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EC number: 204-260-8 | CAS number: 118-56-9
These reports, which presented in SCCP 1086/07, were performed in 2005 in compliance with GLP regulations according to approved study protocol and standard operating procedures by the New England Institutional Review Board (NEIRB) 2005.
209 volunteers completed the study and 27 discontinued but not due to test material reaction. During the induction phase each one volunteers showed a transient and negligible erythema after application of sunscreen SPF-30 (a) or 45 (b) on single readings, while no skin findings were observed on the tested skin areas of any of the volunteers at any time challenge tested with these materials. With sunscreen SPF-30 (c), no skin finding was noted during induction in any of the volunteers, while one subject showed a low level reaction on the 48 hour reading but not at 24, 72 or 96 hours readings. Based on these results, no potentical for dermal irritation and sensitisation to human was associated with test article (10%-15%).
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