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 mdang@spectrumchemical.com

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

Product code: HY113 Product name: HYDROQUINONE,USP

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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.

Product code: HY113 Product name: HYDROQUINONE,USP

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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

Product code: HY113 Product name: HYDROQUINONE,USP

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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.

Product code: HY113 Product name: HYDROQUINONE,USP

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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 mdang@spectrumchemical.com 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 qualityassurance@spectrumchemical.com

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 techservices@spectrumchemical.com. 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 techservices@spectrumchemical.com. 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 techservices@spectrumchemical.com. 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.

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

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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 qualityassurance@spectrumchemical.com 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