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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

- Bacterial Reverse Mutation Test (B.13/14, GLP), with and without metabolic activation, S.typhimurium TA98, TA100, TA 1535 and TA1537, E.coli WP2 uvrA:

-Mutagenic for tester strains S. typhimurium TA 98 with and without metabolic activation and equivocal results for TA1537 with metabolic activation,

-Non-mutagenic for: TA 100, TA 1535 and E.Coli, with and without metabolic activation, and TA 1537 without metabolic activation

Chromosome aberration test to CHL/IU cells in vitro: Negative

Read Across to Analogue Substance (Solvent Blue 98):

In-vitro chromosomal abberation test (OECD 473): Negative: Not genotoxic

 

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

Genetic toxicity in vivo

Description of key information

Read Across to Analogue Substance (Solvent Blue 98):

In vivo mutagenicity assay (Pig A) integrated into the OECD 422 assay.

Negative: Not genotoxic

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

Additional information

Justification for classification or non-classification

Although a positive baceterial mutagenicity assay indicated a potential for mutagenicity in vitro, a Chromosome aberration test to CHL/IU cells in vitrogave a negative result. In addition

read ascross to an Analogue substance in vivo mutagenicity assay (pig A) was negative and a chromosomal abberation test (OECD 473) for the analogue substance was also negative (despite also giving a positive result in an Ames study). Consequently it is concluded that at this time, the substance does not meet the criteria for classification for mutagenicity.