Registration Dossier
Registration Dossier
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EC number: 449-400-0 | CAS number: 25822-43-9
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:
The aim of the study was to investigate the sensitising potential of the test item using a traditional sensitising test with guinea pig. The study was performed according to the OECD 406, adopted in 1989. 10 females and 5 females were used as treatment and negative control group, respectively. For the first induction the test item was administered epicutaneously following the injection of Freund's complete adjuvant. Before the second induction exposure, the animals were pre-treated with n-dodecylsulfate, sodium salt (10 % in white petrolatum (w/w)). The second induction followed epicutanously on day 8 using a test item concentration of 50 % (w/w) in white petrolatum. At day 23 the epicutanous challenge was performed again with 50 % (w/w) in white petrolatum. Test sites were covered with occlusive dressings. The results of skin examinations were decisive for the grading of the potential of sensitisation. No positive skin reactions were observed after 24 hours and 48 hours. The test item is considered to be "non-sensitising" by skin contact.
Migrated from Short description of key information:
The test item was tested for skin sensitisation in a GLP study according to OECD 406 in guinea pigs. The test item is considered to be "non-sensitising" by skin contact.
Justification for selection of skin sensitisation endpoint:
GLP and guideline compliant
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data on sensitisation the test item is not subjected to classification and labelling according to Regulation 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).
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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