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Key value for chemical safety assessment

Additional information

For this endpoint, four studies are available. All are quoted Klimisch 1 since they are OECD guideline and GLP. They all gave negative results.

The in vitro potential mutagenic activity of the substance was investigated by the Ames test using 5 strains of bacteria Salmonella typhimurium: TA 1535, TA 1537, TA 102, TA 98 and TA 100.(Molinier, 1992a). The substance did not induce any significant increase in the revertant number with or without S9 mix in any of the 5 strains. In a mouse lymphoma assay (Molinier, 1996), the test substance did not induce any biologically significant increase in the mutation frequency, with and without S9 mix. In an in vitro mammalian chromosome aberration test (Molinier, 1992b), the incidence of aberrant cells in the cultures treated with the test substance was similar to that in the control cultures for both sampling times, with and without S9 mix.

The in vivo potential mutagenicity of the substance was tested in a micronucleus test in mice (Gudi, 1998).Male and female mice were dosed with 113, 225 or 450 mg test article/kg body weight. No mortality was observed in any male or female mice in the micronucleus study. Clinical signs following dose administration included: lethargy in 2/5 female mice at 113 mg/kg and lethargy and piloerection in ail male and female mice at 225 and 450 mg/kg. Bone marrow cells, collected 24 and 48 hours after treatment, were examined microscopically for micronucleated polychromatic erythrocytes. A moderate reduction (up to 40%) in the ratio of polychromatic erythrocytes to total erythrocytes were observed in some of the test article-treated groups relative to the respective vehicle controls. These reductions suggest bioavailability of the test article to the bone marrow target.

No significant increase in micronucleated polychromatic erythrocytes in test article-treated groups relative to the respective vehicle control group was observed in male or female mice at 24 or 48 hours after dose administration.

Short description of key information:
3-hydroxy-1,1-dimethylbutylperoxyneodecanoate induced negative responses in several well conducted studies(OECD guidelines, GLP):
- In vitro: Ames test negative (Molinier, 1992 a), mouse lymphoma assay negative (Moliner, 1996), chromosomal aberration test (Molinier, 1992b)
- In vivo: micronucleus test negative (Gudi, 1998)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

According to EU Regulation (EC) N0. 1272/2008 (CLP), the substance is not classified for genotoxicity.