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Toxicological information

Carcinogenicity

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Administrative data

Description of key information

Not specifically tested for this endpoint. However, no adverse or proliferative lesions were produced in the acute or repeated dose oral studies, and the acute dermal study. No adverse or proliferative respiratory tissue produced in the acute inhalation study. Not mutagenic nor clastogenic. No evidence of reproductive or teratogenic effects by the oral route.

Key value for chemical safety assessment

Justification for classification or non-classification

The substance is not classified for mutagenicity. Additionally, no tissue damage or systemic effects, including microscopic evidence of cell hypertrophy, hyperplasia, or pre-neoplastic lesions were observed during a repeated oral toxicity-one generation reproduction study, up to the highest dose tested (1000 mg/kg bw/day). Therefore, the substance is considered non-carcinogenic. The substance does not need to be classified for carcinogenicity according to the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Additional information

The test substance did not produce mutagenicity or genetic damage when tested in bacterial and mammalian cell cultures. Carcinogenicity is not predicted. Additionally, no tissue damage or systemic effects were observed during a repeated dose oral toxicity/one-generation reproduction study up to the limit dose of 1000 mg/kg/day, No such effects were observed in acute oral or dermal toxicity studies up to 5000 mg/kg/day or in an acute inhalation study up to 0.89 mg/L, the highest achievable concentration. The lack of active genetic and epigenetic effects support the position that carcinogenicity is not likely to be a concern with this test substance.