Registration Dossier
Registration Dossier
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EC number: 949-740-4 | CAS number: -
Endpoint summary
Administrative data
Description of key information
RIPT (VP Rosa, 2019): No sensitisation reaction observed
Additional information
To prove the absence of the skin sensitisation potential of a product applied to the skin, under maximized conditions, with controlled product amount and application site, supervised by a dermatologist. 0.05 g/cm2 of undiluted form) and control were applied to patch test filter paper discs and then applied to the right or left back (scapular area) of the study subjects (56 participants). 9 applications on the 3 first weeks (induction period) followed by 10 days rest then 1 application on the last week (challenge period).
During the study, no subjects presented skin clinical signs related to the product. The product did not induce a skin sensitisation process in the study group. The product was considered safe under the study conditions. The claim “dermatologically tested” can be supported.
The test item does not meet the criteria for classification according to the Globally Harmonized Classification System and to the Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
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.
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