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EC number: 257-861-2 | CAS number: 52338-87-1
A Guinea Pig Maximization Test (GPMT) is available for 3-(dimethylamino)propylurea (EC 401-950-2), which is as an impurity present in the registered substance 1,3-bis[3-(dimethylamino)propyl]urea (bisDMAPU) up to approximately 15%. Based on the result of this GPMT test, 3-(dimethylamino)propylurea is not considered to be a guinea pig skin sensitizer.
Furthermore, as the registered substance 1,3-bis[3-(dimethylamino)propyl]urea (bisDMAPU) contains up to 5% of 3-aminopropyldimethylamine (DMAPA), CAS 109-55-7, as an impurity, which is classified as a sensitizer with H317, the registered substance also has to be classified to be a skin sensitizer with H317.
The purpose of this study was to assess the potential of 3 -(Dimethylamino)propylurea to elicit skinsensitization (delayed contact hypersensitivity) in guinea pigs. Twenty test and ten control animals wereused in ths study.Based on preliminary tests the following concentrations were determined for the test material applications tobe used in the study:Intradermal induction: 0.1%,Topical induction: 12%,and Initiation: 10%. A skin sensitization response was observed in one out of ten control animals and in four out of twenty animals treated with 3 -(Dimethylamino)propylurea.
Under the protocol (Magnusson and KligmanMaximization) a 30% response is required foramaterial to be considered a skin sensitizer. These results do not show any indication of the test material having a skin sensitizing effect inguinea pigs.
A skin sensitization study was performed in guinea pigs treated with 3 -(Dimethylamino)propylurea (monoDMAPAU)
These results do not show any indication of the test material having a skin sensitizing effect in guinea pigs.
Based on the presence of approximately 15% of 1,3-bis[3-(dimethylamino)propyl]urea.(bisDMAPAU) in the test item, and according to the attached read-across justification this result is also deemed valid for 1,3-bis[3-(dimethylamino)propyl]urea (bisDMAPU).
As the registered substance 1,3-bis[3-(dimethylamino)propyl]urea (bisDMAPU) contains up to 5% of 3-aminopropyldimethylamine, CAS 109-55-7 (DMAPA) which is classified as a sensitizer with H317 as an impurity the registered substance has also to be classified to be a skin sensitizer with H317.
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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