Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

The genotoxicity of the substance has been assessed for two genotoxicity endpoints, genotoxicity in bacteria and chromosomal aberration, in in vitro and in vivo tests, 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 study available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The genotoxicity of the substance has been assessed for two genotoxicity endpoints, genotoxicity in bacteria and chromosomal aberration in 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 Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

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 test 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 313 μg/plate. Cytotoxicity was observed at the higher concentrations. The substance was concluded to be positive for the induction of structural chromosome aberrations in human lymphocytes cells in the presence of S9 metabolic activation. 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 1250 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.