Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

As in different assays on cytogenicity and mutation, no indications for any genetic toxicity was observed, it can be concluded that BMDBM is not genotoxic in vitro or in vivo.


Justification for selection of genetic toxicity endpoint
Comparable to guideline in vivo study.

Short description of key information:
The study records on genetic toxicity of butyl methoxydibenzoylmethane (BMDBM) comprise two in vitro tests and one in vivo micronucleus test.

In vitro gene mutation study in bacteria
Dr. Dr. Ming Tzan-King 2000 (key): BMDBM showed no mutagenic effect in the Ames test (7 strains, with/without S9 metabolic activation).

In vitro gene mutation study in mammalian cells
Strobel 1984: BMDBM showed no mutagenic effect in the HGPRT test (with/without S9 metabolic activation)

In vivo cytogenicity study
Hugentobler 1989 (key): BMDBM induced neither chromosome breaks nor mitotic non-disjunctions in mouse bone marrow cells after twofold oral application of up to 5000 mg/kg bw/day.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

As no mutagenic or cytogenetic behaviour of BMDBM was found in different vitro or in vivo assays, it can be concluded that BMDBM is not genotoxic and therefore, classification of BMDBM as genotoxic is not needed.