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 – NOAEC ≥10400 mg/m3 for rats (similar to OECD TG 413)
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: inhalation - local effects

Endpoint conclusion
Dose descriptor:
NOAEC
10 400 mg/m³
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

No repeated dose toxicity studies are available for the registration substance itself. Reliable data are therefore read across from related substances in the relevant carbon number range.

Oral: Members of the Category “Hydrocarbons, 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 90-day repeated dose toxicity study by the inhalation route is available for the structurally analogous test material “Hydrocarbons, C10-C12, isoalkanes, <2% aromatics”. The test was performed in a manner similar or equivalent to OECD Test Guideline 413. The NOAEC for male and female albino rats was ≥10400 mg/m3(nominal). There were no treatment-related mortalities or significant adverse clinical effects.

 

Dermal: Members of the Category “Hydrocarbons, 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 hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics, however, available worst-case read-across data from 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

The findings of the available repeated dose toxicity studies do not warrant the classification of Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics as a repeated dose toxicant according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC.