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EC number: 244-617-5
CAS number: 21850-44-2
Main study, Intradermal induction:
Well defined erythema was noted at the intradermal induction sites of
the test group animals at the 24 hr observation with very slight to
moderate to severe erythema at the 48 hr observation.
Very slight erythema was noted at the intradermal induction sites of all
test group animals at the 24 hr observation and in two control group
animals at the 48 hr observation.
Main study, Topical induction:
Very slight to well defined erythema was noted at the induction sites of
all test group animals at the 1 -hr observation and in six test group
animals at the 24 hr observation.
No skin reactions were noted at the treatment sites of control group
animals at the 1 and 24 hr observations.
Main study, Topical challenge:
No skin reactions were noted at the challenge sites of the test or
control group animals at the 24 or 48 hr observations.
M&K maximisation test was conducted in albino guinea pigs using OECD
guidelines 406 and method B6 of the commission directive 92/69/EEC.
Ten test and five control animals were used for the main study.
Based on the results of sighting tests, the concentrations of test
material for the induction and challenge phases were selected as follows:
Intradermal induction: 10% w/v in arachis oil BP
Topical induction: 75% w/w in arachis oil BP
Topical challenge: 75% and 50% w/w in arachis oil BP
The test material produced a 0% (0/10) sensitisation rate and was
classified as a NON-SENSITISER to guinea pig skin.
Based on the results of the M&K sensitisation test, the test material
did not meet the criteria for classification and labelling under Annex
VI of Council Directive 67/548/EEC and the EU Classification, Labelling
and Packaging of Substances and Mixtures (CLP) Regulation (EC)
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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