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EC number: 700-814-2 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In-vitro studies:
Ames Test
In a reverse gene mutation assay in bacteria according to OECD Guideline 471 and EU Method B.13/14, the strains TA 1535, TA 1537, TA 100 and TA98 of Salmonella typhimurium and Escherichia coli WP2uvrA were exposed to ZINN(II)-RICINOLEAT in the presence and absence of mammalian metabolic activation.
Based on information from a dose range finding test, in the first mutation experiment, the test item was tested up to concentrations of 3330 µg/plate in the absence and presence of S9-mix in the strains TA1535, TA1537 and TA98. In the second mutation experiment, it was tested up to concentrations of 3330 µg/plate in the absence and presence of S9-mix in the strains TA 1535, TA98, TA 100 and WP2uvrA. The test item was tested up to concentrations of 1670 µg/plate in the absence and presence of S9-mix in the strain TA1537.
ZINN(II)-RICINOLEAT did not induce a dose-related, two-fold, increase in the number of revertant (His+) colonies in each of the four tester strains (TA 1535, TA 1537, TA98 and TA 100) and in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in an independently repeated experiment.
Based on the results of this study it is concluded that ZINN(II)-RICINOLEAT is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
Chromosome aberration:
In a mammalian cell cytogenetics assay according to OECD Guideline 473 and EU Method B10, cultured peripheral human lymphocytes were exposed to ZINN(II)-RICINOLEAT in the presence and absence of a metabolic activation system (Aroclor-1254 induced rat liver S9-mix).
In the absence of S9-mix the test item was tested up to 75 µg/ml for a 3 h treatment time with a 24 h fixation time in the first experiment. In the second experiment it was tested up to 75 µg/ml for a 24 h treatment time with a 24 h fixation time and the test item was tested up to 100 µg/ml for a 48 h treatment time with a 48 h fixation time.
In the presence of 1.8% (v/v) S9-fraction it was tested up to 130 µg/ml for a 3 h treatment time with a 24 h fixation time in the first experiment. In the second experiment the test item was tested up to 110 µg/ml for a 3 h treatment time with a 48 h fixation time.
Positive control chemicals, mitomycin C and cyclophosphamide, both produced a statistically significant increase in the incidence of cells with chromosome aberrations, indicating that the test conditions were adequate and that the metabolic activation system (S9-mix) functioned properly.
ZINN(II)-RICINOLEAT did not induce a statistically or biologically significant increase in the number of cells with chromosome aberrations in the absence and in the presence of S9-mix, in two independently repeated experiments.
However, it was noted that at the 48 h fixation time the number of polyploid cells and cells with endoreduplicated chromosomes was increased. This increase was most distinct in the absence of S9-mix, where cells have been treated continuously for 48 hours. This may indicate that ZINN(II)-RICINOLEAT has the potential to inhibit mitotic processes and cell cycle progression, thereby inducing numerical chromosome aberrations.
It is concluded that ZINN(II)-RICINOLEAT is not clastogenic in human lymphocytes under the experimental conditions described in this report.
Gene mutation in mammalian cells
In a mammalian gene mutation assay according to OECD Guideline 476 and EU Method B.17, Chinese hamster lung fibroblasts (V79) cells cultured in vitro were exposed to PU-2014-537 (ZINN(II)-RICINOLEAT) in the presence and absence of mammalian metabolic activation.
The study was performed in two independent experiments, using identical experimental procedures.
In the pre-experiment, the maximum concentration of 3600 μg/mL was limited by the solubility properties of the test item in acetone and aqueous medium. The concentration range of the main experiments was limited by cytotoxic effects of the test item.
The main experiments were evaluated at the following concentrations:
Experiment I: 4 hour exposure; without S9 mix: 0.9, 1.8, 3.5, 7.0, 14.0 µg/mL
4 hour exposure; with S9 mix:3.5, 7.0, 14.0, 21.0, 28.0 µg/mL
Experiment II: 24 hour exposure; without S9 mix:3.5, 7.0, 14.0, 28.0, 56.0 µg/mL
4 hour exposure; with S9 mix:3.5, 7.0, 14.0, 21.0, 28.0 µg/mL
No relevant and reproducible increase in mutant colony numbers/106 cells was observed in the main experiments up to the maximum concentration.
Appropriate reference mutagens, used as positive controls, induced a distinct increase in mutant colonies and thus, showed the sensitivity of the test system and the activity of the metabolic activation system.
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. Therefore, PU-2014-537 is considered to be non-mutagenic in this HPRT assay.
Conclusion
In conclusion, ZINN(II)-RICINOLEAT is considered to have no genotoxic properties as shown in the Ames-Tests, mammalian gene mutation assay (HPRT) and chromosome aberration study.
Justification for selection of genetic toxicity endpoint
Data are from GLP compliant guideline studies with reliability 1. No single key study has been selected since all available studies were negative.
Short description of key information:
Based on the results of the full set of in-vitro genotoxicity tests required by REACH regulation, there is no evidence for genotoxic properties of ZINN(II)-RICINOLEAT.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the results of the full set of in-vitro genotoxicity tests required by REACH regulation, there is no evidence for genotoxic properties of ZINN(II)-RICINOLEAT.
Thus ZINN(II)-RICINOLEAT does not need to be classified as “genotoxic” according to Directive 67/548/EEC as well as GHS Regulation EC No 1272/2008. No labelling is required.
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