Pyrrolo[3,4-c]pyrrole-1,4-dione, 2,5-dihydro-3,6-bis(4-methylphenyl)-

Endpoint summary

Additional information

Genotoxicity tests in vitro

The material 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 (TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA). The test item was applied at concentrations of 3.3 μg - 5000 μg/plate in presence and absence of a metabolic activation system (S9 mix). Cytotoxicity was observed at the highest concentration in presence and absence of the metabolic activation system. A relevant increase in the number of his+ or trp+ revertants was not observed in both experiments either without S9 mix or after the addition of a metabolizing system.

Chinese hamster V79 cells were exposed to the test substance concentrations up to 90 ug/ml both in the presence and absence of S-9 mix. In two independent experiments, there were no biologically relevant increases in cells with structural aberrations and in

in the frequencies of polyploid metaphases after treatment with the test article at fixation intervals 18 h and 28 h (with and without S9 mix).

read across to CAS 84632 -59 -7

The potential of the test item to induce mutagenicity in mammalien cells was not examined. Reliable data on a structural analogue are available. Both substances are pigments and share high similarity in structure and are of low solubilitx in water (< 0.1 mg/l). The analogue has a slightly higher molecular weight which gives an additional safety margin.

This study was performed to investigate the potential of the analogue to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster. The first main experiment was performed with and without liver microsomal activation and a treatment period of 4 hours. The second experiment was performed with a treatment time of 4 hours with and 24 hours without metabolic activation. The concentration range of the main experiments was limited by precipitation of the test item. No substantial and reproducible dose dependent increase of the mutation frequency was observed up to the maximum concentration with and without metabolic activation.

In summary, the test compound is not considered to have a genotoxic potential.

Justification for selection of genetic toxicity endpoint
Arbitrary, test with highest sensitivity.

Short description of key information:
Several in vitro assays were performed to assess the genotoxic potential of the test item. The substance and a structural analogue did not induce mutagenicity in bacterial or mammalian cells and is not clastogenic (according to GLP and OECD guidelines 471, 473 and 476). The test item is therefore not considered to have a genotoxic potential.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for genotoxicity under Directive 67/548/EEC.

 

 

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for genotoxicity under Regulation (EC) No. 1272/2008.