Registration Dossier

Administrative data

Description of key information

The following information is taken into account for any hazard / risk assessment:
In accordance with Annex VIII information on carcinogenicity is not required for a substance manufactured/imported in amounts 10-100 tons. The genotoxicity of the substance has been assessed in vitro for three genotoxicity endpoints: genotoxicity in bacteria, genotoxicity in mammalian cells and chromosomal aberration in human lymphocytes, resulting in the absence of genotoxicity. 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

Additional information

Justification for selection of carcinogenicity via oral route endpoint:
The genotoxic carcinogenicity has been assessed using the information from the in vitro genotoxicity tests, which information is sufficiently adequate to cover this endpoint.

Justification for classification or non-classification

The genotoxicity of the substance has been assessed in vitro for three genotoxicity endpoints: genotoxicity in bacteria, chromosomal aberration in human lymphocytes and genotoxicity in mammalian cells, resulting in the absence of genotoxicity. Therefore no genotoxic carcinogenicity is expected, via the oral, inhalation and dermal route. The substance does not have to be classified for genotoxic carcinogenicity via the oral, inhalation and dermal route in accordance with the criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EEC.