Safety Data Sheet
according to Regulation (EC) No 1907/2006 1. Identification of the substance/preparation and of the company/undertaking
- pharmaceutical active substance: bacteriostatic, especially in combination with trimethoprim (e.g. BACTRIM,trimethoprim:sulfamethoxazole 1:5) F. Hoffmann-La Roche AGPostfachCH-4070 BaselSwitzerland 2. Hazards identification
- Very toxic to aquatic organisms, may cause long-term adverse 3. Composition/Information on ingredients
- N'-(5-Methyl-3-isoxazolyl)-sulfanilamide - GANTANOL substance- 3-(4-Aminobenzenesulfonamide)-5-methylisoxazole- 4-Amino-N-(5-methyl-3-isoxazolyl)-benzenesulfonamide- 5-Methyl-3-sulfanilamido-isoxazole Sulfamethoxazole
4. First-aid measures
- rinse immediately with tap water for 10 minutes - open eyelids - remove contaminated clothes, wash affected skin with water and 5. Fire-fighting measures
- water spray jet, dry powder, foam, carbon dioxide - consider dust explosion hazard- violent decomposition after exposure to heat- formation of toxic and corrosive combustion gases (nitrogen - substance is hazardous for water: contain fire-fighting wastewater 6. Accidental release measures
- do not allow to enter drains or waterways- if the substance reaches waters or the sewer system, inform the - collect solids (avoid dust formation) and hand over to waste Sulfamethoxazole
7. Handling and storage
- processing in closed systems, superposed by inert gas (e.g.
- protected from light- local exhaust ventilation necessary- take precautionary measures against electrostatic charging- avoid dust formation; very high dust explosion hazard - stainless steel, aluminium, enamel, glass - protected from heat and light- store under inert gas- keep container tightly closed - tightly closing; material: stainless steel, glass, enamel, aluminium, plywood, cardboard, plastic (polyethylene) 8. Exposure controls/Personal protection
Engineering Measures
- IOEL (Internal Occupational Exposure Limit): 1.0 mg/m3 - sampling on glass fibre filter and gravimetric or chemical Personal protective equipment
- in case of open handling or accidental release: particle mask or respirator with independent air supply - protective gloves (neoprene, nitrile or butyl rubber) Sulfamethoxazole
9. Physical and chemical properties
136 mg/l, water (37 °C)easily soluble, acetone (20 °C)slightly soluble, chloroform (20 °C)slightly soluble, ether (20 °C) 10. Stability and reactivity
- strong acids, oxidizing agents, atmospheric oxygen - strongly exothermic decomposition at higher temperatures (>> 11. Toxicological information
- skin: non-irritant (rabbit)- eye: slightly irritating (rabbit) - non-sensitizing (guinea pig)- may be sensitizing; (man, therapeutic use) - not mutagenic (various in vivo and in vitro test systems) - does not lower parental fertility (200 mg/kg/d, rat)- not teratogenic; (man, therapeutic doses) - antibacterial chemotherapeutic, which, through folic acid antagonism, inhibits the synthesis of proteins and nucleic acidsessential for cell division - in human cells, therapeutic doses of sulfamethoxazole do not significantly disturb folic acid metabolism - therapeutic oral doses for monodrug use of sulfamethoxazol: 2g - biological half-life: 10 hours; rapid and efficient resorption from the Sulfamethoxazole
- rarely, systemic use may induce allergic skin reactions with - other side effects: gastroinsteninal disturbances after oral uptake, disorders of liver function; at high doses: urinary stones,disturbances of haematological parameters 12. Ecological information
0 %, 28 d(Closed Bottle Test, OECD No. 301 D) 0 %, 28 days(Zahn-Wellens test, OECD No. 302 B) - rapid degradation, photodegradation (surface waters) t1/2 10 h, summer, 50° Nt1/2 58 h, winter, 50° N(literature citation) - highly toxic for algae (Selenastrum capricornutum) EbC50 (72 h) 0.81 mg/lNOEbC (72 h) 0.22 mg/lErC50 (72 h) 3.4 mg/lNOErC (72 h) 0.45 mg/l(OECD No. 201) - highly toxic for bluegreen algae (Synechococcus leopoliensis, Cyanobacteria)EC50 (96 h) 0.0268 mg/lNOEC (96 h) 0.0059 mg/l(growth test) - moderately toxic for planktonic crustaceans (Daphnia magna) EC50 (48 h) 75 mg/lNOEC (48 h) 36 mg/l(OECD No. 202) - barely inhibitory on aerobic bacterial reproduction (activated sludge), no adverse influence on substrate biodegradation(activated sludge)NOEC 3.76 mg/l (highest concentration tested)(Closed Bottle Test, OECD No. 301 D) - no adverse influence on substrate biodegradation (activated sludge)concentration 3.8 mg/l(Closed Bottle Test, OECD No. 301 D) 13. Disposal considerations
- incinerate in qualified installation with flue gas scrubbing- observe local/national regulations regarding waste disposal Sulfamethoxazole
14. Transport information
15. Regulatory information
Classification and labelling according to EU directives Very toxic to aquatic organisms, may cause long-term adverseeffects in the aquatic environment.
This material and its container must be disposed of as hazardouswaste.
Avoid release to the environment. Refer to specialinstructions/Safety data sheets.
2: hazardous for water (own classification according to directiveVwVwS of 17.05.1999) Sulfamethoxazole
16. Other information
- Additional safety investigations, e.g. from Hazard Research Corporation (Denville, N.J. or Bundesamt für Materialprüfung (BAM, Berlin; dust explosion behaviour) are available from the safety laboratory.
- changes from previous version in sections 1, 2, 3, 6, 11, 16 The information in this safety data sheet is based on current scientific knowledge. It should not betaken as expressing or implying any warranty concerning product characteristics.


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