Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Key, OECD 471, GLP, S. typhimurium TA 98, TA 100, TA 102, TA 1535 and TA 1537, E. coli WP2 uvrA, +/- S9: negative

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Bacterial reverse mutation assay

Study Design

The GLP compliant study was performed in accordance with OECD Guideline 471 (adopted 1997), EEC Annex V Test B 13B 14 (2000), UKEMS Guidelines (1990) and ICH Harmonised Tripartite Guideline (1997). The investigations for mutagenic potential were performed using Salmonella typhimurium tester strains TA 98, TA 100, TA 102, TA 1535 and TA 1537, and Escherichia coli WP2 uvrA. The plate incorporation test with and without addition of liver S9 mix from Aroclor 1254-pretreated rats was used. Two independent experimental series were performed. In the two series with S9 mix, 10 % and 30 % S9 in the S9 mix were used in the 1stand 2ndseries, respectively.

Results

The test item  was dissolved in dimethyl sulfoxide (DMSO) and tested at concentrations ranging from 5.53 to 5530 µg/plate. Precipitation of the test material on the agar plates occurred at concentrations ≥ 553 µg/plate. Toxicity to the bacteria was observed at concentrations ≥ 1750 µg/plate.
Daunomycin, N-ethyl-N`-nitro-N-nitrosoguanidine, 9-aminoacridine and cumene hydroperoxide served as strain specific positive control compounds in the absence of S9 mix. 2-Aminoanthracene and benzo[a]pyrene were used for testing the bacteria and the activity of the S9 mix. Each treatment with the substances used as positive controls led to a clear increase in revertant colonies, thus, showing the expected reversion properties of all strains and good metabolic activity of the S9 mix used.
In both series of experiments, each performed with and without the addition of rat liver S9 mix as the external metabolizing system, the test material showed no increase in the number of revertants of any bacterial strain.
Thus, the test item was not mutagenic under the described experimental conditions.

Conclusion

With and without addition of S9 mix as the external metabolizing system, the test material was not mutagenic under the experimental conditions described.

Justification for classification or non-classification

Based on the results of the available study the registered substance is not subject to classification according to Regulation (EC) No 1272/2008.