Acetic acid, C8-10-branched alkyl esters, C9-rich

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The study was performed according to a method equivalent to guideline OECD TG 406 and EU Method B.6 and consistent with Magnusson-Kligman Guinea Pig Maximisation test to assess the skin sensitisation potential of the test substance. Test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, after induction (intradermic injection at 20% and topical application at 100%) and a ten day rest phase of ten experimental animals were challenged with 20% test item in liquid paraffin along with parallel control challenged at 20% in liquid paraffin in five animals. The treated group (treatment dose of 20%), indicated a discrete erythema was noted in 10% (1/10) of the treated animals at the reading time 24 hours. No cutaneous reaction attributable to allergy was recorded at the reading time 48 hours. In the control group (associated with the treatment dose of 20%), no cutaneous intolerance reaction was recorded at 24 and 48 hours. No cutaneous reaction was recorded in animals from the treated and control groups after the challenge phase, on the treated area with liquid paraffin (control item). Under the conditions of this study, the test substance is not considered to be a contact skin sensitizer.

Migrated from Short description of key information:
non-sensitising, Guinea Pig (female), OECD TG 406, Phycher Bio Developpement 2016

Justification for selection of skin sensitisation endpoint:
one in vivo study Klimisch 1 and following Magnusson-Kligman GPMT Method methodology.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The applicant conducted appropriate in silico assessment using appropriate computational models prior to testing and there was an absence of known skin sensitisation protein binding alerts on associated constituents. Appropriate in chemico or in vitro methods were not available due to limited test assay domains of respective methods when applied to the substance.

 

In the GPMT test the severity of effects were limited to score = 1 at 24 hours in one out of ten organisms in all organisms when topically challenged at the maximum non-irritating concentration 20%v/v (liquid paraffin) following intradermal induction at 20%v/v (olive oil) with topical booster at 100%. The test was consistent with established adjuvant-test methodology. Under EU criteria there was only very limited effects observed in the in vivo GPMT study on exposure to the substance at > 1% v/v intradermal induction dose inadequate for classification. The substance cannot be considered a skin sensitiser as there is no evidence of significant effects in available animal studies and no history of the test item yielding positive responses in humans.

 

The overall weight of evidence is indicative of the substance not meeting the relevant classification criteria.

 

References:

1. ECHA Guidance on Application on the CLP Criteria, section 3.4.2.2 (v4.1), June 2015