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Key value for chemical safety assessment

Additional information

Benzophenone was tested in several standard in vitro and in vivo studies performed according to recent guidelines. All of these studies gave no indications for a mutagenic/genotoxic potential.

In vitro:

Bacterial Reverse Mutation Assay equivalent or similar to OECD Guideline 471: negative in S. typhimurium TA1535, TA1537, TA98 and TA100 both with and without metabolic activation (Mortelmans et al., 1986; NTP, 2006)

Bacterial Reverse Mutation Assay equivalent or similar to OECD Guideline 471: negative in S. typhimurium TA98, TA100, TA1535, TA1537 and TA1538 both with and without metabolic activation (Seifried et al., 2006)

DNA damage and repair assay (unscheduled DNA synthesis in mammalian cells in vitro): negative in E. coli W3110 (Pol A+) and p3478 (Pol A-) both with and without metabolic activation (Fluck et al., 1976)

Mouse lymphoma assay equivalent or similar to OECD Guideline 476 (In vitro Mammalian Cell Gene Mutation Test): negative in L5178Y cells both with and without metabolic activation (Seifried et al., 2006)

In vivo:

Micronucleus assay according to OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test): negative (NTP, 2000)

Micronucleus assay equivalent or similar to OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test): negative (Abramsson-Zetterberg & Svensson, 2011)


Short description of key information:
In vitro studies:
Bacterial Reverse Mutation Assay equivalent or similar to OECD Guideline 471: negative in S. typhimurium TA1535, TA1537, TA98 and TA100 both with and without metabolic activation (Mortelmans et al., 1986; NTP, 2006)
Bacterial Reverse Mutation Assay equivalent or similar to OECD Guideline 471: negative in S. typhimurium TA98, TA100, TA1535, TA1537 and TA1538 both with and without metabolic activation (Seifried et al., 2006)
DNA damage and repair assay (unscheduled DNA synthesis in mammalian cells in vitro): negative in E. coli W3110 (Pol A+) and p3478 (Pol A-) both with and without metabolic activation (Fluck et al., 1976)
Mouse lymphoma assay equivalent or similar to OECD Guideline 476 (In vitro Mammalian Cell Gene Mutation Test): negative in L5178Y cells both with and without metabolic activation (Seifried et al., 2006)

In vivo studies:
Micronucleus assay according to OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test): negative (NTP, 2000)
Micronucleus assay equivalent or similar to OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test): negative (Abramsson-Zetterberg & Svensson, 2011)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The experimental data are not indicating a possible mutagenic/genotoxic potential. Therefore, there is no need for a classification according to the criteria of EC Directive 1272/2008 and of the GHS.