Propanoic acid, 2-hydroxy-, C12-13-branched alkyl esters

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Skin sensitisation

The skin sensitisation potential of Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters was investigated in a GLP-conform Guinea Pig Maximisation Test (GPMT) performed similar to OECD guideline 406 (Biffi, 1993). Ten female Hartley guinea pigs were induced by intradermal injections of the test material diluted in water (1:1), the test material in Freund’s adjuvant (50% v/v) (1:1) and Freund’s adjuvant alone. In a similar manner, a control group, consisting of 20 females was injected with vehicle only (water) and/or FCA. On Day 8 of the study, a 48-hour epicutaneous induction treatment with the undiluted test substance or vehicle only was performed in the treated or control animals on the regions of intradermal injections. On Day 22, the challenge treatment was performed by topical application of the undiluted test substance (right flank) and the vehicle (left flank) to all animals for 24 h. Skin reactions were evaluated 24, 48 and 72 h after patch removal (i.e. 48, 72 and 96 h after challenge application). All animals in the treatment and the control group had scattered mild redness (skin irritation score 1 of 3) at the 24 -, 48- and 72 hour reading time points after the challenge treatment. Since positive reactions were also seen in all animals of the control group, it was concluded that skin reactions were not attributable to a specific immune reaction. The erythema observed is considered an irritant effect, and not a sensitising effect. No signs of systemic toxicity were observed in any of the treated animals. The reliability of the test system was verified independently in regular periods using mercaptobenzothiazole, which induced a clear positive result under the experimental conditions used. Based on these results, the test substance was considered to be not sensitising in guinea pigs.

 

Conclusions for skin sensitisation

A Guinea Pig Maximisation Test is available, demonstrating that Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters is not sensitising to skin.

Migrated from Short description of key information:
Skin sensitisation (OECD 406): not sensitising

Justification for selection of skin sensitisation endpoint:
There is only one study available.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The available data on skin sensitisation of Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.