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EC number: 222-720-6
CAS number: 3586-55-8
The test substance was considered
sensitizing under the condition of the GPMT assay. In the study
according to OECD guideline 406 with GLP10 guinea pigs (control n=5)
received for induction intradermal injection of 5% (v/v) test substance
solved in purified water and FCA:physiological saline and topical
application 50% (v/v) in purified water and FCA:physiological saline.
For challenge 25% (v/v) in purified water and FCA:physiological saline
was used. After challenge no dermal reactions were detected for all
Ten female Himalayan spotted guinea pigs
each received intradermal applications of 5% MERGAL V615 in both
purified water and in a 1:1 (v/v) mixture of FCA: physiological saline,
followed a week later by an epidermal application of 50% MERGAL V615 in
purified water (occlusive) during the induction period. Two weeks after
the epidermal induction, the animals received a topical application of
the test article (25% in purified water), which was the previously
determined maximum non-irritating concentration of the test article.
Twenty-one hours after removal of the dressing, treated sites were
depilated as described previously. Five guinea pigs served as controls
that received the intradermal and epidermal inductions without the test
agent. Two weeks after induction, the control animals received challenge
applications of purified water and 25% MERGAL V615 in purified water.
All animals were observed for erythema and oedema at 24 and 48 hours
after removal of the occlusive dressings.
Classification, Labeling, 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. Based on these data, the substance is not considered
to be classified for skin sensitisation under Regulation (EC) No
1272/2008, as amended for the tenth time in Regulation (EC) No 2017/776.
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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