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Toxicological information

Carcinogenicity

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Description of key information

Two carcinogenicity studies are available:
Stott WT, Yano BL, Beyer JE, Kropscott BE, Eddy SL (1991): 2 year study in rats: NOAEL (carcinogenicity): 1000 mg/kg bw/day (actual ingested) (male) and 1000 mg/kg bw/day (actual ingested) (female)
Bond DM, Crissman JW, Kropscott BE, Quast JF (1991): 2 year study in mice: NOEL (carcinogenicity): > 1000 mg/kg bw/day (actual ingested) (male/female)

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day

Additional information

The key study was selected on the basis that it was performed on the most typical species (rat) used to address the carcinogenicity endpoint. The key study gives the same NOAEL as the supporting mouse study, and therefore the worst case is represented by the key study. In the key study, no treatment-related tumorigenic response was observed in either sex of rats administered Flumetsulam at dose levels of up to 1000 mg/kg bw/day.

The key study is a reliable EPA guideline study, performed to GLP standard.

No evidence of carcinogenicity was seen in either mice or rats.

Justification for classification or non-classification

With reference to the information available on this substance, no classification for carcinogenicity is required in accordance with Directive 67/548/EEC or Regulation (EC) No. 1272/2008.