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					Safety Data Sheet


1. Product and Company Identification
Product name Product code Company information Azosemide 04 7710 9 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. Composition/Information on ingredients
Characterization Chemical name Synonyms CAS number EINECS number Roche number Empirical formula Molecular mass substituted tetrazole sulfonilamide compound - 2-Chloro-5(1H-tetrazol-5-yl)-N-2-thienyl-sulfanilamide - BM 02.001 27589-33-9 258 923 1 Ro2004737-000 C12H11ClN6O2S2 370.45 g/mol

Cl H 2N S O O



3. Hazards identification
Most important hazards - Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

Date: 24.6.04/CSE (SEISMO)

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4. First-aid measures
Eye contact Skin contact Inhalation Note to physician - 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 - remove the casualty to fresh air and keep him/her calm - treat symptomatically

5. Fire-fighting measures
Suitable extinguishing media Specific hazards Protection of fire-fighters - water spray jet, dry powder, foam, carbon dioxide - formation of toxic and corrosive combustion gases (nitrogen oxides, hydrogen chloride, sulfur oxides) possible - precipitate gases/vapours/mists with water spray - use self-contained breathing apparatus

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

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; high dust explosion hazard - aluminium, enamel, glass, plastic, stainless steel

Suitable materials Storage Storage conditions Packaging materials

- dry, cool and ventilated place - tightly closing; material: aluminium, cardboard (lined with polyethylene bag), plastic, stainless steel

Date: 24.6.04/CSE (SEISMO)

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8. Exposure controls/Personal protection

Engineering Measures Personal protective equipment Respiratory protection Hand protection Eye protection Body protection

- see 7.

- in case of open handling or accidental release: particle mask or respirator with independent air supply - protective gloves (eg made of neopren, nitrile or butyl rubber) - safety glasses - light protective clothing

9. Physical and chemical properties
Colour Form Odour Solubility white solid odourless 9.2 mg/l, water (22 °C, pH 5.2, HPLC) ≥ 87 mg/l, aquatic ecotoxicity media (22 °C, pH 8, HPLC) barely soluble, acetone barely soluble, methanol well soluble, dimethyl formamide log Pow < 3 (n-octanol/water) (calculated, consensus of various QSARs) 230 °C (with decomposition)

Partition coefficient Melting temperature

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

11. Toxicological information
Acute toxicity - LD50 - LD50 - NOAEL 2’271 252 1 mg/kg mg/kg (oral, rat) (i.v., rat)

Subacute toxicity Chronic toxicity Mutagenicity Reproduction toxicity Note

mg/kg/d (oral, rat, 14 d)

- NOAEL 12 mg/kg/d (oral, dog; 1 year) - not mutagenic (various in vitro test systems) - no indication for teratogenicity (90 mg/kg; oral, rat) side effects: dehydrogenation, hepatobiliary function disturbance metabolisation and elimination via liver and faeces therapeutic dose (p.o.): 60 mg/d elimination half-life: 2 to 3 h

Date: 24.6.04/CSE (SEISMO)

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12. Ecological information
Ready biodegradability - not readily biodegradable 0 %, 28 d (Manometric Respirometry Test, OECD No. 301 F) - barely toxic for algae (nominal concentration = 100 mg/l) (Scenedesmus subspicatus) EC50 (72 h) > 100 mg/l (nominal concentration) NOEC (72 h) 92.6 mg/l (average measured concentration) (OECD No. 201) - moderately toxic for planktonic crustaceans (Daphnia magna) EC50 (48 h) 67.4 mg/l (average measured concentration) NOEC (48 h) 9.7 mg/l (average measured concentration) (OECD No. 202) - acute fish toxicity in a limit test is lower than daphnid or algal toxicity, hence not relevant for classification (guppy) LC50 (96 h) > 87.3 mg/l (highest concentration tested) LC0 (96 h) 87.3 mg/l (nominal concentration) NOEC (96 h) < 86.4 mg/l (average measured concentration) (OECD No. 203) - no adverse influence on substrate biodegradation (activated sludge) concentration (28 d) 100 mg/l (Manometric Respirometry Test, OECD No. 301 F) - medium adsorption (water-activated sludge, 24 h) Kd = 21400 l/kg (Adsorption to activated sludge in biodegradability test) - observe local/national regulations



Air pollution

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

14. Transport information
Note - not classified by transport regulations

15. Regulatory information
Classification and labelling according to EU directives R52/53 S61 Water hazard class (Germany) Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment. Avoid release to the environment. Refer to special instructions/Safety data sheets. 1: weakly hazardous for water (own classification according to directive VwVwS of 17.05.1999)

Date: 24.6.04/CSE (SEISMO)

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16. Other information
Use Safety-lab number Edition documentation - pharmaceutical active substance (hypotensive) - BS-7925 - changes from previous version in sections 2, 3, 6, 9, 12, 15

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: 24.6.04/CSE (SEISMO) Replacing edition of: 28.11.03 Page: 5/5

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