Registration Dossier
Registration Dossier
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EC number: 928-253-0 | CAS number: 1174918-40-1
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 Dermal 90d – NOAEL ≥495 mg/kg for rats, highest dose tested (similar to OECD TG 410)
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: dermal - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 495 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
Oral: C14-20 Aliphatics (≤2% aromatic) 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.
Dermal: C14-20 Aliphatics (≤2% aromatic) are expected to have a low order of repeated dose toxicity by the dermal route of exposure. No study was located for the test substance C14-C20 aliphatics, <2% aromatics, however, available read-across data from the structurally analogous test material hydrodesulfurized kerosene was analysed. All tests were performed in a manner similar or equivalent to currently established OECD guidelines. In a repeated dose study where hydrodesulfurized kerosene was administered via semi-occlusive patch, the systemic NOAEL was determined to be ≥495 mg/kg/day, which was the highest dose tested.
Justification for classification or non-classification
These findings do not warrant the classification of C14-20 Aliphatics (≤2% aromatic) 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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