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Registration Dossier
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EC number: 934-956-3 | CAS number: 1335203-17-2
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 – NOAEC >=10400 mg/m3 for rats (similar to OECD TG 413)
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 5 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEC
- 10 400 mg/m³
- Study duration:
- subchronic
- Species:
- rat
Additional information
Oral: C14-C20 aliphatics, <2% aromatics are expected to have a low order of repeated dose toxicity by the oral route of exposure. Two read-across studies from the structurally analogous test materials "Hydrocarbons C12-C16, 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 were determined to be higher than 1000 and 5000 mg/kg/day, respectively.
Inhalation: a repeated inhalation toxicity study was performed with "Hydrocarbons, C10 – C12, isoalkanes, < 2% aromatics" similarly to OECD guideline 413. Albino rats were exposed for 6 hours/day, 5 days/week for 13 weeks at nominal vapor concentrations of 10400 mg/m3, 5200 mg/m3, and 2600 mg/m3 to assess inhalation toxicity. As there were no pathologic changes, changes in organ weights were judged to have been compensatory rather than toxic effects. Based on these results, the No Observed Adverse Effect Concentration (NOAEC) was greater than or equal to 10400 mg/m3.
Justification for classification or non-classification
These findings do not warrant the classification of C15-C20, n-alkanes, isoalkanes, cyclics, <0.03% aromatics, 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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