T1050, Thymol, Crystal, NF - Spectrum Chemical · Specification for Thymol, Crystal, NF (T1050)...
Transcript of T1050, Thymol, Crystal, NF - Spectrum Chemical · Specification for Thymol, Crystal, NF (T1050)...
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
Product code: T1050 Product name: THYMOL, CRYSTAL,NF
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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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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
TO PASS TEST PASSES TEST
31-MAR-2020
01-APR-2018
WHITE CRYSTALS
TO PASS TEST PASSES TEST
<5000 ppm
Spectrum Chemical Mfg Corp
14422 South San Pedro Street
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
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.
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
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Empirical Formula, Formula Weight and Technical Specifications Panel
Expiration Information
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Kosher Certified by Kosher Supervision of America (KSA).
Bar CodeGHS Hazard PictogramsWarning, Safety Data and Precautionary InformationProduct Catalog NumberItem Name, Form, Grade
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Caution Information
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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
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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
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
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