Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

In the key study (40M0098/934071), no mutagenic potential has been observed in the Ames Assay for the strains TA1535, TA98 and TA100. The results for the strain TA1537 were ambiguous i.e. negative and weakly positive in 5 independent experiments. A further series of Ames tests was performed within a screening program, testing different batches of 3-(4-Methoxyphenyl)-3-methoxypropionsaeuremethylester, (techn).

In a screening assay for the strain TA1537 with 3-(4-Methoxyphenyl)-3-methoxypropionsaeuremethylester (supportive study), pure (purity 97.6 %) showed no mutagenic potential of the test substance.

Further screening tests for the strain TA1537 with eight different batches of 3-(4-Methoxyphenyl)-3-methoxypropionsaeuremethylester, (techn.; approx. 60%) showed no mutagenic potential, as well as the screening tests for the strain TA98 with two out of the eight different batches.

Taking into account all the results of the key study, the supportive study (with the pure test substance) and the additional evidence from further screening studies (with the different batches of the test substance, techn.) it was concluded, that 3-(4-Methoxyphenyl)-3-methoxypropionsaeuremethylester was not mutagenic in a bacterial mutagenicity test.

Endpoint Conclusion:

Justification for classification or non-classification

The present data on genetic toxicity do not fulfill the criteria laid down in 67/548/EEC and 1272/2008/EEC and therefore, a non-classification is warranted.