Oxybispropanediol

Endpoint summary

Additional information

Diglycerol was tested in the Ames test for its ability to induce mutations in five histidine dependent Salmonella typhimurium strains. Two independent mutation tests were performed, each in presence and absence of a metabolic activation system (S9-mix). The bacterial strains were exposed to 0-5000 μg/plate diglycerol dissolved in DMSO (which was also a solvent control). The test substance showed no reproducible increase or a concentration-related increase in any of the strains tested. The negative and positive control values were within the expected ranges. Therefore, diglycerol was not mutagenic in this study.

Another Ames test was performed with diglycerol using Salmonella typhimurium spp. and Escherichia coli according to current OECD/EC guidelines and GLP priniples. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, at any dose level either with or without metabolic activation. The highest concentration tested was 5000 µg/plate. No cytotoxicity nor precipitation of the test material was observed. In two independent experiments, the test material was found to be non-mutagenic with or without metabolic activation.

Cycl. diglycerol was tested in an Ames test for its ability to induce mutations in five strains of Salmonella typhimurium according to OECD 471 and GLP. Two independent mutations tests were performed, each in the presence and absence of a metabolic activation system (S9-mix). The bacterial strains were exposed to 0-5000 μg/plate Cycl. diglycerol dissolved in DMSO (which was also a solvent control). The test substance showed no evidence of mutagenic activity in the Ames plate incorporation assay under the experimental conditions employed. The number of revertants in the solvent control and positive control were within the expected range.

The ability of Diglycerol to induce chromosome aberrations in human peripheral lymphocytes was investigated in two independent experiments with and without metabolic activation according to OECD 473 and GLP. No effects of diglycerol on the number of polyploid cells and cells with endoreduplicated chromosomes were observed both in the absence and presence of metabolic activation. Therefore it was concluded that diglycerol does not disturb mitotic processes and cell cycle progression and does not induce numerical chromosome aberrations. Diglycerol did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations in the absence and presence of metabolic activation. It was concluded that diglycerol is not clastogenic.

The effects of diglycerol on the induction of forward mutations at the thymidine-kinase locus (TK-locus) were studied in L5178Y mouse lymphoma cells. Diglycerol was tested up to concentrations of 1662 µg/ml (0.01 M) in the absence and presence of S9-mix in two independent experiments according to OECD 476 and GLP. Diglycerol did not induce a significant increase in the mutation frequency with or without metabolic activation. In conclusion, diglycerol is not mutagenic in the TK mutation test system.

Short description of key information:

Two Ames tests with diglycerol and one Ames test with cycl. diglycerol showed these substances to be not mutagenic with or without metabolic activation. Diglycerol was not clastogenic in a chromosome aberration test and did not disturb mitotic processes and cell cycle progression in the absence and presence of metabolic activation. Diglycerol was not mutagenic in the mouse lymphoma assay in the absence and presence of metabolic activation. Studies were performed according to OECD guidelines and GLP.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the genotoxicity studies performed, diglycerol does not have to be classified for mutagenicity according to CLP Regulation (EC) No. 1272/2008.