Fatty acids, C16-18 and C18-unsatd., branched and linear, reaction products with diethanolamine

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

In a GLP, guideline compliant study Isostearamide DEA was tested for dermal sensitization potential utilizing a Buehler Technique Guinea Pig Sensitization Protocol. The test substance was evaluated for sensitization potential by applying 0.4 ml at a 50% concentration in mineral oil directly into Hilltop Chambers® and applying them to the clipped left shoulder of twenty albino guinea pigs on 3 occasions at weekly intervals. Two weeks after the final application the animals received a topical primary challenge dose (6 hour contact) of Isostearamide DEA at 25% concentration in mineral oil on a naive site located on the right shoulder. Animals were scored for irritation at 24 and 48 hours after initiation of the primary challenge application. Ten guinea pigs served as a naive control group, and remained untreated through the induction phase. Five naive control animals received only the primary challenge dose, at a 25% concentration. The five remaining guinea pigs were designated for a re-challenge, if necessary.

Following primary challenge of Isostearamide DEA at 25% concentration, the incidence of grade 1 response or greater in the test group (0 of 20) was compared to that of the naive control group (0 of 5). The incidence and severity of these responses were not significantly greater than those produced by the naive control group indicating that sensitization had not been induced.

Conclusion for skin sensitisation

It may therefore be concluded that Isostearamide DEA is not a skin sensitiser based on the results from a GLP, guideline compliant in-vivo study in guinea pigs.

Justification for selection of skin sensitisation endpoint:
Key study