2,6-difluorobenzonitrile

Endpoint summary

Additional information

In vitro data

Bacterial reverse mutation

The potential of the test material to cause gene mutation in bacterial strains was determined in accordance with standard guidelines OECD 471 and EU Method B.14. Five strains of Salmonella typhimurium (TA 98, TA 100, TA 1535, TA 1537 and TA 1538) were treated in the presence and absence of a rat liver derived metabolic activation system (S9 mix). In two separate assays the test material did not induce any significant, reproducible increases in the observed number of revertant colonies in any of the tester strains used in the presence or in the absence of metabolic activation. It was therefore concluded that the test material showed no evidence of mutagenic potential both in the presence and in the absence of metabolic activation at the dose levels used.

Chromosome aberration test in vitro

The potential of the test material to induce structural chromosomal aberrations in cultured peripheral human lymphocytes, in the presence and absence of a metabolic activation system (Aroclor-1254 induced rat liver S9-mix) was determined in a study performed in accordance with standardised guidelines OECD 473, EU Method B.10 and EPA OPPTS 870.5375.

During the study the test material was tested up to 333 µg/ml in the absence and up to 1000 µg/ml in the presence of the S9 mix for a 24 h and 48 h fixation period in the first experiment, and for a 24 h fixation period in the second experiment. None of the tested concentrations induced a statistically and biologically significant increase in the number of cells with chromosome aberrations, neither in the absence nor in the presence of S9-mix. Positive control chemicals, mitomycin C and cyclophosphamide, both produced a statistically significant increase in the incidence of cells with chromosome aberrations, indicating that the test conditions were optimal and that the metabolic activation system (S9-mix) functioned properly.

It was concluded that the test material was not clastogenic in human lymphocytes when tested under the experimental conditions presented both in the presence and absence of metabolic activation.

The available data is considered to be complete and the conclusion, non-mutagenic, was taken forward for risk assessment.

Short description of key information:
IN VITRO DATA
Reverse mutation in bacteria, negative (S. typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 in the presence and absence of metabolic activation); OECD 471, EU Method B.13; Koorn JC, 1993

In vitro chromosome aberration, negative, human lymphocytes with and without metabolic activation; OECD 473, EU Method B.10, EPA OPPTS 870.5375; van de Waart EJ, 1993

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

In accordance with criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for genetic toxicity based on the overall negative response noted in the available genetic toxicity studies.