AC115, Acetone, NF - Spectrum Chemicaltrifluoride. Thiodiglycol. 2,4,6-trichloro-1,3,5-triazine +...

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Not appropriate for regulatory submission. Please visit www.spectrumchemical.com or contact Tech Services for the most uptodate information contained in this information package. Spectrum Chemical Mfg Corp 769 Jersey Avenue New Brunswick, NJ 08901 Phone 732.214.1300 Ver4.01 15.April.2016 Scientific Documentation AC115, Acetone, NF

Transcript of AC115, Acetone, NF - Spectrum Chemicaltrifluoride. Thiodiglycol. 2,4,6-trichloro-1,3,5-triazine +...

Page 1: AC115, Acetone, NF - Spectrum Chemicaltrifluoride. Thiodiglycol. 2,4,6-trichloro-1,3,5-triazine + water. 2-Methyl-1,3-butadiene. Chloroform. 8. EXPOSURE CONTROLS/PERSONAL PROTECTION

                   

 

Not appropriate for regulatory submission. Please visit www.spectrumchemical.com or contact Tech Services for the most up‐to‐date information contained in this information package.    

Spectrum Chemical Mfg Corp 769 Jersey Avenue New Brunswick, NJ 08901 Phone  732.214.1300   

Ver4.01   15.April.2016 

    Scientific DocumentationAC115, Acetone, NF

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15.Apr.2016

Dear Customer, Thank you for your interest in Spectrum’s quality products and services. Spectrum has been proudly serving our scientific community for over 45 years. It is our mission to manufacture and distribute fine chemicals and laboratory products with Quality and delivery you can count on every time. To accomplish our mission, Spectrum utilizes our sourcing leverage and supplier qualification expertise in offering one of the industry’s most comprehensive line of fine chemical products under one brand, in packaging configurations designed to meet your research and production requirements. Our product grades include: USP, NF, BP, EP, JP, FCC, ACS, KSA, Reagent grade, as well as DEA controlled substances. We operate facilities in the United States on the East Coast, West Coast, as well as in Shanghai, China in order to provide the best logistical support for our customers. At Spectrum, Quality is priority number one. Suppliers with the best qualifications are preferred and we employ full-functioning in-house analytical laboratories at each of our facilities. Our facilities and systems are USFDA registered and ISO certified. We frequently host customer audits and cherish opportunities for improvements. Quality is engrained into our culture. Quality is priority number one. In the following pages, we have designed and prepared documented scientific information to aid you in your initial qualification or your continual use of our products. Please do not hesitate to contact us if further information or the most up-to-date documentation is desired from any of the covered areas. We appreciate your business and we look forward to hearing from you. Sincerely,

Alan Wang, MSQA, ASQ CQA Senior Manager, Global Supplier Quality Assurance [email protected]

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15.Apr.2016

AC115, Acetone, NF

Table of Contents Product Specification

Safety Data Sheet (SDS)

Manufacturer

Certification of Quality Mangement System (QMS)

Certification of current Good Manufacturing Practices (cGMP)

Product BSE/TSE Statement

Product Allergen Statement

Product Aflatoxins Statement

General Label Information – Sample Label

Product Certificate of Analysis Sample(s)

General Lot Numbering System Guidance

Stability – Shelf Life Guidance

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Specification for Acetone, NF (AC115)

Item Number AC115

Item Acetone, NF

CAS Number 67-64-1

Molecular Formula C3H6O

Molecular Weight 58.08

MDL Number

Synonyms Dimethyl Ketone ; 2-Propanone

Test SpecificationMin Max

ASSAY [(CH3)2CO] 99.0 %

SPECIFIC GRAVITY @ 25oC 0.789

WATER 0.5 %

NONVOLATILE RESIDUE 0.004 %

READILY OXIDIZABLE SUBSTANCES TO PASS TEST

IDENTIFICATION TO PASS TEST

EXPIRATION DATE

RESIDUAL SOLVENTS TO PASS TEST

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SAFETY DATA SHEET

1. IDENTIFICATIONProduct identifier

Product code: AC115Product Name: ACETONE, NF

Other means of identification

Synonyms: beta-KetopropaneDimethyl ketoneDimethylformaldehydeDimethylketalKetone propaneKetone, dimethylMethyl ketonePropanonePyroacetic acidPyroacetic etherAcétone (French)Acetona (Spanish)

CAS #: 67-64-1RTECS # AL3150000CI#: Not available

Recommended use of the chemical and restrictions on use

Recommended use: Solvent.Uses advised against No information available

Supplier: Spectrum Chemical Mfg. Corp14422 South San Pedro St.Gardena, CA 90248(310) 516-8000

Order Online At: https://www.spectrumchemical.com

Emergency telephone number Chemtrec 1-800-424-9300Contact Person: Martin LaBenz (West Coast)Contact Person: Ibad Tirmiz (East Coast)

2. HAZARDS IDENTIFICATION

Classification

This chemical is considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200)

Serious eye damage/eye irritation Category 2Reproductive toxicity Category 2Specific target organ toxicity (single exposure) Category 3

Category 2

Revision Number: G2Preparation Date: 1/15/2014 Revision Date: 8/17/2015

Product code: AC115 Product name: ACETONE, NF

Flammable liquids

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Label elements

Hazards not otherwise classified (HNOC)Not Applicable

Other hazardsCauses mild skin irritationRepeated exposure may cause skin dryness or cracking

Precautionary Statements - PreventionObtain special instructions before useDo not handle until all safety precautions have been read and understoodWash face, hands and any exposed skin thoroughly after handlingWear protective gloves/protective clothing/eye protection/face protectionAvoid breathing dust/fume/gas/mist/vapors/sprayUse only outdoors or in a well-ventilated areaKeep away from heat/sparks/open flames/hot surfaces. — No smokingKeep container tightly closedGround/bond container and receiving equipmentUse explosion-proof electrical/ventilating/lighting/ .? /equipmentUse only non-sparking toolsTake precautionary measures against static dischargeKeep cool

Precautionary Statements - ResponseIF exposed or concerned: Get medical advice/attentionIn case of fire: Use CO2, dry chemical, or foam to extinguish.IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eyeirritation persists: Get medical advice/attention.IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/showerIF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTER ordoctor/physician if you feel unwell.

Precautionary Statements - StorageStore locked upStore in a well-ventilated place. Keep container tightly closed

Precautionary Statements - DisposalDispose of contents/container to an approved waste disposal plant

Highly flammable liquid and vapor

Danger

Product code: AC115 Product name: ACETONE, NF 2 / 16

Hazard statementsCauses serious eye irritationSuspected of damaging fertility or the unborn childMay cause respiratory irritation. May cause drowsiness or dizziness

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3. COMPOSITION/INFORMATION ON INGREDIENTS

Components CAS-No. Weight % Trade SecretAcetone67-64-1

67-64-1 99-100.5 *

Benzene71-43-2

71-43-2 0-0.003 *

Formaldehyde50-00-0

50-00-0 0-0.002 *

4. FIRST AID MEASURES

First aid measuresGeneral Advice: Poison information centers in each State capital city can provide additional

assistance for scheduled poisons (13 1126)

Skin Contact: Wash off immediately with soap and plenty of water removing all contaminated clothes andshoes. Get medical attention. If skin irritation persists, call a physician.

Eye Contact: Flush eye with water for 15 minutes. Get medical attention.

Inhalation: Move to fresh air. If breathing is difficult, give oxygen. If not breathing, give artificial respiration.Get medical attention.

Ingestion: Do not induce vomiting without medical advice. Never give anything by mouth to anunconscious person. Consult a physician if necessary.

Most important symptoms and effects, both acute and delayedSymptoms Moderate eye irritation. Mild skin irritation. Nausea. Vomiting. Central nervous system effects.

Dizziness. Drowsiness. Fatigue. Narcosis. Ataxia. Staggering gait. Headache. May affectrespiration. Respiratory depression. May cause cardiovascular effects. Hypotension. Weak,rapid pulse or rapid heart rate (Tachycardia). May cause metabolic acidosis.

Indication of any immediate medical attention and special treatment neededNotes to Physician: Treat symptomatically

Protection of first-aidersFirst-Aid Providers: Avoid exposure to blood or body fluids. Wear gloves and other necessary protective clothing. Dispose ofcontaminated clothing and equipment as bio-hazardous waste

5. FIRE-FIGHTING MEASURES

Extinguishing MediaSuitable Extinguishing Media: Carbon dioxide (CO2). Dry chemical. Alcohol-resistant foam.

Water spray.

Unsuitable Extinguishing Media: Do not use a solid (straight) water stream as it may scatterand spread fire.

Specific hazards arising from the chemical

Hazardous Combustion Products: Carbon monoxide; carbon dioxide

Product name: ACETONE, NF 3 / 16Product code: AC115

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Specific hazards: FlammableMay be ignited by heat, sparks or flamesVapor may travel considerable distance to source of ignitionand flash backVapors may form explosive mixtures with airMost vapors are heavier than air. They will spread along theground and collect in low or confined areas (sewers,basements, tanks)Container explosion may occur under fire conditions or whenheatedFire may produce irritating, corrosive and/or toxic gases

Special Protective Actions for Firefighters

Specific Methods: Water mist may be used to cool closed containers. Forlarger fires, use water spray or fog. Cool containers withflooding quantities of water until well after fire is out.

Special Protective Equipment for Firefighters: As in any fire, wear self-contained breathing apparatuspressure-demand, MSHA/NIOSH (approved or equivalent)and full protective gear

6. ACCIDENTAL RELEASE MEASURES

Personal precautions, protective equipment and emergency procedures

Personal Precautions: Ensure adequate ventilation. Keep people away from and upwind of spill/leak. Avoid contactwith skin, eyes and clothing. Use personal protective equipment. Remove all sources ofignition. Pay attention to flashback. Take precautionary measures against static discharges. Allequipment used when handling the product must be grounded. Use spark-proof tools andexplosion-proof equipment. In case of large spill, water spray or vapor suppressing foam maybe used to reduce vapors, but may not prevent ignition in closed spaces.

Environmental precautions Prevent further leakage or spillage if safe to do so. Prevent product from enteringdrains. Prevent entry into waterways, sewers, basements or confined areas.

Methods and material for containment and cleaning up

Methods for containment Stop leak if you can do it without risk. Absorb spill with inert material (e.g. vermiculite,dry sand or earth). In case of large spill, dike if needed. Dike far ahead of liquid spillfor later disposal.

Methods for cleaning up Use appropriate tools to put the spilled material in a suitable chemical waste disposalcontainer. Use only non-sparking tools. Clean contaminated surface thoroughly.

7. HANDLING AND STORAGEPrecautions for safe handling

Technical Measures/Precautions:Provide sufficient air exchange and/or exhaust in work rooms. Remove all sources of ignition. To avoid ignition ofvapors by static electricity discharge, all metal parts of the equipment must be grounded. Keep away fromincompatible materials.

Safe Handling AdviceWear personal protective equipment. Use only in well-ventilated areas. Avoid contact with skin, eyes and clothing.Keep away from heat and sources of ignition. Do not breathe vapors or spray mist. Do not ingest. When using donot smoke. Handle in accordance with good industrial hygiene and safety practice.

Conditions for safe storage, including any incompatibilities

Product name: ACETONE, NF 4 / 16Product code: AC115

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Technical Measures/Storage Conditions:Keep container tightly closed in a dry and well-ventilated place. Store at room temperature in the original container.Keep away from heat and sources of ignition. Store in a segrated and approved area. Store away from incompatiblematerials.

Incompatible Materials:Oxidizing agents. Reducing agents. Bases. Acids. activated carbon. chromium trioxide . dioxygen difluoride +carbon dioxide . Potassium dichromate or Sodium dichromate. Potassium t-butoxide. Hydrogen peroxide. Chromicanhydride. Chromyl chloride. Hexachloromelamine. Nitrosyl chloride + Platinum. Nitrosyl chloride. Brominetrifluoride. Thiodiglycol. 2,4,6-trichloro-1,3,5-triazine + water. 2-Methyl-1,3-butadiene. Chloroform.

8. EXPOSURE CONTROLS/PERSONAL PROTECTIONControl parameters

National occupational exposure limits

United StatesComponents OSHA NIOSH ACGIH AIHA WHEEL

Acetone67-64-1

1000 ppm TWA2400 mg/m3 TWA

250 ppm TWA590 mg/m3 TWA

750 ppm STEL500 ppm TWA

None

Benzene71-43-2

10 ppm TWA1 ppm TWA25 ppm Ceiling5 ppm STEL

0.1 ppm TWA1 ppm STEL

2.5 ppm STEL0.5 ppm TWA

None

Formaldehyde50-00-0

0.75 ppm TWA2 ppm STEL

0.016 ppm TWA0.1 ppm Ceiling 15 min

0.3 ppm Ceiling None

CanadaComponents Alberta British Columbia Ontario Quebec

Acetone67-64-1

500 ppm TWA1200 mg/m3 TWA

750 ppm STEL1800 mg/m3 STEL

250 ppm TWA500 ppm STEL

500 ppm TWA750 ppm STEL

500 ppm TWAEV1190 mg/m3 TWAEV

1000 ppm STEV2380 mg/m3 STEV

Benzene71-43-2

0.5 ppm TWA1.6 mg/m3 TWA2.5 ppm STEL8 mg/m3 STEL

0.5 ppm TWA2.5 ppm STEL

0.5 ppm TWA 1 ppm TWAEV3 mg/m3 TWAEV

5 ppm STEV15.5 mg/m3 STEV

Formaldehyde50-00-0

1 ppm Ceiling1.3 mg/m3 Ceiling

0.75 ppm TWA0.9 mg/m3 TWA

0.3 ppm TWA1 ppm Ceiling

1.5 ppm Ceiling1.0 ppm STEL

2 ppm Ceiling3 mg/m3 Ceiling

Australia and MexicoComponents Australia Mexico

Acetone67-64-1

1000 ppm STEL2375 mg/m3 STEL1185 mg/m3TWA

500 ppm TWA

1000 ppm TWA2400 mg/m3 TWA1260 ppm STEL

3000 mg/m3 STELBenzene71-43-2

1.0 ppm//3.2 mg/m3TWAconfirmed carcinogen

1 ppm TWA3.2 mg/m3 TWA

5 ppm STEL16 mg/m3 STEL

Formaldehyde50-00-0

1 ppm/1.2 mg/m3TWA2 ppm/2.5 mg/m3STELprobable carcinogen

2 ppm Ceiling3 mg/m3 Ceiling

Appropriate engineering controls

Engineering measures to reduce exposure: Ensure adequate ventilation. Provide exhaust ventilation orother engineering controls to keep the airborneconcentrations of vapors and mist below their respectivethreshold limit value.

Product name: ACETONE, NF 5 / 16Product code: AC115

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Individual protection measures, such as personal protective equipment

Personal Protective Equipment

Eye protection: Goggles

Skin and body protection: Chemical resistant apron. Long sleeved clothing. Gloves.

Respiratory protection: Vapor respirator. Be sure to use an approved/certified respirator or equivalent.

Hygiene measures: Avoid contact with skin, eyes and clothing. When using, do not eat, drink or smoke.Wash hands before breaks and immediately after handling the product.

9. PHYSICAL AND CHEMICAL PROPERTIES

10. STABILITY AND REACTIVITYReactivity

Molecular/Formula weight:58.08

Melting point/range(°C/°F):-94.7 to -95.4 °C/-138.46 to -139.72

Boiling point/range(°C/°F):56.2 °C/133.2 °F

Decomposition temperature(°C/°F):No information available

Formula:C3-H6-O

Bulk density:No information available

Color:Clear. Colorless.

Specific gravity:0.79 @ 20 °C

Density (g/cm3):0.780 @ 30 °C0.784 @ 25 °C0.79 @ 20 °C

Flammability:No information available

Vapor pressure @ 20°C (kPa):24

Evaporation rate:5.6 (Butyl acetate = 1)

Vapor density:2.0

Flash point (°C):-20 °C

VOC content (g/L):780-790

Physical state:Liquid.

Odor threshold (ppm):62-140

Partition coefficient(n-octanol/water):- 0.24

Flashpoint (°C/°F):-20 to -17 °C/-4 to 1.4 °F-9.4 to -9 °C/15.1 to 15.8 °F

Viscosity:No information available

Odor:Fruity. Mint-like. Fragrant. Ethereal.

Miscibility:Miscible with waterMiscible with EtherMiscible with ChloroformMiscible with BenzeneMiscible with alcohol

Solubility:No information available

Flash Point Tested according to:Closed cupOpen cup

Autoignition Temperature (°C/°F):465 °C/869 °F

Appearance:No information available

Lower Explosion Limit (%):2.5-2.6%

TastePungent. Sweetish.

Upper Explosion Limit (%):12.8%

Product code: AC115 Product name: ACETONE, NF 6 / 16

pH:No information available

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10. STABILITY AND REACTIVITYReactive with oxidizing agentsReacts with reducing agentsReactive with acidsReacts with strong basesAcetone ignites on contact with activated carbon, chromium trioxide, dioxygen difluoride + carbon dioxide, potassium-tert-butoxide,sulfuric acid + potassium dichromateAcetone may form explosive mixtures with chromic anhydride, chromyl chloride, hexachloromelamine, hydrogen peroxide, nitric acidand acetic acid, nitric acid and sulfuric acid, nitrosyl chloride, nitrosyl chloride + platinum, nitrosyl perchlorate, nitryl perchlorate,permonosulfuric acid, potassium tert-butoxide, thiodiglycol, chloroform, bromine trifluoride, thiotrithiazyl perchlorate, 2,4,6-trichloro-1,3,5-triazine + water, 2-methyl-1,3-butadiene, peroxomonosulfuric acidAn explosion occurred during an attempt to prepare bromoform from acetone by the haloform reactionChloroform and acetone interact vigorously and exothermally in presence of solid potassium hydroxide or calcium hydroxide to form1,1,1-trichloro-2-hydroxy-2-methylpropane

Chemical stabilityStability: Stable under recommended storage conditions

Possibility of Hazardous Reactions: Hazardous polymerization does not occur

Conditions to avoid: Heat. Ignition sources. Incompatible materials.

Incompatible Materials: Oxidizing agents. Reducing agents. Bases. Acids. activated carbon. chromiumtrioxide . dioxygen difluoride + carbon dioxide . Potassium dichromate or Sodiumdichromate. Potassium t-butoxide. Hydrogen peroxide. Chromic anhydride. Chromylchloride. Hexachloromelamine. Nitrosyl chloride + Platinum. Nitrosyl chloride.Bromine trifluoride. Thiodiglycol. 2,4,6-trichloro-1,3,5-triazine + water. 2-Methyl-1,3-butadiene. Chloroform.

Hazardous decomposition products: Carbon monoxide. Carbon dioxide.

Other InformationCorrosivity: No information available

Special Remarks on Corrosivity: No information available

11. TOXICOLOGICAL INFORMATION

Information on likely routes of exposure

Principal Routes of Exposure:Ingestion. Skin. Eyes. Inhalation.

Acute Toxicity

Component Information

LC50/inhalation/rat = 50100 mg/m3 Inhalation LC50 Rat 8 h

LD50/oral/mouse = 3 gm/kg

LC50/inhalation/mouse = 44 gm/m3/4H

LD50/oral/rat = 5800 mg/kg Oral LD50 Rat

LD50/dermal/rat = No information available

Acetone - 67-64-1

Product code: AC115 Product name: ACETONE, NF

LD50/dermal/rabbit = No information available

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Product Information

LD50/oral/rat =VALUE- Acute Tox Oral = 5800

LD50/oral/mouse =Value - Acute Tox Oral = 3000mg/kg

LD50/dermal/rabbitVALUE-Acute Tox Dermal = 20000mg/kg

LD50/dermal/ratVALUE -Acute Tox Dermal = No information available

LC50/inhalation/ratVALUE-Vapor = 76mg/l (4-hr)VALUE-Gas = No information availableVALUE-Dust/Mist = No information available

LC50/Inhalation/mouseVALUE-Vapor = No information availableVALUE - Gas = No information available

VALUE - Dust/Mist = No information availableSymptoms

Skin Contact: May cause skin irritation. Mildly to moderately irritating to the skin. It may beabsorbed through the skin. If absorbed through skin it may cause systemic effectswith symptoms similar to those of ingestion.

Eye Contact: Causes eye irritation. Moderately irritating to the eyes. May cause corneal injury.

LC50/inhalation/rat = 0.578 mg/L Inhalation LC50 Rat 4 h

LC50/inhalation/rat = 13050 - 14380 ppm Inhalation LC50 Rat 4 h44.66 mg/L Inhalation LC50 Rat

LC50/inhalation/mouse = No infomation available

Benzene - 71-43-2

Other LD50 or LC50information = 260 mg/kg oral LD50 Guinea Pig

LC50/inhalation/mouse = No infomation available

LD50/oral/mouse = 4700 mg/kg

Other LD50 or LC50information = >9400 uL/kg LD50 Dermal Guinea Pig

Formaldehyde - 50-00-0

LD50/dermal/rat = No information available

LD50/oral/rat = 500 mg/kg Oral LD50 Rat (RTECS and LOLI)100 mg/kg (RTECS)LD50/oral/mouse = 500 mg/kg (RTECS)385 mg/kg (RTECS)42 mg/kg (RTECS)LD50/dermal/rat = No information available

LD50/dermal/rabbit = >9400 mg/kg Dermal LD50 Rabbit (RTECS)>8200 mg/kg (LOLI)

LD50/oral/rat = 1800 mg/kg (LOLI)930-6400 mg/kg (RTECS)810 mg/kg Oral LD50 Rat

Product code: AC115

LD50/dermal/rabbit = 270 mg/kg Dermal LD50Rabbit

Product name: ACETONE, NF 8 / 16

Other LD50 or LC50information = >9400 uL/kg LD50 Dermal Guinea Pig5340 mg/kg LD50 Oral Rabbit

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Inhalation Irritating to respiratory system. May cause conjunctival irritation. May cause nausea,vomiting. May cause loss of appetite. May affect the brain. May affect the kidneys.May cause muscle weakness. May affect respiration (respiratory depression).Inhalation of high concentrations may cause central nervous system effectscharacterized by headache, dizziness, unsteady gait, drowsiness, lethargy,sleepiness lightheadness, fainting, narcosis, confusion, loss of coordination,lassitude, speech abnormalities, tremor, unconciousness, coma. May causemetabolic acidosis. May cause other symptoms similar to those of ingestion.

Ingestion May cause digestive (gastointestinal) tract irritation. Ingestion may cause nausea,vomiting. It may affect metabolism (ketosis/ketonemia/ketonuria). May causehyperglycemia. May affect liver . May affect respiration. May affect the cardiovascularsystem (hypotension). May affect the cardiovascular system (weak rapid pulse,tachycardia). May cause metabolic acidosis. May affect urinary system (kidneys). Itmay affect the joints. It may affect the skeletal muscles. It may affect behavior/centralnervous system (depression, headache, tremors, ataxia, hyperesthesia, stupor,sedation, fatigue, excitement, seizures, coma).

Aspiration hazard No information available

Delayed and immediate effects as well as chronic effects from short and long-term exposure

Chronic Toxicity Prolonged or repeated skin contact may cause defatting and drying of the skin, andbrittle nails. Prolonged or repeated inhalation may affect the brain. Prolonged orrepeated inhalation may affect the blood (changes in red blood cell count,granulocytopenia). Prolonged or repeated inhalation may affect the cardiovascularsystem. Prolonged or repeated inhalation may affect the thyroid (evidence of thyroidhyperfunction). Prolonged or repeated ingestion may affect the spleen. Prolonged orrepeated ingestion may affect the bladder. Prolonged or repeated ingestion mayaffect the liver, and kidneys. Prolonged or repeated ingestion may affect the blood(normocytic anemia, macrocytosis). Prolonged or repeated inhalation may cause eyeand throat irritation and bronchitis. Prolonged or repeated inhalation may causenausea, gastritis, loss of appetite, and weight loss. Prolonged or repeated inhalationmay cause central nervous system effects such as weakness, dizziness, drowsiness,and vertigo.

Sensitization: No information available

Mutagenic Effects: May affect genetic materialSex Chromosome Loss and Nondisjunction in Saccharomyces cerevisiae (yeast)Cytogenetic analysis (Hamster fibroblast)

Carcinogenic effects: Not classifiable as a human carcinogen.

Components IARC ACGIH -Carcinogens

NTP OSHA HCS -Carcinogens

Australia - ProhibitedCarcinogenicSubstances

Australia - NotifiableCarcinogenicSubstances

Acetone Not listed A4 NotClassifiable asa HumanCarcinogen

Not listed Not listed Not listed Not listed

Benzene Monograph 100F[2012]Supplement 7 [1987]Monograph 29[1982]

A1 ConfirmedHumanCarcinogen

Known HumanCarcinogen

PresentCancer hazard - see 29CFR 1910.1028

Not listed Present when used infeedstock containingmore than 50% ofBenzene by volume

Product name: ACETONE, NF 9 / 16Product code: AC115

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Formaldehyde Monograph 100F[2012]Monograph 88[2006]Monograph 62[1995]Supplement 7 [1987]

A2 SuspectedHumanCarcinogen

Known HumanCarcinogen

Presentsee 29 CFR 1910.1048

Not listed Not listed

Reproductive toxicity Suspected of damaging fertility or the unborn child

Reproductive Effects: No information availableDevelopmental Effects: Possible risk of harm to the unborn childTeratogenic Effects: No information available

Specific Target Organ Toxicity

STOT - single exposure Respiratory system. central nervous system.STOT - repeated exposure No information availableTarget Organs: Skin. Central nervous system. Peripheral nervous system. Kidneys. Liver.

12. ECOLOGICAL INFORMATION

Ecotoxicity

Ecotoxicity effects: Aquatic environment.

Persistence and degradability: No information available

Benzene - 71-43-2

Freshwater Fish Species Data: 0.032 - 0.226 mL/L LC50 Oncorhynchus mykiss 96 h flow-through 1100 - 136 mg/L LC50 Oncorhynchus mykiss 96 h static 122.6 - 25.7 mg/L LC50 Pimephales promelas 96 h flow-through 123.2 - 29.7 mg/L LC50 Pimephales promelas 96 h static 11510 µg/L LC50 Lepomis macrochirus 96 h static 141 mg/L LC50 Brachydanio rerio 96 h static 1

Acetone - 67-64-1

Water Flea Data: 11.3 - 18 mg/L EC50 Daphnia magna 48 h2 mg/L LC50 Daphnia magna 48 h

Freshwater Algae Data: 29 mg/L EC50 Pseudokirchneriella subcapitata 72 h

Water Flea Data:

Freshwater Fish Species Data: 10.7-14.7 mg/L LC50 Pimephales promelas 96 h flow-through 122330-41160 µg/L LC50 Pimephales promelas 96 h static 170000-142000 µg/L LC50 Lepomis macrochirus 96 h static 122.49 mg/L LC50 Lepomis macrochirus 96 h static 128.6 mg/L LC50 Poecilia reticulata 96 h static 15.3 mg/L LC50 Oncorhynchus mykiss 96 h flow-through 1

10294 - 17704 mg/L EC50 Daphnia magna 48 h12600 - 12700 mg/L EC50 Daphnia magna 48 h

Water Flea Data: 8.76 - 15.6 mg/L EC50 Daphnia magna 48 h10 mg/L EC50 Daphnia magna 48 h

Product code: AC115

Freshwater Fish Species Data: 4.74 - 6.33 mL/L LC50 Oncorhynchus mykiss 96 h 18300 mg/L LC50 Lepomis macrochirus 96 h 16210 - 8120 mg/L LC50 Pimephales promelas 96 h static 1

Product name: ACETONE, NF 10 / 16

Formaldehyde - 50-00-0

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Bioaccumulative potential: No information available

Mobility: No information available

13. DISPOSAL CONSIDERATIONS

Disposal Methods

Waste from residues / unused products:Waste must be disposed of in accordance with Federal, State and Local regulation.

Contaminated packaging:Empty containers should be taken for local recycling, recovery or waste disposal

Components RCRA - F SeriesWastes

RCRA - K SeriesWastes

RCRA - PSeriesWastes

RCRA - U Series Wastes

Acetone None None None U002 Ignitable wasteBenzene None None None U019 Ignitable waste, Toxic wasteFormaldehyde None None None U122

14. TRANSPORT INFORMATION

DOTUN-No: UN1090Proper Shipping Name: AcetoneHazard Class: 3Subsidiary Risk: No information availablePacking Group: IIERG No: 127Marine Pollutant No data availableDOT RQ (lbs): 5000 lbs./2270 kg

Symbol(s): R5

TDG (Canada)UN-No: UN1090Proper Shipping Name: AcetoneHazard Class: 3Subsidiary Risk: No information availablePacking Group: IIDescription: No information available

ADR

UN-No: UN1090Proper Shipping Name: AcetoneHazard Class: 3Packing Group: IISubsidiary Risk: No information availableClassification Code: No information availableDescription: No information availableCEFIC Tremcard No: No information available

IMO / IMDGUN-No: UN1090Proper Shipping Name: Acetone (Acetone solutions)Hazard Class: 3

Product name: ACETONE, NF 11 / 16Product code: AC115

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14. TRANSPORT INFORMATIONSubsidiary Risk: No information availablePacking Group: IIDescription: No information availableIMDG Page: No information availableMarine Pollutant No information availableEMS: F-EMFAG: No information availableMaximum Quantity: No information available

RIDUN-No: UN1090Proper Shipping Name: AcetoneHazard Class: 3Subsidiary Risk: 3Packing Group: IIClassification Code: No information availableDescription: No information available

ICAOUN-No: UN1090Proper Shipping Name: AcetoneHazard Class: 3Subsidiary Risk: No information availablePacking Group: IIDescription: No information available

IATAUN-No: UN1090Proper Shipping Name: AcetoneHazard Class: 3Subsidiary Risk: No information availablePacking Group: IIERG Code: 3HDescription: No information available

15. REGULATORY INFORMATION

International Inventories

Components U.S. TSCA KOREA KECL Philippines(PICCS)

Japan ENCS CHINA Australia(AICS)

EINECS-No.

Acetone Present Present KE-29367

Present Present (2)-542

Present Present Present 200-662-2

Benzene Present Present KE-02150

Present Present (3)-1 Present Present Present 200-753-7

Formaldehyde Present Present KE-17074

Present Present (2)-482

Present Present Present 200-001-8

U.S. Regulations

Pennsylvania RTK - Environmental Hazard List Present

New Jersey RTK Hazardous Substance List: Present (sn 006)

Minnesota - Hazardous Substance List: Present

Massachusetts RTK: Present

New Jersey - Discharge Prevention - List of Hazardous Substances: Present

Acetone

Product code: AC115 Product name: ACETONE, NF

Pennsylvania RTK: Environmental hazard

12 / 16

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California Prop. 65: Safe Drinking Water and Toxic Enforcement Act of 1986.

Chemicals Known to the State of California to Cause Cancer:WARNING: This product contains a chemical known to the State of California to cause cancer. (See table below)

Chemicals Known to the State of California to Cause Reproductive Toxicity:WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm (See table below)

Components Carcinogen Developmental Toxicity Male ReproductiveToxicity

Female ReproductiveToxicity:

Acetone Not Listed Not Listed Not Listed Not ListedBenzene carcinogen developmental toxicity male reproductive toxicity Not ListedFormaldehyde carcinogen Not Listed Not Listed Not Listed

CERCLA/SARA

New Jersey - Discharge Prevention - List of Hazardous Substances: PresentNew Jersey TCPA - EHS: 175lbTQ15000lbTQ

FDA - 21 CFR - Total Food Additives

Pennsylvania RTK: Environmental hazardSpecial hazardous substance

Pennsylvania RTK - Environmental Hazard List Present

173.210 175.105 175.320 176.180 176.300 177.2600 73.1 73.30 73.345 73.615

Pennsylvania RTK - Environmental Hazard List Present

Louisana Reportable Quantity List for Pollutants: Listed

Pennsylvania RTK - Special Hazardous Substances Present

Pennsylvania RTK - Special Hazardous Substances Present

Michigan PSM HHC: = 1000 lb TQMinnesota - Hazardous Substance List: Present

Michigan - Critical Materials List: Present

New York Release Reporting - List of Hazardous Substances:100 lb RQ1 lb RQ

Benzene

Louisana Reportable Quantity List for Pollutants: 100lbfinal RQ45.4kgfinal RQCalifornia Directors List of Hazardous Substances: Present

Minnesota - Hazardous Substance List: Present

New York Release Reporting - List of Hazardous Substances:= 1 lb RQ (land/water)= 5000 lb RQ (air)

FDA - Direct Food Additives 21 CFR 173.340FDA - 21 CFR - Total Food Additives 173.340 175.105 175.210 175.300 176.170 176.180 176.200 177.1200 177.2410

178.3120 573.460

New York Release Reporting - List of Hazardous Substances:10 lb RQ1 lb RQ

Massachusetts RTK: Present

Connecticut - Carcinogenic Substances: Present

California Directors List of Hazardous Substances: Present

Louisana Reportable Quantity List for Pollutants: 10lbfinal RQreceives an adjustable RQ of 10 lbs based on potential carcinogenicity inAugust 14, 1989 final rule4.54kgfinal RQreceives an adjustable RQ of 10 lbs based on potential carcinogenicity in August 14, 1989 final rule

New Jersey RTK Hazardous Substance List: 0197

California Directors List of Hazardous Substances: Present

FDA - 21 CFR - Total Food Additives 172.560 175.105

Acetone

Formaldehyde

New Jersey (EHS) List: 0197 500 lb TPQ

Massachusetts RTK: Present

FDA - Direct Food Additives 21 CFR 173.210

Massachusetts EHS: carcinogen; extraordinarily hazardous

New Jersey - Discharge Prevention - List of Hazardous Substances: Present

New Jersey RTK Hazardous Substance List: 0946

Product code: AC115

New Jersey (EHS) List: 0946 500 lb TPQ

Product name: ACETONE, NF 13 / 16

Pennsylvania RTK: Environmental hazardSpecial hazardous substance

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Components CERCLA - HazardousSubstances and theirReportable Quantities

Section 302 ExtremelyHazardous

Substances and TPQs

Section 302 ExtremelyHazardous

Substances and RQs

Section 313 -Chemical Category

Section 313 - Reportingde minimis

Acetone 5000 lb final RQ2270 kg final RQ

None None None None

Benzene 10 lb final RQ4.54 kg final RQ

None None None 0.1 % de minimisconcentration

Formaldehyde 100 lb final RQ45.4 kg final RQ

100 lb EPCRA RQ None None 0.1 % de minimisconcentration

U.S. TSCA

Components TSCA Section 5(a)2 - Chemicals With SignificantNew Use Rules (SNURS)

TSCA 8(d) -Health and Safety Reporting

Acetone Not Applicable Not ApplicableBenzene Not Applicable Not ApplicableFormaldehyde Not Applicable Not Applicable

Canada

WHMIS hazard class:B2 Flammable liquidD2B Toxic materials

Canada Controlled Products Regulation:This product has been classified according to the hazard criteria of the CPR (Controlled Products Regulation) and the MSDS containsall of the information required by the CPR.

Components WHMIS Ingredient Disclosure List -Acetone 1 %Benzene 0.1 %Formaldehyde 0.1 %

Inventory

Components Canada (DSL) Canada (NDSL)Acetone Present Not ListedBenzene Present Not ListedFormaldehyde Present Not Listed

Components CEPA Schedule I - Toxic Substances CEPA - 2010 Greenhouse Gases Subject to ManditoryReporting

Acetone Not listed Not listedBenzene Present Not listedFormaldehyde Present Not listed

EU Classification

Acetone

Formaldehyde

Benzene

A B1 D1A D2A D2BB3 D1A D2A D2B E regulated under Formol

Product code: AC115 Product name: ACETONE, NF

B2 D2B

14 / 16

B2 D2A D2B

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R-phrase(s)R11 - Highly flammable.R36 - Irritating to eyes.R66 - Repeated exposure may cause skin dryness or cracking.R67 - Vapors may cause drowsiness and diziness.

S -phrase(s)S 9 - Keep container in a well-ventilated place.S16 - Keep away from sources of ignition - No smoking.S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

Components Classification Concentration Limits: Safety PhrasesAcetone F; R11

Xi; R36R66R67

No information S2 S9 S16 S26

Benzene F; R11Xi; R36/38Carc.Cat.1; R45Muta.Cat.2; R46T; R48/23/24/25Xn; R65

No information S53 S45

Formaldehyde C;R34Carc. Cat.3;R40R23R43T;R23/24/25

0.2%<=C<1% Xi;R431%<=C<5% Xn;R40-4325%<=C T;R23/24/25-34-40-435%<=C<25% Xn;R20/21/22-36/37/38-40-43

S(1/2)-S26-S36/37/39-S45-S51

The product is classified in accordance with Annex VI to Directive 67/548/EEC

Indication of danger:FlammableXi - Irritant.

16. OTHER INFORMATION

Product code: AC115 Product name: ACETONE, NF 15 / 16

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16. OTHER INFORMATION

Disclaimer: All chemicals may pose unknown hazards and should be used with caution. ThisSafety Data Sheet (SDS) applies only to the material as packaged. If this product iscombined with other materials, deteriorates, or becomes contaminated, it may posehazards not mentioned in this SDS. The physical properties reported in this SDS areobtained from the literature and do not constitute product specifications. Informationcontained herein does not constitute a warranty, whether expressed or implied, as tothe safety, merchantability or fitness of the goods for a particular purpose. SpectrumChemicals & Laboratory Products, Inc. assumes no responsibility for results obtainedor for incidental or consequential damages, including lost profits, arising from the useof these data. No warranty against infringement of any patent, copyright or trademarkis made or implied. It shall be the user's responsibility to develop proper methods ofhandling and personal protection based on the actual conditions of use. While thisSDS is based on technical data judged to be reliable, Spectrum assumes noresponsibility for the completeness or accuracy of the information contained herein.

Preparation Date:

End of Safety Data Sheet

1/15/2014Revision Date: 8/17/2015

Product code: AC115 Product name: ACETONE, NF 16 / 16

Prepared by: Sonia Owen

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15.Apr.2016

Manufacturer Product Covered: AC115, Acetone, NF Spectrum takes ownership as the manufacturer for the Spectrum product listed above and provides full quality assurance, customer service, and technical product support. While information concerning the raw material manufacturer of our starting materials is considered proprietary, such information can be made available upon request contingent on demonstration of business volume justification and successful execution of confidential disclosure agreement (CDA). Requests for disclosure of proprietary raw material manufacturer information may be submitted to the assigned account representative for consideration. Sincerely,

Alan Wang, MSQA, ASQ CQA Senior Manager, Global Supplier Quality Assurance [email protected]

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Page 23: AC115, Acetone, NF - Spectrum Chemicaltrifluoride. Thiodiglycol. 2,4,6-trichloro-1,3,5-triazine + water. 2-Methyl-1,3-butadiene. Chloroform. 8. EXPOSURE CONTROLS/PERSONAL PROTECTION

Intertek Certification Limited is a UKAS accredited body under schedule of accreditation no. 014.

In the issuance of this certificate, Intertek assumes no liability to any party other than to the client, and then only in accordance with the agreed upon Certification Agreement. This certificate’s validity is subject to the organization maintaining their system in accordance with Intertek’s requirements for systems certification. Validity may be confirmed via email at [email protected] or by scanning the code to the right with a smartphone. The annual validity of the certificate can also be checked through the website http://www.cnca.gov.cn of CNCA in China. The certificate remains the property of Intertek, to whom it must be returned upon request.

This is to certify that the quality management system of

Spectrum China Ltd.

has been assessed and registered by Intertek as conforming to the requirements of

ISO 9001: 2008 The quality management system is applicable to:

Provision of service of purchase, testing and sales for chemical products, repacking of non-hazardous chemical products.

Building A20, No. 3802, Shengang Road, Songjiang District, Shanghai, China

Organization Code: 77762704-8 Certificate Number: 111310001-01 Certificate Issue Date: 17 November 2015 Certificate Expiry Date: 14 September 2018

Authorised Signature: Calin Moldovean – President, Business Assurance Intertek Certification Limited, 10A Victory Park, Victory Road, Derby DE24 8ZF, United Kingdom

Certificate of Registration

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March 28, 2016

Certificate of cGMP

Dear Valued Customer: Spectrum Chemicals and Laboratory Products certify that our USP, NF, FCC, EP, BP, JP, and food grade products are produced, processed, packaged and held in compliance with current Good Manufacturing Practices (cGMP) in accordance with the applicable parts of 21 CFR, parts 210 and 211 of the Code of Federal Regulations. Spectrum is an FDA registered and inspected drug establishment. Our United States Food and Drug Administration (USFDA) Registration numbers are as follows: Spectrum-Gardena, CA: 2020632 Spectrum-New Brunswick, NJ: 2246824 Spectrum -Shanghai, China: 3006174778 Thank you for your interest with Spectrum products. Please feel free to contact the Quality Assurance department at 310-516-8000 or via email at [email protected] if we may be of further assistance. Sincerely,

Michelle Weston Quality Assurance Specialist

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March 31, 2016

Certificate of cGMP

Dear Valued Customer: Spectrum Chemicals and Laboratory Products certify that the following product(s) is produced, processed, packaged and held in compliance with current Good Manufacturing Practices (cGMP) in accordance with the applicable parts of 21 CFR, parts 210 and 211 of the Code of Federal Regulations.

Catalog Number Product Name AC115 Acetone, NF

Spectrum is an FDA registered and inspected drug establishment. Our United States Food and Drug Administration (USFDA) Registration numbers are as follows: Spectrum-Gardena, CA: 2020632 Spectrum-New Brunswick, NJ: 2246824 Spectrum-Shanghai, China: 3006174778 Thank you for your interest with Spectrum products. Please feel free to contact the Quality Assurance department at 310-516-8000 or via email at [email protected] if we may be of further assistance. Sincerely,

Michelle Weston Quality Assurance Specialist

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April 8, 2016 RE: Acetone, NF – AC115 To Whom It May Concern: Thank you for your interest in Spectrum high quality chemicals. Spectrum Chemical Mfg Corp. shares your concern regarding Bovine Spongiform Encephalopathy (BSE). This will certify that the following chemical is BSE/TSE free. Acetone, NF – AC115 If you have any further questions, please contact us by telephone at 1-800-772-8786 or 1-310-516-8000 extension 5741, or by email at [email protected]. Sincerely, Rose Briceño Technical Services Spectrum Chemical Mfg Corp. This document has been produced electronically and is valid without a signature

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April 8, 2016 RE: Acetone, NF – AC115 To Whom It May Concern: Thank you for your interest in Spectrum high quality chemicals. We at Spectrum Chemical Mfg Corp. understand the concern regarding the presence of allergens in raw materials. Please be assured that the following chemical does not contain (Milk, Egg, Fish, Shellfish, Tree nuts, Wheat, Peanuts, Soy, Cereals containing Gluten, Celery, Mustard, Sesame Seed). Acetone, NF – AC115 If you have any further questions, please contact us by telephone at 1-800-772-8786 or 1-310-516-8000 extension 5471, or by email at [email protected]. Sincerely, Rose Briceño Technical Services Spectrum Chemical Mfg Corp. This document has been produced electronically and is valid without a signature

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April 14, 2016 RE: Acetone, NF – AC115 To Whom It May Concern: Thank you for your interest in Spectrum high quality chemicals. We at Spectrum Chemical Mfg Corp. understand the concern regarding the presence of aflatoxins in raw materials. Please be assured that the product does not contain nor is it manufactured using aflatoxins. Acetone, NF – AC115 If you have any further questions, please contact us by telephone at 1-800-772-8786 or 1-310-516-8000 extension 5471, or by email at [email protected]. Sincerely, Rose Briceño Technical Services Spectrum Chemical Mfg Corp. This document has been produced electronically and is valid without a signature

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Chemical Emergency: (800)424-9300*49452AC115062233A0A* AC115 4 L

Acetone(Dimethyl Ketone; 2-Propanone)

N.F.CAS 67-64-1

CAUTION: For manufacturing, processing or repacking. Not for pesticide use.Read and understand the label and Safety Data Sheet (SDS) prior to use.

DANGERHighly flammable liquid and vapor • Causes serious eye irritation • May cause respiratory irritation • May cause drowsiness or dizziness • Suspected of damaging fertility or the unborn child • Causes mild skin irritation • Repeated exposure may cause skin dryness or crackingKeep away from heat, sparks, open flames, hot surfaces • No smoking • Take precautionary measures against static discharge • Use personal protective equipment as required • Avoid breathing mist or vapors • Use only outdoors or in a well-ventilated area • Wash face, hands and any exposed skin thoroughly after handling.FIRST AID: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical attention. IF ON SKIN (or hair): Remove immediately all contaminated clothing. Rinse skin with water. If skin irritation occurs: Get medical attention. IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTER or physician if you feel unwell.IN CASE OF FIRE: Use dry chemical, foam or CO2 to extinguish.

KEEP FROM CHILDREN

DOT: UN1090, Acetone, 3, PG II

R 13/D1GHS A Lot No. 062233

C3H6O F.W. 58.08Assay (Anhydrous Basis) .................. Min. 99.0%

MAXIMUM LIMITSSpecific Gravity @ 25°C ..............................0.789Water .......................................................... 0.5%Nonvolatile Residue ................................ 0.004%Readily Oxidizable Substances ..........To pass testResidual Solvents .............................To pass test

WARNING: This product contains a chemical known to the State of California to cause cancer.

WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm.

NON-PHOTOCHEMICALLY REACTIVE

www.SpectrumChemical.com

Exp.

Dat

e: 0

3-31

-201

5

FfXxSs

SPECTRUM CHEMICAL MFG. CORP. Gardena, CA 90248 • New Brunswick, NJ 08901

Empirical Formula, Formula Weight and Technical Specifications Panel

Expiration Information

Lot Number

Bar CodeGHS Hazard PictogramsWarning, Safety Data and Precautionary InformationProduct Catalog NumberItem Name, Form, Grade

Size/Quantity

Chemical Abstracts Service (CAS) Registry Number

Caution Information

DOT Shipping Information

Toll-Free 24-Hour Chemical Emergency Telephone Number

B

K

D

A

I

C

H

F

G

L

E

J

YELLOW: Oxidizer

RED: Flammable

GREEN: General Storage

BLUE: Health Hazard

WHITE: Corrosive

Storage Color Band

This color-coded band indicates the hazard most likely to be posed by that material under storage conditions. The criteria used to assign band colors have been established by the Storage Code working group of the Society for Chemical Hazard Communication (SCHC). It is recommended that like colors be stored together, unless otherwise stated, based on the color codes indicated to the right. However, it is the responsibility of the customer to check with their local fire department for possible conflicts with our recommendations when storing hazardous chemicals.

N

Label Legend

M

The Spectrum label presents technical and safety information in an easily understood format. Our technical specialists stay abreast of the latest requirements of the Globally Harmonized System for Classification and Labelling of Chemicals (GHS), as well as the Occupational Safety and Health Administration (OSHA), the Food and Drug Administration (FDA) and other government regulatory agencies in order to ensure compliance, accuracy and concise hazard communication.

G

D

J

H

C

B

E

F

K

A

M

NL

I

Spectrum Chemical Mfg Corp

Corporate Headquarters: West Coast Facility:

769 Jersey Ave. 14422 S. San Pedro St.

New Brunswick, NJ 08901 Gardena, CA 90248

732.214.1300 310.516.8000

Label Information

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Certificate Of Analysis

Item Number AC115 Lot Number 1EI0266

Item Acetone, NF

CAS Number 67-64-1

Molecular Formula C3H6O Molecular Weight 58.08

Test Specification Resultmin max

ASSAY [(CH3)2CO] 99.0 % 99.97 %

SPECIFIC GRAVITY @ 25oC 0.789 0.7873

WATER 0.5 % 0.27 %

NONVOLATILE RESIDUE 0.004 % 0.000 %

READILY OXIDIZABLE SUBSTANCES TO PASS TEST PASSES TEST

IDENTIFICATION TO PASS TEST PASSES TEST

EXPIRATION DATE 15-JUL-2020

RESIDUAL SOLVENTS TO PASS TEST .

CLASS 1 (solvent) / BENZENE <2 ppm

CLASS 2 (SOLVENT) / CUMENE <70 ppm

CLASS 2 (SOLVENT) / METHANOL <3000 ppm

CLASS 3 (solvent) / ETHANOL <5000 ppm

CLASS 3 (solvent) / ETHYL ACETATE <5000 ppm

CLASS 3 (solvent) / 1-PROPANOL <5000 ppm

APPEARANCECLEAR

COLORLESSLIQUID

MANUFACTURE DATE 15-JUL-2015

Spectrum Chemical Mfg Corp

14422 South San Pedro Street

Gardena 90248 CA

All pharmaceutical ingredients are tested using current edition of applicable pharmacopeia.

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Certificate Of Analysis

Item Number AC115 Lot Number 2EI0222

Item Acetone, NF

CAS Number 67-64-1

Molecular Formula C3H6O Molecular Weight 58.08

Test Specification Resultmin max

ASSAY [(CH3)2CO] 99.0 % 99.97 %

SPECIFIC GRAVITY @ 25oC 0.789 0.7871

WATER 0.5 % 0.29 %

NONVOLATILE RESIDUE 0.004 % <0.001 %

READILY OXIDIZABLE SUBSTANCES TO PASS TEST PASSES TEST

IDENTIFICATION TO PASS TEST PASSES TEST

EXPIRATION DATE 02-SEP-2020

RESIDUAL SOLVENTS TO PASS TEST .

CLASS 1 (solvent) / BENZENE <2 ppm

CLASS 2 (SOLVENT) / CUMENE <70 ppm

CLASS 2 (SOLVENT) / METHANOL <3000 ppm

CLASS 3 (solvent) / ETHANOL <5000 ppm

CLASS 3 (solvent) / ETHYL ACETATE <5000 ppm

CLASS 3 (solvent) / 1-PROPANOL <5000 ppm

APPEARANCE COLORLESSLIQUID

DATE OF MANUFACTURE 02-SEP-2015

Spectrum Chemical Mfg Corp

755 Jersey Avenue

New Brunswick 08901 NJ

All pharmaceutical ingredients are tested using current edition of applicable pharmacopeia.

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January 26, 2016 RE: Lot Numbering System Dear Valued Customer: This letter is to inform you of Spectrum Chemicals and Laboratory Products’ Lot Numbering System. The system is based on an alpha-numerical sequence which provides the month, year and location of production. The lot numbering system utilized until 2010 is a sequence of six characters, two letters followed by four numbers. The first letter represents the year, for example, Y denotes 2009 and Z denotes 2010. The second letter represents the month and site, for example, A-L denotes January through December at Spectrum’s Gardena, CA facility, while M-X denotes January through December at the New Brunswick, NJ facility. The following four numbers are sequentially assigned.

Example: ZI0928 = The 928th material produced in California in September 2010 The lot numbering system utilized for 2011 and forward, is a sequence of seven characters. The first character, a number, represents the production facility: 1 = Gardena, CA Facility 2 = New Brunswick, NJ Facility 3 = China Facility The second character, a letter, represents the year. For example, A denotes 2011 and B denotes 2012. The third character, a letter, represents the month, with A denoting January and L denoting December. The following four numbers are sequentially assigned.

Example: 2AA0706 = The 706th material produced in New Jersey in January 2011 Thank you for your interest with Spectrum products. Please feel free to contact us at 310-516-8000 or via email at [email protected] if we may be of further assistance. Sincerely,

Michael Dang Manager, GMP Compliance

Page 33: AC115, Acetone, NF - Spectrum Chemicaltrifluoride. Thiodiglycol. 2,4,6-trichloro-1,3,5-triazine + water. 2-Methyl-1,3-butadiene. Chloroform. 8. EXPOSURE CONTROLS/PERSONAL PROTECTION

15.Apr.2016

Stability – Shelf Life Guidance Product Covered: AC115, Acetone, NF Spectrum Chemical’s manufacturing partner has assigned the following shelf life guidance for the product listed above. The product, AC115, Acetone, NF, is assigned a 60 months shelf life from date of manufacturing. The quality and integrity of the chemical depends on the handling and storage conditions. Please refer to the Safety Data Sheet for proper storage and handling procedures. Adan R. Hernandez Quality Control Manager

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