Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 483-980-6 | CAS number: -
Endpoint summary
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
