53152-21-9

CAS#53152-21-9
Manufacturer
RTECSKM7758000
SPECTRUM QUALITY PRODUCTS INC.
TSCATSCA 8(b) inventory: No
products were found.
Commercial Name(s)Not available.
CI# Not available.
SynonymNot available.
IN CASE OF EMERGENCY
Buprenorphine Hydrochloride
Chemical Name
Chemical FamilyNot available.CALL (310) 516-8000
C29-H41-N-O4.HCl
Chemical Formula
SPECTRUM QUALITY PRODUCTS INC.

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Section 2.Composition and Information on Ingredients
Exposure Limits
TWA (mg/m3)STEL (mg/m3) CEIL (mg/m3)
NameCAS #% by Weight
1) Buprenorphine Hydrochloride53152-21-9100
Toxicological DataBuprenorphine Hydrochloride:
on IngredientsORAL (LD50):Acute: 1000 mg/kg [Rat]. 800 mg/kg [Mouse].

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Section 3. Hazards Identification
Potential Acute Health Effects Hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion.
Potential Chronic HealthCARCINOGENIC EFFECTS: Not available.
MUTAGENIC EFFECTS: Not available.
Effects
TERATOGENIC EFFECTS: Not available.
DEVELOPMENTAL TOXICITY: Classified Reproductive system/toxin/female, Development toxin [POSSIBLE].
The substance may be toxic to blood, lungs, liver, upper respiratory tract, skin, central nervous system (CNS).
Repeated or prolonged exposure to the substance can produce target organs damage. Repeated exposure to a
highly toxic material may produce general deterioration of health by an accumulation in one or many human
organs.
Buprenorphine Hydrochloride

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Section 4. First Aid Measures
Eye ContactCheck for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at
least 15 minutes. Get medical attention.
Skin ContactIn case of contact, immediately flush skin with plenty of water. Cover the irritated skin with an emollient. Remove
contaminated clothing and shoes. Wash clothing before reuse. Thoroughly clean shoes before reuse. Get
medical attention.
Serious Skin ContactWash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek immediate
medical attention.
InhalationIf inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get
medical attention immediately.
Serious InhalationNot available.
IngestionDo NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an
unconscious person. If large quantities of this material are swallowed, call a physician immediately. Loosen tight
clothing such as a collar, tie, belt or waistband.
Serious IngestionNot available.

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Section 5. Fire and Explosion Data
Flammability of the Product May be combustible at high temperature.
Auto-Ignition Temperature Not available.
Flash PointsNot available.
Flammable LimitsNot available.
Products of CombustionThese products are carbon oxides (CO, CO2), nitrogen oxides (NO, NO2...).
Fire Hazards in Presence of Not available.
Various Substances
Explosion Hazards in Presence Risks of explosion of the product in presence of mechanical impact: Not available.
of Various SubstancesRisks of explosion of the product in presence of static discharge: Not available.
Fire Fighting MediaSMALL FIRE: Use DRY chemical powder.
and InstructionsLARGE FIRE: Use water spray, fog or foam. Do not use water jet.
Special Remarks onNot available.
Fire Hazards
Special Remarks on Explosion Not available.
Hazards

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Section 6. Accidental Release Measures
Small SpillUse appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by
spreading water on the contaminated surface and dispose of according to local and regional authority
requirements.
Large SpillPoisonous solid.
Stop leak if without risk. Do not get water inside container. Do not touch spilled material. Use water spray to
reduce vapors. Prevent entry into sewers, basements or confined areas; dike if needed. Eliminate all ignition
allow to evacuate through the sanitary system.
Buprenorphine Hydrochloride

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Section 7. Handling and Storage
PrecautionsKeep locked up.. Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk,
evaporate the residue under a fume hood. Ground all equipment containing material. Do not ingest. Do not
breathe dust. Wear suitable protective clothing. If ingested, seek medical advice immediately and show the
container or the label. Avoid contact with skin and eyes.
StorageKeep container tightly closed. Keep container in a cool, well-ventilated area.

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Section 8. Exposure Controls/Personal Protection
Engineering ControlsUse process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below
recommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to
airborne contaminants below the exposure limit.
Personal ProtectionSplash goggles. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent.
Gloves.
Personal Protection in Case of Splash goggles. Full suit. Dust respirator. Boots. Gloves. A self contained breathing apparatus should be used
a Large Spillto avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist
BEFORE handling this product.
Exposure LimitsNot available.

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Section 9. Physical and Chemical Properties
Physical state and appearance Solid.OdorNot available.
Not available.
Taste
Molecular Weight504.17 g/mole
Not available.
Color
Not available.
pH (1% soln/water)
Boiling PointNot available.
Melting PointNot available.
Critical TemperatureNot available.
Specific GravityNot available.
Not applicable.
Vapor Pressure
Vapor DensityNot available.
Not available.
Volatility
Odor ThresholdNot available.
Water/Oil Dist. Coeff.Not available.
Ionicity (in Water)Not available.
Dispersion PropertiesNot available.
SolubilityNot available.

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Section 10. Stability and Reactivity Data
StabilityThe product is stable.
Instability TemperatureNot available.
Conditions of InstabilityNot available.
Incompatibility with variousNot available.
substances
CorrosivityNot available.
Buprenorphine Hydrochloride
Special Remarks onNot available.
Reactivity
Special Remarks onNot available.
Corrosivity
PolymerizationWill not occur.

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Section 11. Toxicological Information
Routes of EntryAbsorbed through skin. Eye contact. Inhalation. Ingestion.
Toxicity to AnimalsAcute oral toxicity (LD50): 800 mg/kg [Mouse].
Chronic Effects on HumansDEVELOPMENTAL TOXICITY: Classified Reproductive system/toxin/female, Development toxin [POSSIBLE].
May cause damage to the following organs: blood, lungs, liver, upper respiratory tract, skin, central nervous
system (CNS).
Other Toxic Effects onHazardous in case of skin contact (irritant), of ingestion.
Humans
Special Remarks onNot available.
Toxicity to Animals
Special Remarks onNot available.
Chronic Effects on Humans
Special Remarks on otherNot available.
Toxic Effects on Humans

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Section 12. Ecological Information
EcotoxicityNot available.
Not available.
BOD5 and COD
Possibly hazardous short term degradation products are not likely. However, long term degradation products may
Products of Biodegradation
arise.
Toxicity of the ProductsThe products of degradation are less toxic than the product itself.
of Biodegradation
Special Remarks on theNot available.
Products of Biodegradation

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Section 13. Disposal Considerations
Waste Disposal

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Section 14. Transport Information
DOT ClassificationNot a DOT controlled material (United States).
IdentificationNot applicable.
Not applicable.
Special Provisions for
Transport
Buprenorphine Hydrochloride
DOT (Pictograms)

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Section 15. Other Regulatory Information and Pictograms
No products were found.
Federal and State
Regulations
California
Proposition 65
Warnings
Other RegulationsEINECS: This product is on the European Inventory of Existing Commercial Chemical Substances.
WHMIS (Canada) Not controlled under WHMIS (Canada).
Other Classifications
DSCL (EEC)R22- Harmful if swallowed.
R26- Very toxic by inhalation.
R36- Irritating to eyes.
R62- Possible risk of impaired fertility.
Health Hazard
HMIS (U.S.A.)2 National Fire Protection
1 Flammability
1 Association (U.S.A.)
Fire Hazard
2 0 Reactivity
Health
Reactivity
0
Specific hazard
Personal Protection
E
WHMIS (Canada)
(Pictograms)
DSCL (Europe)
(Pictograms)
TDG (Canada)
(Pictograms)
ADR (Europe)
(Pictograms)
Protective Equipment
Gloves.
Lab coat.
Buprenorphine Hydrochloride
Dust respirator. Be sure to use an
approved/certified respirator or
equivalent.

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SECTION 16 - ADDITIONAL INFORMATION
N/A

MOLECULAR FORMULA :

C29-H41-N-O4.Cl-H

MOLECULAR WEIGHT :

504.17

HEALTH HAZARD DATA

ACUTE TOXICITY DATA

TYPE OF TEST :

TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE :

Oral

SPECIES OBSERVED :

Human - man

DOSE/DURATION :

2857 ug/kg

TOXIC EFFECTS :

Behavioral - hallucinations, distorted perceptions Behavioral - excitement

REFERENCE :

BMJOAE British Medical Journal. (British Medical Assoc., BMA House, Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year: 296,214,1988

TYPE OF TEST :

LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE :

Oral

SPECIES OBSERVED :

Rodent - rat

DOSE/DURATION :

>1 gm/kg

TOXIC EFFECTS :

Behavioral - convulsions or effect on seizure threshold Behavioral - changes in motor activity (specific assay) Skin and Appendages - hair

REFERENCE :

IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 13,486,1982

TYPE OF TEST :

LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE :

Subcutaneous

SPECIES OBSERVED :

Rodent - rat

DOSE/DURATION :

>1 gm/kg

TOXIC EFFECTS :

Sense Organs and Special Senses (Eye) - effect, not otherwise specified Behavioral - somnolence (general depressed activity) Blood - changes in spleen

REFERENCE :

IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 13,486,1982

TYPE OF TEST :

LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE :

Intravenous

SPECIES OBSERVED :

Rodent - rat

DOSE/DURATION :

62 mg/kg

TOXIC EFFECTS :

Lungs, Thorax, or Respiration - respiratory stimulation

REFERENCE :

IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 13,486,1982

TYPE OF TEST :

LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE :

Intramuscular

SPECIES OBSERVED :

Rodent - rat

DOSE/DURATION :

>600 mg/kg

TOXIC EFFECTS :

Behavioral - food intake (animal) Behavioral - ataxia Blood - changes in spleen

REFERENCE :

IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 13,486,1982

TYPE OF TEST :

LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE :

Oral

SPECIES OBSERVED :

Rodent - mouse

DOSE/DURATION :

800 mg/kg

TOXIC EFFECTS :

Behavioral - convulsions or effect on seizure threshold Behavioral - changes in motor activity (specific assay) Liver - other changes

REFERENCE :

IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 13,486,1982

TYPE OF TEST :

LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE :

Subcutaneous

SPECIES OBSERVED :

Rodent - mouse

DOSE/DURATION :

>1 gm/kg

TOXIC EFFECTS :

Sense Organs and Special Senses (Eye) - effect, not otherwise specified Behavioral - somnolence (general depressed activity) Blood - changes in spleen

REFERENCE :

IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 13,486,1982

TYPE OF TEST :

LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE :

Intravenous

SPECIES OBSERVED :

Rodent - mouse

DOSE/DURATION :

72 mg/kg

TOXIC EFFECTS :

Lungs, Thorax, or Respiration - respiratory stimulation

REFERENCE :

IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 13,486,1982

TYPE OF TEST :

LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE :

Intramuscular

SPECIES OBSERVED :

Rodent - mouse

DOSE/DURATION :

>600 mg/kg

TOXIC EFFECTS :

Behavioral - food intake (animal) Behavioral - ataxia Blood - changes in spleen

REFERENCE :

IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 13,486,1982

TYPE OF TEST :

LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE :

Intravenous

SPECIES OBSERVED :

Mammal - dog

DOSE/DURATION :

79 mg/kg

TOXIC EFFECTS :

Details of toxic effects not reported other than lethal dose value

REFERENCE :

YKYUA6 Yakkyoku. Pharmacy. (Nanzando, 4-1-11, Yushima, Bunkyo-ku, Tokyo, Japan) V.1- 1950- Volume(issue)/page/year: 35,1351,1984

TYPE OF TEST :

LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE :

Intravenous

SPECIES OBSERVED :

Mammal - species unspecified

DOSE/DURATION :

40 mg/kg

TOXIC EFFECTS :

Details of toxic effects not reported other than lethal dose value

REFERENCE :

YKYUA6 Yakkyoku. Pharmacy. (Nanzando, 4-1-11, Yushima, Bunkyo-ku, Tokyo, Japan) V.1- 1950- Volume(issue)/page/year: 35,1351,1984 ** OTHER MULTIPLE DOSE TOXICITY DATA **

TYPE OF TEST :

TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE :

Intramuscular

SPECIES OBSERVED :

Rodent - rat

DOSE/DURATION :

35 mg/kg/5W-C

TOXIC EFFECTS :

Liver - other changes Liver - changes in liver weight Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol)

REFERENCE :

IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 13,486,1982 ** REPRODUCTIVE DATA **

TYPE OF TEST :

TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE :

Intramuscular

DOSE :

1350 ug/kg

SEX/DURATION :

female 17-22 day(s) after conception lactating female 21 day(s) post-birth

TOXIC EFFECTS :

Reproductive - Effects on Newborn - viability index (e.g., # alive at day 4 per # born alive) Reproductive - Effects on Newborn - behavioral Reproductive - Effects on Newborn - physical

REFERENCE :

IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 13,532,1982

TYPE OF TEST :

TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE :

Intramuscular

DOSE :

300 ug/kg

SEX/DURATION :

female 17-22 day(s) after conception

TOXIC EFFECTS :

Reproductive - Maternal Effects - parturition

REFERENCE :

IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 13,532,1982

TYPE OF TEST :

TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE :

Intramuscular

DOSE :

550 ug/kg

SEX/DURATION :

female 7-17 day(s) after conception

TOXIC EFFECTS :

Reproductive - Specific Developmental Abnormalities - musculoskeletal system Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight gain)

REFERENCE :

IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970- Volume(issue)/page/year: 13,509,1982