Registration Dossier

Diss Factsheets

Administrative data

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

Justification for classification or non-classification

Based on the negative results of all genetic toxicity studies and the repeated dose toxicity studies from the substance, no (genotoxic) carcinogenicity is expected and classification for carcinogenicity of the substance is not warranted according to EU CLP (EC 1272/2008 and its amendments).

Additional information