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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The test item did not lead to an increase of the number of revertant colonies with or without S9 in the standard plate and preincubation test with Salmonella typhimurum and Escherichia coli. The substance is considered to be not mutagenic in bacterial reverse mutation assays, neither in absence nor presence of a metabolic activation system. The Prival modification which is important for an accurate interpretation of the results when testing an azo dye was missing in this assay. Therefore, an OECD 471 test with a structural analogue substance was considered in a weight-of-evidence approach. The structural analogue was found to be non mutagenic in an OECD 471 test neither in presence nor in absence of a metabolic activation system. The Prival modification assay proved the results of the plate incorporation method. It is concluded that Disperse Yellow 198 does not cause mutagenic effects in bacteria (considering the Prival modification of the structural analogue).

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The substance and its structural analogue are not mutagenic in bacteria. No classification applies.