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 – NOAEL 10400 mg/m3 for rats (similar to OECD TG 413)

Key value for chemical safety assessment

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral: 

C9-C14 aliphatic, <2% aromatic hydrocarbon fluids are expected to have a low order of repeated dose toxicity by the oral route of exposure.  All tests were performed in a manner similar or equivalent to currently established OECD guidelines. In a repeated dose study where C9-C14 aliphatic, <2% aromatic hydrocarbon fluids were administered via oral gavage, no signs of toxicity were observed at the maximum experimental dose tested, 5000 mg/kg/day.  

Inhalation:

In a repeated dose study where C9-C14 aliphatic, <2% aromatic hydrocarbon fluids were administered via inhalation, no signs of toxicity were observed at 10400 mg/m3. Based on these observations, the repeat inhalation concentration NOAEL is 10400 mg/m3 (10.4 mg/L) for C9-C14 aliphatic, <2% aromatic hydrocarbon fluids.

Justification for classification or non-classification

These findings do not warrant the classification of C9-C14 aliphatic, <2% aromatic hydrocarbons 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 and Directive 1999/45/EC for preparations.