Registration Dossier

Toxicological information

Carcinogenicity

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Description of key information

The genotoxicity of the substance has been assessed for two genotoxicity endpoints, genotoxicity in bacteria and chromosomal aberrationIn in vitro and in vivo, resulting in absence of genotoxicity in vivo. Therefore no genotoxic carcinogenicity is expected. 

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of carcinogenicity via oral route endpoint:
In accordance with REACH Annex IX, information on carcinogenicity is not required for a substance produced in amounts of 100-1000 tonnes per year. For the assessment of genotoxic carcinogenicity data on genotoxicity can be used to assess this potential. The substance gave negative results in an Ames tests with S. typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538 and E. coli strain WP2 uvr A, with and without metabolic activation, at concentration levels up to 5000 μg/plate. Cytotoxicity was observed at the highest concentration level. The substance was concluded to be positive for the induction of structural chromosome aberrations in CHO cells in the presence of S9 metabolic activation, and negative for the induction of numerical chromosome aberrations in both the non-activated and S9 activated test systems. In the in vivo micronucleus assay with male and female mice no statistically significant increase in the number of micronucleated polychromatic erythrocytes was observed at dose levels up to and including 900 mg/kg bw, following a single intraperitoneal administration. Based on these results, the substance is considered to be not genotoxic in vivo and therefore not a genotoxic carcinogen.

Justification for classification or non-classification

The genotoxicity of the substance has been assessed for two genotoxicity endpoints, genotoxicity in bacteria and chromosomal aberrationIn in vitro and in vivo, resulting in absence of genotoxicity in vivo. Therefore no genotoxic carcinogenicity is expected. Classification for carcinogenicity of the substance is not warranted in accordance with EU Directive 67/548 (DSD) and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.