Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Ames-Test (BASF, 2015): negative

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Ames-Test

The test substance Eukesolar Rubine EB Liquid - dried was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay (Ames standard plate test and Prival preincubation test, OECD 471 guideline and GLP, BASF 2015). The modified Bacterial Reverse Mutation Test according to Prival facilitates azo reduction and is therefore the most approriate method for the investigation of azo-dyes and diazo compounds.

STRAINS: TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA

DOSE RANGE: 33 μg - 5 200 μg/plate (SPT) 33 μg - 5 200μg/plate (Prival)

TEST CONDITIONS: Standard plate test (SPT) and Prival preincubation test (Prival) both with and without metabolic activation. SOLUBILITY: Precipitation of the test substance was found from about 2 600 μg/plate onward with and without S9 mix.

TOXICITY: A bacteriotoxic effect was occasionally observed depending on the strain and test conditions from about 1 000 μg/plate onward.

MUTAGENICITY: A relevant increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the prival preincubation test either without S9 mix or after the addition of a metabolizing system.

CONCLUSION: Thus, under the experimental conditions of this study, the test substance Eukesolar Rubine EB Liquid - dried is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.


Justification for classification or non-classification

Based on the results of the Ames Test, no classification is required.