Registration Dossier

Administrative data

Description of key information

As a weight of evidence approach, three in vitro assays were carried out, namely DPRA, LuSens and h-CLAT for Ethyl caproate (Ethyl hexanoate) as a Read -across substance.

The DPRA study was negative as the test substance showed no chemical reactivity under the current conditions. The LuSens assay showed a negative result regarding sensitization as the test substance did not have a keratinocyte activation potential. The h-CLAT assay was positive regarding sensitization as the substance activated dendritic cells.

Based on a weight of evidence approach according to Bauch et al 2012 two negative results drive the prediction of a test substance to be a non-sensitizer.

Bauch C. et al, (2012), Regul Toxicol Pharmacol, 63(3), 489 -504

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available in vitro result for the read-across substance ethyl caproate, the substance is not classified as sensitising according to Regulation (EC) No 1272/2008.