Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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 (read across with Hyacinth body #3, and supporting results obtained with Hyacinth body), in vitro micronucleus and gene mutation test in mammalian cells, resulting in the absence of genotoxicity. Hyacinth body is considered negative for genotoxicity and therefore is not considered a genotoxic carcinogen.

Key value for chemical safety assessment

Justification for classification or non-classification

The genotoxicity of the substance has been assessed in vitro for three genotoxicity endpoints: genotoxicity in bacteria (read across with Hyacinth body #3, and supporting results obtained with Hyacinth body), in vitro micronucleus and gene mutation 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 in accordance with EU CLP (EC No. 1272/2008 and its amendments).

Additional information

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