Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Short description of key information:
In-vitro assays:
- Ames’ test (OECD TG 471) in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 with/without S-9 mix: negative
- Gene mutation (HPRT) in mouse lymphoma cells (OECD TG 476) with/without S-9 mix: negative
- In-vitro micronucleus test (OECD TG 487) in human lymphocytes with/without S-9 mix: positive

In-vivo assay:
- Rat bone marrow micronucleus test (OECD TG 474): negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Four reliable tests are available concerning this endpoint: three in-vitro tests and one in-vivo test, covering both gene mutation and chromosome aberration. All the results are negative, except the in-vitro micronucleus test (positive but with a questionable biological relevance).

Based on these data, the test item is considered as non mutagenic. No classification for mutagenicity is required.