HY113, Hydroquinone, USP · Black and White Bleaching Cream Derma-Blanch Eldopaque Eldopaque Forte...
Transcript of HY113, Hydroquinone, USP · Black and White Bleaching Cream Derma-Blanch Eldopaque Eldopaque Forte...
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
Ver4.04 30.July.2019
Scientific Documentation HY113, Hydroquinone, USP
Dear Customer,
Thank you for your interest in Spectrum’s quality products and services.
Spectrum has been proudly serving the 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,
Michael Dang Director, Quality Systems & GMP Compliance [email protected]
30.July.2019
HY113, Hydroquinone, USP
Table of Contents
Product Specification
Safety Data Sheet (SDS)
Manufacturing Process Flowchart
Certification of Quality Management System (QMS)
Certification of current Good Manufacturing Practices (cGMP)
Product BSE/TSE Statement
Product Allergen Statement
Product Aflatoxin Statement
Product Certificate of Analysis Sample(s)
General Label Information – Sample Label
General Lot Numbering System Guidance
Stability – Shelf Life Guidance
Specification for Hydroquinone, USP (HY113)
Item Number HY113
Item Hydroquinone, USP
CAS Number 123-31-9
Molecular Formula C6H6O2
Molecular Weight 110.11
MDL Number
Synonyms 1,4-Benzenediol ; 1,4-Dihydroxybenzene ; Quinol
Test SpecificationMin Max
ASSAY (ANHYDROUS BASIS) 99.0 100.5 %MELTING RANGE 172° 174°CRESIDUE ON IGNITION 0.5 %WATER DETERMINATION 0.5 %ELEMENTAL IMPURITIES AS REPORTEDIDENTIFICATION (A) TO PASS TESTIDENTIFICATION (B) TO PASS TESTIDENTIFICATION (C) TO PASS TESTRETEST DATEDATE OF MANUFACTUREAPPEARANCERESIDUAL SOLVENTS TO PASS TEST
SAFETY DATA SHEETPreparation Date: 06/15/2015 Revision Date: 07/30/2018 Revision Number: G2
1. IDENTIFICATIONProduct identifier
Product code: HY113Product Name: HYDROQUINONE, USP
Other means of identificationSynonyms: 1,4-Benzenediol
1,4-Dihydroxy-benzeen [Dutch]1,4-Dihydroxy-benzol [German]1,4-Dihydroxybenzen [Czech]1,4-Dihydroxybenzene1,4-Diidrobenzene [Italian]4-HydroxyphenolBenzene, p-dihydroxy-BenzohydroquinoneBenzoquinolBlack and White Bleaching CreamDerma-BlanchEldopaqueEldopaque ForteEldoquinEldoquin ForteHidroquinoneHydrochinon [Czech, Polish]HydroquinolHydroquinoleHydroquinoneIdrochinone [Italian]PhiaquinPyrogentistic acidQuinolSolaquin ForteTecquinolTequinolp-Benzenediolp-Dihydroxybenzenep-Dioxybenzenep-Hydroquinonep-Hydroxyphenolpara-Dihydroxybenzenepara-Dioxybenzenepara-Hydroquinone
CAS #: 123-31-9RTECS # MX3500000CI#: Not available
Recommended use of the chemical and restrictions on use
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Recommended use: In photography. Dyes. Paints. Motor fuels. Synthesizing polymers. Medicinalproducts.
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.comEmergency 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 according to the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200)
Considered a dangerous substance or mixture according to the Globally Harmonized System (GHS)
Acute toxicity - Oral Category 4Skin corrosion/irritation Category 2Serious eye damage/eye irritation Category 1Skin sensitization Category 1Germ cell mutagenicity Category 2
Label elements
Hazards not otherwise classified (HNOC)Not Applicable
Other hazards Not available
Danger
Hazard statementsHarmful if swallowedCauses skin irritationCauses serious eye damageMay cause an allergic skin reactionSuspected of causing genetic defectsSuspected of causing cancer
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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 handlingDo not eat, drink or smoke when using this productAvoid breathing dust/fume/gas/mist/vapors/sprayContaminated work clothing must not be allowed out of the workplaceWear protective gloves/protective clothing/eye protection/face protection
Precautionary Statements - Response
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.Immediately call a POISON CENTER or doctor/physician.IF ON SKIN: Wash with plenty of waterTake off contaminated clothing and wash it before reuseIf skin irritation or rash occurs: Get medical advice/attentionIF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwellRinse mouth
Precautionary Statements - StorageStore locked up
Precautionary Statements - DisposalDispose of contents/container to an approved waste disposal plant
3. COMPOSITION/INFORMATION ON INGREDIENTS
Components CAS-No. Weight %Hydroquinone 123-31-9 100
4. FIRST AID MEASURES
First aid measures
General Advice: National Capital Poison Center in the United States can provide assistance if youhave a poison emergency and need to talk to a poison specialist. Call1-800-222-1222. Ensure that medical personnel are aware of the material(s)involved and take precautions to protect themselves. First aider needs to protecthimself.
Skin Contact: Wash off immediately with soap and plenty of water removing all contaminated clothing andshoes. Get medical attention. If symptoms persist, call a physician.
Eye Contact: Flush eyes with water for 15 minutes. Immediate medical attention is required. Call aphysician immediately.
Inhalation: Move to fresh air. If not breathing, give artificial respiration. If breathing is difficult, giveoxygen. Get medical attention.
Ingestion: Do not induce vomiting without medical advice. Never give anything by mouth to anunconscious person. Obtain medical attention.
Most important symptoms and effects, both acute and delayed
Symptoms Causes skin irritationCauses serious eye irritationMay cause corneal opacityInflammation of the eye is characterized by redness, watering and itchingMay cause methemoglobinemia and cyanosisMay cause central nervous system effectsMay affect the liver
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It may affect the kidneysMay cause an allergic skin reactionMay cause abdominal pain, nausea, vomiting, diarrheaDepigmentation of skin
Indication of any immediate medical attention and special treatment needed
Notes 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 Media Suitable Extinguishing Media: Dry chemical. Carbon dioxide (CO2). Water spray. Foam.
Unsuitable Extinguishing Media: No information available.
Specific hazards arising from the chemical
Hazardous Combustion Products: Carbon Monoxide, Carbon Dioxide.
Specific hazards: May be combustible at high temperatures.
Special Protective Actions for Firefighters
Specific Methods: No information available.
Special Protective Equipment for Firefighters: As in any fire, wear self-contained breathing apparatuspressure-demand, MSHA/NIOSH (approved or equivalent)and full protective gear
7. HANDLING AND STORAGE
Precautions for safe handling
Technical Measures/Precautions:
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. Do not touchdamaged containers or spilled material unless wearing appropriate protective clothing.Avoid contact with skin, eyes and clothing. Use personal protective equipment. Avoid dustformation. Avoid breathing dust. Remove all sources of ignition.
Environmental precautions Prevent further leakage or spillage if safe to do so. Do not let product enter drains.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. Cover with plastic sheet to preventspreading.
Methods for cleaning up Use appropriate tools to put the spilled solid in a suitable waste disposal container.Clean contaminated surface thoroughly.
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Provide sufficient air exchange and/or exhaust in work rooms. Avoid dust formation. Keep away from incompatiblematerials.
Safe Handling AdviceWear personal protective equipment. Avoid contact with skin, eyes and clothing. Avoid dust formation. Do notingest. Do not breathe dust. Keep away from heat and sources of ignition. Handle in accordance with goodindustrial hygiene and safety practice.
Conditions for safe storage, including any incompatibilities
Technical Measures/Storage Conditions:Keep container tightly closed in a dry and well-ventilated place. Store at room temperature in the originalcontainer. Sensitive to light. Store in light-resistant containers. Store away from incompatible materials.
Incompatible Materials:Oxidizing agentsAlkalis
8. EXPOSURE CONTROLS/PERSONAL PROTECTIONControl parameters
National occupational exposure limits
United States
Components CAS-No. OSHA NIOSH ACGIH AIHA WEELHydroquinone 123-31-9 2 mg/m3 TWA 2 mg/m3 Ceiling 15
min1 mg/m3 TWA None
Canada
Components CAS-No. Canada - Alberta Canada - BritishColumbia
Canada - Ontario Canada - Quebec
Hydroquinone 123-31-9 2 mg/m3 TWA 1 mg/m3 TWA None None
Australia and Mexico
Components CAS-No. Australia MexicoHydroquinone 123-31-9 2 mg/m3 TWA None
Appropriate engineering controls
Engineering measures to reduce exposure: Ensure adequate ventilation. Use process enclosures,local exhaust ventilation, or other engineering controls tokeep airborne levels below recommended exposure limits.If user operations generate dust, fume or mist, useventilation to keep exposure to airborne contaminantsbelow the exposure limit.
Individual protection measures, such as personal protective equipment
Personal Protective Equipment
Eye protection: Goggles
Skin and body protection: Long sleeved clothingChemical resistant apron
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Gloves
Respiratory protection: Wear respirator with dust filter. Use a dust respirator under conditions whereexposure to the substance is apparent (e.g. generation of high concentration ofdust (dust clouds) , inadequate ventilation, development of respiratory tractirritation), and engineering controls are not feasible. Be sure to use anapproved/certified respirator or equivalent.
Hygiene measures: Avoid contact with skin, eyes and clothing. When using, do not eat, drink orsmoke. Wash hands before breaks and immediately after handling the product.
9. PHYSICAL AND CHEMICAL PROPERTIES
10. STABILITY AND REACTIVITYReactivityReactive with oxidizing agentsReactive with alkalis
Chemical stability
Stability: Sensitive to light. Exposure to light accelerates decomposition. Stable under recommendedstorage conditions.
Physical state:Solid
Appearance:Crystals.
Color:White.
Odor:No information available.
TasteSweet.
Formula:C6H6O2
Molecular/Formula weight (g/mole):110.11
Flammability:No information available
Flash point (°C):165°C
Flashpoint (°C/°F):165°C/ 329°F
Flash Point Tested according to:Closed cup
Autoignition Temperature (°C/°F):515.56°C/ 960°F
Lower Explosion Limit (%):No information available
Upper Explosion Limit (%):No information available
Melting point/range(°C/°F):170-174°C/ 338-345.2°F
Decomposition temperature(°C/°F):No information available
Boiling point/range(°C/°F):285-287°C/ 545-548.6°F
Bulk density:No information available
Density (g/cm3):No information available
Specific gravity:1.332
pH:No information available
Vapor pressure @ 20°C (kPa):No information available
Evaporation rate:No information available
Vapor density:3.81
VOC content (g/L):No information available
Odor threshold (ppm):No information available
Partition coefficient(n-octanol/water):0.59
Viscosity:No information available
Miscibility:No information available
Solubility:Soluble in diethyl etherSoluble in AcetonePartially soluble in cold waterSoluble in AlcoholSoluble in Carbon tetrachlorideSolubility in water: 73,333 mg/l at 25°C
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Possibility of Hazardous Reactions: Hazardous polymerization does not occur
Conditions to avoid: Heat. Exposure to light. Incompatible materials.
Incompatible Materials: Oxidizing agentsAlkalis
Hazardous decompositionproducts:
Carbon oxides.
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:Skin. Inhalation. Ingestion.
Acute Toxicity
Component Information
HydroquinoneCAS-No. 123-31-9
LD50/oral/rat = 298 mg/kg Oral LD50 Rat(LOLI)mg/kg(RTECS)(European Chemicals Bureau IUCID dataset)LD50/oral/mouse = 245-350 mg/kg (RTECS)245-400 mg/kg (European Chemicals Bureau IUCLID dataset)LD50/dermal/rabbit = 74800 mg/kg Dermal LD50 RabbitLD50/dermal/rat = No information availableLC50/inhalation/rat = No information availableLC50/inhalation/mouse = No information availableOther LD50 or LC50information = 550 mg/kg Oral LD50 Guinea pig>1000 mg/kg Dermal LD50 Guinea pig
Product Information
LD50/oral/rat =VALUE- Acute Tox Oral = 302 mg/kg
LD50/oral/mouse =Value - Acute Tox Oral = 245 mg/kg
LD50/dermal/rabbitVALUE-Acute Tox Dermal = 74800 mg/kg
LD50/dermal/ratVALUE -Acute Tox Dermal = > 900 mg/kg
LC50/inhalation/rat
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VALUE-Vapor = No information available
VALUE-Gas = No information availableVALUE-Dust/Mist = No information available
LC50/Inhalation/mouseVALUE-Vapor = No information availableVALUE - Gas = No information availableVALUE - Dust/Mist = No information available
Symptoms
Skin Contact: Causes skin irritation. Moderately to strongly irritating. Causes a rash and changesin skin color.
Eye Contact: Causes serious eye irritation. May cause corneal ulceration.
Inhalation May cause irritation of respiratory tract.
Ingestion Harmful if swallowed. Amounts of 1 gram or more can cause pallor, tinnitus,abdominal cramps, nausea, vomiting, diarrhea, dizziness, twitching, delirium,tremors, excitement, convulsions, muscle contraction or spasticity, ataxia,headache, a sense of suffocation, breathing difficulty, methemoglobinemia (anincrease in the level of methemoglobin in the blood which decreases the amountof oxygen in the blood), cyanosis (a bluish discoloration of the skin, lips, nails dueto deficient oxygenation of the blood), increased pulse rate, cardiovascularcollapse, coma. It may also affect the liver, kidney damage (urine may turn agreen or brown-green color which darkens upon standing), bronchopneumonia.Ingestions in the range of 5 to 12 grams have been fatal.
Aspiration hazard No information available.
Delayed and immediate effects as well as chronic effects from short and long-term exposure
Chronic Toxicity Skin: It is a sensitizer and may cause dermatitis upon repeated or prolonged skincontact. Repeated skin contact causes depigmentation similar in appearance tovitiligo.Eyes: Prolonged or repeated exposure to dust at airborne concentrations in therange of 10 to 30 mg/m3 can cause staining of the conjunctiva, corneal opacity,alterations in the corneal curvature as well as pitting and erosion of the cornealsurface. These conditions require at least 5 years of exposure to develop, but maypersist for some time after removal from exposure.Inhalation: Prolonged or repeated inhalation may cause respiratory tract irritationand decreased pulmonary function.Ingestion: Prolonged or repeated ingestion may cause wieght loss, changes in redblood cell count, normocytic or aplastic anemia, atrophy of the liver, andphotosensitization, It may also affect the kidneys and behavior/central nervoussystem (similar effects to acute ingestion), brain.
Sensitization: May cause sensitization by skin contact.
Mutagenic Effects: May affect genetic materialMutations in microorganismsExperiments with bacteria and/or yeast have shown mutagenic effectsMutagenic effects in mammalian somatic cellsSister Chromatid Exchange: Hamster ovary (RTECS)Sister Chromatid Exchange (human lymphocyte)Sister Chromatid Exchange (hamster embryo)
Carcinogenic effects: Suspected of causing cancer.
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Components CAS-No. IARC ACGIH -Carcinogens
NTP OSHA HCS -Carcinogens
Australia -Notifiable
CarcinogenicSubstances
Australia -Prohibited
CarcinogenicSubstances
Hydroquinone 123-31-9 Group 3 - NotClassifiable -Monograph 71[1999]Supplement 7[1987]Monograph 15[1977]
A3 ConfirmedAnimalCarcinogenwith UnknownRelevance toHumans
Not listed Not listed Not listed Not listed
ACGIH (American Conference of Governmental Industrial Hygienists)
IARC (International Agency for Research on Cancer)
NTP (National Toxicology Program)
OSHA (Occupational Safety and Health Administration of the US Department of Labor)
Reproductive toxicity No data is available
Reproductive Effects: May cause adverse reproductive effects based on animal dataNo information on reproductive toxicity effects on humans was found
Developmental Effects: No information availableTeratogenic Effects: No information available
Specific Target Organ Toxicity
STOT - single exposure No information available.STOT - repeated exposure No information available.Target Organs: Kidneys. Liver. Skin. Eyes.
12. ECOLOGICAL INFORMATION
Ecotoxicity
Ecotoxicity effects: Aquatic environment. Very toxic to aquatic organisms.
Hydroquinone - 123-31-9Freshwater Algae Data: 0.335 mg/L EC50 Pseudokirchneriella subcapitata 72 h 13.5 mg/L EC50
Desmodesmus subspicatus 120 hFreshwater Fish Species Data: 0.044 mg/L LC50 Oncorhynchus mykiss 96 h flow-through 1 0.044 mg/L LC50
Pimephales promelas 96 h flow-through 1 0.1 - 0.18 mg/L LC50 Pimephalespromelas 96 h static 1 0.17 mg/L LC50 Brachydanio rerio 96 h 1
Water Flea Data: 0.29 mg/L EC50 Daphnia magna 48 h
Persistence and degradability: No information available
Bioaccumulative potential: Potential for bioconcentration in aquatic organisms is low.
Mobility: It is expected to have a moderate mobility in soil upon estimated Koc.
13. DISPOSAL CONSIDERATIONS
Disposal Methods
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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 CAS-No. RCRA - F SeriesWastes
RCRA - K SeriesWastes
RCRA - P SeriesWastes
RCRA - U SeriesWastes
Hydroquinone 123-31-9 None None None None
14. TRANSPORT INFORMATION
DOTUN-No: UN3077Proper Shipping Name: Environmentally hazardous substance, solid, n.o.s. (hydroquinone)Hazard Class: 9Subsidiary Class No information availablePacking group: IIIEmergency Response GuideNumber
No information available
Marine Pollutant No data availableDOT RQ (lbs): 100 lbs./454 kgSpecial Provisions No Information availableSymbol(s): [DOT]: (G) - Identifies proper shipping names for which one or more technical
names of the hazardous material must be entered in parentheses, in associationwith the basic description.
Description: UN3077,Environmentally hazardous substance, solid, n.o.s. (Hydroquinone ),9,PGIII
TDG (Canada)UN-No: UN3077Proper Shipping Name: Environmentally hazardous substance, solid, n.o.s. (fluoxetine hydrochloride)Hazard Class: 9Subsidiary Risk: No information availablePacking Group: IIIMarine Pollutant No Information availableDescription: UN3077,ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.(Hydroquinone ),9,PG III
ADRUN-No: UN3077Proper Shipping Name: Environmentally hazardous substance, solid, n.o.s. (fluoxetine hydrochloride)Hazard Class: 9Packing Group: IIISubsidiary Risk: No information availableDescription: UN3077 Environmentally hazardous substance, solid, n.o.s.(Hydroquinone ),9,III
IMO / IMDGUN-No: UN3077Proper Shipping Name: Environmentally hazardous substance, solid, n.o.s. (fluoxetine hydrochloride)Hazard Class: 9Subsidiary Risk: No information availablePacking Group: IIIMarine Pollutant No information availableEMS: F-A
RIDUN-No: UN3077Proper Shipping Name: Environmentally hazardous substance, solid, n.o.s. (fluoxetine hydrochloride)
Product code: HY113 Product name: HYDROQUINONE,USP
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Hazard Class: 9Subsidiary Risk: No information availablePacking Group: IIIDescription: UN3077 Environmentally hazardous substance, solid, n.o.s.(Hydroquinone ),9,III
ICAOUN-No: UN3077Proper Shipping Name: Environmentally hazardous substance, solid, n.o.s. (fluoxetine hydrochloride)Hazard Class: 9Subsidiary Risk: No information availablePacking Group: IIIDescription: UN3077,Environmentally hazardous substance, solid, n.o.s.(Hydroquinone ),9,PG
III
IATAUN-No: UN3077Proper Shipping Name: Environmentally hazardous substance, solid, n.o.s. (fluoxetine hydrochloride)Hazard Class: 9Subsidiary Risk: No information availablePacking Group: IIIERG Code: 9LSpecial Provisions No information availableDescription: UN3077,Environmentally hazardous substance, solid, n.o.s.(Hydroquinone ),9,PG
III
15. REGULATORY INFORMATION
International Inventories
Components CAS-No. U.S. TSCA KOREA KECL Philippines(PICCS)
Japan ENCS CHINA Australia(AICS)
EINECS-No.
Hydroquinone 123-31-9 PresentACTIVE
PresentKE-02558
Present Present(3)-543
Present Present Present204-617-8
U.S. Regulations
HydroquinoneMassachusetts RTK: PresentNew Jersey RTK Hazardous Substance List: 1019New Jersey (EHS) List: 1019 500 lb TPQNew Jersey - Discharge Prevention - List of Hazardous Substances: PresentPennsylvania RTK: Environmental hazardPennsylvania RTK - Environmental Hazard List PresentMinnesota - Hazardous Substance List: PresentNew York Release Reporting - List of Hazardous Substances:1 lb RQLouisana Reportable Quantity List for Pollutants: ListedCalifornia Directors List of Hazardous Substances: Present
California Prop. 65: Safe Drinking Water and Toxic Enforcement Act of 1986.
Chemicals Known to the State of California to Cause Cancer:This product does not contain a chemical requiring a warning under California Prop. 65. (See table below)
Chemicals Known to the State of California to Cause Reproductive Toxicity:This product does not contain a chemical requiring a warning under California Prop. 65. (See table below)
Components CAS-No. Carcinogen Developmental Toxicity MaleReproductiveToxicity
FemaleReproductiveToxicity:
Hydroquinone 123-31-9 Not Listed Not Listed Not Listed Not Listed
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CERCLA/SARA
Components CAS-No. CERCLA -Hazardous
Substances andtheir Reportable
Quantities
Section 302ExtremelyHazardousSubstancesand TPQs
Section 302ExtremelyHazardous
Substances andRQs
Section 313 -Chemical Category
Section 313 -Reporting
de minimis
Hydroquinone 123-31-9 100 lb final RQ45.4 kg final RQ
100 lb EPCRARQ
None None 1.0 % de minimisconcentration
U.S. TSCA
Components CAS-No. TSCA Section 5(a)2 - ChemicalsWith Significant New Use Rules(SNURS)
TSCA 8(d) -Health and SafetyReporting
Hydroquinone 123-31-9 Not Applicable Not Applicable
Canada
WHIMIS 2015 - GHS Classifications
WHMIS 2015 Hazard ClassificationInformation:
.
Component WHMIS 2015 Hazard ClassificationHydroquinone 123-31-9 ( 100 )
Acute toxicity - Oral - Category 4: H302 Harmful if swallowed.;Serious Eye Damage/Eye Irritation - Category 2: H319 Causesserious eye irritation.; Skin sensitizers - Category 1: H317 Maycause allergic skin reaction.; Germ cell mutagenicity - Category 2:H341 Suspected of causing genetic defects.; Combustible Dust -Category 1: May form combustible dust concentrations in air(factors such as combustibility and explosiveness of dustsincluding composition and shape and size of particles could causesubstance to belong to 'Combustible dust' hazard class)
Canada Hazardous Products Regulation This product has been classified according to the hazard criteria of the HPR (HazardousProducts Regulation) and the SDS contains all of the information required by the HPR
WHMIS 1988 Hazard ClassD1B Toxic materialsD2B Toxic materials
Components WHMIS 1988Hydroquinone D1B,D2B
Canada Controlled Products Regulation:This product has been classified according to the hazard criteria of the CPR (Controlled Products Regulation) and the MSDScontains all of the information required by the CPR.
Components WHMIS Ingredient Disclosure List -Hydroquinone 1 %
Inventory
Components CAS-No. Canada (DSL) Canada (NDSL)Hydroquinone 123-31-9 Present Not Listed
Components CAS-No. CEPA Schedule I - Toxic SubstancesHydroquinone 123-31-9 PresentComponents CAS-No. CEPA - 2010 Greenhouse Gases Subject
to Mandatory ReportingHydroquinone 123-31-9 Not listed
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EU Classification
EU GHS - SV - CLP 1272/2008
Components CAS-No. EU GHS - SV - CLP (1272/2008)Hydroquinone 123-31-9 Acute toxicity - Oral - Acute Tox. 4:
H302 Harmful if swallowed. (Minimumclassification); Serious Eye
Damage/Eye Irritation - Eye Dam. 1:H318 Causes serious eye damage.;Skin sensitizers - Skin Sens. 1: H317
May cause allergic skin reaction.;Germ cell mutagenicity - Muta. 2:
H341 Suspected of causing geneticdefects.; Carcinogenicity - Carc. 2:
H351 Suspected of causing cancer.;Hazardous to aquatic environment -
acute hazard - Aquatic Acute 1: H400Very toxic to aquatic life. (M Factor:
10)604-005-00-4
EU - CLP (1272/2008)
R-phrase(s)R22 - Harmful if swallowed.R40 - Limited evidence of a carcinogenic effectR41 - Risk of serious damage to eyes.R43 - May cause sensitization by skin contact.R50 - Very toxic to aquatic organisms.R68 - Possible risk of irreversible effects.
S -phrase(s)S 2 - Keep out of the reach of children.S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.S61 - Avoid release to the environment. Refer to special instructions/safety data sheets.S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection.
Components CAS-No. Classification ConcentrationLimits:
Safety Phrases
Hydroquinone 123-31-9 Xn; R22Carc.Cat.3; R40Xi; R41R43N; R50Muta.Cat.3; R68
2.5%<=C N; R50 S2 S26 S36/37/39S61
The product is classified in accordance with Annex VI to Directive 67/548/EEC
Indication of danger:Xi - Irritant.Xn - Harmful.N - Dangerous for the environment.
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16. OTHER INFORMATION
Preparation Date: 06/15/2015Revision Date: 07/30/2018Prepared by: Sonia Owen
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 productis combined with other materials, deteriorates, or becomes contaminated, it maypose hazards not mentioned in this SDS. The physical properties reported in thisSDS are obtained from the literature and do not constitute product specifications.Information contained herein does not constitute a warranty, whether expressed orimplied, as to the safety, merchantability or fitness of the goods for a particularpurpose. Spectrum Chemicals & Laboratory Products, Inc. assumes noresponsibility for results obtained or for incidental or consequential damages,including lost profits, arising from the use of these data. No warranty againstinfringement of any patent, copyright or trademark is made or implied. It shall bethe user's responsibility to develop proper methods of handling and personalprotection based on the actual conditions of use. While this SDS is based ontechnical data judged to be reliable, Spectrum assumes no responsibility for thecompleteness or accuracy of the information contained herein.
End of Safety Data Sheet
Product code: HY113 Product name: HYDROQUINONE,USP
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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
Manufacturing Process Flowchart
Hydroquinone, USP - HY113
Reactor
Sparkler filter
Reactor
Sulfuric acid
Hydroquinone (Technical Grade)
Centrifuge
Dryer (semi drying)Miller (milling)
Dryer (final drying)
Blender
Sifter
Packing
DM water
Hydroquinone, USP
Chilled DM water
C O R P O R A T E H E A D Q U A R T E R S
769 Jersey Avenue
New Brunswick, NJ 08901
PHONE 732.214.1300
FAX 732.246.7132
A N I S O 90 0 1 :2 0 15 RE G IS T E RE D COM P A NY
W E S T C O A S T F A C I L I T Y
14422 South San Pedro Street
Gardena, California 90248
PHONE 310.516.8000
FAX 310.516.9843
w w w . s p e c t r u m c h e m i c a l . c o m
January 08, 2019 Certification of Compliance with current Good Manufacturing Practices Dear Valued Customer: Spectrum Chemical Mfg Corp certifies 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 and parts 110 and 111 of the Code of Federal Regulations, respectively. Spectrum is an FDA registered and inspected Drug Establishment. Our United States Food and Drug Administration (USFDA) Registration numbers are as follows: Spectrum Gardena, California: 2020632 Spectrum New Brunswick, New Jersey: 2246824 Thank you for your interest in Spectrum products. Please feel free to contact me at 310-516-8000, extension 5610 or via email at [email protected] if I may be of further assistance. Sincerely,
Michael Dang Director, Quality Systems & GMP Compliance
July 30, 2019
Certification of Compliance with current Good Manufacturing Practices
Dear Valued Customer:
Spectrum Chemical Mfg Corp certifies 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 HY113 Hydroquinone, USP
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: 03006174778
Thank you for your interest in Spectrum products. If we may be of further assistance, please feel free to contact the Quality Assurance department at 310-516-8000 or via email at [email protected]
Sincerely,
Oralia Chavez Quality Assurance Specialist
March 31, 2016 Re: Hydroquinone, USP- HY113 To Whom It May Concern: Thank you for your interest in Spectrum high quality chemicals. We at Spectrum Chemical Mfr. Corp. understand the concern regarding Bovine Spongiform Encephalopathy (BSE). Please be assured that the chemical Hydroquinone, USP- HY113 is BSE/TSE free. If you have any further questions, please contact Tech Services at (310) 516- 8000 Extension 5471, or by email at [email protected]. Sincerely, Darlene Dagdag- Lyudmirskiy Technical Services Spectrum Chemical Mfr. Corp. This document has been produced electronically and is valid without a signature
April 5, 2016 Re: Hydroquinone, USP- HY113 To Whom It May Concern: Thank you for your interest in Spectrum high quality chemicals. We at Spectrum Chemical Mfr. 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, Corn, Dioxin, Lactose, Latex, Melamine, Rice, Tartrazine, Tree Nut, Wheat, Peanut, Soy, Cereals containing Gluten and Sesame Seed). Hydroquinone, USP- HY113
If you have any further questions, please contact Tech Services at (310) 516- 8000 Extension 5471, or by email at [email protected]. Sincerely, Darlene Dagdag- Lyudmirskiy Technical Services Spectrum Chemical Mfr. Corp. This document has been produced electronically and is valid without a signature
April 1, 2016 Re: Hydroquinone, USP- HY113 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 Aflatoxins in raw materials. To the best of our knowledge, the product listed below is not contaminated with Aflatoxins. Aflatoxins are not used in production. The following product does not come in contact with Aflatoxins at any stage of production. Hydroquinone, USP- HY113 If you have any further questions, please contact Tech Services at (310) 516- 8000 Extension 5471, or by email at [email protected]. Sincerely, Darlene Dagdag-Lyudmirskiy Technical Services Spectrum Chemical Mfr. Corp. This document has been produced electronically and is valid without a signature
Certificate Of Analysis
Item Number HY113 Lot Number 2HH0303
Item Hydroquinone, USP
CAS Number 123-31-9Molecular Formula C6H6O2 Molecular Weight 110.11
Test Specification Resultmin max
99.0 100.5 % 99.8 %172° 174°C 172.2°C
0.5 % 0.02 %0.5 % 0.26 %
AS REPORTEDNO ELEMENTAL
IMPURITIESPRESENT
TO PASS TEST PASSES TESTTO PASS TEST PASSES TESTTO PASS TEST PASSES TEST
30-JUN-202101-JUL-2018WHITE FINE
NEEDLE LIKECRYSTALS
TO PASS TEST NO RESIDUALSOLVENTS USED
Spectrum Chemical Mfg Corp
755 Jersey Avenue
New Brunswick 08901 NJ
All pharmaceutical ingredients are tested using current edition of applicable pharmacopeia.
Read and understand label and SDS before handling any chemicals. All Spectrum's chemicals are for manufacturing, processing,repacking or research purposes by experienced personnel only. It is the customer's responsibility to provide adequate hazardousmaterial training and ensure that appropriate Personal Protective Equipment (PPE) is used before handling any chemical.
SPECTRUM CHEMICAL MFG. CORP. Gardena, CA 90248 • New Brunswick, NJ 08901
Chemical Emergency: (800)424-9300*49452HY113062233LVA* HY113 12 KG
Hydroquinone(1,4-Dihydroxybenzene)
U.S.P.CAS 123-31-9
CAUTION: For manufacturing, processing or repacking. Read and understand the label and Safety Data Sheet (SDS) prior to use.
DANGER• Causes serious eye damage • Causes skin irritation • May cause an allergic skin reaction • Harmful if swallowed • Suspected of causing genetic defects • Suspected of causing cancer.• Obtain special instructions before use • Do not handle until all safety precautions have been read and understood • Do not eat, drink or smoke when using this product • Wear protective gloves, protective clothing, eye protection, face protection • Do not breathe dust • Wash face, hands, and any exposed skin thoroughly after handling • Contaminated work clothing must not be allowed out of the workplace.FIRST AID: Immediately call a POISON CENTER or physician. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. IF ON SKIN: Wash with plenty of water. Take off contaminated clothing and wash it before reuse. If skin irritation or rash occurs: Get medical attention. IF SWALLOWED: Rinse mouth.
KEEP FROM CHILDREN
DOT: UN3077, Environmentally hazardous substance, solid, n.o.s. (hydroquinone), 9, PG III
B 11/E2GHS A Lot No. 062233www.SpectrumChemical.com
C6H6O2 F.W. 110.11
Assay (Anhydrous Basis) ................. 99.0-100.5%Melting Range .................................... 172°-174°C
MAXIMUM LIMITS Residue on Ignition ...................................... 0.5%Water ........................................................... 0.5%Residual Solvents ..............................To pass test
LIGHT SENSITIVE: Keep tightly closed in light-resistant containers.
FLUSHED WITH NITROGENRete
st D
ate:
03-
31-2
025
SsXxAa
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
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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.
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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.
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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
C O R P O R A T E H E A D Q U A R T E R S
769 Jersey Avenue
New Brunswick, NJ 08901
PHONE 732.214.1300
FAX 732.246.7132
A N I S O 90 0 1 :2 0 15 RE G IS T E RE D COM P A NY
W E S T C O A S T F A C I L I T Y
14422 South San Pedro Street
Gardena, California 90248
PHONE 310.516.8000
FAX 310.516.9843
w w w . s p e c t r u m c h e m i c a l . c o m
February 1, 2019 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 4 = Pharmacy, NJ 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,
Howard Lau, Quality Assurance Specialist
30.July.2019
Stability – Shelf Life Guidance Product Covered: HY113, Hydroquinone, USP
Spectrum Chemical’s manufacturing partner has assigned the following shelf life guidance for the product listed above. The product, HY113, Hydroquinone, USP, is assigned a 36 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
Corporate Headquarters 769 Jersey Avenue New Brunswick, NJ 08901-3605