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 Local Lymph Node Assay was performed to evaluate a possible skin sensitising potential of "VEGEFLUX SOY" according to the OECD-Guideline 429 and GLP.

The test substance was administrated epicutaneously on three consecutive days to three groups of 5 mices at the concentration of 10, 25 and 50% in acetone:olive oil (AOO). Two groups with 5 animals each served as positive and negative controls.

5 days after the first topical application, 3H-methyl thymidine was intravenously administered to all mice via a tail vein. Approximately 5 hours later all animals were sacrificed, the draining auricular lymph nodes were excised, pooled for each group, and single cell suspensions were prepared. The desintegration per minut (dpm) and the stimulation index (SI) were measured and compared with the negative control.

No adverse effect was observed, except a slight erythema in all animals of the high dose group and the positive control.

The SIs of the tested test substance concentrations were 1.0 (low dose), 1.0 (mid dose) and 2.5 (high dose).

The positive control substance led to a stimulation index of 7.2, thus demonstrating the validity of the experiment.

According to this test, Vegeflux soy is regarded as a non sensitiser in the LLNA assay and needs not to be labelled with "R43 May cause sensitisation by skin contact".


Migrated from Short description of key information:
Vegeflux soy was tested for skin sensitisation according to OECD testing guideline 429 and GLP. According to this test, Vegeflux soy is regarded as a non sensitiser in the LLNA assay.

Justification for classification or non-classification

Based on the classification criteria of Annex VI Directive 67/548/EEC or UN/EU GHS, and given the absence of reactions in a LLNA assay, Vegeflux Soy is not classified as a skin sensitizer.