2-propylheptyl methacrylate

Endpoint summary

Additional information

In vitro gene mutation assay on bacteria

The test substance 2-Propylheptyl methacrylate was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay (OECD 471). Test conditions: Standard plate test (SPT) and preincubation test (PIT) both with and without metabolic activation (liver S9 mix from induced rats). Strains: TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA, dose range: 33 μg - 5 400 μg/plate (SPT) 33 μg - 5 400 μg/plate (PIT). Precipitation of the test substance was found from about 333 μg/plate onward with and without S9 mix. A bacteriotoxic effect was occasionally observed depending on the strain and test conditions from about 1 000 μg/plate onward. No biologically relevant increase in the number of his+ or trp+ revertants was observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system. Based on this result 2-Propylheptyl methacrylate is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation. (BASF, 2014)

In vitro chromosomal aberration assay on mammalian cells

The test substance 2-Propylheptyl methacrylate was assessed for its potential to induce micronuclei in V79 cells in vitro (clastogenic or aneugenic activity) (OECD 487). Two independent experiments were carried out, both with and without the addition of liver S9 mix from induced rats (exogenous metabolic activation). 1st Experiment 4 hours exposure; 24 hours harvest time; without S9 mix: 0; 3.13; 6.25; 12.50; 25.00; 50.00; 100.00 μg/mL 4 hours exposure, 24 hours harvest time, with S9 mix: 0; 6.25; 12.50; 25.00; 50.00; 100.00; 200.00 μg/mL 2nd Experiment 24 hours exposure, 24 hours harvest time, without S9 mix 0; 1.56; 3.13; 6.25; 12.50; 25.00; 50.00 μg/mL 4 hours exposure, 44 hours harvest time, with S9 mix 0; 6.25; 12.50; 25.00; 50.00; 100.00; 200.00 μg/mL. In this study, cytotoxicity indicated by clearly reduced cell count was observed at the highest applied test substance concentrations in all experimental parts without S9 mix. In the presence of metabolic activation, no cytotoxicity was observed in the pretest. Therefore, dose selection for the main experiments was based on the solubility properties of the test substance. No cytotoxicity was obtained when tested up to clearly precipitating concentrations. On the basis of the results of the present study, the test substance did not cause any biologically relevant increase in the number of cells containing micronuclei either without S9 mix or after adding a metabolizing system. The dose-dependencies observed in both parts of the 1st Experiment have to be considered as biologically irrelevant.

Based on this result 2-Propylheptyl methacrylate is considered not to have a chromosome-damaging (clastogenic) effect nor to induce numerical chromosomal aberrations (aneugenic activity) under in vitro conditions in V79 cells in the absence and the presence of metabolic activation. (BASF SE, 2014)

In vitro gene mutation assay on mammalian cells (read-across to 2 -Ethylhexyl methacylate)

The potential of 2-Ethylhexyl methacrylate to induce gene mutations at the HPRT locus in V79 tells of the Chinese hamster was investigated in an OECD guideline 476 and GLP study (Harlan, 2008). The assay was performed in two independent experiments. The cells were exposed to the test item for 4 hours in the first experiment with and without metabolic activation. The second experiment was performed with a treatment period of 24 hours in the absence and 4 hours in the presence of metabolic activation. The maximum dose of the pre-test was 2000 µg/mL corresponding to a molar concentration of about 10 mM. The concentration range of the main experiments was limited by cytotoxic effects and was 0.1 - 16.0 (1st experiment) and 3.8 – 60.0 (2nd experiment) µg/ml without S9 and 62.5 – 2000 µg/ml with S9 (1st and 2nd experiments). No substantial and reproducible dose dependent increase of the mutation frequency was observed in the main experiments up to the maximum concentration. Appropriate reference mutagens were used as positive controls and showed a distinct increase in induced mutant colonies and thus showed the sensitivity of the test system and the activity of the S9 mix. In conclusion, 2-ethylhexyl methacrylate did not induce gene mutations et the HPRT locus in V79 cells. (Harlan, 2008)

Short description of key information:
Ames: negative
MNT: negative
HPRT: negative (read-across to 2-Ethylhexyl methacrylate)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the results, 2 -Propylheptyl methacrylate is no subject to classification and labelling according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).