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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 treated animals.
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.
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