Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The test item DMAC Trocken Flüssig was tested for its mutagenic potential in Salmonella typhimurium and Escherichia coli, in the standard plate test (SPT) and the preincubation test (PIT), according to the OECD TG 471 (1997). The tester strains were: TA1535, TA100, TA1537, TA98 and E. coli WP2 uvrA. Testing was done in absence and presence of S9 mix. Negative and positive controls were included.The test concentrations were as follows:

- 1st Experiment (all strains, standard plate test with and without S-9 mix, 3 plates/dose): 0; 20; 100; 500; 2500 and 5000 µg/plate

- 2nd Experiment (all strains, preincubation test with and without S-9 mix, 3 plates/dose): 0; 20; 100; 500; 2500 and 5000 µg/plate

When tested in all strains mentioned above under SPT and PIT conditions, with and without S9 mix, the test item did not induce an increase in his+ or trp+ revertant colonies at concentrations up to 5000 µg/plate. A slight cytototoxic effect was observed both in the SPT and the PIT from 2500 μg/plate onward. No test item precipitation was observed within the concentration range tested, with and without S9-mix. Referring to controls, the results of the negative as well as the positive controls performed in parallel corroborated the validity of this study, since the values fulfilled the acceptance criteria of this study. Thus, under the experimental conditions chosen, the test item DMAC Trocken Flüssig is not mutagenic in bacteria.

Short description of key information:
A valid Ames Test conducted according to the OECD 471 (1997) is available (BASFAG40M0246/994078). According to this study, the test item was not foud to be mutagenic either in S. typhimurium strains or in E. coli, both in presence and absence of S9 mix.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The test item was tested for bacterial mutagenicity according to the OECD TG 471 (1997). Because of negative results, there is no need to classify the test item for mutagenicity according to the EU Directive 67/548/EC and according to the CLP Regulation 1272/2008.