Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The test substance did not show any mutagenic response in the bacterial reverse mutation assay (BASF SE, 40M0567/14M250, 2015).

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

Additional information

In a reverse mutation assay in bacteria according to OECD guideline 471, strains of S. typhimurium (TA1535, TA1537, TA98, TA100) and E. coli (WP2 uvr A) were exposed to the test substance at concentrations of 33, 100, 333, 1000, 2700, 5400 µg/plate) in the presence and absence of metabolic activation (S9 mix) (BASF SE, 40M0567/14M250, 2015). A standard plate incorporation test and a pre-inucbation assay were performed. Three test plates per dose were tested.

The test substance was tested up to the limit concentration of 5400 µg/plate. Precipitation was observed from about 2700 µg/plate onward with and without S9 mix. Bacteriotoxic effects were occasionally observed depending on the strain and test conditions in both the standard plate assay as well as the pre incubation assay.

According to the results of the present study, the test substance did not lead to an increase in the number of revertant colonies either without S9 mix or after adding a metabolizing system in two experiments carried out independently of each other (standard plate test and preincubation assay).

Besides, 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. In this study with and without S9 mix, the number of revertant colonies in the negative controls was within or nearby the range of the historical negative control data for each tester strain. In addition, the positive control substances both with and without S9 mix induced a significant increase in the number of revertant colonies within the range of the historical positive control data.

Thus, under the experimental conditions chosen here, it is concluded that the test substance is not mutagenic in the bacterial reverse mutation test in the absence and the presence of metabolic activation.

Justification for classification or non-classification

Based on the study and taking into account the provisions laid down in Regulation (EC) No 1272/2008 as amended for the ninth time in Regulation (EU) No 2016/1179, the test substance does not need to be classified as mutagenic.