Registration Dossier

Administrative data

Description of key information

Repeated Dose Inhalation 90d – NOAEC >=10000 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: inhalation - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEC
10 000 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

Inhalation: Renewable hydrocarbons, C15-C18, branched alkanes are expected to have a low order of repeated dose toxicity by the inhalation route of exposure. One read-across study from the structurally analogous test materials hydrocarbons C9-C15, n-alkanes, isoalkanes, <0.005% aromatics was analysed. Test was performed in a manner similar or equivalent to currently established OECD guidelines. The systemic NOAEC was determined to be higher than 10000 mg/m3.

 

Dermal: Test material, Hydrodesulfurized kerosene, was applied at concentrations of 165, 330 or 495 mg/kg/day. Dosing was continued daily for five consecutive days each week, five days a week for 13 weeks. In addition a group of 12 male and 12 female rats of similar age was administered mineral oil as vehicle controls and an additional high dose group was maintained for a 4-week recovery period following dosing for 13 weeks. At the 14 week necropsy, blood samples were collected from 12 animals/sex/group and at the week 18 necropsy from the recovery rats (vehicle and high dose groups). There were no systemic or neurological effects noted at any of the tested doses. The systemic NOAEL was >495 mg/kg/day.

Oral: In accordance with column 2 of REACH Annex VIII (8.6.1) and Annex VIII (8.6.2), repeated dose testing should be by an appropriate route. Results are available from guideline repeated dose toxicity study by inhalation and will be used to derive a NAEL and DNEL for oral exposure. However, as no effect was observed is both inhalation and dermal route, no DNEL was derived.

Justification for classification or non-classification

These findings do not warrant the classification of Renewable hydrocarbons, C15-C18, branched alkanes as a repeated dose toxicant under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) .