Registration Dossier

Toxicological information

Carcinogenicity

Currently viewing:

Administrative data

Description of key information

No carcinogenicity study is available but there is information from a qualitative and quantitative understanding of the toxicological properties of the substance that a weight of evidence approach was used to decide on classification.

Key value for chemical safety assessment

Justification for classification or non-classification

Although no carcinogenicity study is available, it is concluded that carcinogenicity is not an endpoint of concern. There is no evidence from the in vitro genotoxicity studies (Ames, IVC/HPRT/ML) that the substance is able to induce mutagenicity. Furthermore the available repeated dose toxicity study gives no evidence of serious or severe toxicity up to and including 1000 mg/kg (NOEAL= 1000 mg/kg). Using the weight of evidence, it is concluded that carcinogenicity is not an endpoint of concern.

Additional information