Prednisolone Acetate

CAS#52-21-1
Manufacturer
RTECSTU4152500
SPECTRUM CHEMICAL MFG. CORP.
TSCATSCA 8(b) inventory:
Prednisolone acetate
Commercial Name(s)Prednisolone 21-Acetate; Cormalone; Cortpred; Meticortelone
CI#Not available.
acetate; Nisolone; Prediacortine; Perdicort
(11beta)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione acetate
Synonym
IN CASE OF EMERGENCY
Chemical Name
(11.beta.)-
Chemical FamilyNot available.CALL (310) 516-8000
Chemical FormulaC21H26O5
SPECTRUM CHEMICAL MFG. CORP.

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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) Prednisolone acetate52-21-1100
Not applicable.
Toxicological Data
on Ingredients

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Section 3. Hazards Identification
Potential Acute Health Effects Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation.
CARCINOGENIC EFFECTS: Not available.
Potential Chronic Health
EffectsMUTAGENIC EFFECTS: Not available.
TERATOGENIC EFFECTS: Not available.
DEVELOPMENTAL TOXICITY: Classified Reproductive system/toxin/female, Reproductive system/toxin/male
[POSSIBLE].
Repeated or prolonged exposure is not known to aggravate medical condition.
Prednisolone acetate

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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 if irritation occurs.
Skin ContactWash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation develops.
Serious Skin ContactNot available.
InhalationIf inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get
medical attention.
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).
Fire Hazards in Presence of Slightly flammable to flammable in presence of heat.
Various Substances
Explosion Hazards in Presence Risks of explosion of the product in presence of mechanical impact: Not available.
Risks of explosion of the product in presence of static discharge: Not available.
of Various Substances
SMALL FIRE: Use DRY chemical powder.
Fire Fighting Media
and InstructionsLARGE FIRE: Use water spray, fog or foam. Do not use water jet.
Not available.
Special Remarks on
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 SpillUse a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water
on the contaminated surface and allow to evacuate through the sanitary system.
Prednisolone acetate

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Section 7. Handling and Storage
PrecautionsKeep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not
breathe dust.
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 Protection
Safety glasses. 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. (Solid crystalline powder.)OdorOdorless.
TasteNot available.
Molecular Weight402.49 g/mole
ColorWhite.
pH (1% soln/water)Not available.
Boiling PointNot available.
Melting PointDecomposes. (237°C or 458.6°F)
Critical TemperatureNot available.
Not available.
Specific Gravity
Vapor PressureNot applicable.
Vapor DensityNot available.
VolatilityNot available.
Odor ThresholdNot available.
Not available.
Water/Oil Dist. Coeff.
Ionicity (in Water)Not available.
See solubility in water, methanol, acetone.
Dispersion Properties
SolubilitySoluble in methanol, acetone.

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Section 10. Stability and Reactivity Data
StabilityThe product is stable.
Not available.
Instability Temperature
Conditions of InstabilityNot available.
Incompatibility with variousNot available.
substances
CorrosivityNon-corrosive in presence of glass.
Prednisolone acetate
Special Remarks onNot available.
Reactivity
Special Remarks onNot available.
Corrosivity
PolymerizationNo.

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Section 11. Toxicological Information
Routes of EntryInhalation. Ingestion.
Toxicity to AnimalsLD50: Not available.
LC50: Not available.
Chronic Effects on Humans Not available.
Other Toxic Effects onSlightly hazardous in case of skin contact (irritant), of ingestion, of inhalation.
Humans
Special Remarks onNot available.
Toxicity to Animals
Special Remarks on
May cause adverse reproductive effects and birth defects (teratogenic).
Chronic Effects on Humans
Excreted in maternal milk in human.
Special Remarks on otherAcute Potential Health Effects:
Toxic Effects on HumansSkin: May cause skin irritation. It may be absorbed through the skin.
Eyes: Dust may cause eye irritation.
Inhalation: Dust may cause respiratory tract irritation.
Ingestion: May cause gastrointestinal tract irritation. May also affect behavior (toxic psychosis), metabolism
(anorexia), and urinary system. This material is readily absorbed from the gastrointestinal tract. Ingestion of a
massive single dose is unlikely to cause adverse effects.
Chronic Potential Health Effects:
Prolonged or repeated exposure by inhalation, ingestion, or skin contact may cause allergic reaction (possible
hypersensitization).
Other symptoms of chronic overdose effects may include, acne or other skin problems, weight loss or weight
gain, hip or shoulder pain, fullness in face, fluid retention associated with sodium retention, potassium
loss,swelling of feet or lower legs, excess or abnormal thirst, menstrual irregularities, nausea, vomiting, irregular
heartbeat, muscle cramps, weakness, osteoporosis, increased susceptibility to infection, psychosis, and eye
problems. May also affect urinary system (polyuria), liver, adrenal gland.

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Section 12. Ecological Information
EcotoxicityNot available.
BOD5 and CODNot available.
Products of BiodegradationPossibly hazardous short term degradation products are not likely. However, long term degradation products may
arise.
The product itself and its products of degradation are not toxic.
Toxicity of the Products
of Biodegradation
Special Remarks on theNot available.
Products of Biodegradation

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Section 13. Disposal Considerations
Waste DisposalWaste must be disposed of in accordance with federal, state and local environmental
control regulations.
Prednisolone acetate

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

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Section 15. Other Regulatory Information and Pictograms
TSCA 8(b) inventory: Prednisolone acetate
Federal and State
Regulations
CaliforniaCalifornia prop. 65: This product contains the following ingredients for which the State of California has found
to cause cancer which would require a warning under the statute: No products were found.
Proposition 65
Warnings
California prop. 65: This product contains the following ingredients for which the State of California has found
to cause birth defects which would require a warning under the statute: No products were found.
Other RegulationsEINECS: This product is on the European Inventory of Existing Commercial Chemical Substances (EINECS No.
200-134-1).
Canada: Listed on Canadian Domestic Substance List (DSL).
China: Not listed on National Inventory.
Japan: Not listed on National Inventory (ENCS).
Korea: Listed on National Inventory (KECI).
Philippines: Mot listed on National Inventory (PICCS).
Australia: Listed on AICS.
WHMIS (Canada) CLASS D-2A: Material causing other toxic effects (VERY TOXIC).
Other Classifications
DSCL (EEC)
R62- Possible risk of impaired fertility.S36- Wear suitable protective clothing.
R63- Possible risk of harm to the
unborn child.
Health Hazard
HMIS (U.S.A.)1 National Fire Protection
1 Flammability
1 Association (U.S.A.)
Fire Hazard
1 0 Reactivity
Health
Reactivity
0
Specific hazard
Personal Protection
E
WHMIS (Canada)
(Pictograms)
DSCL (Europe)
(Pictograms)
TDG (Canada)
(Pictograms)
Prednisolone acetate
ADR (Europe)
(Pictograms)
Protective Equipment
Gloves.
Lab coat.
Dust respirator. Be sure to use an
approved/certified respirator or
equivalent. Wear appropriate respirator
when ventilation is inadequate.

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SECTION 16 - ADDITIONAL INFORMATION
N/A

DATA ITEMS CITED :

7

MOLECULAR FORMULA :

C23-H30-O6

MOLECULAR WEIGHT :

402.53

WISWESSER LINE NOTATION :

L E5 B666 OV AHTTT&J A1 CQ E1 FV1OV1 FQ

HEALTH HAZARD DATA

ACUTE TOXICITY DATA

TYPE OF TEST :

LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE :

Subcutaneous

SPECIES OBSERVED :

Rodent - rat

DOSE/DURATION :

>240 mg/kg

TOXIC EFFECTS :

Details of toxic effects not reported other than lethal dose value

REFERENCE :

NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo, Japan) Volume(issue)/page/year: 6,713,1982

TYPE OF TEST :

LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE :

Subcutaneous

SPECIES OBSERVED :

Rodent - mouse

DOSE/DURATION :

3500 mg/kg

TOXIC EFFECTS :

Details of toxic effects not reported other than lethal dose value

REFERENCE :

NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo, Japan) Volume(issue)/page/year: 6,713,1982 ** REPRODUCTIVE DATA **

TYPE OF TEST :

TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE :

Oral

DOSE :

1800 mg/kg

SEX/DURATION :

female 2-19 day(s) after conception

TOXIC EFFECTS :

Reproductive - Fertility - post-implantation mortality (e.g. dead and/or resorbed implants per total number of implants) Reproductive - Fertility - abortion

REFERENCE :

FESTAS Fertility and Sterility. (American Fertility Soc., 608 13th Ave. S, Birmingham, AL 35282) V.1- 1950- Volume(issue)/page/year: 22,735,1971

TYPE OF TEST :

TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE :

Subcutaneous

DOSE :

96 mg/kg

SEX/DURATION :

female 11 day(s) after conception

TOXIC EFFECTS :

Reproductive - Fertility - post-implantation mortality (e.g. dead and/or resorbed implants per total number of implants) Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death, e.g., stunted fetus) Reproductive - Specific Developmental Abnormalities - craniofacial (including nose and tongue)

REFERENCE :

SEIJBO Senten Ijo. Congenital Anomalies. (Nippon Senten Ijo Gakkai, c/o Kinki Daigaku Igakubu Kaibagaku Kyoshitsu, 380 Nishiyama, Sayama-cho, Mirami-Kawachi-gun, Osaka-fu, Japan) V.1-26, 1960-86. For publisher information, see CGANE7. Volume(issue)/page/year: 13,245,1973

TYPE OF TEST :

TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE :

Intravenous

DOSE :

96 mg/kg

SEX/DURATION :

female 11-14 day(s) after conception

TOXIC EFFECTS :

Reproductive - Fertility - post-implantation mortality (e.g. dead and/or resorbed implants per total number of implants) Reproductive - Specific Developmental Abnormalities - craniofacial (including nose and tongue)

REFERENCE :

SEIJBO Senten Ijo. Congenital Anomalies. (Nippon Senten Ijo Gakkai, c/o Kinki Daigaku Igakubu Kaibagaku Kyoshitsu, 380 Nishiyama, Sayama-cho, Mirami-Kawachi-gun, Osaka-fu, Japan) V.1-26, 1960-86. For publisher information, see CGANE7. Volume(issue)/page/year: 13,245,1973 *** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA *** NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA : NOES - National Occupational Exposure Survey (1983) NOES Hazard Code - X1855 No. of Facilities: 8 (estimated) No. of Industries: 1 No. of Occupations: 1 No. of Employees: 138 (estimated) No. of Female Employees: 130 (estimated) NOES - National Occupational Exposure Survey (1983) NOES Hazard Code - X3752 No. of Facilities: 30 (estimated) No. of Industries: 1 No. of Occupations: 2 No. of Employees: 726 (estimated) No. of Female Employees: 429 (estimated)