Registration Dossier
Registration Dossier
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EC number: 700-672-1 | CAS number: 70226-26-5
Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Justification for classification or non-classification
Additional information
For Reaction product of lauric acid and oxybis(propanediol) (List No. 700-672-1) there are no data available for carcinogenicity.
According to Regulation (EC) No 1907/2006, a carcinogenicity study may be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if the substance has a widespread dispersive use or there is evidence of frequent or long-term human exposure, and the substance is classified as mutagen category 3 or there is evidence from repeated dose studies that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.
There is no evidence, that the test material causes carcinogenicity by a direct genotoxic mechanism as the results of all genotoxicity studies with surrogate substances and metabolites were negative. Furthermore, in repeated dose toxicity studies and developmental studies with surrogates substances and metabolites no evidence for hyperplasia or preneoplastic lesions was seen. Moreover, a chronic study investigating the carcinogenic properties of the structurally related polyol dipropylene glycol to the predicted metabolite diglycerol is available and showedno evidence of carcinogenic activity of dipropylene glycol in male and female rats (NTP, 2004).
Thus, the proposal for a carcinogenicity study would be scientifically unjustified.
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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