category 1 are certain hydrocarbons, turpentine and pine oil.



A mixture is classified in Category 1 based on reliable human evidence.


NOTE Where the mixture itself has not been tested to determine its aspiration toxicity, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterize the hazard of the mixture, these data will be used in accordance with the following bridging principles. This ensures that the classification process uses the available data to the greatest extent possible in characterizing the hazards of the mixture without the necessity of additional testing in animals.

5.11.2.2.1 Dilution

If a mixture is diluted with a substance that does not pose an aspiration toxicity hazard, and which is not expected to affect the aspiration toxicity of other ingredients or the mixture, then the new mixture may be classified as equivalent to the original mixture. However, the concentration of aspiration toxicant(s) should not drop below 10%.

5.11.2.2.2 Batching

The aspiration toxicity of one production batch of a complex mixture can be assumed equivalent to that of another production batch of the same commercial product, and produced by or under the control of the same manufacturer, unless there is reason to believe there is significant variation such that the aspiration toxicity, reflected by viscosity or concentration, of the batch has changed. If the latter occurs, new classification is necessary.



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5.11.2.2.3 Concentration of Category 1 mixtures

If a mixture is classified in Category 1, and the concentration of one of the toxic ingredients of the mixture that are in Category 1 is increased, the new mixture should be classified in Category 1 without additional testing.

5.11.2.2.4 Interpolation within one category




a) Two mixtures:

1) A + B;

2) C + B;



d) Aspiration toxicity for A and C is equivalent, i.e. they are in the same hazard category and are not expected to affect the aspiration toxicity of B.

If mixture (1) is already classified by testing, then mixture (2) can be assigned the same hazard category.

5.11.2.2.6 Classification of mixtures when data are available for all components or only for some components of the mixture

5.11.2.2.6.1 Category 1

A mixture that contains a total of 10% or more of a substance or substances classified in Category 1, and has a kinematic viscosity of 20.5 mm2/s or less, measured at 40 °C, will be classified in Category 1.

In the case of a mixture that separates into two or more distinct layers, one of which contains 10 %, more of a substance or substances classified in Category 1 and has a kinematic viscosity of 20.5 mm2/s, or less, measured at 40 °C, then the entire mixture is classified in Category 1.

5.11.2.2.6.2 Category 2

A mixture that contains a total of 10% or more of a substance or substances classified in Category 2, and has a kinematic viscosity of 14.0 mm2/s or less, measured at 40 °C, will be classified in Category 2.

In classifying mixtures in this category, the use of expert judgment that considers surface tension, water solubility, boiling point, volatility is critical and especially when Category 2 substances are mixed with water.

In the case of a mixture that separates into two or more distinct layers, one of which contains 10 %, more of a substance or substances classified in Category 2 and has a kinematic viscosity of 14.0 mm2/s, or less, measured at 40 °C, then the entire mixture is classified in Category 2.



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5.11.3 Decision logic diagrams

Figures 20 and 21 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic.

Figure 20 — Decision Logic Diagram for classification of aspiration toxicity


No

No

No

No

Yes

Yes

Yes

Yes



See Figure 21

Category 1

Danger

Is there practical experience in humans from reliable and good quality evidence, for example, certain hydrocarbons, turpentine and pine oil, or is the substance a hydrocarbon with a kinematic viscosity of 20.5 mm2/s or less measured at 40 °C?

Mixture: Does the mixture as a whole show aspiration toxicity based on practical experience in humans from reliable and good quality evidence?

Mixture: Does the mixture as a whole or its ingredients have aspiration toxicity data?

Substance: Does the substance have aspiration toxicity data?

No

Yes

Not classified

Category 2

Warning

Is there evidence-causing concern based on animal studies and expert judgment, and does the substance have a kinematic viscosity of 14 mm2/s or less, measured at 40 °C?


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Figure 21 — Decision Logic Diagram for classification of aspiration toxicity - Classification of mixtures based on the ingredients information

6 Hazardous to the aquatic environment


The hazards of pure substances and mixtures due to their toxic properties to the environment should be evaluated through the ecotoxicological properties of the substances and mixtures undergoing classification (see Annex A).

Whenever the formula of the mixture is modified with a variation in mass or volume, a new evaluation and hazard classification should be performed. This new evaluation will apply unless there is valid scientific justification for considering that a re-evaluation of the hazard will not result in a change of classification.

Experimental data already generated for substances and mixtures previously classified by other existing systems should be accepted when applied to the classification of these chemicals in GHS, thereby avoiding duplicative testing and unnecessary use of laboratory animals.

6.2 Classification criteria for substances

The harmonized classification system for substances consists of three acute classification categories and four chronic classification categories. The acute and the chronic classification categories are applied independently. The criteria for classification of a substance in acute categories 1 to 3 are defined based on the acute toxicity data only (EC50 or LC50).


Danger

No

Yes

Yes

Not classified

Does the mixture contain 10% or more of a substance or substances classified in Category 1 and have a kinematic viscosity of 20.5 mm2/s or less measured at 40 °C?


category No


No

Danger

Category 2

Category 1

Does the mixture contain 10% or more of a substance or substances classified in Category 2 and have a kinematic viscosity of 14 mm2/s or less measured at 40 °C?


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The criteria for classification of a substance into chronic categories combine two types of information, i.e. acute toxicity data and environmental fate data (degradability and bioaccumulation data). For assignment of mixtures to chronic categories, degradation and bioaccumulation properties are derived from tests on components.

Substances are classified according to the criteria of Table 25 for acute and toxic toxicity to the aquatic environment.

Table 25 — Categories for substances hazardous to the aquatic environment

Category Acute and chronic toxicity in mg/L

Acute toxicity

196 hr LC50 (for fish) c ≤ 1EC50 (for crustacea) c ≤ 172 or 96hr ErC50 (for algae or other aquatic plants) c ≤ 1

296 hr LC50 (for fish) 1 < c ≤ 10EC50 (for crustacea) 1 < c ≤ 1072 or 96hr ErC50 (for algae or other aquatic plants) 1 < c ≤ 10

396 hr LC50 (for fish) 10 < c ≤ 100EC50 (for crustacea) 10 < c ≤ 10072 or 96hr ErC50 (for algae or other aquatic plants) 10 < c ≤ 100

Chronic toxicity

1a96 hr LC50 (for fish) c ≤ 1EC50 (for crustacea) c ≤ 172 or 96hr ErC50 (for algae or other aquatic plants) c ≤ 1

2b96 hr LC50 (for fish) 1 < c ≤ 10EC50 (for crustacea) 1 < c ≤ 1072 or 96hr ErC50 (for algae or other aquatic plants) 1 < c ≤ 10

3b96 hr LC50 (for fish) 10 < c ≤ 100EC50 (for crustacea) 10 < c ≤ 10072 or 96hr ErC50 (for algae or other aquatic plants) 10 < c ≤ 100

4

Poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility, and which are not rapidly degradable and have a log Kow ≥ 4, indicating a potential to bioaccumulate, will be classified in this category unless other scientific evidence exists showing classification to be unnecessary. Such evidence would include an experimentally determined BCF < 500, or a chronic toxicity NOECs (non observed effect concentration) > 1 mg/l, or evidence of rapid degradation in the environment.

a If the substance is not rapidly degradable and/or if log10Kow ≥ 4. Do not consider log 10 Kow if value of BFC < 500 obtained from laboratory experiments.b If the substance is not rapidly degradable and/or if log10Kow ≥ 4 (do not consider log 10 Kow if value of BFC < 500 obtained from laboratory experiments), unless the chronic toxicity NOEC is > 1 mg/l.NOTE c means LC50 or ECr50 or EC50.

NOTE The classification of mixtures based on the principles of additivity and in the summation method of ingredients is detailed presented in GHS.



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6.3 Classification criteria for mixtures

6.3.1 Flow diagram for classification

The classification system for mixtures covers all classification categories which are used for substances meaning Acute Categories I to III and Chronic Categories I to IV.

In order to make use of all available data for purposes of classifying the aquatic environmental hazards of the mixture, the following assumption has been made and is applied where appropriate.

The relevant components of a mixture are those which are present in a concentration of 1% (weight/weight) or greater, unless there is a presumption (e.g. in the case of highly toxic components) that a component present at less than 1% can still be relevant for classifying the mixture for aquatic environmental hazards.

The approach for classification of aquatic environmental hazards depends upon the type of information available for the mixture itself and for its components. The approach elements include:

a) Classification based on tested mixtures;

b) Classification based on bridging principles;

c) The use of summation of classified components and /or an additivity formula. Figure 22 outlines the process to be followed.

Aquatic environment toxicity test data available on the mixture

Figure 22 — Flow diagram for classification of mixtures for acute and chronic aquatic environmental hazards


Yes

No

Classify for acute/chronic toxicity hazard (see 6.3.2)

Yes

Yes

Yes

No

No

No

Classify for acute/chronic toxicity hazard



Apply bridging principle (see 6.3.3)

Apply Summation Method and/or Additive Formula (see 6.3.4)

Sufficient data available on similar mixtures to estimate

Apply bridging principle (see 6.3.3)

Aquatic environment toxicity test data available on the mixture

Classification data available for toxicity in water for all relevant components

Use available hazard data of known components

See 6.3.9


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6.3.2 Classification of mixtures when data are available for toxicity of aquatic organisms

When the mixture as a whole has been tested to determine its aquatic toxicity, it can be classified according to the criteria that have been agreed for substances, but only for acute toxicity. The classification should be based on the data for fish, crustacea and algae/plants. Classification of mixtures by using LC50 or EC50 data for the mixture as a whole is not possible for chronic categories since both toxicity data and environmental fate data are needed, and there are no degradability and bioaccumulation data for mixtures as a whole. It is not possible to apply the criteria for chronic classification because the data from degradability and bio-accumulation tests of mixtures cannot be interpreted; they are meaningful only for single substances.

When there is acute toxicity test data (LC50 or EC50) available for the mixture as a whole, this data as well as information with respect to the classification of components for chronic toxicity should be used to complete the classification for tested mixtures as follows. When chronic (long-term) toxicity data (NOEC) is also available, this should be used as follows:

a) LC50 or EC50 of the tested mixture ≤ 100mg/l and NOEC of the tested mixture ≤ 1.0 mg/l or unknown:

1) Classify mixture as Category Acute 1, 2 or 3;

2) Apply Summation of Classified Components approach (see items that follows) for chronic classification (Chronic 1, 2, 3, 4 or no need of chronic classification);

b) LC50 or EC50 of the tested mixture ≤ 100 mg/L and NOEC of the tested mixture > 1,0 mg/L:

1) Classify mixture as Category Acute 1, 2 or 3;

2) Apply Summation of Classified Components approach for Chronic classification 1 (If mixture is not classified as Category Chronic 1 there is no need for chronic classification);

c) CLC50 or EC50 of the tested mixture >100mg/L, or above the water solubility, and NOEC of the tested mixture ≤ 1.0mg/L or unknown:

1) No need to classify for acute toxicity hazard.

2) Apply Summation of Classified Components approach for Chronic classification (Category Chronic 4 or no need for chronic classification);

d) LC50 or EC50 of the tested mixture >100mg/L, or above the water solubility, and NOEC of the tested mixture > 1.0mg/L, no need for either chronic or acute toxicity classification.

6.3.3 Classification of mixtures when aquatic data assays are not available for the mixture: Bridging principles

NOTE Where the mixture itself has not been tested to determine its aquatic environmental hazard, but there are sufficient data on the individual components and similar tested mixtures to adequately characterize the hazards of the mixture, this data will be used in accordance with the following agreed bridging rules. This ensures that the classification process uses the available data to the greatest extent possible in characterizing the hazards of the mixture without the necessity for additional testing in animals.

6.3.3.1 Dilution

If a mixture is formed by diluting another classified mixture or a substance with a diluent which has an equivalent or lower aquatic hazard classification than the least toxic original component and which is not expected to affect the aquatic hazards of other components, then the new mixture may be classified as equivalent to the original mixture.



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6.3.3.2 Batching

The aquatic hazard classification of one production batch of a complex mixture can be assumed equivalent to that of another production batch of the same commercial product and produced by or under the control of the same manufacturer, unless there is reason to believe there is significant variation such that the aquatic hazard classification of the batch has changed. If the latter occurs, new classification is necessary.

6.3.3.3 Concentration of mixtures which are classified with the most severe classification categories (Chronic 1 and/or Acute 1)

If a mixture is classified as Chronic 1 and/or Acute 1, and components of the mixture which are classified as Chronic 1 and/or Acute 1 are further concentrated, the more concentrated mixture should be classified with the same classification category as the original mixture without additional testing.

6.3.3.4 Interpolation within one toxicity category


6.3.3.5 Substantially similar mixtures


a) Two mixtures::

1) A + B;

2) C + B;



d) Classification for A and C are available and are the same, i.e. they are in the same hazard category and are not expected to affect the aquatic toxicity of B.


6.3.4 Classification of mixtures when data are available for all components or only for some components of the mixture The classification of a mixture is based on summation of the classification of its components. In this case, apply the Summation Method or the Additive Formula as advised in GHS book.

6.3.5 Classification procedure

In general, a more severe classification for mixtures overrides a less severe classification. For instance, a classification with Chronic 1 overrides a classification with Chronic 2. Consequently, the classification procedure is already completed if the result of the classification is Chronic 1. A more severe classification than Chronic 1 is not possible, therefore, it is not necessary to undergo the further classification procedure.



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6.3.6 Classification for the Acute Categories 1, 2 and 3

First, all components classified as Acute 1 are considered. If the sum of these components is greater than 25% the whole mixture is classified as Category Acute 1. If the result of the calculation is a classification of the mixture as Category Acute 1, the classification process is completed.

In cases where the mixture is not classified as Acute 1, classification of the mixture as Acute 2 is considered. If the result of the calculation is classification of the mixture as Category Acute 2, the classification process is completed. If the result of the calculation is classification of the mixture as Category Acute 2, the classification process is completed.

In cases where the mixture is not classified either as Acute 1 or as Acute 2, classification of the mixture as Acute 3 is considered. A mixture is classified as Acute 3 if 100 times the sum of all components classified as Acute 1, plus 10 times the sum of all components classified as Acute 2, plus the sum of all components classified as Acute 3 is greater than 25%.

The classification of mixtures for acute hazards based on this summation of classified components, is summarized in Table 26.

Table 26 — Classification of a mixture for acute hazards, based on summation of classified components

Sum of components classified as: Mixture is classified as:

Acute 1 x M a > 25 % Acute 1(M x 10 x acute 1) + acute 2 > 25 % Acute 2(M x 100 x acute 1) + (10 x acute 2) + acute 3 > 25 % Acute 3a M is a multiplier factor to the base 10 (see 6.3.8) (see 6.3.8).

6.3.7 Classification for the Chronic Categories 1, 2, 3 and 4

First, all components classified as Chronic 1 are considered. If the sum of these components is greater than 25%, the whole mixture is classified as Category Chronic 1. If the result of the calculation is a classification of the mixture as Category Chronic 1, the classification process is completed.

In cases where the mixture is not classified as Chronic 1, classification of the mixture as Chronic 2 is considered. A mixture is classified as Chronic 2 if ten times the sum of all components classified as Chronic 1, plus the sum of all components classified as Chronic 2, is greater than 25%. If the result of the calculation is classification of the mixture as Category Chronic 2, the classification process is completed.

In cases where the mixture is not classified as either Chronic 1 or Chronic 2, classification of the mixture as Chronic 3 is considered. A mixture is classified as Chronic 3 if 100 times the sum of all components classified as Chronic 1 plus 10 times the sum of all components classified with Chronic 2 plus the sum of all components classified as Chronic 3 is greater than 25%.

The classification of mixtures for chronic hazards, based on this summation of classified components, is summarized in Table 27.



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Table 27 — Classification of a mixture for chronic hazards, based on summation of classified components

Sum of ingredients Mixture classification

Chronic 1 x Ma > 25 % Chronic 1(M x_10 x Chronic 1) + Chronic 2 > 25 % Chronic 2(M x 100 x Chronic 1) + (10 x Chronic 2) + Chronic 3 > 25 %

Chronic 3

Chronic 1 + Chronic 2 + Chronic 3 +Chronic 4 > 25 % Chronic 4a M is a multiplier factor to the base 10 (see 6.3.8).

6.3.8 Mixtures with highly toxic components Acute Category 1 components with toxicities well below 1 mg/l may influence the toxicity of the mixture and should be given increased weight in applying the summation of classification approach. Values to be used in these cases are in Table 28.

Table 28 — Multiplying factors for highly toxic components (Category 1) of mixtures

LC50 or EC50 valuesmg/L

Multiplying factor (M)

0,1 < c ≤ 1 10,01 < c ≤ 0,1 10

0,001 < c ≤ 0,01 1000,0001 < c ≤ 0,001 1 000

0,00001 < c ≤ 0,0001 10 000NOTE 1 Continues in 10s intervals.NOTE 2 c means either LC50 or EC50

6.3.9 Classification of mixtures with components without any useable information

In the event that no useable information on acute and/or chronic aquatic hazard is available for one or more relevant components, it is concluded that the mixture cannot be attributed a definitive hazard category(ies). In this situation the mixture should be classified based on the known components only, with the additional statement that x percent of the mixture consists of components(s) of unknown hazards to the aquatic environment

6.4 Decision logic diagrams

Figures 23, 24, and 25, can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic.



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Figure 23 — Decision logic diagram for hazard classification in aquatic environment


Yes

No

No

No

No

Yes

Yes

Yes

Go to Figure 24

Acute Category 1

Acute

Category 2

ChronicCategory 1

ChronicCategory 2

Warning

Warning

Yes

Unless chronic NOEC(s) >1

mgL

Substance: Is there sufficient information (toxicity, degradation bioaccumulation) for classification?

Acute toxicity Does it have a: 96 hr LC50 (fish) ≤ 1 mg/L? and/or

48 hr EC50 (crustacea) ≤ 1 mg/L? and/or

72 or 96 hr ErC50 (algae or other aquatic plants) ≤ 1 mg/L?

and

Chronic toxicity Does it not degrade rapidly; and/or Does it have the potential to

bioaccumulate? (BCF> 500 or in absence, log10 Kow ≥ 4?)

Acute toxicity Does it have a:96 hr LC50 (fish) ≤ 10 mg/L? and/or 48 hr EC50 (crustacea) ≤ 10 mg/L? and/or72 or 96 hr ErC50 (algae or other aquatic plants) ≤ 10 mg/L?

and

Chronic toxicity Does it lack the potential to rapidly degrade; and/or Does it have the potential to bioaccumulate?

(BCF ≥ 500 ou na falta, log10 Kow ≥ 4)?


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Figure 23 (continuing)


Not classified

No

No

No

Yes

Yes

AcuteCategory 3

Chronic Category 4

Chronic Category 3

Yes

Unless chronic NOEC(s) >1

mg/L




and

Chronic toxicity Does it not degrade rapidly; and/or Does it have the potential to

bioaccumulate? (BCF> 500 or in absence, log10 Kow ≥ 4?)

Chronic toxicity Is it poorly soluble with no acute toxicity? and Does it not degrade rapidly? and Does it have the potential to bioaccumulate?

(BCF ≥ 500 or if absent, log10 Kow ≥ 4)?Unless chronic NOEC(s) >1

mg/L


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Not classified for acute toxicity

Yes

Yes

AcuteCategory 1

Warning

AcuteCategory 3

AcuteCategory 2

Yes

Yes

No

No

No

Values from mixtures/decision logic Figure 24

and

and

and

Mixture: Does the mixture as a whole have aquatic toxicity data for fish, crustacea, and algae/aquatic plants?




Acute toxicity Does it have a: 96 hr LC50 (fish) ≤ 10 mg/L? and/or 48 hr EC50 (crustacea) ≤ 10 mg/L? and/or 72 or 96 hr ErC50 (algae or other aquatic plants)

≤ 10 mg/L?

Acute toxicity Does it have a: 96 hr LC50 (fish) ≤ 100 mg/L? and/or 48 hr EC50 (crustacea) ≤ 100 mg/L?

and/or 72 or 96 hr ErC50 (algae or other

aquatic plants) ≤ 100 mg/L?

Chronic toxicitySee Figure 25


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Not classified for acute

Yes

Yes

Help Category 1

Warning

Help Category 3

Help Category 2

Yes

No

and

Chronic toxicitySee Figure 25

No

No

No

No

Yes

Yes

and

and



category

Use all available ingredient information in the summation method as follows: For ingredients with available toxicity value(s) apply the additive formula (see Figure 22) ,

determine the toxicity category for that part of the mixture and use this information in the summation method;

Classified ingredients will feed directly into the summation method below.

Sum of ingredients classified as Acute 1 × M ≥ 25%?

Sum of ingredients classified as(Acute 1 × M × 10) + Acute 2 ≥ 25%?

Sum of ingredients classified as(Acute 1 × M × 100) + (Acute 2 x 10) + Acute 3 ≥ 25%?


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Figure 24 — Decision logic diagram for hazard classification in aquatic environment - Mixture

Summation method

Figure 25 — Decision logic diagram to assess chronic hazards to the environment


where

Ci is the ingredient concentration i;

L(E)C50m is the part of the mixture with test data;

n is the number of components;

L(E)Cocc is the CL50 or the CE50 for the component.

Mixture valueGo back to Figure 23

Yes

No

Yes

Yes

YesSum of ingredients classified as Chronic 1 × M ≥ 25%?

Chronic Category 1

Chronic Category 3

Chronic Category 2

Chronic Category 4

Warning

No

No

No

Sum of ingredients classified as [(Chronic toxicity 1 x M x 10) + (Chronic toxicity 2)] ≥ 25 %?

Sum of ingredients classified as [(Chronic toxicity 1 x M x 100) + (Chronic toxicity 2 x 10) + (Chronic toxicity 3)] ≥ 25 %?

Sum of Ingredient classification (Chronic toxicity 1 + Chronic toxicity 2 + Chronic toxicity 3 + Chronic toxicity 4) ≥ 25 %?

Not classifiedas

Chronic toxicity


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7 Physical hazards


Hazards associate to substances and mixtures are assessed through their physic-chemical properties applying the methods outlined on the UN Manual of Tests and Criteria, using for substances classification for the transport of dangerous goods.

It is not necessary to determine the explosibility, combustion or flammability of certain mixture if:

— any of its ingredients present such properties based on information available from the manufacturer and if it is not probable that the mixture poses such type of hazard.

— this is a change in the composition of a mixture of known composition and there is valid scientific justification for considering that this modification does not affect the classification of the mixture.

Experimental data already generated for substances and mixtures previously classified by other existing systems should be accepted when applied to the classification of these chemicals in the GHS, thereby avoiding duplication of testing.

For classification of gases and their mixtures (flammable gases, aerosols, gases and oxidizing gases under pressure) and organic peroxides, additional information can be obtained in the GHS.

7.2 Classification criteria for substances, mixtures and explosive articles

Substances, mixtures and explosive articles are classified according to the criteria that follow:

a) Division 1.1: Substances, mixtures and articles which have a mass explosion hazard;

b) Division 1.2: Substances, mixtures and articles which have a projection hazard but not a mass explosion hazard;

c) Division 1.3: Substances, mixtures and articles which have a fire hazard and either a minor blast hazard or a minor projection hazard or both, but not a mass explosion hazard:

1) Combustion of which gives rise to considerable radiant heat; or;

2) which burn one after another, producing minor blast or projection effects or both;

d) Division 1.4: Substances, mixtures and articles which present no significant hazard: substances, mixtures and articles which present only a small hazard in the event of ignition or initiation. An external fire shall not cause virtually instantaneous explosion of almost the entire contents of the package;

e) Division 1.5: Very insensitive substances or mixtures which have a mass explosion hazard: substances and mixtures which have a mass explosion hazard but are so insensitive that there is very little probability of initiation or of transition from burning to detonation under normal conditions;

f) Division 1.6: Extremely insensitive articles which do not have a mass explosion hazard: articles which contain only extremely insensitive detonating substances or mixtures and which demonstrate a negligible probability of accidental initiation or propagation.

The classification criteria for substances, mixtures and explosives are summarized in Table 29.



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Table 29 — Classification criteria for substances, mixtures and explosive articles

Category Criteria

Unstable substances, mixtures and articles or explosives in Divisions 1.1 - 1.6

Explosibility: according to UN Test Series 2 from the UN Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria, Part 1, Section 12Sensitiveness: according to UN Test Series 3 from the UN Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria, Part 1, Section 13Thermal stability: according to UN Test Series 3c from the UN Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria, Part 1, Subsection 13.6.1

NOTE Further tests are necessary to allocate the correct Division.

7.3 Classification criteria for flammable gases

A flammable gas is classified in one of the two categories for this class according to Table 30.

Table 30 — Classification criteria for flammable gases

Category Criteria

1

Gases, which at 20 °C and a standard pressure of 101.3 kPa:a) are ignitable when in a mixture of 13% (volume/volume) or less in air; or

b) have a flammable range with air of at least 12 percent regardless of the lower flammable limit.

2Gases, other than those of Category 1, which, at 20 °C and a standard pressure of 101.3 kPa, have a flammable range while mixed in air.

Figure 26 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic.



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Figure 26 — Decision logic for flammable gases

7.4 Classification criteria for flammable aerosols

Aerosols should undergo classification procedures and will be deemed flammable if contain any flammable classified ingredient according to the criteria outlined in 7.3, 7.7 and 7.8 for gases, liquids and solids.

Figures 27, 28 e 29 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic.

NOTE Classification of a flammable aerosol requires data on its flammable ingredients, combustion heat, and if applicable, results from the ignition distance test, enclosed space test (for spray aerosols), and foam test (for foam aerosols).


No

Yes

Yes

Not classified

Category 1

Danger

No

Category 2

Warning

Gaseous substance or mixture of gases

Does it have a flammable range with air at 20 °C and a standard pressure of 101.3 kPa?

At 20 °C and a standard pressure of 101.3 kPa, does it:

a) ignite when in a mixture of 13% or less by volume in air?; orb) has a flammable range with air of at least 12 percentage points regardless of the lower flammable limit?


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Figure 27 — Decision logic for flammable aerosols


No

Yes

Yes

Not classified

Category 1

Aerosol

No

Does it contain ≤ 1% flammable components and does it have a heat of combustion < 20 kJ/g?

Danger

Does it contain ≤ 85 % flammable components and does it have a heat of combustion < 30 kJ/g?

See Figure 28 (for spray aerosols) or see Figure 29 (for foam aerosols).


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Figure 28 — Decision logic for spray aerosols


No

Yes

Yes

Not classified

Category 2

No

Warning

Category 2

Warning

Category 2

Warning

Category 1

Danger

No

Yes

Yes

No

Spray aerosol

In the ignition distance test, does ignition occur at a distance ≥ 75 cm?

Is the heat of combustion < 20 kJ/g?

In the ignition distance test, does ignition occur at a distance ≥ 15cm?

In the enclosed space ignition test, is the

flammability time equivalent ≤ 300 s/m3; or

deflagration density ≤ 300 g/m3?


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Figure 29 — Decision logic for foam aerosols

7.5 Criteria for classification of oxidizing gases

Oxidizing gas is any gas causing or contributing more than air for the combustion of another material, generally because it provides oxygen. Oxidizing gases should be classified in one single category (Category 1).



No

Foam aerosol

Yes

Not classified

Category 2

No

Warning

Category 1

Danger

Yes

In the flammability foam test, is the

(a) flame height ≥ 20 cm and the flame duration ≥ 2 s; or

(b) flame height ≥ 4 cm and the flame duration ≥ 7 s?

In the foam test, is the flame height ≥ 4 cm and the flame duration ≥ 2 s?


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Figure 30 — Decision logic for oxidizing gases

7.6 Criteria for classification of gases under pressure

Gases under pressure are compressed, liquefied, dissolved under pressure or liquid refrigerated gases. Gases under pressure should be classified within one of the groups of Table 31.

Table 31 — Criteria for classification of gases under pressure

Group Criteria

Compressed gasGas that when packaged under pressure is entirely gaseous at -50 °C; including all gases with a critical temperature ≤ -50 °C.

Liquefied gas

A gas, which when packaged under pressure is partially liquid at temperatures above -50 °C is different from:— High pressure liquefied gas, whose critical temperature is between -50°C and +65°C;

and

— Low pressure liquefied gas, whose critical temperature is above +65°C.

Refrigerated liquefied gas

Gas that when packaged is made partially liquid because of its low temperature.

Dissolved gas Gas that when packaged under pressure is dissolved in a liquid phase solvent.



Gaseous substance or mixture of gases

Yes

Not classified

Category 1

No

Danger

Does the gas contribute to the combustion of other material more than air does?


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Figure 31 — Decision logic for gases under pressure


No

Yes

Substance or mixture

Dissolved gas

No

Warning

Not classified

Warning

Yes

No

Yes

No

Yes

Warning

Warning

Warning

Liquefied gas

Liquefied gas

Refrigerated liquefied gas

Compressed gas

Yes

No

Yes

Is: (a) the vapor pressure at 50 °C greater than 3 bar?; or(b) the substance or mixture completely gaseous at 20°C and 101.3kPa?

Is the gas dissolved in a liquid solvent under pressure?

Is the critical temperature above +65 °C?

Is the critical temperature between –50 °C and +65 °C?

Is the gas made partially liquid because of its low temperature?

Is the gas entirely in gaseous state at –50 °C


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7.7 Criteria classification for flammable liquids

A flammable liquid is classified in one of the categories of Table 32.

Table 32 — Criteria for flammable liquids

Category Criteria1 Flash point < 23 °C and initial boiling point ≤ 35 °C 2 Flash point < 23 °C and initial boiling point > 35 °C3 Flash point ≥ 23 °C and ≤ 60 °C 4 Flash point > 60 °C and < 93 °C


Figure 32 — Decision logic for flammable liquids


No

Yes

Yes

Not classified

Category 2

No Warning

Category 3

Danger

Category 4

Warning

Categoria 1PerigoNãoSim

Yes

No

Does it have a flash point > 60°C?

Em ensaio de queima à distância há inflamabilidade a uma distância ≥ 75 cm?

The substance or mixture is a liquid

Does it have a flash point ≤ 93 °C?

Does it have a flash point ≥ 23°C?

Yes

Category 1

No

Danger

Does it have an initial boiling point > 35°C?


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7.8 Criteria classification for flammable solids

A flammable solid should be classified in one of the categories of Table 33.

Table 33 — Criteria for flammable solids

Category Criteria — Burning rate test

1

— Substances or mixtures other than metal powders:

a) Wetted zone does not stop fire and;

b) Burning time < 45 s or burning rate > 2.2 mm/s.

— Metal powders: burning time ≤ 5 min.

2

— Substances or mixtures other than metal powders:

a) Wetted zone stops the fire for at least 4 min and

b) Burning time < 45 s or burning rate > 2.2 mm/s.

— Metal powders: burning time > 5 min and ≤ 10 min

Figure 33 can be used as additional guidance for hazard classification.

It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic as set forth on UN Manual of Tests and Criteria.



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Figure 33 — Decision logic for flammable solids


Yes

Category 1

No Not classified

Danger

Burning rate test:

For substances or mixtures other than metal powders: Burning time < 45 s or burning rate > 2.2 mm/s? ; or

Metal powders: burning time ≤ 10 min ?

YesCategory 2

No

Warning

For substances or mixtures other than metal powders: Does the wetted zone stop propagation of the flame?

Metal powders: burning time > 5 min?

Not classified

Substance or solid mixture

Screening test Negative

Positive


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7.9 Classification criteria for self-reactive substances and mixtures - Substances liable to spontaneous combustion

Any self-reactive substance or mixture should be considered for classification in this class unless:

a) They are explosives, according to criteria on 7.2;

b) They are organic peroxides, according to criteria on 7.16;

c) Their heat of decomposition is less than 300 J/g;

d) Their self-accelerating decomposition temperature (SADT) is greater than 75 °C for a 50 kg package, or

e) They are oxidizing liquids or solids, according to the criteria on 7.14 and 7.15 respectively, except that mixtures of oxidizing substances that contain 5% or more of combustible organic substances, which should be classified as self-reactive substances.

Mixtures of oxidizing substances, meeting the criteria for classification as oxidizing substances, which contain 5.0% or more of combustible organic substances and which do not meet the criteria mentioned in (a), (b), (c) or (d) above, shall be subjected to the self-reactive substances classification procedure.

Self-reactive substances and mixtures are classified in one of the seven categories of (types A to G) for this class, according to the following principles:

a) Type A: Any self-reactive substance or mixture, which can detonate or deflagrate rapidly, as packaged;

b) Type B: Any self-reactive substance or mixture possessing explosive properties and which, as packaged, neither detonates nor deflagrates rapidly, but is liable to undergo a thermal explosion in that package;

c) Type C: Any self-reactive substance or mixture possessing explosive properties when the substance or mixture as packaged cannot detonate or deflagrate rapidly or undergo a thermal explosion;

d) Type D: Any self-reactive substance or mixture which in laboratory testing:

1) detonates partially, does not deflagrate rapidly and shows no violent effect when heated under confinement; or

2) does not detonate at all, deflagrates slowly and shows no violent effect when heated under confinement;

3) does not detonate or deflagrate at all and shows a medium effect when heated under confinement;

e) Type E: Any self-reactive substance or mixture which, in laboratory testing, neither detonates nor deflagrates at all and shows low or no effect when heated under confinement;

f) Type F: Any self-reactive substance or mixture which, in laboratory testing, neither detonates in the cavitated state nor deflagrates at all and shows only a low or no effect when heated under confinement as well as low or no explosive power;

g) Type G: Any self-reactive substance or mixture which, in laboratory testing, neither detonates in the cavitated state nor deflagrates at all and shows no effect when heated under confinement nor any explosive power, provided that it is thermally stable (self-accelerating decomposition temperature is 60 °C to 75 °C for a 50 kg package), and, for liquid mixtures, a diluent having a boiling point not less than 150 °C is used for desensitization. If the mixture is not thermally stable or a diluent having a boiling point less than 150 °C is used for desensitization, the mixture shall be defined as self-reactive substance Type F.



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7.10 Criteria classification for pyrophoric liquids

A pyrophoric liquid is a liquid which is liable to ignite within five minutes if placed over an inert material or on a filter -paper (which is carbonized) after coming into contact with air. Pyrophoric liquids should be classified in one single category (Category 1).


NOTE The classification procedure for pyrophoric liquids need not be applied when experience in production or handling shows that the substance or mixture does not ignite spontaneously on coming into contact with air at normal temperatures.

Figure 34 — Decision logic for pyrophoric liquid


Category 1

No

Not classified

Danger

Category 1

No

Danger

Yes

Yes

Substance or liquid mixture

Does it ignite within 5 minutes after placed on a porcelain vessel with diatom earth or silica gel?

Provokes ignition or no flame combustion from a filter-paper in less than 5 min?


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7.11 Criteria classification for pyrophoric solids

A pyrophoric solid is a solid that is liable to ignite within five minutes after coming into contact with air. Pyrophoric solids should be classified in one single category (Category 1).


Figure 35 — Decision logic for pyrophoric solids

7.12 Classification criteria for self-heating substances and mixtures

A self-heating substance or mixture with self-heating capability is classified according to Table 34.

Table 34 — Classification criteria for self-heating substances or mixtures

Category Criteria1 It does self-heats in a test using a 25 mm sample cube at 140 °C2 a) It does self-heats in a test using a 100 mm sample cube at 140 °C but it

does not self-heats in a test using a 25 mm cube sample at 140 °C and the substance or mixture was packed in packages with a volume of more than more than 3 m3;

b) It does self-heats in a test using a 100 mm sample cube at 140 °C, but it does not self-heats in a test using a 25 mm cube sample at 140 °C, and it does self-heats in a test using a 100 mm cube sample at 120 °C and the substance or mixture was packed in packages with a volume of more than 450 L

c) It does self-heats in a test using a 100 mm sample cube at 140 °C and It does not self-heats in a test using a 25 mm cube sample at 140 °C and It does self-heats in a test using a 100 mm cube sample at 100 °C.



Not classified

Category 1

NoDanger

YesDoes it ignite within five minutes after coming into contact with air?


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Figure 36 — Decision logic for self-heating substances and mixtures


No

Yes

Yes

Not classified

Category 2

NoWarning

Category 2

Warning

Category 2

Warning

Category 1

DangerNo

Yes

Yes

No


Is it packaged in more than 3 m3?

Does it undergo dangerous self-heating when tested in a 100 mm sample cube at 120 °C?

Is it packaged in more than 450 litres volume


Not classified

Not classified

No

Yes

No

Yes




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7.13 Classification criteria for substances and mixtures which, in contact with water, emit flammable gases

A substance or mixture, which, in contact with water, emits flammable gases, should be classified in one of the categories of Table 35.

Table 35 — Classification criteria for substances and mixtures which, in contact with water, emit flammable gases

Category Criteria

1 Any substance or mixture which reacts vigorously with water at ambient temperatures and demonstrates generally a tendency for the gas produced to ignite spontaneously, or which reacts readily with water at ambient temperatures such that the rate of evolution of flammable gas is equal to or greater than 10 liters per kilogram of substance over any one minute.

2 Any substance or mixture which reacts readily with water at ambient temperatures such that the maximum rate of evolution of flammable gas is equal to or greater than 20 liters per kilogram of substance per hour, and which does not meet the criteria for Category 1.

3 Any substance or mixture which reacts slowly with water at ambient temperatures such that the maximum rate of evolution of flammable gas is equal to or greater than 1 liter per kilogram of substance per hour, and which does not meet the criteria for Categories 1 and 2.




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Figure 37 — Decision logic for substances and mixtures which, in contact with water, emit flammable gases


No

Yes

Yes

No

Category 2

No

Warning

Category 1

Danger

Yes

In contact with water, does it react slowly at ambient temperatures such that the maximum rate of evolution of flammable gas is equal to or greater than ≥ 1 L/kg of substance per hour?

In contact with water, does the substance react vigorously with water at ambient temperatures and the gas produced is liable to ignite spontaneously, or does it react readily with water at ambient temperatures such that the rate of evolution of flammable gas is ≥ 10 L/kg of substance per minute?

In contact with water, does it react readily with water at ambient temperatures such that the maximum rate of evolution of flammable gas is ≥ 20 L/kg of substance per hour?

Not classified

Danger

Category 3



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7.14 Criteria classification for oxidizing liquids

An oxidizing liquid should be classified in one of the categories of the Table 36.

Table 36 — Criteria for oxidizing liquids

Category Criteria

1

Oxidizing liquid is any substance or mixture which, in the 1:1 mixture, by mass, of substance (or mixture) and cellulose tested, spontaneously ignites; or the mean pressure rise time of a 1:1 mixture, by mass, of substance and cellulose is less than that of a 1:1 mixture, by mass, of 50% perchloric acid and cellulose;

2

Any substance or mixture which, in the 1:1 mixture, by mass, of substance (or mixture) and cellulose tested, exhibits a mean pressure rise time less than or equal to the mean pressure rise time of a 1:1 mixture, by mass, of 40% aqueous sodium chlorate solution and cellulose; and the criteria for Category 1 are not met;

3

Any substance or mixture which, in the 1:1 mixture, by mass, of substance (or mixture) and cellulose tested, exhibits a mean pressure rise time less than or equal to the mean pressure rise time of a 1:1 mixture, by mass, of 65% aqueous nitric acid and cellulose; and the criteria for Categories 1 and 2 are not met.




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Figure 38 — Decision logic for oxidant liquids


No

Yes

Yes

No

Category 2

No

Warning

Category 1

Danger

Yes

No

Does it, in the 1:1 mixture, by mass, of substance (or mixture) and cellulose tested, exhibits a pressure rise ≥ 2070 kPa gauge?

Does it, in the 1:1 mixture, by mass, of substance (or mixture) and cellulose tested, exhibit a mean pressure rise time less than or equal to the mean pressure rise time of a 1:1 mixture, by mass, of 65% aqueous nitric acid and cellulose?

Does it, in the 1:1 mixture, by mass, of substance (or mixture) and cellulose tested, exhibit a mean pressure rise time less than or equal to the mean pressure rise time of a 1:1 mixture, by mass, of 40% aqueous sodium chlorate and cellulose?

Not classified

Danger

Category 3

Substance or liquid mixture

Not classified

Yes

Does it, in the 1:1 mixture, by mass, of substance (or mixture) and cellulose tested, spontaneously ignite or exhibit a mean pressure rise time less than that of a 1:1 mixture, by mass, of 50% perchloric acid and cellulose?


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7.15 Criteria classification for oxidizing solids

An oxidizing solid should be classified in one of the categories of Table 37.

Table 37 — Criteria for oxidizing solids

Category Criteria

1 Oxidizing solid is any substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning time less than the mean burning time of a 3:2 mixture, by mass, of potassium bromate and cellulose.

2 Any substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning time equal to or less than the mean burning time of a 2:3 mixture (by mass) of potassium bromate and cellulose and the criteria for Category 1 are not met.

3 Any substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning time equal to or less than the mean burning time of a 3:7 mixture (by mass) of potassium bromate and cellulose and the criteria for Categories 1 and 2 are not met.




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Figure 39 — Decision logic for oxidant solids


No

Yes

Yes

No

Category 2

No

Warning

Category 1

Danger

Yes

No

Does it, in the 4:1 or 1:1 sample-to-cellulose ratio, by mass, tested ignite or burn?

Does it, in the 4:1 or 1:1 sample-to-cellulose ratio, by mass, tested, exhibit a mean burning time less than or equal to the mean burning time of a 3:7 mixture, by mass, of potassium bromate and cellulose?

Does it, in the 4:1 or 1:1 sample-to-cellulose ratio, by mass, tested, exhibit a mean burning time less than or equal to the mean burning time of a 2:3 mixture, by mass, of potassium bromate and cellulose?

Not classified

Danger

Category 3


Not classified

Yes

Does it, in the 4:1 or 1:1 sample-to-cellulose ratio, by mass, tested, exhibit a mean burning time less than the mean burning time of a 3:2 mixture, by mass, of potassium bromate and cellulose?


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7.16 Classification criteria for organic peroxides

Any organic peroxide shall be considered for classification in this class, unless it contains:

— Not more than 1.0% available oxygen from the organic peroxides when containing not more than 1.0% hydrogen peroxide; or

— Not more than 0.5% available oxygen from the organic peroxides when containing more than 1.0% but not more than 7.0% hydrogen peroxide.

Organic peroxides should be classified in one of the seven categories (A - G) according to the following principles:

a) Type A: Any organic peroxide that can detonate or deflagrate rapidly depending upon how it was packed;

b) Type B: Any organic peroxide possessing explosive properties that neither detonates nor deflagrates rapidly after packed, but is liable to undergo a thermal explosion within that package;

c) Type C: Any organic peroxide possessing explosive properties that cannot detonate or deflagrate rapidly or undergo a thermal explosion after packed;

d) Type D: Any organic peroxide which has the following behavior in laboratory testing:

1) Detonates partially, does not deflagrate rapidly and shows no violent effect when heated under confinement; or

2) Does not detonate at all, deflagrates slowly and shows no violent effect when heated under confinement; or

3) Does not detonate or deflagrate at all and shows a medium effect when heated under confinement:

e) Type E: Any organic peroxide that when tested in a laboratory neither detonates nor deflagrates at all and shows low or no effect when heated under confinement ;

f) Type F: Any organic peroxide that when tested in a laboratory neither detonates in the cavitated state, nor deflagrates at all, and shows only a low or no effect when heated under confinement as well as low or no explosive power

g) Type G: Any organic peroxide that when tested in a laboratory neither detonates in the cavitated state nor deflagrates completely not showing any effect when heated under confinement nor any explosive power, provided that it is thermally stable. (self-accelerating decomposition temperature is 60°C or higher for a 50 kg package), and, for if a liquid mixtures is diluted with a diluent whose boiling point is above 150 °C aiming at achieving desensitization, such mixture is classified as an organic peroxide type G. If the mixture was no stable or if the diluent boiling point is less than 150 °C the mixture should be classified as Type F.



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7.17 Classification criteria for substances and mixtures corrosive to metals

A substance or a mixture that is corrosive to metals has a corrosion rate on steel or aluminium surfaces exceeding 6.25 mm per year at a test temperature of 55 °C, and should be classified in a single category (Category 1).


Figure 40 — Decision logic for substances and mixtures corrosive to metal


No

Yes

Does it corrode on steel or aluminium surfaces at a rate exceeding 6.25 mm/year at a test temperature of 55 °C?

Not classified


Warning

Category 1


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ABNT NBR 14725-2:2009Anexo A (informativo) Métodos de ensaios

Annex A(informative)

Test methodsThe physico-chemical properties, toxicity and ecotoxicity tests mentioned in this Annex should be performed following the basic principles of Good Laboratory Practices (GLP), according to GHS instructions. Although the international testing methods are preferred (OECD), national methods can also be used, if deemed equivalent.

The referenced test methods mentioned in GHS and in ABNT NBR 14725-4 are shown in Table A.1.

Table A.1 — Test methods

Tests Methods

Toxicology tests

General

Oral toxicity - LD50 - rats OECD 420, 423 e 425Dermal toxicity - LD50 - rats OECD 402Inhalation toxicity LC50 - rats OECD 403Skin corrosion/irritation test - rabbits or rats OECD 404In vitro assays (Skin corrosion) OECD 430 e 431Eye irritation/corrosion test - rabbits OECD 405Skin sensitivity test, guinea pig OECD 406 e 429

Mutagenicity

Lethal mutation in rodents OECD 478Translocation in mice OECD 485Mammalian bone marrow chromosome aberration test

OECD 475

Mouse spot test OECD 484Micronucleus test OECD 474Mammalian spermatogonial chromosome aberration test

OECD 483

Liver DNA synthesis assay OECD 486In vitro assays OECD 473, 476 e 471

Carcinogeni-city

Carcinogenicity OECD 451 e 453

Toxicity to reproduction and lactation

Reproductive toxicity test OECD 414, 415 e 416

Screening test OECD 421 e 422

Target organ toxicity-repeated exposure

Target organ toxicity-repeated exposure test OECD 408

Ecotoxicological tests on freshwater organisms

Fish toxicity: 96hr LC50 test OECD 203Chronic toxicity test with fishes OECD 210 e 212Acute toxicity test with Daphnia: 48hr, EC50 OECD 202Toxicity test with algae OECD 201Toxicity test with lemma OECD 221Bioaccumulation test OECD 305Biodegradation test OECD 301Chronic toxicity test with Daphnia OECD 211

Ecotoxicologic tests: marine organisms

Toxicity test with marine algae OECD 201Acute toxicity test with Mysidacea OPPTS 8501035Chronic toxicity test with Mysidacea OPPTS 8501350Acute toxicity test with marine fishes OECD 203Chronic toxicity test with marine fishes OECD 210 e 212Marine biodegradation tests OECD 306



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Table A.1 (continuing)

Tests Methods

Physico-Chemical Tests

General

Self-heating VDI Guidelines 2263Partition coefficient n-octanol/water OECD 107 ou 117Color OPPTS8306302

CorrosivityASTM G31-72 , OPPTS 8306320

Density of liquid and solids OECD 109Burning rate EEC A17Thermal stability OECD 104Physical state OPPTS8306303Explosivity EEC A13 e EEC A14Boiling point temperature range OECD 103

FlammabilityASTM D240, ISO 13943, ISO 10156, EEC A12

Upper and lower explosion limits EEC A 14Odor OPPTS8306304pH OPPTS87000, CIPAC MT75Boiling point OECD 103

Flash pointASTM D 3828-93,56-93, 3278-96, ISO 1516, EEC A9

Melting point OECD 102Vapor pressure and pressure at 20°C OECD 104Oxidizing properties OPPTS 8306314, EEC A17Solubility with solvent(s) mixture OECD 105Solubility in water EEC A6Self-ignition temperature EEC A15, CIPAC MT 84Decomposition temperature OECD 113



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Bibliography

[1] Decree 2657, of 03 of July of 1998, which publishes the Convention No 170 of the International Labour Organization (ILO)

[2] CIPAC (Collaborative International Pesticides Analytical Council). 1995. Handbook. Vol. F. Physico- Chemical Methods for Technical and formulated pesticide. Eds. W. DORAT and A.MARTIJN. Black Bear Press Ltda, Cambridge CB42PQ. England. 472pp.

[3] EEC (Economic European Community). Methods for the determination of physico-chemical properties, toxicity and ecotoxicity. Official Journal references. http://jrc.it/testing-methods/

[4] OECD (Organization for Economic Cooperation and Development), Guidelines for Testing of Chemicals

[5] OPPTS Harmonized Guidelines. US.EPA (United States Environmental Protection Agency)


http://jrc.it/testing-methods/


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STANDARDABNT NBR

14725-3




Chemicals — Information about safety, health and environment

Chemicals – Information about safety, health and environmentPart 3: Labeling

ICS 71.100.01 ISBN 978-85-07-01705-9



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ABNT NBR 14725-3:2009



33 pages

© ABNT 2009



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Contents Página

Foreword................................................................................................................................................................... iv

Introduction............................................................................................................................................................... v

1 Scope.......................................................................................................................................................... 1

2 Normative references................................................................................................................................ 1

3 Terms and definitions............................................................................................................................... 1

4 General considerations............................................................................................................................. 1

5 Safety information for the labeling hazardous chemicals.....................................................................2

6 Product label specifications..................................................................................................................... 2

Annex A (informative) Correlation between the information in FISOQ sheets and the

labeling of the hazardous chemical........................................................................................................................ 4

Annex B (normative) Instructions on how to include safety information in the label of hazardous chemicals................................................................................................................................ 5

B.1 Product identification and supplier emergency telephone....................................................................5

B.2 Chemical composition.............................................................................................................................. 5

B.3 Hazard pictograms.................................................................................................................................... 5

B.4 Signal word................................................................................................................................................ 6

B.5 Hazard statement....................................................................................................................................... 6

B.6 Precautionary statements......................................................................................................................... 6

B.7 Other information...................................................................................................................................... 6

Annex C (normative) Hazard symbols...................................................................................................................... 7

Annex D (normative) Hazard pictograms, signal word and hazard statements...................................................8

Annex E (informative) Precautionary statements..................................................................................................20

Annex F (informative) Illustrative examples of labels...........................................................................................28

F.1 Combination packaging for a Category 2 flammable liquid.................................................................28

F.2 Inner packaging: Category 2 flammable liquid and Category 2 skin irritant......................................30

F.3 Overwrapping with two combined packages: one with flammable liquid Category 2 and another containing a skin irritant Category 2..................................................................................................................... 31

F.4 Product label............................................................................................................................................ 32

Bibliography............................................................................................................................................................ 33



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ABNT NBR 14725-3:2009

Foreword





ABNT NBR 14725-1 has been worked out within the Brazilian Committee of Chemistry (ABNT/CB-10) by members of the Committee for Information Studies on Safety, Health and Environment related to Chemicals (CE-10:101.05). Their 1st Project was sent to a Nationwide Query according to the Invitation to Bid no. 12, carried out from 12/21/2007 until 02/18/2008, with the Project number 10:101.05-004, has been worked out within the Brazilian Committee of Chemistry (ABNT/CB-10) by members of the Committee for Information Studies on Safety, Health and Environment related to Chemicals (CE-10:101.05). Their 1st Project was sent to a Nationwide Query according to the Invitation to Bid no. 12, carried out from 12/21/2007 until 02/18/2008, with the Project number 10:101.05-002.



— Part 2: Hazard Rating System;


— Part 4: Material Safety Data Sheet (MSDS).

WARNING - Other classification systems, besides those described in this part of ABNT NBR 14725, may be used until 02.26.2011. After 02/27/2011, all chemicals should be classified only in accordance with this part of ABNT NBR 14725 (ABNT NBR 14725-3:2009).

This ABNT NBR ABNT NBR 14725-3, jointly with Parts 2, 3 and 4, supersedes and cancel the ABNT NBR 14725:2005 print, which has been technically revised and dismembered in parts.




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ABNT NBR 14725-3:2009

Introduction

This ABNT NBR 14725 part was meant to set forth the criteria to include safety information in labels of hazardous chemical products (in accordance with the classification system), and additional legal requirements should be apply when labeling each type of product.


Decree 2657 of July, 3rd, 1998, which issued the Convention No.170 of the International Labor Organization (ILO), establishes some responsibilities for the implementation of the ABNT NBR 14725 standard.

Labeling hazardous chemical products is one out of several ways a supplier uses to transfer to the target public all essential information (including transport, handling, storage and emergency acts) about chemical products hazards.

Focusing the obligations of the target public towards hazardous chemicals are beyond the scope of this ABNT NBR 14725 part. However, we have included some of them aiming at clearly establishing the difference between supplier obligations and target public obligations, as far as hazardous chemicals are concerned.

ABNT NBR 14725 information on safety are included on the label of a hazardous chemical product, but it should be recognized that there are circumstances when demand and logic justify some flexibility regarding how appropriate is to include certain information for some specific target publics. This part of ABNT NBR 14725 also allows flexibility to adapt different ways to display, print or attach safety information on the packaging of dangerous chemicals.

Target publics of interest for this part of ABNT NBR 14725 are employers and workers, consumers, and professionals working in emergency services and transport.

This part of the ABNT NBR 14725 was based on the following GHS basic assumptions:

ABNT NBR 14725 was based on the following GHS basic assumptions:

— The need to provide information on hazardous chemicals related to safety, health and environment issues;

— The right of the target public become familiar and able to identify the dangerous chemicals commonly used and their associated risks;

— The utilization of a simple identification system, which could be easily understood and applied in the different sites where dangerous chemicals are used;

— The need to make this consistent system compatible with the classification criteria for all anticipated hazards by GHS;

— The need to facilitate international agreements and to protect industrial secrets and confidential information;

— The workers' training and skill building, and

— The development of consumers' education and awareness.

This Standard is not applicable to chemicals already manufactured and labeled before the enforcement of this Standard. Such products hold valid conditions until their expiration date as stated in each respective package.



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Chemicals — Information about safety, health and environment Part 3 Labeling

1 Scope

This ABNT NBR 14725 part defines the safety information concerning hazardous chemicals that should be included when labeling the product and does not establish a fix format.



ABNT NBR 7500, Identification for transportation, handling, movement and storage of materials


ABNT NBR 14725-2, Chemicals — Information about safety, health and environment Part 2: - Hazard Classification System

ABNT NBR 14725-4, Chemicals — Information about safety, health and environment Part 4: Material Safety Data Sheet - MSDS (Ficha de Informações de Segurança de Produtos Químicos ─ FISPQ Brazil).


This part of ABNT NBR 14725, uses the terms and definitions of ABNT NBR 14725-1.

4 General considerations

4.1 The productive sectors already regulated with respect to labeling of chemicals must meet their specific legislation.4.2 Whenever necessary the suppliers periodically should review the information in which the labeling and the Material Safety Data Sheet (MSDS) were being based for the substance or mixture. The MSDS is the medium used to update such information and Annex A provides the correlation between the labeling information of dangerous chemical and the MSDS (see ABNT NBR 14725-4).

4.3 Regarding the transfer of hazardous chemicals to other containers or equipment, employers should inform workers about the identification of such products (through codes, chemical names, trade names etc). Employers should provide all hazard information regarding chemicals handling, storage and transportation, besides all precautions and safety measures required based on the MSDS, whose availability should be assured by their management system.



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4.4 As the labeling of a hazardous chemical is merely related to the product, it does not take into consideration all situations that may occur when a label is consulted. Therefore, the labeling of hazardous chemicals is only part of the information needed to design a program addressing the safety, health and environment.

4.5 The labeling of a hazardous chemical must meet this part of ABNT NBR 14725 at the time the hazardous chemical is about to be enclosed in its final packaging to be sold in the domestic market.

4.6 The labeling of a hazardous chemical should not have images or information that may mislead the target-public.

4.7 The text of hazardous chemicals labels should be brief, precise, and use simple meaningful words to minimize or avoid the risks from the normal use and storage of the product.

4.8 The supplier must check if the identification of the labeled hazardous chemical is correct, for it has the essential information to avoid safety, health and environmental risks. In the case of products packaged in the final packaging for sale, the supplier should consult the MSDS to update the information contained on the label of dangerous chemicals using his/her own criteria to adopt other measures deemed necessary.

4.9 It is the responsibility of the target public to respond according to a risk assessment, to follow the recommendations when using a hazardous chemical, and to take all necessary precautions regarding the associated relevant hazards. The target public is also responsible to preserve the information conveyed by the label of the hazardous chemical up to its appropriate final destination.

4.10 The conditions adopted for the protection of trade secrets should not compromise the health and the safety of workers or consumers, neither the protection of the environment. For this reason, the dangers associated with hazardous chemicals covered by these criteria must be disclosed on the label, even though the information about the composition of the hazardous chemical are not fully provided.

5 Safety information for the labeling hazardous chemicals

The label of a hazardous chemical should contain the following information (see Annex B):

a) Product identification and supplier emergency telephone

b) Chemical composition

c) Hazard pictograms (see Annex C and D)

d) Signal word (see Annex D)

e) Hazard statement (see Annex D)

f) Precautionary statement (see Annex E)

g) Other information.

6 Product label specifications

NOTE Illustrative examples of labels are shown in Annex F.



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6.1 The signal word(s), hazard statement(s), precautionary statement(s), and hazard pictogram(s) should be placed close to each other in the label of the hazardous chemical. The hazard pictograms may be included in the package itself of the hazardous chemical, close to the label and in the very same surface of the package.

6.2 The label format of a hazardous chemical is at supplier discretion.

6.3 The minimum size of letters for labels of dangerous chemicals should be designed to ensure clarity and legibility of the mandatory information, but letters smaller than 1 mm are not allowed.

6.4 The minimum size of the hazard pictogram should be 1 cm x 1 cm, except in the case of packages with dimensions where the room available only admits smaller labels. Safety pictograms can be used with a minimum size of 1 cm x 1 cm or a minimum diameter of 1 cm, except in the case of packages with dimensions where the room available only admits smaller labels.

6.5 The label of a hazardous chemical should be made of a material that will withstand normal use, transport and storage within the validity period of the product.

6.6 All security information in the label of a hazardous chemical must be written in Portuguese (Brazil).

6.7 There are no restrictions on concurrent use of other languages on labels of dangerous chemicals. In the case of export of dangerous chemicals:

— The inner packaging may contain label in another language, provided that its respective outer packaging meets the requirements of this part of ABNT NBR 14725;

— Simple packaging must be labeled according to the requirements of this part of ABNT NBR 14725, and

— Overwrapping must be labeled according to the requirements of this part of ABNT NBR 14725, but the label on the contained package should not be visible. If visible, it should comply with this part of ABNT NBR 14725.

6.8 Import operations do not require compliance with the requirements of this part of ABNT NBR 14725 for dangerous chemical labels until the delivering to the importer.

6.9 Pictograms must be posted on a background of contrasting color.

6.10 Alternative means can be used to provide workers with safety information on labels of hazardous chemicals in the workplace, provided that such methods ensure clear communication of danger and that workers are properly trained.



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ABNT NBR 14725-3:2009Anexo A (informativo) Correlação entre as informações da FISPQ e da rotulagem de produto químico perigoso

Annex A

(informative)

Correlation between the information in FISPQ sheets and the labeling of the hazardous chemical

Label elements Correlation with FISPQ sections

Product identification and supplier emergency telephone

Section 1 - Product and company identifications

Chemical compositionSection 3 - Composition and information on

ingredients

Hazard pictogramsSection 2 - Hazard identification Section 14 -

Transport information

Signal word Section 2 - Hazards awareness

Hazard statement Section 2 - Hazard awareness

Precautionay statements Section 2 - Hazard awereness

Other informationAny other information available in the FISPQ and

still not mentioned



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ABNT NBR 14725-3:2009Anexo B (normativo) Instruções para inclusão das informações de segurança no rótulo do produto químico perigoso

Annex B

(normative)

Instructions on how to include safety information in the label of hazardous chemicals

NOTE The directives provided by this Annex deal with the preparation of security labels for hazardous chemicals. The instructions aiming at ensuring that the content of the information enable the product receivers to take the essential steps to deal with risks, safety, health protection in the workplace and for the environment.

B.1 Product identification and supplier emergency telephone

The product label of the hazardous chemical should contain the trade name and the technical name of the product as used in the MSDS.

The product label of the hazardous chemical should contain the supplier emergency phone number(s). The emergency phone number(s) should provide support for emergency situations, providing safety, health (including toxicological), and environmental information.

B.2 Chemical composition

The product label of the hazardous chemical should contain the name(s) of the ingredient(s) contributing in making the substance or mixture hazardous through its common chemical or generic name.

To ingredients or impurities contributing to the hazardous nature of the chemical should comply with the limits set in ABNT NBR 14725-2.

If any ingredient that contributes to make the chemical hazardous is a trade secret in accordance with the relevant regulations, the supplier will be free from the obligation to inform such ingredient on the label of the hazardous chemical and should attend to what is described in 4.10.

B.3 Hazard pictograms

The hazardous nature of the chemical product(s) should be informed on the label through its hazard pictograms (see Annex D). The symbols used in these pictograms should comply with Annex C. The variation in design and pictograms should be prepared according to ABNT NBR 7500. Such pictograms should consist of a black symbol on a white background and red border. The edge can be in black if the pictogram is used in containers not intended for export.

If dangerous chemical has the same hazard identification assigned to transport, only the pictogram (risk label) of transport may be used on the outer package so that duplication is avoided (see Figure F.1). Hazard pictograms presented in this part of ABNT NBR 14725 should be placed in the inner container (see Figure F.2).

The following priority criteria should be applied to health hazards:

a) When required to use two pictograms for the same class of hazard, only the higher hazard category should be used. For example, in a acute toxicity case, when using the pictogram of categories 1, 2 or 3 (skull and crossbones), a category 4 (exclamation point) pictogram of this same hazard class should not be used;



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b) If the pictogram of the hazard class category 1 for respiratory sensitivity is adopted, the pictogram of category 1 of the hazard class awareness to the skin (exclamation point), if applicable, should not be employed;

c) A pictogram should be used only once if two hazard classes require the adoption of the same pictogram. For example, a mixture having an ingredient category 2A of the eye irritation class and another category 4 of the class of acute toxicity, the exclamation point pictogram should be used only once.

B.4 Signal words

Signal words means a word used to indicate the relative level of severity of hazard and alert the reader to a potential hazard on the label. "Danger” and “Warning” are used as signal words. The first is used for the more severe hazard categories, while the second is used for the less severe according to ABNT NBR 14725-2. Signal words, when used, should be included in the labeling of the hazardous chemical, as provided in Annex D.

B.5 Hazard statement

Hazard statements are standardized texts and should be included in the label of the hazardous chemical according to Annex D.

B.6 Precautionary statements

The applicable precautionary statements should be included on the label of dangerous chemical and include information on:

— Physical hazard;

— How to avoid potential misuse and exposure to health

— Applications in cases of accidents with the product and how to protect the environment

— Suitable methods for disposal.

Annex E provides some examples of precautionary statements that can be used depending on the characteristics of the hazardous chemical

B.7 Other information

The label of a hazardous chemical must contain the following sentence:

"The Material Safety Data Sheet for Chemical Products of this hazardous chemical can be obtained through…".

Other relevant safety information on hazardous chemicals may be provided if not hindering the clear identification of the information included in this part of ABNT NBR 14725.



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ABNT NBR 14725-3:2009Anexo C (normativo) Símbolos de perigo

Annex C

(normative)

Hazard symbols

Hazard symbol Name

Exploding bomb

Flame

Flame over circle

Gas cylinder

Corrosion

Skull and crossbones

Exclamation point

Health hazard

Environment



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ABNT NBR 14725-3:2009Anexo D (normativo) Pictogramas de perigo, palavras de advertência e frases de perigo

Annex D(normative)

Hazard pictograms, signal word and hazard statements

This Annex presents the hazard pictograms, signal words and hazard statements that should be included on the label of a hazardous chemical according to its own hazard identification (see Tables D.1 to D.31). The hazard statements should stay as presented in this Annex, they should not be modified or merged.

Table D.1 — Explosives

Explosive typeUnstable

explosivesDivision 1.1 Division 1.2 Division 1.3 Division 1.4 Division 1.5 Division 1.6

Pictogram - -

Signal word Danger Danger Danger Danger Warning Danger -

Hazard statement

Unstable explosive

Explosive;mass explosion

hazard

Explosive; severe

projection hazard

Explosive; fire, blast or

projection hazard

Fire or projection

hazard

Mass can explode in fire

-

Table D.2 — Flammable gases

Category 1 2

Pictogram -

Signal word Danger Warning

Hazard statementExtremely

flammable gas Flammable gas



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Table D.3 — Flammable aerosolsCategory 1 2

Pictogram


Hazard statementExtremely flammable

aerosol

Flammable aerosol

Table D.4 — Oxidizing gases

Category 1

Pictogram

Signal word Danger

Hazard statementCan cause serious fire;

oxidizer

Table D.5 — Gases under pressure

Gas Compressed gas Liquefied gas Refrigerated gas Dissolved gas

Pictogram

Signal word Warning Warning Warning Warning

Hazard statement

Containsgas under

pressure; can explode if heated

Contains refrigerated gas;

can cause cryogenic burns

or injury

Contains refrigerated gas;

can cause cryogenic burns

or injury

Contains gas under

pressure; can explode if heated



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Table D.6 — Flammable liquids

Category 1 2 3 4

Pictogram -

Signal word Danger Danger Warning Warning

Hazard statementExtremely

flammable liquid and vapor

Highly flammable liquid

and vapor

Flammableliquid and vapor

Combustible liquid

Table D.7 — Flammable solidsCategory 1 2

Pictogram


Hazard statementFlammable solid

matterFlammable solid

matter

Table D.8 — Self-reactive substances and mixtures

Type A B C and D E and F G

Pictogram

There are no label elements allocated

to this hazard category

Signal word Danger Danger Danger Warning

Hazard statementCan explode

if heated

Can explode or become

flammable if heated

Can become flammable if

heated

May become flammable if

heated



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Table D.9 — Pyrophoric liquids

Category 1

Pictogram

Signal word Danger

Hazard statement

Ignites immediately in contact with air

Table D.10 — Pyrophoric Solids

Category 1

Pictogram

Signal word Danger

Hazard statement

Ignites immediately in contact with air

Table D.11 — Self-heating substances and mixtures

Category 1 2

Pictogram


Hazard statement

Self-heated matter; can

ignite

Self-heated matter in large quantities; may

ignite



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Table D.12 — Substances and mixtures that emit flammable gases in contact with water

Category 1 2 3

Pictogram

Signal word Danger Danger Warning

Hazard statement

In contact with water releases

flammable gases which may ignite spontaneously

In contact with water releases

flammable gases

In contact with water may

release flammable

gases

Table D.13 — Oxidizing liquidsCategory 1 2 3

Pictogram


Hazard statement

Can cause fire or explosion;

strong oxidizer

Can intensify fire; oxidizer

May intensify fire; oxidizer

Table D.14 — Oxidizing solids

Category 1 2 3

Pictogram


Hazard statement

Can cause fire or explosion;

strong oxidizer

Can intensify fire; oxidizer

May intensify fire; oxidizer



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Table D.15 — Organic peroxidesType A B C and D E and F G

Pictogram

There are no label elements

allocated to this hazard

category

Signal word Danger Danger Danger Warning

Hazard statement

Heating can cause an explosion

Heating can cause a fire or

explosion

Can ignite if heated

May ignite if heated

Table D.16 — Corrosive to metals

Category 1

Pictogram

Signal word Warning

Hazard statementMay be corrosive

to metals

Table D.17 — Acute toxicity - Oral

Category 1 2 3 4 5

Pictogram -

Signal word Danger Danger Danger Warning Warning

Hazard statement

Fatal if swallowed

Fatal if swallowed

Toxic if swallowed

Harmful if swallowed

May be harmful if swallowed



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Table D.18 — Acute toxicity - Skin Category 1 2 3 4 5

Pictogram -


Hazard statement

Fatal in contact with skin

Fatal in contact with skin

Toxic in contact with skin

Harmful in contact with

skin

May be harmful in contact with

skin

Table D.19 — Acute toxicity - Inhalation

Categoria 1 2 3 4 5

Pictogram -


Hazard statement

Fatal if inhaled Fatal if inhaled Toxic if inhaled Harmful if inhaled

May be harmful if inhaled

Table D.20 — Skin corrosive/Irritant

Category 1A 1B 1C 2 3

Pictogram -


Hazard statement

Causes severe skin burns and eye damage



Causes skin irritation

Causes mild skin irritation



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Table D.21 — Serious eye damage/eye irritation

Categoria 1 2A 2B

Pictogram -

Signal word Danger Warning Warning

Hazard statement

Causes serious eye damage

Causes serious eye irritation

Causes eye irritation

Table D.22 — Respiratory sensitization

Category 1

Pictogram

Signal word Danger

Hazard statement

When inhalated may cause alergic syntoms, asthma

or breathing difficulties

Table D.23 — Skin sensitization

Category 1

Pictogram

Signal word Warning

Hazard statement

May cause skin alergy



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Table D.24 — Mutagenicity

Category 1A 1B 2

Pictogram


Hazard statement

Can cause genetic defects (state route of exposure if it is

conclusively proven that no other routes of exposure cause

the hazard)

Can cause genetic defects (state route of exposure if it is

conclusively proven that no other routes of

exposure cause the hazard)

Suspected of causing genetic

defects (state route of exposure if it is

conclusively proven that no other routes

of exposure cause the hazard)

Table D.25 — Carcinogenicity

Category 1A 1B 2

Pictogram


Hazard statement

Can cause cancer (state route of exposure if it is


the hazard )

Can cause cancer (state route of exposure if it is


of exposure cause the hazard )

Suspected of causing cancer (state route of exposure if it is


the hazard)



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Table D.26 — Toxic to reproduction

Category 1A 1B 2

Additional Category on


Pictogram -

Signal word Danger Danger Warning -

Hazard statement

Can damage fertility or the

unborn child (state specific effect if

known) if…(state route of exposure if

it is conclusively proven that no other routes of

exposure cause the hazard )

Can damage fertility or the

unborn child (state specific effect if

known) if…(state route of exposure if it is conclusively

proven that no other routes of

exposure cause the hazard )

Suspected of damaging fertility

or the unborn child(state specific effect if known) if…(state

route of exposure if it is conclusively

proven that no other routes of exposure cause the hazard)

May cause harm to breast-fed children.

Table D.27 — Specific target organ systemic toxicity (single exposure)

Category 1 2 3

Pictogram

Signal word Danger Warning Warning

Hazard statement

Causes damage to organs (state all

organs affected, if known) if… (state

route of exposure if it is conclusively proven that no other routes of


May cause damage to organs

(state all organs affected, if known) if… (state route of exposure if

it is conclusively proven that no other routes of


May cause respiratory irritation

(respiratory tract irritation)

or May cause

drowsiness and dizziness (Narcotic

effects)



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Table D.28 — Specific target organ systemic toxicity (repeated exposure)

Category 1 2

Pictogram


Hazard statement

Causes damage to organs (state all organs affected,

if known) through prolonged or repeated

exposure (state route of exposure if it is


of exposure cause the hazard)

May cause damage to organs (state all organs

affected, if known) through prolonged or repeated exposure

(state route of exposure if it is conclusively

proven that no other routes of exposure cause the hazard)

Table D.29 — Aspiration hazard

Category 1 2

Pictogram


Hazard statement

Can be fatal if swallowed and enters airways

May be harmful if swallowed and enters

airways



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Table D.30 — Hazard to aquatic environment

Category 1 2 3

Pictogram - -

Signal word Warning - -

Hazard statement

Very toxic to aquatic life

Toxic to aquatic lifeHarzardous to

aquatic life

Table D.31 — Aquatic toxicity (chronic)

Category 1 2 3 4

Pictogram - -

Signal word Danger - - -

Hazard statement

Very toxic to aquatic life,

with prolonged effects

Toxic to aquatic life, with

prolonged effects

Harmful to aquatic life, with

prolonged effects

May cause long lasting harmful

effects to aquatic life



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ABNT NBR 14725-3:2009Anexo E (informativo) Frases de precaução

Annex E(informative)

Precautionary statements

This annex lists the preventive information frequently used in labeling (see Tables E.1 to E.4). This list was designed to expose examples of information that may be appropriate for certain labels for a specific substance or mixture. Suppliers can make use of those phrases they may consider most appropriate for each particular situation, taking into account the hazard(s) defined indicated by the product classification.

When a sentence contains words in brackets, any word within brackets in the sentence may be used in addition to the core information given.[Keep away from fire] or [Keep away from heat and sparks] or [Keep away from sparks and or flames], etc. Likewise, phrases of different groups can be used in combination, for example: [Keep away from heat and ignition sources and store in a cool and well-ventilated place].

NOTE It should be taken into consideration the experience of professionals related to the specific areas used to employ such precautionary statements.



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Table E.1 — Physical hazard statements

Liquids, solids and flammable gases

Ignition sources precautions

Keep away from fire [No smoking]

Keep away from heat [sparks] [and open flame] [No smoking]

Keep away from heat and ignition sources [No smoking]

Avoid heat and ignition sources [and oxidizers][No smoking]

Do not produce open flames or sparks and do not smoke

Take preventive measures against static charges

Use only non-sparking tools

Keep away from direct sun light

Keep away from flames and hot surfaces

Do not use or store near heat or flames

Use explosion-proof ventilating and lighting equipment

Container precautions

Keep container closed

Keep container closed when not using

Store container tightly

Keep only in the original container

Storage of containers or packings

Store in a cool place

Store in cool place at temperature not exceeding ...°C

Decomposes below the boiling point at…°C

Decomposes below the melting point at…°C

Keep container/package in well-ventilated place

Keep container/package tightly closed in a cool place [well -ventilated]

Keep container/package only in original packing, in a cool and well-ventilated place

Store in a cool place/low temperature, well ventilated [dry] [away from heat and ignition sources]

Suitable materials for packaging the product (storage and/or transport) are listed in FISPQ.

Range/limit of explosivity

May cause explosion if exposed at temperatures of about... °C

Store away from incompatible material

Do not store and/or transport with oxidizers [flammable] [corrosives] [oxygen] [explosives] [halogens] [compressed air] [acids] [bases] [intended additive] [etc]

FirefightingUse CO2, dry chemical or foam

In case of fire, use [...]

Liquid and pyrophoric solids of spontaneous ignition a

Keep in inert media (include name of inert media)

Do not allow contact with air

Protect from light, moisture and damage

Self-heating substances b Keep at a temperature not exceeding ... °C



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Table E.1 (continuing)

Substances and mixtures that emit flammable gases in contact with water a

Keep away from water

Keep recipient dry

Never add water to this product

No contact with water

Do not add water to contents while in a container because of violent reaction and possible spark.

Store in a dry place

Protect from moisture and damage

Handle in inert atmosphere (insert name of inert gas)

Protect from moisture

Liquids, solids and oxidizer gasesc

Mantenha afastado de material combustível

Keep away from (insert the name of incompatible material)

Keep from contact with clothing and other combustible materials to avoid fire

Prevent contamination with readily oxidizable materials and polymerization accelerators

Do not store near combustible materials

Drying of this product on clothing or combustible materials may cause fire

Put safety caps and shockproof rubber rings on cylinders in transport

Do not store and transport with flammable/combustible materials etc

Isolate from reducers and flammable/ combustible materials etc in storage

Do not store and transport with halogens and acids, etc.

Separate from reducers and finely powdered metals in storage and transport.

Organic peroxides c

Keep away from combustible material

Keep away from (insert the name of incompatible material)






Do not store and transport with flammable/combustible materials etc

Isolate from reducers and flammable/ combustible materials etc in storage

Do not store and transport with halogens and acids, etc

Separate from reducers and finely powdered metals in storage and transport

Keep away from chemicals specified by the manufacturer [relevant authority]



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Self-reacting substances

Keep away from heat

Store at temperature not exceeding ...°C

Keep away from heat.

Keep away from heat [sparks] [flame]

Keep away from heat and ignition sources

Keep away from ignition sources

Avoid heat and ignition sources


Keep away from combustible material

Keep away from (incompatible material to be specified by manufacturer)






Do not store and transport with flammable/combustible materials etc.

Explosives d

Avoid shock [impact], [friction], [and rough handling]

Keep away from fire


Explosive vapor/air mixtures may be formed above... °C

Gas/air or vapor/air mixtures are explosive

Finely dispersed particles form explosive mixtures with air

Do not use compressed air for filling, discharging or handling

Corrosive to metal (insert name of metal/alloy)

Suitable materials for containment (storage and transport) are listed in the FISPQ

Avoid contact with skin and eyesa Use phrases with any combination of the phrases "Liquids, solids and flammable gases".b Use phrases with any combination of the phrases "Liquids, solids and flammable gases", regarding the

"Containment and storage of the container or package", relating to store separately from incompatible materials.

c Use phrases with any combination of the phrases "Liquids, solids and flammable gases", regarding the "Containment and storage of the container or package", as appropriate.

d Use phrases with any combination of the phrases "Liquids, solids and flammable gases", regarding "Precautions against sources of ignition".



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Table E.2 — Statements to prevent potential misuse and exposure to health

Ventilation controls

Use only in ventilated areasUse only with adequate ventilation [or closed system ventilation]Do not enter areas where used or stored until adequately ventilatedUse only with adequate ventilation to keep exposures (airborne levels of dust, fume, vapor etc) below recommended exposure limits.Use adequate ventilation to remove vapors (fumes, dust etc).Use adequate ventilation and/or engineering controls in high temperature processing to prevent exposure to vaporsPrevent vapor build up by providing adequate ventilation during and after use[Use with] [ventilation], local exhaust ventilation [or breathing protection]Do not use in areas without adequate ventilationNever breath dust, vapor or mist

Hygiene measures

When using do not [smoke] [eat] [or drink]Do not eat, drink or smoke during workWash hands before eating [drinking] [or smoking]Wash thoroughly after handlingAvoid direct contactAvoid contact with [skin] [skin and eyes] [clothing]Wash thoroughly with soap and water after handlingWash thoroughly with soap and water after handling before eating, drinking, or smokingKeep out of reach of children and domestic petsBefore using, read carefully the label instructionsProduct is strictly for professional useKeep only in the original containerDo not reuse empty packages

Personal protection equipment (PPE)

Wear protective clothing (specify protective clothing)Wear protective gloves (specify protective gloves)Wear protective eyewear (specify type of protection)Wear appropriate personal protective equipment (specify type of personal protective equipment)Avoid direct contact

Respiratory protective equipment

In case of insufficient ventilation, wear suitable respiratory equipment (specify type of respiratory protective equipment)During fumigation/spraying, wear suitable respiratory equipment (specify type of respiratory protective equipment)Always wear a self-contained breathing apparatus or full-face airline respirator when using this chemicalWear a mask or pesticide respirator jointly approved by the relevant authorities



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Table E.3 — Statements explaining appropriate action in the event of an accident

Spills

In event of a spill, evacuate danger area

In event of a spill, consult an expert

To clean the floor and all objects contaminated by this material, use… (specify material)

Cover [Contain] the spilled material with…

Collect the spilled material and mark it for final disposal

Absorb remaining liquid with… (specify material)

Treat remaining liquid with… (specify material)

Do not wash away into sewer

Avoid run off to waterways and sewers

Allow product to cool/solidify and pick up as a solid

Sweep up and remove immediately

Use non-sparking equipment when picking up flammable spill, [remove all ignition sources]

Use adequate ventilation to remove vapors (fumes, dust etc)

Collect leaking liquid in containers (specify type of container)

Cautiously neutralize spilled liquid with… (specify neutralizer)

Vacuum spilled material

Sweep spilled substances into containers (specify type of container)

Do not absorb in saw-dust or other combustible absorbents

Never direct water jet on liquid

Firefighting

In case of fire use ... (specify type of firefighting equipment to be used)

Never use water because it increases the risks

Use CO2, dry chemical, or foam

Water can be used to cool and protect exposed material

Allow gas to burn if flow cannot be shut off

Shut off supply

Let the fire burn itself out

First-aid measures

General

In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible)

Have the product container or label with you when calling a poison control center or doctor, or going for treatment

Accident caused by inhalation

In case of accident by inhalation, remove casualty to fresh air and keep at rest [get medical attention immediately]

If inhaled, get medical attention immediately

If signs/symptoms continue, get medical attention

If breathing has stopped, apply artificial respiration under medical advice

If breathing is labored, administer oxygen under medical advice

If inahaled, give oxygen or artificial respiration and look for medical services

If inhaled, give… (specify antidote) and get medical attention

If person has breathing difficulties, call emergency telephone number…and get medical attention

Call a poison control centre or doctor for further treatment advice



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First-aid measures

Accident caused by ingestion

Obtain medical attention immediately if ingested

If swallowed, do not induce vomiting: seek medical advice immediately and show the container or label

If swallowed, seek medical advice immediately and show the container or label

If swallowed, rinse mouth with water [only if the person is conscious]

[Do not induce vomiting] [If conscious, give two glasses of water. Get immediate medical attention]

Drink [one glass] [two glasses] of water. Call a physician [or poison control center] immediately

Rinse mouth

Never induce vomiting

Give nothing to drink

Let the person rest and give and give plenty of water to drink

If ingested, call control center or doctor immediately for treatment advice

Do not give anything by mouth to an unconscious person

Accident caused by skin contact

After contact with skin, take off immediately all contaminated clothing and wash immediately with plenty of... [If irritation develops and persists, get medical attention]

If irritation develops, get medical attention

Immediately wash with mild soap in flowing water for 15 minutes. Flush skin with large amounts of water. [If irritation develops and persists, get medical attention]

Immediately flush skin with large amounts of water. Remove contaminated clothing. If irritation [redness, rash, blistering] develops, get medical attention

Wash contaminated clothing before reuse

Remove contaminated clothing and wash clothing before reuse

Remove contaminated clothing and wash clothing before reuse. Flush the contaminated area of body with large amounts of water

Wash the contaminated area of body with soap and fresh water

If contact occurs with body directly, immediately obtain medical attention

Flush with fresh water if contact with skin or eyes

Take off contaminated clothing

Rinse skin immediately with plenty of water for 15-20 minutes

Accident caused by contact with eyes

In case of contact with eyes rinse immediately with plenty of… [to be specified by manufacturer]

Immediately flush eyes for at least 15 minutes. Get medical attention

Hold eyelids apart and flush eyes with plenty of water for at least 15 minutes. Get medical attention

Flush eyes with water for at least 15 minutes while holding eyelids open

Remove contact lenses if worn. Get medical attention immediately

First rinse with plenty of water for several minutes. Remove contact lenses if easily possible. Get medical attention

If contact with eyes directly, flush with gently flowing fresh water thoroughly



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Table E.4 — Statements for environmental protection and appropriate disposal

Environmental protection

Use appropriate containment to avoid environmental contaminationAvoid release to the environmentDo not let this chemical/product enter the environment.Do not release directly in water coursesThis chemical is known to leach through soil into ground water under certain conditionsDo not allow contact with water courses or sewage

Information on final disposall

Dispose of this container to hazardous or special waste collection pointDispose of this material and its container as hazardous wasteDo not dispose of with household waste, trash or other solid wasteDispose of wastes in an approved landfill duly licensed by the relevant authoritiesThis material and its container must be disposed of in a safe wayFor queries about recovery/recycling, waste disposal of this product or contaminated packaging, consult/contact … [specify information source/contact]The recommended waste management options for this product are [reuse] [recycling] [incineration] [disposal in industrial landfill] [etc]



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ABNT NBR 14725-3:2009Anexo F (informativo) Exemplos ilustrativos de rótulos

Anexo F(informative)

Illustrative examples of labels

NOTE This Annex provides examples of the GHS information on labels of hazardous chemicals. These examples do not encompass all information required by other regulations.

F.1 Combination packaging for a Category 2 flammable liquid

NOTE The proper hazard pictogram required for product classification, indicated in Annex D, can also be inserted

Figure F.1 — Outer packaging: Box with transport label for flammable liquid (Risk Class 3) (see ABNT NBR 7500)


UM 1993

Líquido inflamável

Nome comercial e nome técnico

NOME COMERCIAL E NOME TÉCNICO

Indicação do produto e telefone de emergência, ver B.1 e B.2

Palavra de advertência, ver Anexo D

Hazard statement, ver Anexo D

Frase de precaução, ver Anexo E

“A ficha de informações de Segurança de Produtos Químicos deste produto químico perigoso pode ser obtida por meio de ...

Composição química, ver B.3

"The Material Safety Data Sheet for Chemical Products of this hazardous chemical can be obtained through…"

UM 1993Flammable liquid

Trade name andtechnical name

TRADE NAME AND TECHNICAL NAME

Chemical composition; See B.3

Product identification and supplier's emergency telephone (See B.1 and B.2)

Signal word; See Annex D

Hazard statement; See Annex D

Precautionary statement; See Annex E



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Figure F.2 — Inner packaging: flammable liquid glass bottle with GHS label(Category 2) (see 5.1)


Product identification and supplier's emergency telephone, see B1 and B2

Signal word, see Annex D

Hazard statement, see Annex D

Precautionary Statement, see Annex E

Chemical composition, see B.3


"The Material Safety Data Sheet for Chemical Products of this hazardous chemical can be obtained through…"The Material Safety Data Sheet for Chemical Products of this hazardous chemical can be obtained through…


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F.2 Inner packaging: Category 2 flammable liquid and Category 2 skin irritant

NOTE Hazard pictograms are shown in Annex D

Figure F.3 — Inner packaging: 200 L drum with GHS label and transport label





Product identification and supplier's emergency telephone (See B.1 and B.2)




UN 1993 Flammable liquid TradenameandTechnical name


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F.3 Overwrapping with two combined packages: one with flammable liquid Category 2 and another containing a skin irritant Category 2

NOTE Boxes A and B are inside box C

Figure F.4 – Overwrapping: cardboard box with GHS label and transport label


Label 1

Label 2

UM 1993Flammable liquidTrade name and technical name


Product identification and supplier's emergency telephone (B.1 and B.2)












Product identification and supplier's emergency telephone (B.1 and B.2)


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F.4 Product label

Ch

emic

al c

om

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and

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May

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and

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NOTE The information on this hazardous chemicals label pertains only to this section of ABNT NBR 14725

Figure F.5 — Product classified as Category 2 flammable liquid, acute inhalation toxicity category 4 and systemic toxicity through repeated exposure category 2 to the target organ



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Bibliography


[2] GHS book, Globally Harmonized System of Classification and Labeling of Chemicals (GHS) - Purple Book, 2005

[3] SANS 10234:2007, Globally Harmonized System of classification and labeling of chemicals (GHS) - South African Standard



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STANDARDABNT NBR

14725-4




Chemicals — Information about safety, health and environmentPart 4: Ficha de informações de segurança de produtos químicos (FISPQ)

Chemicals – Information about safety, health and environmentPart 4: Safety data sheet for chemicals (SDS)

ICS 71.100.01 ISBN 978-85-07-01706-6



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ABNT NBR 14725-4:2009

BRAZILIANASSOCIATIONTECHNICALSTANDARDS

Número de referênciaABNT NBR 14725-4:2009

21 páginas

© ABNT 2009



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© ABNT 2009All rights reserved.. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without prior written permission from ABNT.






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Contents Página

Foreword................................................................................................................................................................... iv

Introduction............................................................................................................................................................... v

1 Scope.......................................................................................................................................................... 1

2 Normative references................................................................................................................................ 1

3 Terms and definitions............................................................................................................................... 1

4 General considerations............................................................................................................................. 1

5 Content and general model of a SDS (FISPQ).........................................................................................2

Annex A (normative) Instructions for preparation of the Safety Data Sheet (FDS)............................................4

Annex B (informative) SDS orientative model for chemicals.............................................................................15

Bibliography............................................................................................................................................................ 21



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Foreword




Their 1st Project was sent to a Nationwide Query according to the Invitation to Bid no. 12, carried out from 12/21/2007 until 02/18/2008, with the Project number 10:101.05-005, whereas the 2nd. Project was also sent to Nationwide Query through the Invitation to Bid no 09, carried out from 09/02/2008 until 10.01.2008 named 2nd for Project 10:101.05-005.

The ABNT NBR 14725 standard entitled Chemical Products - Information on Safety, Health and Environment ("Produtos químicos - Informações sobre segurança, saúde e meio ambiente") is expected to approach the following::


— Part 2: Hazard Classification System;


— Part 4: Material Safety Data Sheet - MSDS.

WARNING - the Material Safety Data Sheet - MSDS can be in agreement with the previous edition of this Standard (ABNT NBR 14725:2005) until 02.20.2011. From 02.27.2011, they must comply only with this issue (ABNT NBR 14725-4:2009.





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Introduction

The information document security (MSDS) provides information on various aspects of chemical substances (or mixtures) in the protection, safety, health and to the environment. Under such perspectives, MSDS provides the basic knowledge about chemicals, recommendations on protective measures, and actions in emergency situations. In some countries, this sheet is known as Safety Data Sheet (SDS). Along this part of ABNT NBR 14725, FISPQ is the term used for MSDS. The FISPQ is also known as Sheet of/with Safety Data (FDS).

The FISPQ is a way for the supplier to transfer essential information to the user about the dangers of a chemical (including information on transportation, handling, storage and emergency action), giving him/her the chance to take the necessary measures related to safety, health and environment. The FISPQ can also be used to transfer these information to workers, employers, health and safety professionals, emergency personnel, government agencies, and community members as well, besides institutions, services and other parties involved with the chemicals.

This part of ABNT NBR 14725 establishes the conditions to create consistency in providing information on security issues, health and environment related to chemicals.

Certain requirements have been defined aiming at establishing uniformity on how the product information should be presented (eg, terminology, and the numbering sequence of the sections).

This part of ABNT NBR 14725 is flexible to be adapted to the several editing and publishing systems to transmit the text.

Focusing the obligations of FISPQ towards hazardous chemicals are beyond the scope of this part of ABNT NBR 14725. However, we have included some of them aiming at clearly establishing the difference between the obligations of FISPQ supplier and the duties of the FISPQ user.


Decree 2657 of July, 3rd, 1998, which issued the Convention No.170 of the International Labour Organization (ILO) establishes some responsibilities for the implementation of the ABNT NBR 14725 standard.

The preparation of the ABNT NBR 14725 was based on the following basic assumptions of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS):

— There is a need to provide information on hazardous chemicals concerning safety, health and environment;

— The target public has the right to know and identify the hazardous chemicals they use and the dangers they offer;

— A simple and easy to understand system of identification should be applied in the different locations where the hazardous chemicals are used;

— Such system should be compatible with the classification criteria for all hazards that might be anticipated by GHS;

— International agreements should be facilitated and industrial secrets and confidential information should be protected;

— There is a need to train workers and to improve their capability and

— It is required to foster users' education and awareness.



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Chemicals — Information about safety, health and environment Part 4: Material Safety Data Sheet (FISPQ)

1 Scope

This part of ABNT NBR 14725 has information related to the preparation of sheets about the safety of chemicals (MSDS).

This part of ABNT NBR 14725 particularity defines:

— The FISPQ general presentation model;

— The 16 mandatory sections of a FISPQ;

— The numbered order and the sequence in which the FISPQ is presented;

— The FISPQ information to be filled out and how they should be applied and used.

This part of ABNT NBR 14725 does not define a FISPQ fix format.



Approval of the Metrological Regulation of Units of Measurement, (Conmetro Resolution 11 of 10.12.1988)

Adoption of the General Table of Measurement Units and Use of the International Unit System - SI (Conmetro Resolution 12 of 10.12.1988)


ABNT NBR 14725-2, Chemicals — Information about safety, health and environment Part 2: Hazard Classification System


The terms and definitions of ABNT NBR 14725-1 are relevant for this part of ABNT NBR 14725.

4 General considerations

The FISPQ should be applied as a whole to the chemical product.



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The FISPQ is not a confidential document. It is not necessary to inform the full composition of the chemical, but aiming at not compromise the health and safety of users, and to protect the environment, all information concerning to establish the safe use of a substance or mixture, no matter how confidential such information might be, should be provided.

The conditions adopted for the protection of trade secrets should not compromise the health and the safety of workers or consumers, or the environmental protection. For this reason, the dangers associated with hazardous chemicals covered by these criteria must be disclosed on the report, even though the information about the composition of the hazardous chemical is not fully provided.

The supplier must make available to the receiver / user the complete FISPQ reporting relevant information on safety, health and environment. In the case of changes in the composition of the chemical entailing changes in its hazard classification, yet maintaining its trade name, the vendor must provide the various versions of that FISPQ related to the products on the market and ensure that the chemical use is correct and pertinent to aforementioned FISPQ.

The preparation of the FISPQ requires product specific expertise in relation to the requirements of this part of the ABNT NBR 14725.

The user of the FISPQ is responsible for acting in accordance with a risk assessment considering the conditions of product use, taking the necessary precautionary measures in a given situation at work and keeping the workers informed about the risks relevant to their workplace.

The FISPQ user is responsible for choosing the best way to inform and train workers, at least, regarding the product identification, composition, hazard identification, first aid measures, fire fighting measures, control measures to avoid spilling or leakage, instructions to handle and store the product, exposure control measures and personal protection, information on the chemical stability and reactivity, toxicological information and considerations for treatment and disposal. When formulating the instructions specific to the workplace, the receiver must take into account the relevant recommendations of the FISPQ for each product.

The quantitative information contained in the description must be expressed by the International System of Units (SI).

NOTE The description serves as a basis for preparing the label and the emergency form, rather than replacing these documents.

5 Content and general model of a FDS

The information in the FDS (Ficha de Dados de Segurança [Safety Data Sheet SDS]) should be presented using the following 16 headings in the order given below.

1. Identification

2. Hazard(s) identification

3. Composition/information on ingredients

4. First-aid measures

5. Fire-fighting measures

6. Accidental release measures

7. Handling and storage

8. Exposure controls/personal protection

9. Physical and chemical properties

10. Stability and reactivity



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11. Toxicological information

12. Ecological information

13. Disposal considerations

14. Transport information

15. Regulatory information

16. Other information

Each SDS section correspondent to its standard title should be completed in accordance with the instructions and recommendations in Annex A (chemical).

A SDS sample model is provided in Annex B.



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Anexo A (normativo) Instruções para a elaboração de uma FISPQ

Annex A(normative)

Instructions for preparation of the Safety Data Sheet (FDS)

The instructions in this Annex should be followed for the preparation of a SDS. The purpose of this Annex is to ensure that the contents of each section can enable users to take the required measures related to security, health and environment.

The 16 sections of the SDS must be completed in accordance with the recommendations and requirements of this Annex.

Each SDS section can be divided by subheadings. However, unlike the 16 standard titles, subheadings are not required.

The 16 sections should be clearly separated. Headings and subheadings should have detachable presentation.

This Annex lists the major subheadings used to complete the 16 sections. The SDS may have additional subheadings.

The subheadings terminology is not mandatory, it is recommended.

Information not specific related to one of the subheadings listed in this Annex, but deemed relevant to the SDS, can be presented in an additional subheading named, for instance, "other information" or "specific data".

Such information, relevant to safety, health and environment, should be provided for each one of the 16 sections. The reason for unavailability of certain information should be explained. Blanks are not allowed, except in Section 16, "Other information". Sources of information do not necessarily need to be mentioned, except as noted in this part of ABNT NBR 14725.

Each SDS page should include the product name as used on the product label and should be numbered and dated. The system for numbering the pages should point out the total number of pages, or indicate the last page as such. The date mentioned should correspond to the last revision.

SDS texts should be written in Portuguese (Brazil), capable to be read and in an understandable, clear and concise language. Common phrases are recommended.

1. Identification of the substance or mixture and of the supplier

This section should inform the product name (trade name) as used in the chemical label, the supplier product code if existent, as well as the supplier company name, its address and the contact telephone number of one of the company units. The supplier emergency telephone number should be given. The fax number and e-mail of the company may be given, as well.

2. Hazards identification

This section should present clearly and concisely the hazards and the most relevant effects of the product (adverse effects on the human health, environmental effects, physical and chemical hazards) and when appropriated, it should present the specific hazards. The main symptoms can be informed also.

The chemical classification of the product and the classification system used should be informed. The product classification should be done following the guidelines of the ABNT NBR 14725-2.



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A general view of the emergency situations should be provided, as well.

Based on the classification, the proper elements to accomplish the labeling (symbol name, signal(s) word, hazard statements and precautionary statement) should be provided.

3. Composition/information on ingredients

This section should inform if the chemical is a substance or a mixture.

Should it be a substance, the chemical name or the common name should be given. At least one synonymous, if existent, and the register number in the Chemical Abstract Service (CAS) should be provided. Impurities contributing to the hazard should be pointed out also, together with the respective CAS register.

In case of a mixture, the chemical nature of the product should be informed. It is not required to inform the complete composition of the mixture. Ingredients or impurities contributing to the hazardous nature of the chemical should be informed, including its chemical or common name, the CAS register number and its concentration or concentration range, provided that they are participating in the mixture in higher concentration than the concentration cut off/limits defined for each hazard class in Table A.1. The classification of the mixture can be obtained based on the classification of the ingredients contributing to the hazard.

Table A.1 - Cut-off values/Concentration limits for each health and environmental hazard class

Hazard classCut-off value

/Concentration Limit%

Acute toxicity ≥ 1,0

Skin corrosion/Irritation ≥ 1,0

Serious damage to eyes/eye irritation ≥ 1,0

Respiratory/Skin sensitization ≥ 1,0

Mutagenicity: Category 1 ≥ 0,1

Mutagenicity: Category 2 ≥ 1,0

Carcinogenicity ≥ 0,1

Reproductive toxicity ≥ 0,1

Specific target organ systemic toxicity (single exposure) ≥ 1,0

Specific target organ systemic toxicity (repeated exposure) ≥ 1,0

Hazardous to the aquatic environment ≥ 1,0

Should any ingredient contributing for the hazard is bind by Confidential Business Information ─ CBI (in Brazil, besides trade secret, also used "commercial secret", "industrial secret"), according with the existent relevant regulations, the supplier will not be required to inform the chemical name or the common name, the CAS register name and the concentration or concentration range of such ingredient in the FISPQ of such hazardous chemical product to abide the CBI requirements. However, the associate hazards to such ingredient(s) should be informed.

When any information regarding the composition is omitted due to the prevailing trade secret, an informative phrase should be inserted, such as: "Confidential information retained", "Industrial secret", "Confidential information".



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4. First aid measures

This section should inform the first aid measures to be taken and point out which action should be avoided. The information should be simple to be easily understood to both, to the victim and to the person giving help.

The information should be divided according to the exposition routes, e.g., inhalation, skin contact, eye contact and ingestion.

When pertinent, recommendation should be given to protect the helper person and/or to call the medical attention through annotations. "Annotation to call medical attention" above mentioned refer to measures that should only be executed by or under such professional


This section should inform the fire extinguishing media deemed recommended and those not recommended.

All specific hazards related to the measures and the special firefighting methods, and the special equipment required for protection of the people involved in the firefighting, should be pointed out.

The specific hazard situations that may arise during a chemical combustion should be pointed out, as well.

6. Accidental release control of spilling and leakage

This section should inform on the following:

— Specific instructions related to personal precautions (e.g., removal of ignition sources, dust control, prevention of inhalation and skin contact, mucous membranes, and eyes) in cases of spilling and leakage (see FISPQ, Section 8);

— Measures to be taken related to precautions to protect the environment (e.g., preventing inflow through obstacles, containing barriers, ditches) keeping the discharge from reaching sewers, soil and water courses.

— emergency measures and alarm systems (e.g., need to leave the area);

— Cleaning up measures (e.g., collection, neutralization, decontamination, absorbent materials and vacuum dust aspiration). The accomplishment of the final disposal should follow the steps of FISPQ, Section 13.

These information should include prevention of subsidiary hazards (e.g., ignition sources, spark proof tools, etc).

Distinctions should be made between control measures against large and small spills or leaks.


This sections provides guidance concerning the handling and storage of a substance or mixture as follows:

a) Handling:

1) This item should describe the appropriate handling methods (work exposure prevention, fire and explosion prevention) and precautions for the safe of the chemical, such as local and total ventilation, and measures to prevent airborne particles, vapors and gases. It should bring forth guidance for the safe handling, such as how to avoid contact the contact with incompatible materials and environment contaminations;

2) This item should outline the appropriate and inappropriate general warnings, as well (e.g., general hygiene such as keeping from eating, drinking, and smoking in the work place; removal of contaminated clothing and protection equipment before entering feeding areas);

b) Storage:

11) This section should describe suitable and unsuitable technical measures for storage ;

2) The given recommendation should be consistent with the physical and chemical properties (see FISPQ, Section 9). If the recommendations are deemed pertinent, specific recommendation addressed to the —How to avoid explosive atmospheres, corrosivity, flammability, incompatibilities, evaporation and ignition sources;



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— Environmental conditions of the storage (e.g., pressure, temperature, sun light, and moisture);

— How to keep the integrity of the substance or mixture using stabilizers and antioxidants;

— Other recommendations: For instance, ventilation requirements, specific designs for locals/storage containers, and compatible packages

8. Exposure controls/personal protection.

This section should indicate specific control parameters for substance or ingredients of the mixture (see FISPQ, Section 3), such as tolerance, limits and/or exposure biological indicators or other limits and values, jointly with the pointed references, preferably dated.

The chemical or common name or the CAS register number, as specified in Section 3 of FISPQ, should be used when listing the occupational exposure limits.

Control engineering measures for elimination or risk minimization, if pertinent, also should be pointed out.

The description of the engineering controls should report the conditions of use of the substance or mixture. It is necessary to perform a risk assessment before establishing which engineering controls are recommended. For example:

a) maintain air concentrations below occupational exposure standards

b) use general ventilation system or local exhaust ventilation;

c) use only in an enclosed system or hermetic system;

d) use only in booth;

e) use mechanical handling to reduce human contact with materials, or

f) use explosive dust handling controls.

The information provided in this section should complete Section 7 of FISPQ.

According to the good practices of occupational hygiene, the Personal Protection Equipment (PPE) should be used jointly with other control measures, including the engineering controls (see Section 5 of FISPQ).



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Identification of the required PPE to minimize potential health hazards due to exposure to the substance or mixture, including:

a) Eyes and face protection: Specify the kind of eye and/or face protection commensurate to the hazard presented by the substance or mixture and its contact potential;

b) Skin protection: Specify the protection equipment to be used (e.g., glove type, shoe, body protection) based on hazard- associated to the substance or mixture and its contact potential;

c) Respiratory protection: Specify the kind of respiratory protection based on hazard and exposure potential, including respiratory protection equipment supported by dependent (filter masks cartridges) or independent (self-sustained) equipment.

d) Extreme upper or lower temperatures (thermal danger): The specific PPE for such condition should be informed whenever the product presents as thermal hazard. Example: Organic peroxides.

Special requirements may prevail for gloves or other protection clothing to prevent skin, eye or lung exposure. This type of PPE should be clearly specified, if pertinent, e.g., PVC gloves or nitrile rubber gloves, thickness and wear down time of the glove material. It may be necessary to provide special requirements for Personal Protection Equipments (PPE).

This section should mention the PPE required for the treatment and disposal of product wastes and used packages, according FISPQ, Section 13.

If the PPE for handling and storage of the hazardous chemical is different from the PPE for emergency care, it should be specified in this section.


This section should include information about the chemical.

In the case of a mixture, it should be clearly pointed out to which ingredient the information is applicable, unless if it is valid for the mixture as a whole.

The properties listed below should be clearly identified as well as their measurement units according to International System of Units (SI) and Conmetro Resolutions 11 and 12. Other units also may be used, but only as additional information. The determination method should be informed as well, if pertinent for the interpretation of the numeric value (for instance, the flash point, method of the closed or open vessel).

This section should contain the following items jointly with their respective information:

— Appearance (physical state, color);

— Odor threshold;

— pH;

— Melting point/freezing point;

— Initial boiling point and boiling range;

— Flash point;

— Evaporation rate;

— Flammability;



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— Upper/lower flammability or explosive limits;

— vapor pressure;

— vapor density;

— density;

— solubility;

— Partition coefficient: n-octanol/water;

— Auto-ignition temperature;

— Decomposition temperature;

— Viscosity.

If specific characteristics do not apply or are not available, they should be listed as "not applicable" or "not available" and if any item is not applicable or is not available it should be mentioned "not applicable" or "not available". Other physical or chemical parameters in addition to those listed above may also be included in this section.


This section should outline:

a) Chemical stability

— Indicate if the substance or mixture is stable or unstable under the normal conditions of temperature and pressure. Indicate in which temperature and pressure, during the storage or handling, the substance or mixture is stable or instable;

b) Reactivity

— Describe the reactivity hazards of the substance or mixture in this section. If data for mixtures are not available, ingredient data should be provided;

c) Possibility of hazardous reactions

— If relevant, state if the substance or mixture will react or polymerize, releasing excess pressure or heat, or creating other hazardous conditions. Describe under what conditions the hazardous reactions may occur. Also, state under which conditions hazardous reactions may occur;

d) Conditions to be avoided

— List conditions to be avoided, such as: temperature, pressure, shock/impact/attrition, light, static discharge, vibrations, aging, moisture or other conditions that might result in a hazardous situation;

e) Incompatible materials:

— List classes of chemicals or specific substances with which the substance or mixture could react to produce a hazardous situation (e.g. explosion, release of toxic or flammable materials, liberation of excessive heat);

— In the determination of incompatibility, the contamination that a substance or mixture can be exposed during its transportation, storage and use should consider also its container;

f) Hazardous decomposition products

— List known hazardous decomposition products produced as a result of use, storage and heating;

— Hazardous combustion products should be included in Section 5 of FISPQ.



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This section is used primarily by medical professionals, toxicologists and occupational health safety professionals. It should be provided a concise but complete and comprehensible description of the various toxicological effects, as well as the available data used to identify those effects.

According to ABNT NBR 14725-2, it should be provided, if relevant:

— Acute toxicity;

— Skin corrosion/Irritation;

— Serious damage to eyes/eye irritation;

— Respiratory/Skin sensitization;

— Germ cell mutagenicity;

— Carcinogenicity;

— Toxicity to reproduction and lactation;

— Specific target organ systemic toxicity (single exposure);

— Specific target organ systemic toxicity (repeated exposure);

— Aspiration hazard.

It should be stated if any of these hazards are not available.

The data included in this section should apply to the substance or mixture.

It should be provided the toxicological data should of the mixture. If that information is not available, it should be provided the toxicological properties of the hazardous ingredients.

The health effects included in the FISPQ should be consistent with those described in the studies used for the classification of the substance or mixture.

General statements such as “Toxic” (without supporting data justifying such classification) or “Safe if properly used” are not acceptable. Phrases such as “not applicable”, “not relevant”, or leaving blank spaces in the health effects section can lead to confusion and misunderstanding and should not be used.

It should be describe the product effects and the relevant distinctions to health. For example, allergic contact dermatitis and irritant contact dermatitis should be distinguished from each other.

When there is a substantial amount of test data on the substance or mixture, the results should be summarize.

Also provide information in the case of negative results of the test data of the substance or mixture, e.g. “carcinogenicity studies in the rat have shown no significant increase in the incidence of cancer”.

This section should outline:

a) Routes of exposure:

— Inform routes of exposure (inhalation, ingestion and skin/eyes exposure) and the effects of the substance or mixture for each of them. A statement should be made if health effects are not known.

b) Inform symptoms related to the physical, chemical and toxicological characteristics:

— Describe the potential adverse effects to health and the symptoms associated to exposure to the substance or mixture and to their ingredients or known by-products;



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— Supply information about the symptoms related to the physical, chemical and toxicological of the substance or mixture according to its use. Describe the symptoms observed in both, exposure to low concentrations / doses, and more severe exposures. For example: “Headaches and dizziness may occur, proceeding to fainting or unconsciousness; large doses may result in coma and death”

c) Delayed or immediate effects and also chronic effects consistent with short and long exposures periods:

— Supply information whether delayed or immediate effects should be expected after short or long exposures periods;

— Also, supply information about acute and chronic effects related to human exposure to the substance or mixture. Whenever human data is not available, animal data should be summarized and the species clearly identified. It should be indicated if the toxicological data was obtained from human data or animal data.

d) Inform about the toxicological data (such as acute toxicity estimates);

— Provide information on dosages, concentration and exposure conditions which may cause adverse effects on health;

— Dosages should be associated to symptoms and effects, including the most likely exposure period to be harmful;

e) Substances that may cause interaction, addition, potentiation and sinergy:

— Information about reactions is to be included, if pertinent and available;

f) Not available specific chemical data:

— Not always the information about the hazards of a substance or mixture can be obtained. When the data from the substance or mixture are not available, chemical class data can be used on, if appropriate. It should be mentioned when general data are either used or not available;

g) Mixtures

— if a mixture is not tested for its effects on health as a whole, then the information of each ingredient listed in Section 3 of the FISPQ should be provided and the mixture should be classified according to ABNT NBR 14725-2, i.e., mixture of ingredients versus information about the ingredients.

NOTE Ingredients can interact among themselves in the organism producing different rates of absorption, metabolism and elimination. As a result, toxic actions may be modified and the ultimate toxicity of the mixture may be different of its ingredients.

— It is required to take into account if the concentration of each ingredient is sufficient to contribute to the final effects of the mixture upon health.

— The information about the toxic effects should be presented for each ingredient, except:

1) If the information is duplicated is it required to list it just once. For instance, if two ingredients cause vomiting and diarrhea, it will not be necessary list that ingredient twice. The mixture is generally described as causing vomiting and diarrhea;

2) If it is not likely that the effects occur in the existent concentrations. For example, for example, when a mild irritant is diluted in a non-irritating solution, the overall mixture would be unlikely to cause irritation.

3) Anticipate the interactions among ingredients is extremely difficult, and when the information on the reactions is not available, it is not possible to make assumptions;

i) Other information:

— Other pertinent information about adverse effects should be included, even when not required by ABNT NBR 14725-2.



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Information should be provided to assess the environmental impact of the substance or mixture when released to the environment.

This information can help in cases of leaks / spills, as well as in waste management practices

This section should clearly point out species, medium, units, conditions and duration of tests.

Some ecological properties of specific substances, such as bioaccumulation, persistence and degradability should be provided, when available, for each ingredient of the mixture.

A data summary should be provided, as follows:

a) Ecotoxicity:

— Ecotoxicological information may be provided using data from tests in aquatic and/or terrestrial organism. This information should include the relevant data available relevant to acute and chronic aquatic toxicity for fish, crustaceans, algae and other aquatic plants;

— Data on toxicity to other organisms should be included when available, (also mentioning soil micro and macro-organisms such as birds, bees and plants);

— If a substance or mixture has inhibitory effects on the activity of microorganisms, it should be mentioned that this may have an impact on wastewater treatment plants.

b) Persistence e degradability:

— Degradability tests results deemed relevant should be make available;

— When the half-life of degradation of a substance is determined, it should be indicated if it was obtained through testing of degradation by mineralization or by primary degradation;

— It should be mentioned the potential of the substance or of certain ingredients of the mixture to undergo degradation in wastewater treatment plants.

c) Bioaccumulation potential:

— Bioaccumulation tests results deemed relevant should be make available. These results should include, if available, reference to testing partition coefficient n-octanol-water (Kow) and for the bioconcentration factor (BCF).

d) Mobility in soil

— It should be provided the results obtained from tests of adsorption and leaching, such as assays on the partition coefficient n-octanol-water (Kow), if considered relevant. Leaching and mobility can also be obtained from theoretical models. Actual data of the substance or mixture, when available, outweigh the theoretical models.

e) outros efeitos adversos:

— When available information exists on other adverse effects to the environment, it should be included, for instance: Environmental damages; potential decrease of the ozone layer; photochemical ozone formation potential; endocrine disrupting potential and the global-warming potential.

13. Considerations regarding treatment and disposal

This section should inform the recommended methods for treatment and safe disposal and environmentally approved.

These methods of treatment and disposal (e.g., co-processing, incineration, etc) should be applied to the product, waste products and packaging used.



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The user should be reminded about the possible existence of local regulations for treatment and disposal.


This section should inform on code and classifications in accordance to national and international regulations for transport through different systems, such as:

a) Terrestrial (rail line, highways): National Land Transport Agency (ANTT) ;

b) Waterway (maritime, inland shipment through rivers and lakes): IMDG code (International Maritime Dangerous Goods Code); DPC Standard 5 (Brazilian Directorate of Ports and Coasts of the Brazilian Navy); ANTAQ (National Water Transportation Agency);

c) Aerial: ICAO-TI (International Civil Aviation Organization - Technical Instructions), IATA-DGR (International Air Transport Association ─ Dangerous Goods Regulations); DAC (Department of Civil Aviation)

For products classified as hazardous for transport , it should be pointed out, when suitable and depending upon the modal:

a) UN number;

b) Suitable shipment name;

c) Main and subsidiary class/subclass risks, if pertinent;

d) Risk number;

e) Packing group;

f) Other specific information, for instance, indicate whether the substance or mixture is known as a marine pollutant for waterway transport (IMDG Code), terrestrial or aerial..

Additional regulations may be mentioned.

It should be inform, if deemed significant, the measures and precautionary conditions specific to the transport. .

Information on transport modal mentioned in this section should be written in Portuguese (Brazil) and, when deemed necessary, in English.

15. Regulations

This section should contain information about regulations specifically applicable to the chemical product.

The user should be reminded about the possible existence of local regulations for treatment and disposal.

Any other regulatory information on the chemical that is not covered elsewhere in this part of ABNT NBR 14725 should be described, if deemed applicable, for example: Requirements from the Ministry of Health (ANVISA), Ministry of Defense, Federal Police Department, Mercosur Agreement, and from the Chemical Weapons Convention, Stockholm Convention, Rotterdam Convention, Montreal Protocol, Kyoto Protocol, etc.


This section should provide any other information that may be significant from the standpoint of safety, health and environment, but not specifically relevant to the previous sections. For example, it may be indicated the recommended use and possible restrictions to the chemical to comply with special needs of training.

References may be pointed out.

Legends of labels and abbreviations used in the FISPQ should be discussed in this section.



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Annex B(informative)

SDS orientative model for chemicals

Heading (at the beginning of every page)

Name of the chemical

FISPQ number

Page x/xx

Date of last revision

1. Identification of the substance or mixture and identification of the supplier

— Chemical names and common names (product trade name)

— Product code

— Name of the company

— Address

— Contact telephone number

— Emergency telephone number

— Fax

— E-mail

2. Hazards identification

— Most relevant hazards

— Product effects

— Adverse human health effects

— Environmental effects

— Physical and chemical hazards

— Specific hazards

— Main symptoms

— Chemical hazards classification and classification system used

— Emergency overview

— Suitable elements for labeling



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3. Composition and Information on Ingredients.

— Define whether the chemical is a substance or a mixture

If it is a substance:

— Chemical name or common name

— Synonymous

— CAS number

— Impurities contributing to the hazard (together with the CAS number)

If it is a mixture:


— Chemical nature

— Ingredients contributing to the hazard or impurities contributing to the hazard


— CAS number

— Concentration or concentration range

— Hazard classification

— Classification system used

4. First-aid measures

— First-aid measures

— Inhalational

— Skin contact

— Eye contact

— Ingestion

— Conditions to be avoided

— Protection of first-aiders

— Notes to a physician


— Suitable extinguishing media

— Not suitable extinguishing media

— Specific hazards related to the measures

— Special methods of fire fighting

— Protection of firefighters

— Specific hazards of chemical combustion of the product



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6. Spill / leakage prevention control

— Personal Precautions

— Environmental precautions

— Emergency measures and alarm systems

— Methods for cleaning up

— Subsidiary hazard prevention

— Actions difference in case of leakages: significant leakages against less significant leakages


— Handling

— Suitable technical methods

— Worker exposure prevention

— Fire and explosion prevention

— Precautions and guidelines for safe handling

— Hygiene measures

— Suitable hygiene measures

— Not suitable hygiene measures

— Storage

— Technical measures

— Suitable conditions


— Packaging materials

— Recommended

— Unsuitable



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8. Exposure controls / personal protection

— Specific control parameters

— Occupational exposure limits

— Biological indicators

— Other limits and values

— Engineering control measures

— Suitable Personal Protection Equipment (PPE)

— Eyes and face protection

— Skin and body protection

— Respiratory protection

— Special precautions


— Appearance (physical state, color)

— Odor

— pH

— Melting point / freezing point

— Initial boiling point and boiling temperature range

— Flash point

— Evaporation rate

— Flammability

— Lower / upper flammability or explosive limit

— Vapor pressure

— Vapor density

— Density

— Solubility

— Partition coefficient n-octanol/water

— Self-ignition temperature

— Decomposition temperature

— Viscosity



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— Chemical stability

— Reactivity

— Possibility of hazardous reactions


— Incompatible materials or substances

— Hazardous decomposition products


— Information according to the different exposure routes

— Acute toxicity

— Chronic toxicity

— Main symptoms

— Specific effects

— Substances that may cause

— Interaction effects

— Additive effects

— Potentiation effects

— Synergistic effects


— Environmental, behavioral and product impacts

— Ecotoxicity

— Persistence and degradability

— Bioaccumulation potential

— Mobility through soil

— Other adverse effects

13. Disposal and treatment considerations

— Recommended treatment and disposal methods to the:

— Product

— Product wastes

— Used packages



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— National and international regulations

— Terrestrial

— Waterway

— Aerial

For products classified as hazardous for transport (modal-dependent)

— UN number

— Suitable shipment name

— Main and subsidiary class/subclass risks

— Risk number

— Packing group

— Additional recommendations

15. Regulations

— Chemicals-specific regulations


— Significant information, yet not specifically related to the previous sections

— Bibliographic references

— Labels and abbreviations



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Bibliography


[2] GHS book, Globally Harmonized System of Classification and Labeling of Chemicals (GHS) - Purple Book, 2005


EnglishAll4 1.2.3.4-2009-Versao-Corrigida-2010 Pt.br en HFS (9)

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Transcript of EnglishAll4 1.2.3.4-2009-Versao-Corrigida-2010 Pt.br en HFS (9)