Butanedioic acid, sulfo-, monoesters with lanolin alcs., disodium salts

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Not mutagenic

Not clastogenic

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Sulfosuccinate of Lanoline Alcohol is chemically a complex substance, genetic toxicity in vitro studies available were performed on Lanolin Alcohol portion.

In the Bacterial Reverse Mutation Test on Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and Escherichia coli, no significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material (max 5000 µg/plate) with or without metabolic activation. The substance Lanoline Alcohol is not considered mutagenic.

In a study on structural chromosomal aberrations in cultured mammalian cells the test material was non-toxic in the 4 hours exposure in the presence and absence of metabolic activation (S9) with a 20-hour expression period. However, the test material was toxic in the 24 hours continuous exposure (in the absence of metabolic activation) at 625 µg/ml.

The test material based on Lanoline Alcohol did not induce any toxicologically statistically significant increases in the frequency of cells with aberrations so it was, therefore, considered to be non-clastogenic to human lymphocytes in vitro.

AL5178Y mouse lymphoma cell line study was performed with and without metabolic activation for different duration (4 and 24 hours) and doses in the range between 18.75 and 600 µg/ml.

The test material based on lanoline alcohol did not induce any toxicologically significant or dose-related increases in the mutant frequency at any dose level, either with or without metabolic activation, in any of the exposure groups.

The test material was considered to be non-mutagenic to L5178Y cells under the conditions of the test.

For the Sulfosuccinate portion no genetic toxicity studies are available, however the evidence of non-carcinogenicity property was assessed and reported in section 7.7.

Justification for selection of genetic toxicity endpoint

Sulfosuccinate of Lanoline Alcohol is chemically a complex substance. Several genetic studies on Lanoline Alcohol (AMES, Chromosome Aberration and Mouse lymphoma assay) indicated no genetic toxicity for this portion of the molecule. Furthermore, for the Sulfosuccinic part no genetic toxicity studies are available, however the evidence of non-carcinogenicity property was assessed in rats (section 7.7).

Justification for classification or non-classification

The substance Sulfosuccinate of Lanolin Alcohol is not classified genetic mutagen because it doesn't meet the classification criteria of the CLP regulation n. 1272/2008:

- Category 1 (1A; 1B): substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans. Substances known to induce heritable mutations in the germ cells of humans;

- Category 2: substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans.

Lanoline Alcohol is not a genetic toxicant. For the Sulfosuccinic part no genetic toxicity studies are available, however the evidence of non-carcinogenicity property was assessed in rats (section 7.7).