Fatty acids, C16-18, esters with diethylene glycol

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Ames test (OECD 471): negative with and without metabolic activation in S. typhimurium TA 98, TA 100, TA 102, TA 1535, TA 1537 and TA 1538
Chromosome aberration (OECD 473): negative in Chinese hamster lung fibroblasts (V79) cells with and without metabolic activation
Gene mutation (OECD 476): negative in L5178Y mouse lymphoma cells with and without metabolic activation

The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.

For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.

For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.

Genetic toxicity

Genetic toxicity in bacteria (Ames)

CAS 91031-31-1

The gene mutation properties of Fatty acids, C16-18, esters with ethylene glycol were determined according to OECD guideline 471 under GLP conditions (Henkel, 1991). The tester strains Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537 and TA 1538 were used. The main study was performed in triplicates each in two independent experiments according to the plate incorporation procedure at concentrations from 8 to 5000 µg/plate (vehicle: Tween 80; 1:1 (w/w) dilution with water) with and without a metabolic activation system (Aroclor 1254-induced rat liver S9-mix). No increase in the number of revertant colonies was noted in any of the bacterial strains, with and without metabolic activation system. No cytotoxicity was observed up to the highest dose tested. Precipitation was noted at the highest test concentration of 5000 µg/plate. The positive and negative controls showed the expected results and were therefore considered as valid. Under the conditions of this study, the test substance did not induce mutations in the bacterial mutation tests in the absence and presence of a metabolic activation system in any of the strains tested.

 

 

CAS 1323-39-3/29013-28-3

The in-vitro genetic toxicity of Octadecanoic acid, monoester with 1,2-propanediol (CAS 1323-39-3) and Palmitic acid, monoester with propane-1,2-diol (CAS 29013-28-3) was assessed in a bacterial reverse mutation assay (Ames test) according to GLP criteria and OECD 471 (LPT, 2015). The mutagenic potential of the test substance was assessed in S. typhimurium tester strains TA 98, 100, 102, 1535 and 1537 at concentrations up to 5000 µg/plate in 2 independent experiments, including the plate incorporation and preincubation method. Precipitates were visible at the highest dose tested. The test substance did not induce an increase in reversions in any of the S. typhimurium strains with or without metabolic activation. Cytotoxicity was observed at 5000 µg/plate in TA 1537 (plate incorporation test), TA 98 and TA 1535 (preincubation test) with and without metabolic activation and in TA 1537 with metabolic activation (preincubation test). The vehicle and positive controls were valid and lay within the range of historical control data.

 

 

Genetic toxicity (cytogenicity) in mammalian cells in-vitro

CAS 853947-59-8

An in vitro mammalian chromosome aberration test was conducted with C8-C10-1,3-Butandiolester in accordance with OECD guideline 473 under GLP conditions (Hüls AG, 1997). The induction of structural chromosome aberrations was evaluated in vitro in Chinese hamster lung fibroblasts (V79) cells, incubated for 18 and 28 h with and without a metabolic activation system (S9-mix from rats treated with Aroclor 1245). Concentrations of 10-100 µg/mL (18 h incubation) and 80 and 100 µg/mL (28 h incubation) of the test substance in the vehicle ethanol were applied. The solubility limit of the test substance in the vehicle ethanol in the culture medium was determined to be 100 µg/mL. In the first experiment without metabolic activation, the negative controls exhibited a mitotic index of 2.0% only and the experiment was therefore repeated. Thereafter, the negative as well as the positive controls showed the expected results and were within the range of historical control data. The frequency of polyploidy cells with and without metabolic activation was within the expected range (< 10%). In the experiments both with and without metabolic activation, a systematic influence of the test substance was observed, which led to a reduction in the mitotic index. No statistically or biologically significant increase in the incidence of chromosome aberrations was observed.

Therefore, under the conditions of the study, C8-C10-1,3-Butandiolester did not show clastogenic activity in this chromosomal aberration test with and without metabolic activation performed in Chinese hamster lung fibroblasts in vitro.

 

Genetic toxicity (mutagenicity) in mammalian cells in-vitro

CAS 91031-31-1

Mutagenic properties of Fatty acids, C16-18, esters with ethylene glycol were characterized in an in vitro mammalian cell gene mutation study according to OECD guideline 476 under GLP conditions (NOTOX B.V., 2010). Gene mutations in the thymidine kinase locus were investigated in L5178Y mouse lymphoma cells in the presence and absence of a metabolic activation system (Phenobarbital/β-naphtoflavone-induced rat liver S9). In the first experiment, cells were exposed for 3 h to test substance at concentrations of 0.1-333 µg/mL (in DMSO) with and without metabolic activation. Concentrations of the second experiment without metabolic activation for an exposure time of 24 h ranged from 3-175 µg/mL and with metabolic activation (3 h; 12% S9-mix) from 0.1-333 µg/mL. The vehicle and positive controls in the study showed the expected results and were within the range of historical control data. No cytotoxicity was observed up to the precipitating concentration of 100 µg/mL and up to 333 µg/mL, respectively. There was no significant increase in the number of forward mutations at the thymidine kinase locus of L5178Y mouse lymphoma cells treated with the test material, neither in the presence nor in the absence of a metabolic activation system. Under the conditions of the study, Fatty acids, C16-18, esters with ethylene glycol did not show gene mutation activity in this test performed in L5178Y mouse lymphoma cells in vitro.

 

Conclusion on genetic toxicity

The available data do not provide evidence that the source substances exhibit mutagenic or clastogenic properties in bacteria or mammalian cells. Therefore, no properties for genetic toxicity are expected for Fatty acids, C16-18, esters with diethylene glycol (85116-97-8).

Justification for classification or non-classification

Based on the analogue read-across approach, the available data on genetic toxicity do not meet the classification criteria according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification.