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 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-C20 aliphatics, <2% aromatics are expected to have a low order of repeated dose toxicity by the oral route of exposure. One study was located for the test substance C14-C20 aliphatics, <2% aromatics, showing no adverse systemic effects up to 1000 mg/kg/day. Moreover, one available read-across study from the structurally analogous test material Hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, < 2% aromatics was analysed. All tests were performed in a manner similar or equivalent to currently established OECD guidelines. In a repeated dose study, the systemic NOAEL was determined to be higher than 5000 mg/kg/day.

 

Dermal: C14-C20 aliphatics, <2% aromatics 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-C20 aliphatics, <2% 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 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.