Registration Dossier
Registration Dossier
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EC number: 200-346-4 | CAS number: 57-68-1
Endpoint summary
Administrative data
Description of key information
LD50 oral mouse for Sulfadimidine =50000 mg/kg. No data available regarding acute inhalation toxicity and acute dermal toxicity of Sulfadimidine.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Data reported on public database ChemIdplus free available on web https://chem.nlm.nih.gov/chemidplus/rn/startswith/57-68-1. The primary source is indicated in ChemIdplus database.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral exposure:
LD50 oral mouse for Sulfadimidine = 50000 mg/kg is reported in public database ChemIdplus free available on web https://chem.nlm.nih.gov/chemidplus/rn/startswith/57-68-1. The primary source of this data (Drugs in Japan Vol. 6, Pg. 392, 1982) is indicated in ChemIdplus database.
Inhalation exposure/dermal exposure:
No data is available regarding acute inhalation toxicity and acute dermal toxicity of Sulfadimidine.
Other routes
Some acute toxicity values for other routes are reported always in public database ChemIdplus free available on web https://chem.nlm.nih.gov/chemidplus/rn/startswith/57-68-1 and confirmed also in Lewis, Sax's Dangerous Properties of Industrial Materials. 10th ed. Volumes 1-3 New York, NY:John Wiley & Sons Inc., 1999., p. 3320
- LD50 subcutaneous rat for Sulfadimidine = 2 g/kg (ref. Acta Biologica et Medica Germanica. Vol. 27, Pg. 141, 1971)
- LD50 intraperitoneal mouse for Sulfadimidine = 1060 mg/kg ( ref. Archivum Immunologiae et Therapiae Experimentalis. Vol. 16, Pg. 804, 1968)
- LD50 intravenous mouse for Sulfadimidine = 1776 mg/kg (ref."Handbook of Toxicology," 4 vols., Philadelphia, W.B. Saunders Co., 1956-59Vol. 5, Pg. 163, 1959)
General consideration
As reported in IARC Monographs, Vol.79, 2001, p.344 Sulfamethazine (synonym of Sulfadimidine) is use to treat a variety of bacterial diseases in human and in other species and it is given generally as sodium salt orally or parenterally. The oral route is the major exposure route.
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008) and based on the high value of LD50 oral reported in ChemIdplus database no classification is proposed for acute oral toxicity of Sulfadimidine. No data is available regarding acute inhalation toxicity and acute dermal toxicity of the substance.
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