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Key value for chemical safety assessment

Additional information

Key studies:

- Key studies: Two studies on Bacterial reverse mutation assay (Ames test) according to OECD guideline 471.

Results: negative

- Key study: In vitro mammalian chromosome aberration test according to OECD guideline 473.

Result: negative

- Key study: In vitro mammalian cell gene mutation test according to OECD guideline 476.

Result: negative


Justification for selection of genetic toxicity endpoint
No study was selected since the four in-vitro studies were negative.

Short description of key information:
Key studies:
- Key studies: Two studies on Bacterial reverse mutation assay (Ames test) according to OECD guideline 471. GLP studies.
Results: negative
- Key study: In vitro mammalian chromosome aberration test according to OECD guideline 473. GLP study.
Result: negative
- Key study: In vitro mammalian cell gene mutation test according to OECD guideline 476. GLP study.
Result: negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available data on genetic toxicity in vitro, the substance is considered as negative and therefore, it is not classified.