INVIRASE(R) Capsule Mix (200 mg)
Material Safety Data Sheet
1. Product and Company Identification
Product name INVIRASE(R) Capsule Mix (200 mg)
Product code 03 4301 3
Company information Enquiries: Local representation:
Hoffmann-La Roche Inc.
340 Kingsland Street
USA-Nutley, N.J. 07110-1199
United States of America
Phone 001-973/235 50 00
US Emergency phone: (800)-827-6243
US Chemtrec phone: (800)-424-9300
Roche Nutley Inventory Code 27070155
2. Composition/Information on ingredients
Ingredients (CAS no.) Concentration
Saquinavir mesylate (149845-06-7) 50-60 %
Microcrystalline cellulose (9004-34-6) 10-15 %
Talc (14807-96-6) 5-10 %
Sodium starch glycolate (9063-38-1) <5%
3. Hazards identification
Emergency Overview
Form powder or powder with lumps
Color white to off-white
Hazard Overview - Possible dust explosion hazard based on information on related
materials
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INVIRASE(R) Capsule Mix (200 mg)
Potential Health Effects - Exposure: Inhalation, Ingestion, Skin contact, Eye contact
- Target Organs: eye, mucous membranes, gastrointestinal system,
Central nervous system
- Acute Effects: May cause eye irritation., May cause mucous
membrane irritation (inflammation)., May cause central nervous
system effects., Signs and symptoms may include headache,
dizziness, drowsiness, fatigue and lack of muscular coordination.,
May cause gastrointestinal effects., Signs and symptoms may
include nausea, vomiting, diarrhea, constipation, cramps, and loss
of appetite.
- Chronic Effects: No adverse effects known
- Carcinogenicity: formulation not listed by NTP, IARC or OSHA
- Carcinogenicity: IARC Gr3 not classifiable *1
*1 referring to: Talc
4. First-aid measures
Eye contact - Immediately flush eyes with plenty of water. If irritation occurs or
persists, get medical attention.
Skin contact - Remove contaminated clothing and shoes. Flush skin with plenty
of water. If irritation occurs or persists, get medical attention.
Wash clothing and shoes before reuse.
Inhalation - Remove to fresh air. If discomfort occurs or persists, get medical
attention.
Ingestion - If large quantities of this material are swallowed, get medical
attention immediately. Do not induce vomiting unless directed by
medical personnel. Never give anything by mouth to an
unconscious person.
5. Fire-fighting measures
Suitable extinguishing media - water spray jet, dry powder, foam, carbon dioxide
Flash point (liquid) not applicable
Specific hazards - Toxic emissions may be given off in a fire
Protection of fire-fighters - use self-contained breathing apparatus
Special method of fire-fighting - cool endangered containers with water spray
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INVIRASE(R) Capsule Mix (200 mg)
6. Accidental release measures
Personal precautions - ensure adequate ventilation
Environmental protection - do not allow to enter drains or waterways
Methods for cleaning up - Scoop or shovel spilled material into a suitable labeled open head
drum
- Secure the drum cover and move the container to a safe holding
area
- Wash spill area thoroughly with soapy water
- Collect wash with a noncombustible absorbent material and
transfer to labeled container for treatment and disposal.
- Check area for residual material and repeat clean up if detected
7. Handling and storage
Handling
Technical measures - local exhaust ventilation necessary
- avoid dust formation; consider dust explosion hazard
Storage
Storage conditions - 15 - 25 掳C
- keep containers tightly closed
- store in a dry place
8. Exposure controls/Personal protection
Engineering Measures - see 7.
- ACGIH-TLV: 2 mg/m3 (not classifiable as a human carcinogen,
Threshold value (USA) air
respirable fraction) *1
- ACGIH-TLV: 10 mg/m3 *2
- ACGIH-TLV: 10 mg/m3 *3
- IOEL: 2 mg/m3
Threshold value (Roche) air *4
Personal protective equipment
Respiratory protection - Respiratory protection is recommended as a precaution to minimze
exposure. Effective engineering controls are considered to be the
primary means to control worker exposure. Respiratory protection
should not substitute for feasible engineering controls.
- Respiratory protection is recommended for dusty operations.
- Use of a negative pressure air purifying, half face respirator with a
toxic/dust/mist/fume high efficiency filter in the laboratory or a
supplied-air full facepiece respirator or supplied-air hood for
production operations is recommended.
Hand protection - protective gloves
Eye protection - safety glasses
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INVIRASE(R) Capsule Mix (200 mg)
Body protection - protective clothing
*1 referring to: Talc
*2 referring to: Sodium starch glycolate
*3 referring to: Microcrystalline cellulose
*4 referring to: Saquinavir mesylate
9. Physical and chemical properties
Color white to off-white
Form powder or powder with lumps
10. Stability and reactivity
Stability - stable under normal conditions
11. Toxicological information
Acute toxicity - LD50 > 5鈥?000 mg/kg (oral, mouse) *4
- LD50 > 2鈥?000 mg/kg (oral, marmoset) *4
- LD50 > 5鈥?000 mg/kg (oral, rat) *4
Local effects - skin: non-irritant (man) *4
- eye: irritant (man) *4
Sensitization - not sensitizing (man) *4
Chronic toxicity - low toxicity (oral, several species) *4
Mutagenicity - not mutagenic (various in vivo and in vitro test systems) *4
Reproduction toxicity - not teratogenic, not embryotoxic (several species) *4
*4 referring to: Saquinavir mesylate
12. Ecological information
Ready biodegradability - not readily biodegradable
4 %, 28 days
(CO2 Evolution Test (Modified Sturm Test), OECD No. 301 B) *4
Ecotoxicity - moderately toxic for fish (rainbow trout)
NOEC 38 mg/l
LC50 > 38 mg/l *4
- barely toxic for planktonic crustaceans (Daphnia magna)
NOEC 36 mg/l
EC50 > 100 mg/l *4
- moderately toxic for algae (Selenastrum capricornutum)
NOEbC 20 mg/l *4
- moderately toxic for microorganisms (activated sludge)
EC50 > 59 mg/l
(Activated Sludge Respir. Inhib. Test, OECD No. 209) *4
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INVIRASE(R) Capsule Mix (200 mg)
- barely toxic for microorganisms (bacteria, fungi, cyanobacteria in
pure culture)
NOEbC 312 mg/l
(FDA Technical Assistance Document No. 4.02) *4
- barely toxic for earthworms (earthworms)
LD50 > 1000 mg/l
(method not known) *4
Mobility - low mobility (Soil-Water, 23 掳C)
KOC = 10692 (silty loam)
KOC = 22919 (clay loam)
KOC = 13711 (loam)
(FDA Technical Assistance Document No. 3.08) *4
*4 referring to: Saquinavir mesylate
13. Disposal considerations
Waste from residues - observe local/national regulations regarding waste disposal
- incinerate in qualified installation with flue gas scrubbing
Contaminated packaging - Empty containers must be triple rinsed prior to disposal, recycling
or reuse.
RCRA waste - not regulated under RCRA
14. Transport information
Note - not classified by transport regulations, proper shipping name
non-regulated
15. Regulatory information
TSCA Status - FDA Exemption - not on inventory
Reporting Requirements - The United States Environmental Protection Agency (USEPA) has
not established a Reportable Quantity (RQ) for releases of this
material.
- In New Jersey, report all releases which are likely to endanger the
public health, harm the environment or cause a complaint to the
NJDEPE Hotline (1-609-292-5560) and to local officials.
- State and local regulations vary and may impose additional
reporting requirements.
16. Other information
Use - HIV-protease inhibitor
Edition documentation - first edition
The information in this safety data sheet is based on current scientific knowledge. It should not be
taken as expressing or implying any warranty concerning product characteristics.
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