Registration Dossier
Registration Dossier
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EC number: 423-460-8 | CAS number: 3508-98-3 SALICYNALVA
Endpoint summary
Administrative data
Description of key information
Skin sensitisation: no skin sensitiser based on testing in OECD TG 406
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Guinea Pig Maximization Test
A GPMT was performed to assess the skin sensitisation potential of Salicynalva according to EU Method B.6 and OECD TG 406. Based on the results of a preliminary study and in compliance with the guidelines, the following dose levels were selected: In the preliminary study irritation and necrosis was seen with increasing doses using intradermal injection using 0.1-100% of the test substance in Alembicol D. Therefore in the main study a 40% induction concentration for intradermal application was considered justified showing a score 2 reaction in the preliminary study. In the preliminary study no skin irritation effects were seen up to 100% of the test substance. Therefore in the main study 100% induction concentration for topical application was considered justified and 100 and 50% v/v in Alembicol D for the challenge application. Ten test and five control guinea-pigs were used in this study. In this study Salicynalva did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the ten test animals.HPRT
An available HRIPT test using 4% Salicynalva and 56 subjects did not show any effects. This information was not summarised because it limitedly adds to the negative result of the GPMT test.
Justification for classification or non-classification
The substance does not have to be classified for Skin sensitisation according to EU CLP (EC No. 1272/2008 and its amendments).
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