Fatty acids, C18-unsatd., reaction products with diethylenetriamine, acetates

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

The aim of the study was to evaluate the possible cutaneous allergenic activity of the test item after intradermal and topical administration in guinea pigs. The experimental protocol was established according the OECD guideline No. 406 dated July 17th, 1992 and the test method B.6 of the council regulation No. 440/2008.

Induction of 10 Guinea Pigs in the treated group with the test item Fatty acids, C18 unsaturated, reaction products with diethylenetriamine, acetate salts was by intradermal injections with 0.001% test item in isotonic sodium chloride and in an emulsion of Freund's Complete followed one week later by topical application at 25% test item in distilled water. A negative control group (5 guinea pigs) received intradermal injections of isotonic sodium chloride and an emulsion of Freund’s Complete Adjuvant at 50% / isotonic sodium chloride Freund's Complete followed one week later by topical application of distilled water. After a 10-day rest phase, the treated group and negative control group were challenged with a single topical application of the test item diluted at 2% and 1% in distilled water under an occlusive dressing for 24 hours.

Slight to moderate erythema was observed on the area treated with the test item at 2% in 80% (8/10), in 70% (7/10) and in 60% (6/10) of Group 2 (treated) animals at 24, 48 and 72 hours after the challenge phase respectively. Slight oedema was observed on the area treated with the test item at 2% in 30% (3/10) of Group 2 (treated) animals at 24 hours after the challenge phase.

No cutaneous intolerance reaction was observed on the area treated with the test item at 2% in animals from Group 1 (negative control) after the challenge phase.

Slight erythema was observed on the area treated with the test item at 1% in 20% (2/10) of Group 2 (treated) animals at 24 and 48 hours after the challenge phase. No cutaneous reactions were noted 72 hours after the challenge phase.

No cutaneous intolerance reaction was observed on the area treated with the test item at 1% in animals from Group 1 (negative control) after the challenge phase.

In conclusion, based on these results, under these experimental conditions, the test item must be classified as a skin sensitiser.

Migrated from Short description of key information:
In view of the results of a OECD No,406 study, under the experimental conditions, the test item Fatty acids, C18 unsaturated, reaction products with diethylenetriamine, acetate salts, is a skin sensitiser.

Respiratory sensitisation

Endpoint conclusion

Additional information:

No data available. As the substance is classified as a skin sensitiser, it should be considered to be a potential respiratory sensitisatiser. However, significant inhalation is not anticipated based on the predicted vapour pressure of the substance constituents (ranging from 1.23 x 10^-25 Pa to 4.0 x 10^-16 Pa at 25°C), high boiling point (estimated >300°C) and high viscosity of the substance.

Justification for classification or non-classification

Skin sensitisation:

In conclusion, based on these results, under these experimental conditions, the test item Fatty acids, C18 unsaturated, reaction products with diethylenetriamine, acetate salts must be classified R43 “May cause sensitisation by skin contact”, in accordance with the criteria for classification, packaging and labelling of dangerous substances and preparations of the E.E.C. Directives 67/548,

2001/59 and 99/45. This item must be characterised by the symbol “Xi” and the warning label “Irritant”.

In accordance with the Regulation (EC) No. 1272/2008, the test item must be classified in category 1 (Sub-category 1A). The signal word “Warning” and hazard statement H317 “May cause an allergic skin reaction” are required.