Registration Dossier

Toxicological information

Carcinogenicity

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Administrative data

Description of key information

In accordance with Annex IX information on carcinogenicity is not required for a substance manufactured/imported in amounts 100-1000 tons.The genotoxicty of the substance has been assessed in vitro for three genotoxicity endpoints: genotoxicity in bacteria, genotoxicity in mammalian cells and cytogenicity in a micronucleus test, 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

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Justification for classification or non-classification

The genotoxicty of the substance has been assessed in vitro for three genotoxicity endpoints: genotoxicity in bacteria, genotoxicity in mammalian cells and cytogenicity in a micronucleus test, 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 1 of 1272/2008/EEC.