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Toxicological information

Carcinogenicity

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Description of key information

Testing not required based on Column 2 of REACH Annex X.

Key value for chemical safety assessment

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.

Justification for classification or non-classification

The carcinogenic potential of the submission substance is expected to be low and classification is not warranted.