Registration Dossier
Registration Dossier
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EC number: 811-773-6 | CAS number: 1713250-52-2
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:
To assess the allergenic potential of the test substance (91% act. ingr.) in albino guinea pigs the Maximization test of Magnusson and Kligman was used. A pretest was performed to identify irritant test article concentrations suitable for the induction phase of the main study.In addition, a suitable non-irritant concentration of the test article, by the tropical route of administration, was identified for the challenge application. For the main study ten females were used as control group and 20 females were used as test group. The test group were treated with the following concentrations of the test item:
induction treatment: 5% given intradermal on day 0 and 25% given epidermal on day 8
challenge treatment: 25% two weeks after epidermal induction application.
No skin reactions (erythema or oedema) were observed neither after 24 hours nor after 48 hours.
Formaldehyde was used as positive control which showed 80% positive results in the treated animals after the epidermal challenge application.
Migrated from Short description of key information:
According to a Guinea Pig Maximisation Test of Magnusson and Kligman the test substance (91% act. ingr.) is not a skin-sensitiser.
Justification for selection of skin sensitisation endpoint:
Only one reliable study; this GLP-conform study is in accordance wit the OECD guideline and EU method
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. As a result
the test substance is not considered to be classified for skin
sensitisation under Regulation (EC) No 1272/2008, as amended for the
sixth time in Regulation EC 605/2014.
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.
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