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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.