Registration Dossier
Registration Dossier
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EC number: 442-300-8 | CAS number: -
Endpoint summary
Administrative data
Description of key information
The test item has a skin sensitizing potential as shown in animal studies.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
A guinea pig maximization study according to OECD guideline 406 was performed to evaluate the sensitization potential of the test substance. The test was conducted with 30 female Dunkin-Hartley guinea pigs (20 animals as test group, and 10 animals as control group). During the induction procedure the test group was exposed to 1% test substance via intradermal injections and 100% test substance via topical application. The control group was exposed to vehicle only during this procedure. All animals were challenged with 25% and 50% test item and vehicle, respectively. When challenged with 50% test substance, 9/10 (90%) positive responses were noted in the test groups after 24 h and 10/10 (100%) positive response after 48 hours. Following treatment with 25% test substance, 9/10 animals showed erythema reactions at both 24 and 48 hour time points. Control animals did not show any reactions. In conclusion, the test material produced a 100% (10/10) sensitization rate and was classified as an strong sensitizer to guinea pig skin under the conditions of this study.
In a supporting study performed similarly to OECD Guideline 406, test animals were induced intradermally (5 %) and epicutaneously (100%) with the test article. Epidermal challenge of 5 male and 5 female guinea pigs (test groups) with 50% test material in vaseline resulted in positive responses in 5 guinea pigs (2 males and 3 females) after 24 hours and in 2 guinea pigs (1 male and 1 female) after 48 hours, corresponding to a sensitization rate of 50%. The test material was graded as a moderate sensitizer according to the Magnusson and Kligman maximization scale. Overall, based on the results of the presented studies, the test article is considered as a strong sensitizer and requires classification.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. The epicutaneous
sensitisation study indicates a potential for skin sensitisation.
As a result the substance is considered to be classified as skin
sensitizer category 1A (H317: "May cause an allergic skin reaction")
under Regulation (EC) No 1272/2008, as amended for the eighth time in
Regulation (EU) No 2016/218.
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