Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In vitro gene mutation assay on bacteria

This study was performed to investigate the potential of C 17 Methacrylate dissolved in ethanol to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA. The assay was performed with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations, Pre-experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 μg/plate and Experiment II: 33; 100; 333; 1000; 2500; and 5000 μg/plate. Precipitation of the test item in the overlay agar on the incubated agar plates was observed from 2500 to 5000 μg/plate in experiment I with and without S9 mix and in experiment II with S9 mix. In experiment II without S9 mix precipitation was observed from 1000 to 5000 μg/plate. The undissolved particles had no influence on the data recording. The plates incubated with the test item showed normal background growth up to 5000 μg/plate with and without S9 mix in all strains used. No toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in the test groups with and without metabolic activation in both experiments. No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with C 17 Methacrylate at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies. Therefore, C 17 Methacrylate is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.

In vitro chromosomal aberration assay on mammalian cells

The test substance C 17 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; 6.25; 12.50; 25.00; 50.00; 100.00; 200.00μg/mL 4 hours exposure, 24 hours harvest time, with S9 mix: 0; 6.25; 12.50; 25.00; 50.00; 100.00; 200.00μg/mL. 2nd Experiment 24 hours exposure, 24 hours harvest time, without S9 mix 0; 12.50; 25.00; 50.00; 100.00; 200.00μg/mL 4 hours exposure, 44 hours harvest time, with S9 mix 0; 12.50; 25.00; 50.00; 100.00; 200.00μg/mL. The vehicle controls gave frequencies of micronucleated cells within our historical negative control data range for V79 cells. Both positive control substances, EMS and cyclophosphamide, led to the expected increase in the number of cells containing micronuclei. The test substance was poorly soluble in culture medium. In this study in the absence and the presence of metabolic activation no cytotoxicity indicated by reduced cell count or proliferation index (CBPI) was observed up to the highest applied test substance concentration. Therefore, concentrations at the border of test substance solubility in culture medium were investigated for cytogenetic damage. 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. Thus, under the experimental conditions described, C 17 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, 2015)

In vitro gene mutation assay in mammalian cells (for justification see read-across document)

Isodecyl methacrylate (CAS No. 29964-84-9) was assessed for its potential to induce gene mutations at the HPRT locus using V79 cells of the Chinese hamster. The assay was performed in two independent experiments with identical experimental procedures, using two parallel cultures each. The first main experiment was performed with and without liver microsomal activation and a treatment period of 4 h. The second experiment was performed with a treatment period of 24 hours in the absence of metabolic activation and 4 hours in the presence of metabolic activation. The cell cultures were evaluated at the following concentrations: Experiment I: without S9 mix:  0.1; 0.3; 0.5; 1.0; and 2.0 µg/mL and with S9 mix: 37.5; 75; 150; 300; and 1200 µg/mL. Experiment II: without S9 mix: 18.8 ;37.5; 75.0; 150; and 600 µg/mL and with S9 mix: 37.5; 75.0; 150; 300; and 600 µg/mL. Relevant toxic effects indicated by a relative cloning efficiency 1 below 50 % occurred at 1.0 µg/mL and above in the first experiment without metabolic activation and at 1200.0 µg/mL and above with metabolic activation. In the second experiment toxic effects as described above occurred at 37.5 µg/mL without metabolic activation and at 1200 µg/mL with metabolic activation. No relevant and reproducible increase in mutant colony numbers/1E6cells was observed in the main experiments up to the maximum concentration. In both experiments of this study (with and without S9 mix) the range of the solvent controls was from 5.7 up to 24.0 mutants per 1E6cells; the range of the groups treated with the test item was from 3.3 up to 34.1 mutants per 106cells. EMS(150 µg/mL in experiment I and 75 µg/mL in experiment II) and DMBA (2.0 µg/mL) were used as positive controls and showed a distinct increase in induced mutant colonies. This showed the sensitivity of the test system and the activity of the S9 mix. In conclusion it can be stated that under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells (Evonik Rohm, 2008).


Justification for selection of genetic toxicity endpoint
Key studies

Short description of key information:
Ames: negative (BASF, 2014)
MNT in vitro: negative (BASF, 2015)
HPRT in vitro: negative (Evonik Rohm, 2008)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the results, the test item is no subject to classification and labelling according to Regulation (EC) No 1272/2008 (CLP).