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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Genotoxicity of the structural analogue of the target substance was assessed in two in vitro tests (OECD 471 and OECD 490). The test substance was mutagenic in the bacterial reverse mutation test, but tested negative in the in vitro mammalian cell gene mutation test.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

Genotoxicity of the structural analogue of the target substance was assessed in an in vivo micronucleus test (OECD 474). The test substance was not genotoxic.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

No data is available for the target substance. Thus available data from a suitable structural analogue was used in a read-across approach. Details on the read-across rational are provided in section 13.

The chloride salt of the target substance was tested positive in a bacterial reverse mutation test (OECD 471), but was tested negative in the higher tier studies conducted in accordance with OECD 474 (in vivo micronucleus test) and 490 (in vitro mammalian cell gene mutation).

Justification for classification or non-classification

Genotoxicity of the target substance was assessed in a read-across approach. A suitable read-across substance was tested in an in vitro/in vivo testing battery. The substance was genotoxic in the bacterial reverse mutation test, but was tested negative in higher tier studies (OECD TG 474 and OECD TG 490). Therefore, it can be concluded based on a weight-of-evidence approach of the available data that no classification of the target substance is warranted.