BONIVA(R) Injection (3 mg/3 ml
Material Safety Data Sheet
pre-filled syringes)
1. Product and Company Identification
Product name BONIVA(R) Injection (3 mg/3 ml pre-filled syringes)
Product code CSE-2029
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
Characterization Final Product
2. Composition/Information on ingredients
Ingredients Concentration
Ibandronate ~ 0.1 %
CAS: 138926-19-9
3. Hazards identification
Emergency Overview
Form liquid
Color colorless, clear
Hazard Overview - May cause musculoskeletal effects.
Potential Health Effects - Exposure: Inhalation, Ingestion, Skin contact, Eye contact,
Injection
- Target Organs: Skeletal system
- Acute Effects: This material has not been tested as a whole;
therefore, the information described below is based on one or
more of its ingredients., May cause headache., May cause
musculoskeletal effects., May cause "flu-like" symptoms such as
fever, fatigue, chills, headache, nausea and muscular pain.
- Chronic Effects: No adverse effects known
- Carcinogenicity: formulation not listed by NTP, IARC or OSHA
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BONIVA(R) Injection (3 mg/3 ml pre-filled syringes)
Additional Health Information - Conditions Aggravated: Hypersensitivity to this material and other
materials in its chemical class. Uncorrected hypocalcemia.
Severe renal impairment.
4. First-aid measures
Eye contact - in case of contact with eyes rinse thoroughly with plenty of water
and get medical advice
Skin contact - remove immediately contaminated clothes, wash affected skin
with plenty of water
Inhalation - in case of inhalation remove to fresh air and seek medical aid
Ingestion - consult physician
5. Fire-fighting measures
Suitable extinguishing media - water spray jet, dry powder, foam, carbon dioxide
Flash point (liquid)
Flash point not established
Protection of fire-fighters - use self-contained breathing apparatus
6. Accidental release measures
Personal precautions - ensure adequate ventilation
Methods for cleaning up - Absorb small spills with noncombustible absorbent material
- Put saturated absorbent material into a suitable labeled open
head drum.
- Mop or flush the area with 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 - Use with adequate ventilation
Note - Store pre-filled syringes at 25 C (77 F); excursions permitted to 15
to 30 C (59 to 86 F).
Storage
Storage conditions - room temperature
- dry and ventilated place
- do not freeze
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BONIVA(R) Injection (3 mg/3 ml pre-filled syringes)
8. Exposure controls/Personal protection
Engineering Measures - see 7.
Threshold value (Roche) air - IOEL (Internal Occupational Exposure Limit): 0.002 mg/m3 *1
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 not necessary during normal operations
Hand protection - protective gloves
Eye protection - tightly fitting safety glasses
Body protection - protective clothing
General protective and - instruction of employees mandatory
hygiene measures - shower after work recommended
*1 referring to: Ibandronate
9. Physical and chemical properties
Color colorless, clear
Form liquid
10. Stability and reactivity
Stability - stable under normal conditions
Materials to avoid - strong oxidizing agents
11. Toxicological information
Acute toxicity - LD50 811 mg/kg (oral, rat) *1
- LD50 30 mg/kg (i.v., rat) *1
Subacute toxicity - NOAEL 0.09 mg/kg/d (i.v., dog, 28 d); higher doses cause
kidney damage *1
Local effects - skin, eyes, mucous membranes: corrosive *1
Sensitization - non-sensitizing (guinea pig) *1
Chronic toxicity - NOAEL 0.15 mg/kg/w (i.v., several species; 26 weeks); higher
doses cause kidney damage *1
Mutagenicity - not mutagenic (various in vivo and in vitro test systems) *1
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BONIVA(R) Injection (3 mg/3 ml pre-filled syringes)
Carcinogenicity - not carcinogenic (oral, several species) *1
Reproduction toxicity - not teratogenic, not embryotoxic (i.v., several species) *1
- does not lower parental fertility (i.v., several species) *1
Note - dosage (oral): 2.5 to 50 mg/d *1
- dosage (i.v.): 0.5 mg/3 months to 2.5 mg/day *1
- high doses cause: liver damages, kidney damages *1
- decrease in serum calcium level possible *1
- inhibits mechanisms reducing bone mass by long-term binding to
bone tissue *1
*1 referring to: Ibandronate
12. Ecological information
Ready biodegradability - not readily biodegradable
鈮? 3 %, 28 d
(CO2 Evolution Test, Modified Sturm Test, OECD No. 301B) *1
- not readily biodegradable
0 %, 28 d
(Manometric Respirometry Test, OECD No. 301 F) *1
Inherent biodegradability - not inherently biodegradable
< 10 %, 1 d
< 10 %, 15 d
< 10 %, 28 d
(Zahn-Wellens test, OECD No. 302 B) *1
- not inherently biodegradable
< 10 %, 28 d
(Zahn-Wellens test, OECD No. 302 B) *1
Abiotic degradation - stable in water, no photodegradation (200 mg/l, water)
< 2 %, 14 d, ~ 22 掳C, under illumination *1
Ecotoxicity - no adverse influence on substrate biodegradation (activated
sludge)
concentration (28 d) 41.5 mg/l
(OECD No. 301B, Modified Sturm Test) *1
- barely toxic for planktonic crustaceans (Daphnia magna)
NOEC (48 h) 100 mg/l
EC50 (48 h) > 180 mg/l
(OECD No. 202) *1
- barely toxic for fish (carp)
LC50 (96 h) 200 mg/l
LC0 (96 h) 86 mg/l
(OECD No. 203) *1
- strongly toxic for algae (Selenastrum capricornutum)
EbC50 (72 h) 1.4 mg/l
ErC50 (72 h) 4.7 mg/l
NOEC (72 h) 0.22 mg/l
(OECD No. 201) *1
- barely inhibitory on aerobic bacterial reproduction (activated sludge)
NOEC (5 h) 1300 mg/l
(growth test) *1
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BONIVA(R) Injection (3 mg/3 ml pre-filled syringes)
- highly toxic for algae (Scenedesmus (=Desmodesmus)
subspicatus)
EbC50 (72 h) 0.218 mg/l (nominal concentration)
ErC50 (72 h) 0.390 mg/l (nominal concentration)
NOEC (72 h) < 0.1 mg/l (nominal concentration)
(OECD No. 201) *1
- highly toxic for algae (Scenedesmus (=Desmodesmus)
subspicatus)
EC50 (14 d) 0.5 mg/l (nominal concentration)
NOEC (14 d) 0.1 mg/l (nominal concentration)
(OECD No. 201) *1
- no adverse influence on substrate biodegradation
concentration (28 d) 100 mg/l
(Manometric Respirometry Test, OECD No. 301 F) *1
Mobility - no significant adsorption (, 28 d, ~22 掳C)
Kd = 1210 l/kg (activated sludge)
(Adsorption to activated sludge in biodegradability test) *1
Note - after the regular 28 days in the Zahn-Wellens test, without
significant degradation and still 400 mg DOC/l, 200 mg DOC/l
benzoate was added as a well degradable substrate; after 5 days,
only 150 mg DOC/l was left, showing some cometabolic
degradation *1
- biphosphonates form complexes with bivalent cations, in the
relatively high concentrations in the algal test they deplete the
medium as scavengers; hence, the effect on algae is not toxic in
the strict sense *1
*1 referring to: Ibandronate
13. Disposal considerations
Waste from residues - observe local/national regulations regarding waste disposal
- incinerate in qualified installation with flue gas scrubbing
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.
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BONIVA(R) Injection (3 mg/3 ml pre-filled syringes)
16. Other information
Use - Boniva is used in the treatment and prevention of osteoporosis in
postmenopausal women.
Edition documentation - changes from previous version in sections 1
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.
Date: 23.2.06/CSE (SEISMO) Replacing edition of: 22.2.06 Page: 6/6
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