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Description of key information

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Dose descriptor:
15 mg/kg bw/day

Carcinogenicity: via dermal route

Endpoint conclusion
Dose descriptor:
1 mg/kg bw/day

Justification for classification or non-classification

Additional information

A number of chronic toxicity/carcinogenicity studies have been conducted. In the most recently conducted studies, the NOAEL was 15 and 100 mg/kg/day in male and female rats, respectively, following two years oral administration of BADGE. Decreased body weight and an enlarged cecum were observed in male rats at 15 mg/kg/day in the oral study. In the dermal chronic toxicity/carcinogenicity studies, male mice and female rats were used. The systemic NOEL was 1 mg/kg/day in female rats and 100 mg/kg/day in male mice. Histopathologic changes were observed in the liver of female rats administered 10 and 100 mg/kg/day. These changes were attributed to ingestion since the test material was not occluded. In male mice the NOEL at the application site was 0.1 mg/kg/day. Epidermal hyperplasia, chronic dermal inflammation and epidermal crusts were observed histopathologically at dosages of 10 and 100 mg/kg/application in male mice.

Carcinogenicity: via oral route (target organ): digestive: cecum

Carcinogenicity: via dermal route (target organ): digestive: liver