Fatty acids, sunflower-oil, conjugated, maleated,reation products with diethanolamine, maleated tall-oil fatty acids and triethanolamine

Endpoint summary

Description of key information

DPRA: positive

LuSens: negative

h-Clat: positive

Overall evaluation: skin sensitizer

(BASF 2017)

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

To assess the skin sensitzing potential in vitro, three different non-animal methods have been applied, that address different key events of the skin sensitization Adverse Outcome Pathway. These resulted in two positive results in the DPRA and h-CLAT and in one negative result in the LuSens. The three tests generally used in the “2 out of 3” ITS assess protein binding in chemico (DPRA), triggering an antioxidant response in keratinocytes (LuSens) and activation of dendritic cells (h-CLAT). Of note, the molecular initiating event of protein binding also occurs in the cell-based assays (LuSens, h-CLAT) and is not solely detected via the DPRA. The common outcome of the approach is a consistent prediction in all contributing assays. Cases, where one assay gives a different prediction than the other two are not in conflict with the Adverse Outcome Pathway but reflect known limitations of in-vitro/in-chemico systems. Indeed, judging a test substance as a sensitizer based on only one positive test results in poor predictivity (Urbisch et al., 2015).

Based on these evaluation criteria and the two positive results obtained in 2 out of 3 assays, Fatty acids, sunflower-oil, conjugated, maleated, reaction products with diethanolamine, maleated tall-oil fatty acids and triethanolamine is expected to possess skin sensitizing properties.

The test battery evaluation was performed based on the following publications:

▪ Bauch C, Kolle SN, Ramirez T, Eltze T, Fabian E, Mehling A, Teubner W, van Ravenzwaay B, Landsiedel R. (2012) Putting the parts together: Combining in vitro methods to test for skin sensitizing potentials, Regul Toxicol Pharmacol, 63(3):489-504.

▪ Urbisch D, Mehling A, Guth K, Ramirez T, Honarvar N, Kolle SN, Landsiedel R, Jaworska J, Kern P, Gerberick F, Natsch A, Emter R, Ashikaga T, Miyazawa M, Sakaguchi H. (2015) Assessing skin sensitization hazard in mice and men using non-animal test methods. Regulatory Toxicology and Pharmacology 71(2), 337-351.

Justification for classification or non-classification

Based on the two postitive results obtained in the DPRA and h-Clat assay, the registered substance is expected to be a skin sensitizer. Since in vitro studies are insuffiecent to assess potency, no subcategory can be assigned, and the substance will be labelled as skin sensitizer cat. 1 according to EU GHS, Regulation (EC) 1272/2008.