T1050, Thymol, Crystal, NF - Spectrum Chemical · Specification for Thymol, Crystal, NF (T1050) Item Number T1050 Item Thymol, Crystal, NF CAS Number 89-83-8 Molecular Formula C 10

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 12.August.2019

Scientific Documentation T1050, Thymol, Crystal, NF

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]

12.August.2019

T1050, Thymol, Crystal, NF

Table of Contents

Product Specification

Safety Data Sheet (SDS)

Certification of Quality Management System (QMS)

Certification of current Good Manufacturing Practices (cGMP)

Product BSE/TSE Statement

Product Allergen Statement

Product Aflatoxin

Product Certificate of Analysis Sample(s)

General Label Information – Sample Label

General Lot Numbering System Guidance

Stability – Shelf Life Guidance

Specification for Thymol, Crystal, NF (T1050)

Item Number T1050

Item Thymol, Crystal, NF

CAS Number 89-83-8

Molecular Formula C10H14O

Molecular Weight 150.22

MDL Number

Synonyms 2-Isopropyl-5-methylphenol

Test SpecificationMin Max

ASSAY 99.0 101.0 %

MELTING RANGE 48° 51°C

NONVOLATILE RESIDUE 0.05 %

ELEMENTAL IMPURITIES AS REPORTED

IDENTIFICATION A SPECTRUM MATCHESREFERENCE

IDENTIFICATION B 48 51 C

EXPIRATION DATE

DATE OF MANUFACTURE

APPEARANCE

RESIDUAL SOLVENTS AS REPORTED

SAFETY DATA SHEETPreparation Date: 04/17/2015 Revision Date: 10/31/2018 Revision Number: G3

1. IDENTIFICATIONProduct identifier

Product code: T1050Product Name: THYMOL, CRYSTAL, NF

Other means of identificationSynonyms: 1-Hydroxy-5-methyl-2-isopropylbenzene

1-Methyl-3-hydroxy-4-isopropylbenzene2-Hydroxy-1-isopropyl-4-methylbenzene2-Isopropyl-5-methylphenol3-Hydroxy-1-methyl-4-isopropylbenzene3-Hydroxy-p-cymene3-Methyl-6-isopropylphenol3-p-Cymenol5-Methyl-2-(1-methylethyl)phenol5-Methyl-2-isopropyl-1-phenol5-Methyl-2-isopropylphenol6-Isopropyl-3-methylphenol6-Isopropyl-m-cresolCymophenol, alpha-Isopropyl cresolPhenol, 2-isopropyl-5-methyl-Phenol, 5-methyl-2-(1-methylethyl)-Thyme camphorThymic acidThymol (natural)m-Cresol, 6-isopropyl-m-Thymolp-Cymen-3-olp-Cymene, 3-hydroxy-

CAS #: 89-83-8RTECS # XP2275000CI#: Not available

Recommended use of the chemical and restrictions on useRecommended use: Laboratory reagent. Preservative. Antioxidant. For destroying mold; mold and

mildew preventative; preserving documents, art objects, and urine; stabilizer(antioxidant) for Trichloroethylene, Haloethane. Flavoring ingredient.

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)

Product code: T1050 Product name: THYMOL, CRYSTAL,NF

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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 1 Sub-category BSerious eye damage/eye irritation Category 1

Label elements

Hazards not otherwise classified (HNOC)Not Applicable

Other hazards Toxic to aquatic life with long lasting effects

Precautionary Statements - PreventionWash face, hands and any exposed skin thoroughly after handlingDo not eat, drink or smoke when using this productDo not breathe dust/fume/gas/mist/vapors/sprayWear protective gloves/protective clothing/eye protection/face protection

Precautionary Statements - ResponseImmediately call a POISON CENTER or doctor/physicianIF 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 (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/showerWash contaminated clothing before reuseIF INHALED: Remove person to fresh air and keep comfortable for breathing. Immediately call a POISON CENTER ordoctor/physician.IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwellRinse mouthDo NOT induce vomiting

Danger

Hazard statementsHarmful if swallowedCauses severe skin burns and eye damage


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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 %Thymol 89-83-8 100

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.

Skin Contact: Wash off immediately with soap and plenty of water removing all contaminated clothing andshoes. Continue flushing with plenty of water for at least 15 minutes. Remove allcontaminated clothes and shoes. Immediate medical attention is required. Call a physicianor Poison Control Centre immediately.

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. WARNING! It may be hazardous to the person providing aid to givemouth-to-mouth resuscitation when the inhaled or ingested material is toxic, infectious orcorrosive. Do not use mouth-to-mouth resuscitation if victim ingested or inhaled thesubstance; induce artificial respiration with the aid of a pocket mask equipped with aone-way valve or other proper respiratory medical device. Immediate medical attention isrequired.

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 Severe skin and eye irritation or burnsMay cause abdominal pain, nausea, vomiting, diarrheaCauses digestive (gastrointestinal) tract irritationMay cause gastrointestinal (digestive) tract burnsMay cause central nervous system effectsMay affect the cardiovascular systemMay affect the liverIt may affect the kidneysIrritating to respiratory systemMay cause chemical burns to the respiratory tract

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.


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5. FIRE-FIGHTING MEASURES

Extinguishing Media Suitable Extinguishing Media: Use water spray, mist, alcohol-resistant foam, Dry

chemical or Carbon dioxide (CO2).

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. When heated todecomposition it emits toxic fumes.

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:Ensure adequate ventilation. Provide sufficient air exchange and/or exhaust in work rooms. Avoid dust formation.Remove all sources of ignition.

Safe Handling AdviceWear personal protective equipment. Avoid contact with skin, eyes and clothing. Avoid dust formation. Do notbreathe vapors/dust. Do not ingest. Keep away from heat and sources of ignition. Protect from light. When usingdo not smoke. Handle in accordance with good industrial hygiene and safety practice.

Conditions for safe storage, including any incompatibilities

Technical Measures/Storage Conditions:

6. ACCIDENTAL RELEASE MEASURES

Personal precautions, protective equipment and emergency procedures

Personal Precautions: Keep people away from and upwind of spill/leak. Ensure adequate ventilation. Avoidcontact with skin, eyes and clothing. Do not touch damaged containers or spilled materialunless wearing appropriate protective clothing. Use personal protective equipment. Avoidbreathing dust. Remove all sources of ignition.

Environmental precautions Do not let product enter drains. Prevent further leakage or spillage if safe to do so.Prevent entry into waterways, sewers, basements or confined areas.

Methods and material for containment and cleaning up

Methods for containment Prevent further leakage or spillage if safe to do so. Cover with plastic sheet toprevent spreading.

Methods for cleaning up


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Use appropriate tools to put the spilled solid in a suitable waste disposal container.Clean contaminated surface thoroughly.

Sensitive to light. Store in light-resistant containers. Keep container tightly closed in a dry and well-ventilatedplace. Store away from incompatible materials. Store in a segregated and approved area.

Incompatible Materials:Oxidizing agentsAlkalisAcetanilideAntipyrinecamphorMonobromatedChlorohydrateChloral hydratementholQuinine sulfateSalolUrethaneSpirit nitrous ether

8. EXPOSURE CONTROLS/PERSONAL PROTECTIONControl parameters

National occupational exposure limits

United States

Components CAS-No. OSHA NIOSH ACGIH AIHA WEELThymol 89-83-8 None None None None

Canada

Components CAS-No. Canada - Alberta Canada - BritishColumbia

Canada - Ontario Canada - Quebec

Thymol 89-83-8 None None None None

Australia and Mexico

Components CAS-No. Australia MexicoThymol 89-83-8 None 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 or Safety glasses with side-shields.

Skin and body protection: Long sleeved clothingChemical resistant apronGloves


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Respiratory protection: Respirator with combination filter for vapor/particulate.

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 alkalisIncompatible with Acetanilide, Antipyrine, camphor, Monobromated, Chlorohydrate, Chloral hydrate, menthol, Quinine sulfate,Salol, Urethane, Spirit nitrous ether

Chemical stability

Physical state:Solid

Appearance:Crystals.

Color:Colorless.

Odor:Aromatic. Spicy-herbal. Thyme-like.

TastePungent. Sweet. Spicy.

Formula:C10-H14-O

Molecular/Formula weight (g/mole):150.22 g/mol

Flammability:No information available

Flashpoint (°C/°F):102-104°C/ 215.6-219.2°F

Flash Point Tested according to:Closed cup

Autoignition Temperature (°C/°F):285°C/ 545°F

Lower Explosion Limit (%):No information available

Upper Explosion Limit (%):No information available

Melting point/range(°C/°F):48-52°C/ 118.4-125.6°F

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

Boiling point/range(°C/°F):233°C/451.4°F

Bulk density:No information available

Density (g/cm3):No information available

Specific gravity:0.9699

pH:7

Vapor pressure @ 20°C (kPa):No information available

Evaporation rate:No information available

Vapor density:5.2

VOC content (g/L):No information available

Odor threshold (ppm):No information available

Partition coefficient(n-octanol/water):3.30

Viscosity:No information available

Miscibility:No information available

Solubility:Soluble in diethyl etherVery slightly soluble in cold waterSolubility in water: 1 g/1000 ml water @25°C; 900 mg/1000 ml water @20°CSolubility in alcohol: 1 g/1mlalcohol @ 25°CSolubility in chloroform:1g/0.7 ml chloroform @ 25°CSolubilityin ether: 1 g/1.5 ml ether @25°CSolubility in olive oil: 1 g/1.7 mlolive oil @ 25°CSoluble in glacial Acetic acidSoluble in Oils


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Stability: Sensitive to light. Exposure to light accelerates decomposition. Stable under recommendedstorage conditions.

Possibility of Hazardous Reactions: Hazardous polymerization does not occur

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

Incompatible Materials: Oxidizing agentsAlkalisAcetanilideAntipyrinecamphorMonobromatedChlorohydrateChloral hydratementholQuinine sulfateSalolUrethaneSpirit nitrous ether

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:Ingestion. Inhalation.

Acute Toxicity

Component Information

ThymolCAS-No. 89-83-8

LD50/oral/rat = 980 mg/kg Oral LD50 RatLD50/oral/mouse = 640 mg/kgLD50/dermal/rabbit = No information availableLD50/dermal/rat = > 2000 mg/kg Dermal LD50 RatLC50/inhalation/rat = No information availableLC50/inhalation/mouse = No information availableOther LD50 or LC50information = No information available

Product Information

LD50/oral/rat =VALUE- Acute Tox Oral = 980 mg/kg


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LD50/oral/mouse =

Value - Acute Tox Oral = 640 mg/kg

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

LD50/dermal/ratVALUE -Acute Tox Dermal = > 2000 mg/kg

LC50/inhalation/ratVALUE-Vapor = No information availableVALUE-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. Causes skin burns. Effects may vary from mild irritation tosevere destruction of tissue depending on th intensity and duration of theexposure. It may be absorbed through the skin.

Eye Contact: Causes severe eye irritation and possible burns. Effects can vary from mildirritation to chemical conjunctivitis and corneal damage depending on the intensityand duration of exposure.

Inhalation Causes respiratory tract irritation with possible chemical burns. Aspiration maylead to pulmonary edema.

Ingestion Harmful if swallowed. Causes gastrointestinal tract irritation with abdominal pain,nausea, vomiting, diarrhea and possbile burns. It may affect behavior/centralnervous system/peripheral nervous system (somnolence, headache, weakness,fatigue, lethargy, nervousness, agitation, dizziness, talkativeness, convulsions,spastic paralysis, sleepiness, insomina, ataxia, coma), respiration (dyspnea,respiratory stimulation, tachypnea), cardiovascular system (hypotension,dysrhythmias). It may cause kidney and liver damage, pallor, profuse sweating.

Aspiration hazard No information available.

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

Chronic Toxicity Skin: It may be absorbed by the skin and cause systemic effects similar to acuteingestion. Prolonged or repeated ingestion may have symptoms similar to that ofacute ingestion.

Sensitization: No information available.

Mutagenic Effects: May affect genetic materialExperiments with human lymphocytes have shown mutagenic effectsCytogenic analysis (hamster lung)Sister Chromatid Exchange (hamster embryo)

Carcinogenic effects: Not considered carcinogenic.

Components CAS-No. IARC ACGIH -Carcinogens

NTP OSHA HCS -Carcinogens

Australia -Notifiable

Australia -Prohibited


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CarcinogenicSubstances

CarcinogenicSubstances

Thymol 89-83-8 Not listed Not listed Not listed Not listed Not listed Not listedACGIH (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 dataDevelopmental 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: Mucous membrane. Kidneys. Liver. Central nervous system.

12. ECOLOGICAL INFORMATION

Ecotoxicity

Ecotoxicity effects: Aquatic environment.

Thymol - 89-83-8Freshwater Fish Species Data: 5 mg/L LC50 Brachydanio rerio 96 h static 1 3.2 mg/L LC50 Pimephales promelas

96 h static 1Water Flea Data: 1.7-3.2 mg/L EC50 Daphnia (daphnia) 96 h

Persistence and degradability: No information available

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 CAS-No. RCRA - F SeriesWastes

RCRA - K SeriesWastes

RCRA - P SeriesWastes

RCRA - U SeriesWastes

Thymol 89-83-8 None None None None

14. TRANSPORT INFORMATION


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DOT

UN-No: UN2430Proper Shipping Name: Alkylphenols, solid, n.o.s.Hazard Class: 8Subsidiary Class No information availablePacking group: IIIEmergency Response GuideNumber

153

Marine Pollutant No data availableDOT RQ (lbs): No information availableSpecial Provisions IB8, IP3, T1, TP33Symbol(s): No information availableDescription: UN2430, Alkylphenols, solid, n.o.s., 8, III

TDG (Canada)UN-No: UN2430Proper Shipping Name: Alkylphenols, solid, n.o.s.Hazard Class: 8Subsidiary Risk: No information availablePacking Group: IIIMarine Pollutant No Information availableDescription: UN2430, Alkylphenols, solid, n.o.s., 8, III

ADRUN-No: UN2430Proper Shipping Name: Alkylphenols, solid, n.o.s.Hazard Class: 8Packing Group: IIISubsidiary Risk: No information availableDescription: UN2430, Alkylphenols, solid, n.o.s., 8, III, ENVIRONMENTALLY HAZARDOUS

IMO / IMDGUN-No: UN2430Proper Shipping Name: Alkylphenols, solid, n.o.s.Hazard Class: 8Subsidiary Risk: No information availablePacking Group: IIIMarine Pollutant No information availableEMS: F-ASpecial Provisions 223Description UN2430, Alkylphenols, solid, n.o.s. (THYMOL), 8, III, Marine pollutant

RIDUN-No: UN2430Proper Shipping Name: Alkylphenols, solid, n.o.s.Hazard Class: 8Subsidiary Risk: No information availablePacking Group: IIIDescription: UN2430, Alkylphenols, solid, n.o.s., 8, III, ENVIRONMENTALLY HAZARDOUS

ICAOUN-No: UN2430Proper Shipping Name: Alkylphenols, solid, n.o.s.Hazard Class: 8Subsidiary Risk: No information availablePacking Group: IIIDescription: UN2430, Alkylphenols, solid, n.o.s., 8, IIISpecial Provisions A3


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IATA

UN-No: UN2430Proper Shipping Name: Alkylphenols, solid, n.o.s.Hazard Class: 8Subsidiary Risk: No information availablePacking Group: IIIERG Code: 8LSpecial Provisions No information availableDescription: UN2430, Alkylphenols, solid, n.o.s., 8, III

15. REGULATORY INFORMATION

International Inventories

Components CAS-No. U.S. TSCA KOREA KECL Philippines(PICCS)

Japan ENCS CHINA Australia(AICS)

EINECS-No.

Thymol 89-83-8 PresentACTIVE

PresentKE-24420

Present Present(4)-57,(3)-521

Present Present Present201-944-8

U.S. Regulations

ThymolFDA - Direct Food Additives 21 CFR 172.515FDA - 21 CFR - Total Food Additives- List Sourced from EAFUS

172.515, 175.105

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:

Thymol 89-83-8 Not Listed Not Listed Not Listed Not Listed

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

Thymol 89-83-8 None None None None None

U.S. TSCA

Components CAS-No. TSCA Section 5(a)2 - ChemicalsWith Significant New Use Rules(SNURS)

TSCA 8(d) -Health and SafetyReporting

Thymol 89-83-8 Not Applicable Not Applicable

Canada

WHIMIS 2015 - GHS Classifications

WHMIS 2015 Hazard ClassificationInformation:

The WHMIS 2015 classification of this product has not been validated or reviewed yet.


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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

Inventory

Components CAS-No. Canada (DSL) Canada (NDSL)Thymol 89-83-8 Present Not Listed

Components CAS-No. CEPA Schedule I - Toxic SubstancesThymol 89-83-8 Not listedComponents CAS-No. CEPA - 2010 Greenhouse Gases Subject

to Mandatory ReportingThymol 89-83-8 Not listed

EU Classification

EU GHS - SV - CLP 1272/2008

Components CAS-No. EU GHS - SV - CLP (1272/2008)Thymol 89-83-8 Acute toxicity - Oral - Acute Tox. 4:

H302 Harmful if swallowed. (Minimumclassification); Skin corrosion/irritation- Skin Corr. 1B: H314 Causes severe

skin burns and eye damage.;Hazardous to aquatic environment -chronic hazard - Aquatic Chronic 2:H411 Toxic to aquatic life with long

lasting effects.604-032-00-1

EU - CLP (1272/2008)

R-phrase(s)R34 - Causes burns.R22 - Harmful if swallowed.R51 - Toxic to aquatic organisms.R53 - May cause long-term adverse effects in the aquatic environment.

S -phrase(s)S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.S28 - After contact with skin, wash immediately with plenty of waterS45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible).S61 - Avoid release to the environment. Refer to special instructions/safety data sheets.S 1/2 - Keep locked up and out of the reach of children.S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection.

Components CAS-No. Classification ConcentrationLimits:

Safety Phrases

Thymol 89-83-8 Xn; R22C; R34N; R51-53

No information S1/2 S26 S28S36/37/39 S45 S61

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


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Indication of danger:C - Corrosive.

Xn - Harmful.N - Dangerous for the environment.

16. OTHER INFORMATION

Preparation Date: 04/17/2015Revision Date: 10/31/2018Prepared 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


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C O R P O R A T E H E A D Q U A R T E R S

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New Brunswick, NJ 08901

PHONE 732.214.1300

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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

August 12, 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 T1050 Thymol, Crystal, 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

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

April 22, 2016 Re: Thymol, Crystal, NF-T1050 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 Thymol, Crystal, NF-T1050 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 19, 2016 Re: Thymol, Crystal, NF-T1050 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; Lupin; Tree nuts; Mollusks; Wheat; Peanuts; Soy; Cereals containing Gluten; Celery; Mustard; Sesame Seed). Thymol, Crystal, NF-T1050

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

May 3, 2016 Re: Thymol, Crystal, NF-T1050 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. Thymol, Crystal, NF-T1050 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 T1050 Lot Number 1HG0929

Item Thymol, Crystal, NF Manufacturer Lot 43914

CAS Number 89-83-8 Manufacturer Code 121

Molecular Formula C10H14O Molecular Weight 150.22

Test Specification Resultmin max

99.0 101.0 % 99.7 %

48° 51°C 48 - 50°C

0.05 % 0.005 %

AS REPORTED COMPLIES WITHSTANDARD

TO PASS TEST PASSES TEST


31-MAR-2020

01-APR-2018

WHITE CRYSTALS


<5000 ppm

Spectrum Chemical Mfg Corp


Gardena 90248 CA

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.

The Elemental Impurities standards implemented by USP and other Pharmaceutical Compendia reflect a growing understandingof the toxicology of trace levels of elemental impurities that can remain in drug substances originating from either raw materials ormanufacturing processes. Identifying and quantifying impurities can be critical to predicting the best possible patient outcomes.Elemental Impurities has been a requirement of all products meeting USP/NF, EP and BP monographs since January 1, 2018.More information can be found in USP sections <232> Elemental Impurities – Limits and <233> Elemental Impurities –Procedures. Data for drug substances furnished by Spectrum Chemical Mfg. Corp can be used to ensure that patient dailyexposures by oral administration to the selected elements are not exceeded in the formulation of pharmaceutical products.

Spectrum Chemical Mfg. Corp. repackages Active Pharmaceutical Ingredient chemicals provided by other manufacturers andsuppliers. For traceability purposes, Spectrum's Certificate of Analysis contains an identifier code unique to each manufacturer orsupplier, as well as the chemical's lot number provided on the original manufacturer Certificate of Analysis. Test results for theoriginal Certificate of Analysis are available upon request from your Spectrum Sales Representative or by calling Spectrum'sQuality Department at 1-800-772-8786.

Certificate Of Analysis

Item Number T1050 Lot Number 2HG0334

Item Thymol, Crystal, NF Manufacturer Lot 43914

CAS Number 89-83-8 Manufacturer Code 121

Molecular Formula C10H14O Molecular Weight 150.22

Test Specification Resultmin max

99.0 101.0 % 99.7 %

48° 51°C 48.1 - 50.1 C

0.05 % 0.005 %

AS REPORTED COMPLIES WITHSTANDARD

SPECTRUMMATCHESREFERENCE

SPECTRUMMATCHES

REFERENCE

48 51 C 48.1 - 50.1°C

31-MAR-2020

01-APR-2018

COLORLESSCRYSTALS

AS REPORTED .

< 5000 ppm


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.

The Elemental Impurities standards implemented by USP and other Pharmaceutical Compendia reflect a growing understandingof the toxicology of trace levels of elemental impurities that can remain in drug substances originating from either raw materials ormanufacturing processes. Identifying and quantifying impurities can be critical to predicting the best possible patient outcomes.Elemental Impurities has been a requirement of all products meeting USP/NF, EP and BP monographs since January 1, 2018.More information can be found in USP sections <232> Elemental Impurities – Limits and <233> Elemental Impurities –Procedures. Data for drug substances furnished by Spectrum Chemical Mfg. Corp can be used to ensure that patient dailyexposures by oral administration to the selected elements are not exceeded in the formulation of pharmaceutical products.

Spectrum Chemical Mfg. Corp. repackages Active Pharmaceutical Ingredient chemicals provided by other manufacturers andsuppliers. For traceability purposes, Spectrum's Certificate of Analysis contains an identifier code unique to each manufacturer orsupplier, as well as the chemical's lot number provided on the original manufacturer Certificate of Analysis. Test results for theoriginal Certificate of Analysis are available upon request from your Spectrum Sales Representative or by calling Spectrum'sQuality Department at 1-800-772-8786.

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

Chemical Emergency: (800)424-9300*49452T1050062233BOA* T1050 2.5 KG

ThymolCrystal, N.F.

CAS 89-83-8

CAUTION: For manufacturing, processing or repacking.Read and understand the label and Safety Data Sheet (SDS) prior to use.

DANGER• Causes severe skin burns and eye damage • Harmful if swallowed.• 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.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 (or hair): Take off immediately all contaminated clothing. Rinse skin with water. Wash contaminated clothing before reuse. IF INHALED: Remove person to fresh air and keep comfortable for breathing. IF SWALLOWED: Rinse mouth. DO NOT induce vomiting.

KEEP FROM CHILDREN

DOT: UN2430, Alkylphenols, solid, n.o.s, 8, PG III,marine pollutant

W 7/E1GHS A Lot No. 062233

C10H14O F.W. 150.22

Assay .............................................. 99.0-101.0%Melting Range ....................................... 48°-51°C

MAXIMUM LIMITSNonvolatile Residue .................................. 0.05%Residual Solvents .............................To pass test

LIGHT SENSITIVE: Keep tightly closed in light-resistant containers.

www.SpectrumChemical.com

Exp.

Dat

e: 0

3-31

-202

5

XxAa

Empirical Formula, Formula Weight and Technical Specifications Panel

Expiration Information

Lot Number

Kosher Certified by Kosher Supervision of America (KSA).

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

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A

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C

H

F

G

L

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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.

O

Label Legend

M

N

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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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

F

K

I

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


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

12.August.2019

Stability – Shelf Life Guidance Product Covered: T1050, Thymol, Crystal, NF

Spectrum Chemical’s manufacturing partner has assigned the following shelf life guidance for the product listed above. The product, T1050, Thymol, Crystal, NF, is assigned a 24 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

Documents

T1050, Thymol, Crystal, NF - Spectrum Chemical · Specification for Thymol, Crystal, NF (T1050) Item Number T1050 Item Thymol, Crystal, NF CAS Number 89-83-8 Molecular Formula C 10