Registration Dossier

Administrative data

Description of key information

Orivone is considered negative for genotoxicity and therefore is not considered a genotoxic carcinogen.

Key value for chemical safety assessment

Additional information

In accordance with Annex VIII information on carcinogenicity is not required for a substance manufactured/imported in amounts 10-100 tons. The substance has shown to be not genotoxic in vitro. Therefore no genotoxic carcinogenicity is expected, via the oral, inhalation and dermal route.

Justification for classification or non-classification

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 genemutation test 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 EU CLP (EC 1272/2008 and its updates)