Registration Dossier
Registration Dossier
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EC number: 700-308-1 | CAS number: 1335203-19-4
Carcinogenicity
Administrative data
Description of key information
Testing not required based on Column 2 of REACH Annex X.
Key value for chemical safety assessment
Justification for classification or non-classification
The carcinogenic potential of the submission substance is expected to be low and classification is not warranted.
Additional information
According to REACH Annex X, carcinogenicity testing study does not need to be conducted on the registered substance because the substance is not classified as mutagen category 3 and there is no evidence from the repeated dose studies that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.
Data for structurally analogous substances were submitted for supporting purposes only. These data are not required to meet the standard information requirements of Annex VII-X. These data reinforce the low carcinogenic potential of saturated hydrocarbons. In a dermal carcinogenicity study of 1 -decene homopolymer, hydrogenated, no treatment related tumors were observed following twice weekly application for 104 weeks (ExxonMobil Biomedical Sciences, 1994c). In addition, survival was greater in the treated group versus the control group. Likewise, carcinogenicity data of white mineral oil (saturated C15 -C50 hydrocarbons) show no evidence of carcinogenic potential following dermal exposure (Europoean Commission, 2000). In fact, white mineral oil is routinely used as a negative control and test vehicle in carcinogenicity testing.
Read across justification
Refer to the read-across justification documents appended to the CSR.
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.
