0479098.20071025.7180 by msds

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									Safety Data Sheet

Ibandronat III

according to Regulation (EC) No 1907/2006

1. Identification of the substance/preparation and of the company/undertaking
Product name Product code Use Company information Ibandronat III 04 7909 8 - intermediate Enquiries: F. Hoffmann-La Roche AG Postfach CH-4070 Basel Switzerland Phone Fax +41-61/688 54 80 +41-61/681 72 76 Local representation:

2. Hazards identification
Most important hazards - Irritating to skin. - Risk of serious damage to eyes. - May cause sensitization by skin contact.

3. Composition/Information on ingredients
Chemical name Synonyms - 3-(Methylpentylamino)propanoic acid methyl ester - BM 91.0043 - N-Methyl-N-pentyl-β-alanine methyl ester - Ibandron acid step III 744266-99-7 1993 Ro4982847-000 C10H21NO2 187.28 g/mol

CAS number UN number Roche number Empirical formula Molecular mass

N

O

O

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4. First-aid measures
Eye contact Skin contact - rinse immediately with tap water for 10 minutes - open eyelids forcibly - remove immediately contaminated clothes, wash affected skin with water and soap - do not use any solvents - consult a physician if skin irritation persists - remove the casualty to fresh air and keep him/her calm - get medical treatment - treat symptomatically

Inhalation Note to physician

5. Fire-fighting measures
Suitable extinguishing media Unsuitable extinguishing media Specific hazards - foam, powder, carbon dioxide - use water spray for cooling purposes only (fat explosion hazard) - formation of toxic and corrosive combustion gases (nitrogen oxides (NOx)) possible - heating of container(s) will cause pressure rise with risk of bursting and subsequent explosion - may form potentially explosive mixtures with air - Vapours may be invisible and they are heavier than air. They spread on the soil and could penetrate into the sewerage system and into cellars. - precipitate gases/vapours/mists with water spray - chemical incident emergency response unit with full protective equipment - cool endangered containers with water spray

Protection of fire-fighters

Special method of fire-fighting

6. Accidental release measures
Personal precautions - check the possibility of an explosive atmosphere - do not use tools which produce sparks, make use of explosion proof equipment - if this does not endanger the action force or other people, air sewers and cellars - if possible close leaks - collect the leaked product by all means available - if the substance reaches waters or the sewer system, inform the competent authority - collect liquid by means of sand, earth or another suitable material or cover it with alcohol-resistant foam - during the pouring by a pump bear in mind adequate earthing - make use of explosion-proof pumps - collect the product spilled out into ventilated containers equipped with absorption filters

Environmental protection

Methods for cleaning up

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7. Handling and storage

Handling Technical measures - processing in closed systems, superposed by inert gas (e.g. nitrogen) - local exhaust ventilation necessary - take precautionary measures against electrostatic charging - aluminium, enamel, stainless steel

Suitable materials Storage Storage conditions Packaging materials

- dry, cool and ventilated place - secure container and keep tightly closed - tightly closing; material: aluminium, stainless steel

8. Exposure controls/Personal protection

Engineering Measures Personal protective equipment Respiratory protection

- see 7.

- in case of open handling or accidental release: protective mask with combination filter (e.g. ABEKP) or special filter (e.g. BEP) or respirator with independent air supply - protective gloves (eg made of NBR Acrylnitril-Butadien-Rubber) - safety glasses (i.e. in capsule-shaped frames) - disposable (eg TYVEK) or reusable protective clothing; the latter must be washed (decontaminated) after use - cleanse skin thoroughly after work, apply skin cream

Hand protection Eye protection Body protection General protective and hygiene measures

9. Physical and chemical properties
Form Surface tension Solubility Partition coefficient Hydrolysis liquid 58.3 mN/m (20.5 °C) (OECD No. 115, "Surface Tension of Aqueous Solutions") 4’900 mg/l, water log Pow 2.0 (octanol/water) (calculated) t1/2 = 25.4 h (pH 7.0, 22 °C) t1/2 = 4.1 h (pH 7.8, 22 °C) t1/2 = 0.5 h (pH 9.0, 22 °C)

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Melting temperature Boiling temperature Vapour pressure Flash point (liquid) Ignition point (liquid)

< -70.7 °C (OECD No. 102) 214.5 °C (99.3 kPa) (OECD No. 103) 1.6 Pa (25 °C) (OECD No. 104) 57.9 °C (DIN 51’755) 240 °C

10. Stability and reactivity
Stability Note - stable under the conditions mentioned in chapter 7 - hydrolyses

11. Toxicological information
Acute toxicity Local effects - LD50 > 2’000 mg/kg (oral, rat) (OECD No. 423 (Acute Toxic Class Method)) - skin: irritant (rabbit; OECD No. 404) - eye: irritant; expert statement - sensitizing (mouse) (OECD No. 429, LLNA (Local Lymph Node Assay)) - not mutagenic (in vitro test system; OECD No. 471 (Salmonella typhimurium))

Sensitization Mutagenicity

12. Ecological information
Ready biodegradability - readily biodegradable 98 %, 14 d (DOC Die-Away Test, OECD No. 301A) - barely toxic for planktonic crustaceans (Daphnia magna) EC50 (48 h) > 100 mg/l NOEC (48 h) ≥ 100 mg/l (OECD No. 202) - observe local/national regulations

Ecotoxicity

Air pollution

13. Disposal considerations
Waste from residues - observe local/national regulations regarding waste disposal - incinerate in qualified installation with flue gas scrubbing

Date: 25.10.07/CSE (SEISMO)

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25.10.07

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14. Transport information

IATA

Class 3

UN/ID 1993

PG III

PI 309/310

Label 3

IMDG

Class 3

UN 1993

PG III

EmS F-E S-E

PI P001/IBC03

Label 3

Mark

RID/ADR

Class 3

UN 1993

PG III

Haz.no 30

PI P001/IBC03

Label 3

Classif.code F1

Proper shipping name

FLAMMABLE LIQUID, N.O.S.

Technical name

3-(Methylpentylamino)propanoic acid methyl ester

15. Regulatory information
Classification and labelling according to EU directives

Xi R38 R41 R43 S26 S36/37/39 Water hazard class (Germany) Irritating to skin. Risk of serious damage to eyes. May cause sensitization by skin contact. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. Wear suitable protective clothing, gloves and eye/face protection. 1: weakly hazardous for water (own classification according to directive VwVwS of 17.05.1999)

16. Other information
Safety-lab number Edition documentation - BS-7969 - changes from previous version in sections 1, 2, 3, 5, 6, 9, 16

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: 25.10.07/CSE (SEISMO) Replacing edition of: 25.10.07 Page: 5/5


								
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