Registration Dossier
Registration Dossier
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EC number: 419-210-2 | CAS number: 178452-71-6 OLIVE-GREEN JB 1170
Endpoint summary
Administrative data
Description of key information
not skin sensitizer
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In order to assess the cutaneous allergenic potential of test substance, the Maximization-Test was performed in 30 (10 control and 20 test) female albino guinea pigs, in accordance with OECD Guideline No. 406 (1992) and the method B.6 of EEC-Directive 96/54 EEC. Three pre-tests were performed in order to identify the maximally tolerated concentration of the test substance suitable for the induction phase and the suitable non-irritant concentration of the test substance for the challenge application in the main study. For intradermal and epidermal induction, the test item concentrations selected were 5 % in water and 25 % in vaselium album respectively. The highest non-irritating test item concentration used for challenge application was 3% in vaselinum album.
No toxic symptoms were evident in the guinea pigs of the control or test group and no deaths occurred. None of the animals of the test and control groups were observed with positive skin reactions after treatment with the selected non-irritant test substance concentration of the challenge, at both readings (24 and 48 hours).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In the CLP Regulation (EC 1272/2008) a skin sensitizer is defined as “a substance that will lead to an allergic response following skin contact”. A substance classified as skin sensitiser (Category 1) may be allocated to one of the two sub-categories 1A or 1B in accordance with the criteria given in Annex I, Part 3, Table 3.4.2.. If classification is based on results obtained from studies conducted in experimental animals, the test results from the LLNA, GPMT and the Buehler assay can be used directly for classification. Guidance values are presented in the CLP Regulation (EC 1272/2008) in Annex I, Part 3, Table 3.4.3 for classification in sub-category 1A and in Annex I, Part 3, Table 3.4.4 for classification in sub-category 1B.
Based on the results from the GPMT performed, the substance induces no reactions after the intradermal induction dose of 5 % and the challenge epidermal application dose of 3 % in vaselinum album. This result does not meet the classification criterion for Skin sens. Cat. 1B “≥ 30 % responding at > 1 % intradermal induction dose”.
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