Registration Dossier
Registration Dossier
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EC number: 202-607-8 | CAS number: 97-77-8
Carcinogenicity
Administrative data
Description of key information
Disulfiram was not carcinogenic in rats or mice.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 12.5 mg/kg bw/day
Justification for classification or non-classification
The available data carcinogenicity is conclusive but not sufficient for classification according to the EU Directive 67/548/EEC and the CLP Regulation.
Additional information
In a carcinogenicity study, disulfiram was administered to rats up to the MTD, e. g. 600 ppm, in the diet 107 weeks (National Toxicology Program, 1979). Except for effects on bodyweight gain, no other treatment-related effects were observed throughout the study. No effect on tumour incidence was reported and the NOAEL for carcinogenicity was therefore established at 12.5 mg/kg bw/d, the highest dose tested for male and female animals.
In a simultaniously performed carcinogenicity study in mice, male and female animals received disulfiram in the diet for 108 weeks (National Toxicology Program, 1979). The only systemic effect was a decrease in the body weight which was observed in all dosed animals. Since there was no increase in tumour induction., the NOAEL was set at 14.7 and 60 mg/kg bw/d for females and males, respectively.
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