Registration Dossier
Registration Dossier
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EC number: 286-386-3 | CAS number: 85223-31-0
Endpoint summary
Administrative data
Description of key information
Not skin sensitizing
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The following data were obtained for the Similar Substance 01. It is expected that the Target substance will present similar skin sensitisation potential. Justification for the use of a read-across approach is provided in Section 13 of IUCLID.
The Similar Substance 01 was tested for skin sensitisation potential, performing a Guinea Pig Maximisation test, according to the OECD Guideline 406. Twenty females were initially exposed to the test substance by intradermal injection (5 % in vaselinum album) and epidermal application (25 % in vaselinum album) (induction exposure). Following a period of 14 days (induction period), the animals were exposed to a challenge dose (25 %). A second challenge was performed two weeks after the first challenge; the animals were treated with an additional concentration of 10 % in vaselinum album. At the first challenge and second challenge exposure three out of twenty animals (15 %) of the test group presented positive erythema reactions after the 24 - hour reading, that were not present after 48 hours, when treated with a 25 % test article dilution. Two out of 20 animals (10 %) after the second challenge showed positive erythema reaction after the 24- and 48- hour reading when treated with a 10 % test article dilution. The test group presented a skin sensitisation rate of 10 -15 % in comparison with the control group that presented 0 % of rate. Based on the results obtained, a mild allergenic potency of the test article was concluded.
However, the substance does not meet the criteria to be classified as skin sensitising, according to the CLP Regulation (EC) No 1272/2008.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the CLP Regulation (EC) No 1272/2008, 3.4 Respiratory or skin sensitisation section, skin sensitizer means a substance that will lead to an allergic response following skin contact.
In case of Guinea Pig Maximization Test, a substance can be considered as a skin sensitizer if at least 30 % of the animals respond to an intradermal induction higher than 1 %.
Based on the study outcomes, at the first challenge and second challenge exposure, 15 % of test item treaded group presented positive erythema reactions after the 24-hour reading (which were not present after 48 hours), after induction at doses higher than 1 %.
In conclusion, the substance does not meet the criteria to be classified as skin sensitizer, according to the CLP Regulation (EC) No 1272/2008.
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