Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In vitro gene mutation studies in bacteria concluded that the test substance was not genotoxic under the conditions of the studies either with or without metabolic activation.

An in vitro mouse lymphoma study was negative with and without metabolic activation.

There was a negative results for an in vitro unscheduled DNA synthesis assay, however whilst a chromosome aberration assay was negative, a sister chromatid exchange assay was positive.

The results of an in vivo mouse micronucleus study conducted according to OECD guideline 474 on a structural analogue did not show any evidence of causing chromosome damage when administered orally.


Justification for selection of genetic toxicity endpoint
The results of an in vivo mouse micronuclus study conducted according to OECD guideline 474 on a structural analogue did not show any evidence of causing chromosome damage when administered orally.

Short description of key information:
In vitro gene mutation studies in bacteria concluded that the test substance was not genotoxic under the conditions of the studies either with or without metabolic activation.
An in vitro mouse lymphoma study was negative without metabolic activation but positive with metabolic activation.
There was a negative results for an in vitro unscheduled DNA synthesis assay, however whilst a chromosome aberration assay was negative, a sister chromatid exchange assay was positive.
The results of an in vivo mouse micronucleus study conducted according to OECD guideline 474 on a structural analogue did not show any evidence of causing chromosome damage when administered orally.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The results of an in vivo mouse micronucleus assay conducted according to OECD guideline 474 on a structural analogue did not show any evidence of causing chromosome damage when administered orally.