Pentaerythritol, reaction product with fatty acids, C8 to 18 (even numbered) and/or branched and/or unsaturated

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

LLNA study:

In a mouse lymph node assay, performed according to OECD, EC and EPA test guidelines, mouse were treated with 0%, 25%, 50%, or 100% of Radialube 7819 on three consecutive days by open application on the ears. Three days after the last exposure all animals were injected with 3H-methyl thymidine. Radioactivity measurements of the lymph nodes were performed. Slight erythema was observed in one or both ears of animals at 25% and in both ears of animals at 50 and 100%. No oedema was observed in any of the animals examined. The irritation of the ears as shown by the animals, was considered not to have a toxicologically significant effect on the activity of the nodes. All nodes of the experimental and control groups were considered normal in size and no macroscopic abnormalities of the surrounding area were noted. The SI values calculated for the substance concentrations 25, 50 and 100% were 1.1, 1.6 and 3.3 respectively. These results indicate that the test substance could elicit an SI >= 3. The data showed a dose-response and an EC3 value of 91.2% was calculated. Based on these results the substance is a skin sensitiser.

Company health records:

For Radialube 7819 a medical record on skin sensitisation is provided by the manufacturing company. From this it is clear that operators and lab technicians might be exposed during sampling and analysis of these samples, although operators have RMMs such as gloves and overall in place. Sixty two sampling times over a period of 7 years are recorded, showing that mainly the same operators and technicians have dealt with this work, so if exposure might have taken place, this did not result in skin sensitisation.

Discussion:

In a human patch test with the read-across substance Radiagreen RA, no or only a minimal risk of skin sensitization is present when this substance is coming into contact with human skin. Radiagreen RA is a reaction product of fatty acids (C8-C10) and triglycerol, while Radialube 7819 is a reaction product of also these fatty acids (C8-C10) but in addition several more substances (fatty acids C14-18 and C16-18 unsatd, 2-ethylhexanoic acid and pentaerythritol). All the starting products of Radialube 7819 are currently not classified for sensitization according to GHS. In addition, a literature search shows that decanoic acid, octanoic acid do not show sensitising properties in human patch tests and in other tests with humans (see Toxnet, mainly HSDB and IUCLID data sheets). Also pentaerythritol is considered not sensitizing (Toxnet, HSDB). Several publications have shown that for some type of substances LLNA studies gave positive results while GPMT studies gave negative results. The publications of e.g. Kreiling et al. (Food Chem Tox, 46, p. 1896 -1904, 2008) and Garcia et al. (Reg Tox Pharm, 58, p. 301 -7, 2010) describe the results of LLNA and GPMT testing for several (unsaturated) fatty acids having a chain length from C4 to (>)C18. For most substances the LLNA gave positive results (12 out of 19), while the GPMT did give only one positive result (1 out of 19). As these test substances were either endogenous physiological constituents, common and widely used natural constituents of food and/or cosmetics, or nonionic sugar lipid surfactants, the high number of positives in the LLNA test was unexpected. Radialube 7819 does contain (unsaturated) fatty acids C8-C18 as starting products.

For a NICNAS notification in Australia for the read-across substance Radiagreen RA further data was required, as the available information was not considered sufficient to reverse the classification that was based on the LLNA study. The GPMT skin sensitisation study with the read-across substance Radiagreen RA was performed according to OECD Guideline 406 and GLP principles. The results of both sets of animals indicate a sensitization rate of 25 per cent. Based on the results Radiagreen RA does not have to be classified.

Taking all this information into account, it is concluded that Radialube 7819 is not expected to have sensitising properties and thus does not have to be classified accordingly.

Migrated from Short description of key information:
The skin sensitisation study was performed according to OECD Guideline 429 and GLP principles. In addition, company data and read across data is available. In addition, a human patch test was performed with the read-across substance Radiagreen RA with healthy volunteers according to GCP principles, company data and publicly available data are present. For a NICNAS notification in Australia for the read-across substance Radiagreen RA further data was required, as the available information (see below) was not considered sufficient to reverse the classification that was based on the LLNA study. The GPMT skin sensitisation study with the read-across substance Radiagreen RA was performed according to OECD Guideline 406 and GLP principles. Based on all this information, it is concluded that Radialube 7819 is not sensitising to humans.

Justification for classification or non-classification

Based on all information available, the substance is not classified as skin sensitizer according to CLP Regulation (EC) No. 1272/2008.