Registration Dossier
Registration Dossier
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EC number: 265-232-9 | CAS number: 64771-71-7 A combination of normal paraffins having carbon numbers predominantly greater than C10 obtained by urea adduction or molecular sieve processes.
Endpoint summary
Administrative data
Description of key information
Repeated Dose Oral 90d – NOAEL >=5000 mg/kg for rats (similar to OECD TG 408)
Repeated Dose Inhalation 90d – NOAEL >= 6000 mg/m3 for rats (similar to OECD TG 413)
Key value for chemical safety assessment
Additional information
Oral: Paraffins (petroleum), normal C>10 are expected to have a low order of repeated dose toxicity by the oral route of exposure. Three read-across studies from the substances: Decane, "Hydrocarbons C11 -C14, n-alkanes, isoalkanes, cyclics, <2% aromatics" and "Hydrocarbons, C10 -C13, n-alkanes, isoalkanes, cyclics, < 2% aromatics" were analysed. All tests were performed in a manner similar or equivalent to currently established OECD guidelines. The systemic NOAEL to be higher than 1000 mg/kg/day, (Sasol et al., 1995q and Exxon Mobil et al., 1991b).
Inhalation: Paraffins (petroleum), normal C>10 are expected to have a low order of repeated dose toxicity by the inhalation route of exposure. No study was located for a substance in the category C14-C20 aliphatics, <2% aromatics. However, available read-across data from the substance C11 -C14, n-alkanes, <2% aromatics was analysed. The test was performed in a manner similar or equivalent to currently established OECD guidelines. The systemic NOAEL was determined to be >= 6000 mg/kg/day, (Shell et al., 1980) which was the highest dose tested.
Justification for classification or non-classification
These findings do not warrant the classification of Paraffins (petroleum), normal C>10 as a repeated dose toxicant under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under the Directive 67/548/EEC for dangerous substances.
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