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Administrative data

Key value for chemical safety assessment

Additional information

One in vivo studies (Klimisch score = 2) and three in vitro studies (Klimisch score = 2, 2 and 1) were of high quality, therefore there is no reason to believe that these resutls would not be applicable to human.

Justification for selection of genetic toxicity endpoint
No study was selected as all the three in-vitro studies were negative.
A negative in-vivo study is also available.

Short description of key information:
Clearly negative in vivo study, with and without metabolic activation.
The negative and positive controls fulfilled the requirements for determination of a valid test. Under the conditions of the in vivo study, T2025 was negative in the acute cytogenetics assay using male and female Sprague-Dawley rats.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The substance is not classified as mutagen for germ cell as none of the genotoxicity in-vitro and in-vivo tests gave positive results.