Registration Dossier

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.