Roche-Tiberal

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2. Composition/Information on ingredients
Characterization Chemical name Synonyms CAS number EINECS number Roche number Empirical formula Molecular mass pharmaceutical active substance in the class of nitroimidazoles - α-Chloromethyl-2-methyl-5-nitro-1H-imidazole-1-ethanol - 1-(3-Chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole - TIBERAL substance 16773-42-5 240 826 0 Ro 07-0207/000 C7H10ClN3O3 219.63 g/mol
Safety Data Sheet
Ornidazole
1. Product and Company Identification
Product name Product code Company information Ornidazole 04 4138 4 Manufacturer: F. Hoffmann-La Roche AG Postfach CH-4070 Basel Switzerland Phone Fax *41-61/688 54 80 *41-61/681 72 76 Local representation:
pH value Dissociation constant Melting temperature

88 to 92 °C
10. Stability and reactivity
Conditions to avoid - light: gradual decomposition of solutions - warming: exothermic decomposition with high decomposition capacity at high temperatures (>> 100 °C)
- see 7.
- sampling on glass fibre filter and gravimetric or chemical determination
Personal protective equipment Respiratory protection Hand protection Eye protection - in case of open handling or accidental release: particle mask or respirator with independent air supply - protective gloves - safety glasses
Date: 6.8.02/CSE (SEISMO)
Replacing edition of:
10.5.01
Page: 1/5
Ornidazole
4. First-aid measures
Eye contact - rinse immediately with tap water for 10 minutes - open eyelids forcibly - consult physician - remove immediately contaminated clothes, wash affected skin with water and soap - do not use any solvents - remove the casualty to fresh air and keep him/her calm - consult physician - treat symptomatically
Suitable materials
Storage Storage conditions Validity Packaging materials - protected from light - 48 months, at room temperature - tightly closing; material: metal (lined with polyethylene bag)
- reversible loss of weight, reversible neurologic disturbances (monkey, rat)
Date: 6.8.02/CSE (SEISMO)
Replacing edition of:
10.5.01
Page: 3/5
Ornidazole
Skin contact Inhalation Note to physician
5. Fire-fighting measures
Suitable extinguishing media Specific hazards - water spray jet, dry powder, foam, carbon dioxide - risk of bursting: cool exposed containers with water - formation of toxic and corrosive combustion gases (nitrous oxide, hydrogen chloride) possible - consider dust explosion hazard - precipitate gases/vapours/mists with water spray
7. Handling and storage
Handling Technical measures - processing in closed systems, if possible superposed by inert gas (e.g. nitrogen) - local exhaust ventilation necessary - take precautionary measures against electrostatic charging - avoid dust formation; very high dust explosion hazard - stainless steel, glass, polyethylene - test plastics before use
Protection of fire-fighters
6. Accidental release measures
Environmental protection Methods for cleaning up - do not allow to enter drains or waterways - collect solids (avoid dust formation) and hand over to waste removal - clean contaminated areas with little ethanol
11. Toxicological information
Acute toxicity - LD50 - LD50 - LD50 1’139 1’780 375 mg/kg mg/kg mg/kg (oral, mouse) (oral, rat) (i.v., mouse)
Subchronic toxicity
Date: 6.8.02/CSE (SEISMO)
Replacing edition of:
10.5.01
Page: 2/5
Ornidazole
8. Exposure controls/Personal protection
Engineering Measures Monitoring Analytics
HO N N Cl O
N+ O-
3. Hazards identification
Most important hazards - Harmful if swallowed. - Possible risks of irreversible effects. - Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
Chronic toxicity Mutagenicity Carcinogenicity
- NOAEL 40 mg/kg/d (dog) - mutagenic (various in vivo and in vitro test systems) - carcinogenic - induces, like all nitroimidazoles, after longer during application and in higher dosis, tumors in mouse and rat, no induction of tumors in hamster - preliminary studies in human (10 - 19 years of observation) and the incoming informations did not show any indication for carcinogenic effects in human - not teratogenic - not embryotoxic - reversible retardation of the sperm-mobility, that may lead to reversible disturbances of fertility (male rat, 400 mg/kg*day) - side-effects: dizziness, headache, gastrointestinal disturbances, rarely epileptic seizures and functional disturbances of the peripheral nerves - antiinfectivum for the oral, intravenous and local application against protozoon- and anaerobic bacterial infections - therapeutical daily dose: 750 - 2000 mg/kg oral or i.v. - half-life of elimination: 13 hours