Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

The key study, LLNA in mice, was conducted on the structural analogue, Hypo-Lem.

The positive control, 35% (v/v) HCA, resulted in a stimulation index (SI) of 7.28. A 3-fold or greater increase in proliferative activity relative to the concurrent vehicle treated control is considered a positive response. In addition, the response with the positive control in this study was also statistically significant (p<0.001) when compared to the vehicle control group.

Exposure to 04-230 (10) at 7.5, 15 and 30% (w/v) resulted in stimulation indices of 1.35, 2.39 and 1.22 respectively. There were no statistically significant differences found at 7.5, 15 or 30% when the mean DPM for each treatment group was compared to the vehicle control group.

The structural analogue was therefore not considered to be a skin sensitiser.

The Target Substance and Source Substance have been characterised in using the categories and databases present in the OECD [Q]SAR Toolbox. From the profiling, it can be seen that the two substances share structural similarities and also ‘mechanistic action’ similarities which are both general and endpoint specific. Therefore read across is justified and the substance, Lemonile is considered not to be a skin sensitiser.

In two supporting studies on the substance itself, Lemonile, no adverse reactions were noted up to 2%w/w solution in contact with human skin.. The substance is considered to be non-senstising to human skin.

Migrated from Short description of key information:
LLNA (OECD 429) on structural analogue: Stimulation index<3.
Human Repeat Patch Test on Lemonile (2%): No positive reactions or adverse effects.
Guinea pig maximisation test on Lemonile (photoallergenicity): No reaction up to concentrations of 10%w/w at induction or challenge.

Justification for classification or non-classification