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Description of key information

The genotoxicity of the substance has been assessed in vitro for three genotoxicity endpoints: genotoxicity in bacteria, cytogenicity in a chromosomal aberration test and a gene mutation test in mammalian cells, resulting in the absence of genotoxicity. Furthermore, the available repeated dose toxicity studies do not indicate the development of hyperplasia or pre-neoplastic lesions. Therefore no genotoxic carcinogenicity is expected, via the oral, inhalation and dermal route. 

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Justification for classification or non-classification

The genotoxicity of the substance has been assessed for three genotoxicity endpoints, genotoxicity in bacteria chromosomal aberration and gene mutations in mammalian cells resulting in absence of genotoxicity in vitro. Therefore no genotoxic carcinogenicity is expected. Classification for carcinogenicity of the substance is not warranted in accordance with CLP Regulation (EC) No. 1272/2008 and its amendments.

Additional information

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 all three in vitro genotoxicity assays: Ames tests, chromosomal aberration assay and mouse lymphoma assay. Based on these results, the substance is considered to be not genotoxic in vitro and therefore not a genotoxic carcinogen.

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