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EC number: 201-128-1 | CAS number: 78-63-7
Assessment for contact hypersensitivity to CAS# 1068-27-5 (unsaturated structural analog) was conducted in the Albino Guinea Pig (Maximisation Test -OECD No. 406).
Test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, ten experimental animals were intradermally injected with a 50% concentration and epidermally exposed to a 100% concentration. Five control animals weresimilarly treated, but with vehicle alone (corn oil). Two weeks after the epidermal application all animals were challenged with a 50% testsubstance concentration and the vehicle. No skin reactions were evident after the challenge exposure in the experimental and control animals.
There was no evidence that the test article had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase.
Justification for selection of skin sensitisation endpoint:
Apparently well conducted GLP study.
Assessment for Contact Hypersensitivity to CAS# 1068 -27 -5 in the Albino Guinea Pig(Maximisation Test).
The study was carried out based on the guidelines described in: EC Commission Directive 96/54/EC, Part B.6, "Skin Sensitisation", OECD No. 406, "Skin Sensitisation", EPA OPPTS870.2600 "Skin Sensitisation", August 1998 and JMAFF: Japanese Test Guidelines (draft), July 2000 and based on the method described by Magnusson and Kligman, "Allergic ContactDermatitis in the Guinea Pig - Identification of Contact Allergens".
There was no evidence that the test article had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challengephase. This result indicates a sensitisation rate of 0 per cent.
Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC),TRIGONOX 145-E85 does not have to be classified and has no obligatory labelling requirement for sensitisation by skin contact.
A Buehler test was performed on the registered substance CASA# 78 -63 -7. The results of this study were inconclusive and contradictory to those found for structural analogues. The results of a maximization study, on the read-across substance,1068 -27 -5, are used to support the conclusion that 78 -63 -7 is not sensitizing. In addition, another structural analog, CAS# 2167 -23 -9, was also negative in the guinea pig maximization study. (See section 13 for read-across justification).
Results from guinea pig maximization studies, on analog substances, do not meet the criteria for classification.
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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