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EC number: 269-144-1 | CAS number: 68188-18-1
Based on read across this result of a chronic feeding is relevant for paraffin oils, sulfochlorinated, saponified. As explained in a separate document (Read Across Justification, Sadler, 2017; attached to this dossier, Chapter 13) both paraffin oils, sulfochlorinated, saponified and the read across substance are very similarly composed secondary alkane sulfonates (UVCBs); slight differences are caused by the production processes - for the paraffin oils, sulfochlorinated, saponified the sulfochlorination and for the read across substance the sulfoxidation. A comparative assessment of the available toxicological informations confirms that there is no reason to deviate from the read across approach from a toxicological view. This assessment is also contained in a separate document (Supporting information on human health assessment, Karthaus, 2017; attached to this dossier, Chapter 13).
Here in brief is the result of the chronic feeding study with the read across substance with repsect to carcinogenicity (for other toxicity results see chapter Repeated dose toxicity):
A chronic feeding study similar to OECD TG 452, but conducted at a time before the guideline was available, investigated the chronic toxicity of the substance (test material was as aqueous slurry with 60 % active ingredient; all concentrations quoted here are in terms of the active ingredient). This information is used for a partial assessment of carcinogenicity.
In the study groups of 20 male and 20 female rats were fed diets containing 0.08, 0.4 and 2.0 % (w/w) test substance for 52 weeks (approximate doses 40, 200 and 1000 mg/kg bw and day). A similar sized group received plain diet and served as control. For each dose additional 10 male and 10 female sentinel animals were used for interim pathological examination (terminated after 26 weeks of treatment).
For results with respect to general toxicity see chapter on repeated dose. With respect to carcinogencity it can be stated based on the chronic study that non-neoplastic and neoplastic pathology was unchanged by the chronic treatment.
Based on read across a chronic feeding study is available for the assessment of paraffin oils, sulfochlorinated, saponified. This study similar to OECD TG 452, but conducted at a time before the guideline was available, investigated the chronic toxicity of the read across substance
(test material was as aqueous slurry with 60 % active ingredient; all concentrations quoted here are in terms of the active ingredient), but can also partially be used for assessment on carcinogenicity.
For results with respect to general toxicity see chapter on repeated dose. With respect to carcinogencity it can be stated based on the chronic study that non-neoplastic and neoplastic pathology was not affected by the chronic treatment at any dose investigated.
According to Regulation (EC) No 1272/2008, Annex I, no classification is required for carcinogenicity.
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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