Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The genetic toxicity of DICYCLOEXYLPHTHALATE was assessed in 4 in vitro studies including, 2 bacterial reverse mutation assays, 1 mammalian chromosome aberration tests and a mammalian gene mutation assay. Negative results were reported in all the studies therefore DICYCLOEXYLPHTHALATE is not a genotoxic compound.

1. DICYCLOHEXYLPHTHALATE does not induce reverse mutation in Salmonella typhimurium or Escherichia coli in the absence or presence of S9 metabolism.

2. DICYCLOEXYLPHTHALATE does not induce chromosomal aberrations in human lymphocytes after in vitro treatment.

3. DICYCLOEXYLPHTHALATE does not induce mutation at the TK locus of L5178Y mouse lymphoma cells in vitro in the absence or presence of S9 metabolic activation


Short description of key information:
The genetic toxicity of DICYCLOEXYLPHTHALATE was assessed in 4 in vitro studies including, 2 bacterial reverse mutation assays, 1 mammalian chromosome aberration tests and a mammalian gene mutation assay. Negative results were reported in all the studies therefore DICYCLOEXYLPHTHALATE is not a genotoxic compound.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Genetic Toxicity: the substance is non-mutagenic under the conditions of the available in vitro studies. As a result, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 3.5.