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Maximum concentration not causing irritating effects in preliminary test: 50 %
Signs of irritation during induction: Three test group animals showed slight erythema after the last topical induction application.
Evidence of sensitisation of each challenge concentration: 0
The test item was assessed for skin sensitisation at 50 % w/w suspension in corn oil at induction, and 25 % w/w suspension in corn for each challenge, following the Buehler method. Three test group animals showed slight erythema after the last topical induction application. However, no positive reactions were observed in the test item group at either assessment during the challenge. The test item is therefore not classified for skin sensitisation.
The study is a GLP compliant, guideline study and is suitable for assessment of this endpoint with restrictions.
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