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Additional information

In vitro genotoxicity:

In an Ames test, Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100 were treated with the test substance, Fatty acids, C16-18, esters with pentaerythritol (CAS No. 85116-93-4) diluted in Tween 80 according to OECD Guideline 471 (Key, Cognis, Banduhn, 1991, Ames, RL2).Test substance concentrations of 0, 8, 40, 200, 1000 and 5000 µg/plate were tested in triplicate, both with and without the addition of a rat liver homogenate metabolising system (S9). Precipitation of the test substance was observed at and above 1000 µg/plate. The test material caused no cytotoxicity up to the highest, precipitating dose. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation.

No other studies on the genotoxicity of the test substance were available; therefore data of a study from structural analogues, conducted according to OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test), and OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test) were used for read-across.

 

An in vitro mammalian chromosome aberration test was performed with CAS No. 131459-39-7 (3,5,5-trimethylhexanoic acid mixed tetraesters with PE and valeric acid) in human lymphocytes (RA-S, CAS 131459-39-7, Key, Croda, Wright, 1999, ChrAb, human, RL1).The occurrence of chromosome aberrations was investigated in the presence and absence of metabolic activation (rat liver S9-mix) with test substance concentrations of 0, 312.5, 625, 1250, 2500, 5000 µg/mL diluted with acetone. The test substance did not induce a significant increase in the number of metaphases with aberrations at any preparation time and dose level. No relevant cytotoxic effects were reported. Precipitation of the test substance was observed at and above 1250 µg/ml. Positive controls significantly increased the rate of chromosome aberrations indicating the sensitivity of the assay. In conclusion, the test substance did not induce chromosome aberrations in human lymphocytes, neither in the presence nor in the absence of a metabolic activation system, under these experimental conditions.

An in vitro Mammalian Cell Gene Mutation Test was conducted with CAS No. 85186-89-6 (Fatty acids, C8-18 and C18-unsatd., esters with trimethylolpropane) according to OECD Guideline 476. Mouse lymphoma L5178Y cells were dosed with 0.3, 1, 3, 10, 33, 100, 333 and 750 µg/ml with and without metabolic activation. No signs of toxicity were observed, DMSO was used as vehicle, precipitation was observed at and above 100 µg/ml. 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, indicated by the total number of colonies per plate (RA-S, CAS 85186-89-6, Key, Croda, Verspeek-Rip, 2010, gene mut in mamm cells, RL1).

 

In vivo genotoxicity:

No in vivo studies on the genotoxicity of the test substance were available.Fatty acids, C5-10, esters with pentaerythritol (CAS No. 68424-31-7) were found to be not genotoxic in the micronucleus assay in vivo after intraperitoneal application.The maximum tolerated dose (MTD), 5000 mg/kg (obtained by a pretest with a single intraperitoneal injection without severe reactions of the animals) was applied. No increase in the incidence of micro-nucleated polychromatic erythrocytes in any sex or at any time point in mice treated with 5000 mg/kg bw of the test substance, except for a small but significant decrease of polychromatic erythrocytes in male mice at 5000 mg/kg bw. Therefore no clastogenic potential could be detected in this test (RA-S, CAS 68424-31-7, Key, Croda, Griffiths, 1992, CTL/P/3792, Micronuc.).

Considering the clearly negative results of the available in vitro study together with the negative in vitro and in vivo experiments used as read-across and the proven physiological metabolism of fatty acids and excretion of polyols, it can be assumed that fatty acids, C16-18, esters with pentaerythritol (CAS No. 85116-93-4) are not genotoxic, neither in vitro nor in vivo.


Short description of key information:
Key, Cognis, Banduhn, 1991, Ames, RL2 - not mutagenic
RA-S, CAS 131459-39-7, Key, Croda, Wright, 1999, ChrAb, human, RL1 - not clastogenic
RA-S, CAS 85186-89-6, Key, Croda, Verspeek-Rip, 2010, gene mut in mamm cells, RL1 - not mutagenic
RA-S, CAS 68424-31-7, Key, Croda, Griffiths, 1992, CTL/P/3792, Micronuc., RL1 - not genotoxic

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

According to the DSD and CLP criteria for classification and labelling of dangerous substances the CAS No. 85116-93-4 (Fatty acids, C16-18, esters with pentaerythritol) is not classified as mutagenic.