BEGIN MSDS 00203402
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SECTION 1 CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
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Genetics Institute, Inc. EMERGENCY TELEPHONE NUMBER:
87 Cambridge Park Drive 888-446-3344
Cambridge, MA 02140
SUBSTANCE: REFACTO ANTIHEMOPHILIC FACTOR (RECOMBINANT)
TRADE NAMES/SYNONYMS:
00203402
CHEMICAL FAMILY: glycoproteins
PRODUCT USE: pharmaceutical, treatment for Hemophilia A
CREATION DATE: Jul 30 1999
REVISION DATE: Aug 05 1999
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SECTION 2 COMPOSITION, INFORMATION ON INGREDIENTS
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COMPONENT: REFACTO
CAS NUMBER: Not assigned.
EC NUMBER: Not assigned.
PERCENTAGE: <100
COMPONENT: L-(-) HISTIDINE
CAS NUMBER: 71-00-1
EC NUMBER (EINECS): 200-745-3
PERCENTAGE: >1
COMPONENT: SUCROSE
CAS NUMBER: 57-50-1
EC NUMBER (EINECS): 200-334-9
PERCENTAGE: >1
COMPONENT: CALCIUM CHLORIDE DIHYDRATE
CAS NUMBER: Not assigned.
EC NUMBER: Not assigned.
PERCENTAGE: >1
COMPONENT: SODIUM CHLORIDE
CAS NUMBER: 7647-14-5
EC NUMBER (EINECS): 231-598-3
PERCENTAGE: >1
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SECTION 3 HAZARDS IDENTIFICATION
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NFPA RATINGS (SCALE 0-4): HEALTH=1 FIRE=0 REACTIVITY=0
EC CLASSIFICATION (CALCULATED): Not determined.
EMERGENCY OVERVIEW:
COLOR: colorless
PHYSICAL FORM: powder
MAJOR HEALTH HAZARDS: Refacto is not purified from human blood and contains no
preservatives or added animal or human components in the final form.
PHYSICAL HAZARDS: None under normal conditions of use.
POTENTIAL HEALTH EFFECTS:
INHALATION:
SHORT TERM EXPOSURE: Allergic type hypersensitivity reactions are possible.
Signs of hypersensitivity include hives, generalized uticaria, tightness of
chest, wheezing, hypotension, and anaphylaxis. Known severe hypersensitivity
to the active substance or to other mouse, hamster or bovine proteins or any
of the excipients.
LONG TERM EXPOSURE: no information is available.
SKIN CONTACT:
SHORT TERM EXPOSURE: no information is available
LONG TERM EXPOSURE: no information is available
EYE CONTACT:
SHORT TERM EXPOSURE: no information is available
LONG TERM EXPOSURE: no information is available
INGESTION:
SHORT TERM EXPOSURE: no information is available
LONG TERM EXPOSURE: no information is available
CARCINOGEN STATUS:
OSHA: N
NTP: N
IARC: N
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SECTION 4 FIRST AID MEASURES
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INHALATION: Remove from exposure immediately. Use a bag valve mask or similar
device to perform artificial respiration (rescue breathing) if needed. Get
medical attention.
SKIN CONTACT: Remove contaminated clothing, jewelry, and shoes immediately.
Wash with soap or mild detergent and large amounts of water until no
evidence of material remains (at least 15-20 minutes).
Get medical attention, if needed.
EYE CONTACT: Wash eyes immediately with large amounts of water or normal
saline, occasionally lifting upper and lower lids, until no evidence of
chemical remains. Get medical attention immediately.
INGESTION: If vomiting occurs, keep head lower than hips to help prevent
aspiration. Get medical attention, if needed.
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SECTION 5 FIRE FIGHTING MEASURES
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FIRE AND EXPLOSION HAZARDS: No fire or explosion hazard is expected.
EXTINGUISHING MEDIA: regular dry chemical, carbon dioxide, water, regular foam
Large fires: Use regular foam or flood with fine water spray.
FIRE FIGHTING: Move container from fire area if it can be done without risk.
Do not scatter spilled material with high-pressure water streams. Dike for
later disposal. Use extinguishing agents appropriate for surrounding fire.
Avoid inhalation of material or combustion by-products. Stay upwind and keep
out of low areas.
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SECTION 6 ACCIDENTAL RELEASE MEASURES
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OCCUPATIONAL RELEASE:
Collect spilled material in appropriate container for disposal. Keep out of
water supplies and sewers. Keep unnecessary people away, isolate hazard area
and deny entry.
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SECTION 7 HANDLING AND STORAGE
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Store and handle in accordance with all current regulations and standards.
Refrigerate. Store between 2 C and 8 C to maintain product potency. Keep
separated from incompatible substances.
Use methods to minimize dust.
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SECTION 8 EXPOSURE CONTROLS, PERSONAL PROTECTION
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EXPOSURE LIMITS:
SUCROSE:
5 mg/m3 OSHA TWA (respirable particulate)
15 mg/m3 OSHA TWA (total particulate)
10 mg/m3 ACGIH TWA
10 mg/m3 NIOSH recommended TWA 10 hour(s) (total particulate)
5 mg/m3 NIOSH recommended TWA 10 hour(s) (respirable particulate)
10 mg/m3 UK OES TWA
20 mg/m3 UK OES STEL
MEASUREMENT METHOD: Particulate filter; Gravimetric; NIOSH III # 0500,
Nuisance Dust (total), # 0600 (respirable)
VENTILATION: Under normal conditions of use no special ventilation equipment
is needed.
EYE PROTECTION: Wear splash resistant safety goggles. Provide an emergency eye
wash fountain and quick drench shower in the immediate work area.
CLOTHING: Under normal conditions of use, wear clothing to prevent contact
with skin.
GLOVES: Wear appropriate gloves.
RESPIRATOR: No respirator is required under normal conditions of use.
Under conditions of frequent use or heavy exposure, respiratory protection
may be needed.
Respiratory protection is ranked in order from minimum to maximum.
Consider warning properties before use.
Any dust and mist respirator.
Any air-purifying respirator with a high-efficiency particulate filter.
For Unknown Concentrations or Immediately Dangerous to Life or Health -
Any supplied-air respirator with full facepiece that is operated in a
pressure-demand or other positive-pressure mode.
Any self-contained breathing apparatus.
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SECTION 9 PHYSICAL AND CHEMICAL PROPERTIES
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PHYSICAL STATE: solid
APPEARANCE: clear to opaque
COLOR: colorless
PHYSICAL FORM: powder
ODOR: Not available
BOILING POINT: Not applicable
MELTING POINT: Not available
VAPOR PRESSURE: Not applicable
VAPOR DENSITY: Not applicable
SPECIFIC GRAVITY: Not available
WATER SOLUBILITY: Not available
PH: 6.8-7.4
VOLATILITY: Not applicable
ODOR THRESHOLD: Not available
EVAPORATION RATE: Not applicable
COEFFICIENT OF WATER/OIL DISTRIBUTION: Not available
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SECTION 10 STABILITY AND REACTIVITY
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REACTIVITY: Stable at normal temperatures and pressure.
CONDITIONS TO AVOID: Avoid contact with incompatible materials.
INCOMPATIBILITIES: oxidizing materials
REFACTO:
OXIDIZERS (STRONG): Fire and explosion hazard.
HAZARDOUS DECOMPOSITION:
Thermal decomposition products: oxides of carbon
POLYMERIZATION: Will not polymerize.
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SECTION 11 TOXICOLOGICAL INFORMATION
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REFACTO:
MEDICAL CONDITIONS AGGRAVATED BY EXPOSURE: Known severe hypersensitivity to
the active substance or to other mouse, hamster or bovine proteins or any of
the excipients.
ADDITIONAL DATA: As with any intravenous protein product, allergic type
hypersensitivity reactions are possible. Early signs of hypersensitivity
include hives, generalized uticaria, tightness of chest, wheezing,
hypotension, and anaphylaxis.
Summary of toxicity data for Refacto:
10000 IU/kg IV-rats NoAEL
1600 IU/kg IV-monkeys NoAEL
1600 IU/kg/da IV-rats NoAEL
1250 IU/kg/da IV-rats NoAEL
1250 IU/kg/da IV-monkeys NoAEL
There were no clinical, gross or histologic changes indicative of local
irritation in a beagle dog paravenous and intra-arterial injection study.
Only one mutagenic study (mouse micronucleus assay) was performed, and this
did not reveal any chromosome damageing activity at doses up to 50-fold the
highest anticipated clinical dose.
No carcinogenicity studies have been performed. No specifically designed
reproductive and developmental toxicity studies were performed.
HEALTH EFFECTS:
INHALATION:
ACUTE EXPOSURE:
REFACTO: Allergic type hypersensitivity reactions are possible. Signs of
hypersensitivity include hives, generalized uticaria, tightness of chest,
wheezing, hypotension, and anaphylaxis. Known severe hypersensitivity to
the active substance or to other mouse, hamster or bovine proteins or any
of the excipients.
REFACTO: No data available.
CHRONIC EXPOSURE:
REFACTO: No data available.
SKIN CONTACT:
ACUTE EXPOSURE:
REFACTO: No data available.
CHRONIC EXPOSURE:
REFACTO: No data available.
EYE CONTACT:
ACUTE EXPOSURE:
REFACTO: No data available.
CHRONIC EXPOSURE:
REFACTO: No data available.
INGESTION:
ACUTE EXPOSURE:
REFACTO: No data available.
CHRONIC EXPOSURE:
REFACTO: No data available.
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SECTION 12 ECOLOGICAL INFORMATION
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Not available
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SECTION 13 DISPOSAL CONSIDERATIONS
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Dispose in accordance with all applicable regulations.
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SECTION 14 TRANSPORT INFORMATION
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No classification assigned.
LAND TRANSPORT ADR/RID: No classification assigned.
AIR TRANSPORT IATA/ICAO: No classification assigned.
MARITIME TRANSPORT IMDG: No classification assigned.
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SECTION 15 REGULATORY INFORMATION
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U.S. REGULATIONS:
TSCA INVENTORY STATUS: E
TSCA 12(b) EXPORT NOTIFICATION: Not listed.
CERCLA SECTION 103 (40CFR302.4): N
SARA SECTION 302 (40CFR355.30): N
SARA SECTION 304 (40CFR355.40): N
SARA SECTION 313 (40CFR372.65): N
SARA HAZARD CATEGORIES, SARA SECTIONS 311/312 (40CFR370.21):
ACUTE: N
CHRONIC: N
FIRE: N
REACTIVE: N
SUDDEN RELEASE: N
OSHA PROCESS SAFETY (29CFR1910.119): N
STATE REGULATIONS:
California Proposition 65: N
EUROPEAN REGULATIONS:
EC NUMBER: Not assigned.
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SECTION 16 OTHER INFORMATION
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COPYRIGHT 1984-1999 MDL INFORMATION SYSTEMS, INC. ALL RIGHTS RESERVED.
THE INFORMATION PROVIDED IN THIS MSDS IS BASED UPON SOURCES BELIEVED TO BE
ACCURATE. HOWEVER, THE COMPANY ASSUMES NO RESPONSIBILITY FOR THE ACCURACY,
COMPLETENESS OR SUITABILITY OF THIS INFORMATION. THE PRODUCT USER IS
RESPONSIBLE TO DETERMINE THE SUITABILITY OF THIS INFORMATION FOR THEIR
PARTICULAR PURPOSES.
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