Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

AMES TEST

Macrolex Rot EG suspended in DMSO, was initially investigated in the Ames test according to OECD TG 471 and GLP using the Salmonella typhimurium TA 98, TA100, TA102, TA1535, TA1537 and concentrations up to and including 5000 µg/plate (plate incorporation test) or up to and including 1600 µg/plate (preincubation methodology). Bacteriotoxicity was not reached. Precipitation was observed from 500 µg/plate onwards in both , plate incorporation test and preicubation test. None of the 5 strains used showed a dose-related and biologically relevant increase in mutant counts over those of the negative controls neither in the presence nor in the absence of the metabolic activation system S9 -mix. The positve contols were functional. Therefore, Macrolex Rot EG was considered to be non-mutagenic without and with S9 -mix in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test..

Thus this test confirmes the result of the Ames test which was performed witn only 4 Salmonella typhimurium strains.

HPRT-test

The study was performed to investigate the potential of Macrolex Rot EG to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster according to OECD TG 476.and GLP The assay was performed in two independent experiments, using two parallel cultures each. 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 dose-range of the main experiments was determined in a pre-test. Precipitation of the test item at the end of treatment was noted in Experiment I, with and without S9- mix from 537.5 µg/ml onwards and in Experiment II, with and without S9 -mix from 500.0 µg/ml onwards . No substantial and reproducible dose dependent increase of the mutation frequency was observed in both main experiments. Appropriate reference mutagens, used as positive controls, induced a distinct increase in mutant colonies and thus, showed the sensitivity of the test system and the activity of the metabolic activation system. In conclusion, it can be stated that under the experimental conditions reported, the test item did not induce gene mutations at the HPRT locus in V79 cells. Therefore, Macrolex Rot EG is considered to be non-mutagenic in this HPRT assay.

MNT-in-vitro

Macrolex Rot EG was examined for mutagenic activity in the micronucleus test in vitro according to OECD TG 487 in the presense and in th absence of a metabolic activation system..No cytotoxic effects were observed. . Precipitation in the medium could be observed at 1 µg/ml and above with and without S9 -mix regardless of the treatment time. No biologically relevant increase in the frequencies of micronucleus containing V79 cells treated with the test item in the absence (4 hours or 24 hours treatment) or in the presence of S9 mix.were seen.

Evaluation of the data do not indicate that Macrolex Rot EG is a mutagen in the micronucleus test in vitro in the absence or presence of metabolic activation.


Justification for selection of genetic toxicity endpoint
No study was selected since all available in vitro studies were negative

Short description of key information:
Macrolex Rot EG proved to be not mutagenic in the Ames test, HPRT test and MNT in vitro

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available data no classification or labelling is required.