Registration Dossier

Administrative data

Description of key information

Acute Toxicity-Oral LD50 > 4150 mg/kg in rats (OECD TG 401)

Acute Toxicity-Dermal LD50 > 1700 mg/kg in rabbits (OECD TG 402)

Acute Toxicity-Inhalation LC50 > 5.28 mg/L (OECD TG 403)

Key value for chemical safety assessment

Additional information

The acute toxicity of C14-C20 aliphatic, 2 -30% aromatic hydrocarbon fluids has been fully evaluated.  All of the animal studies were performed in a manner similar or equivalent to currently established OECD guidelines.  Based on these data, C14-C20 aliphatic, 2 -30% aromatic hydrocarbons have a low order of acute toxicity by the oral, dermal, and inhalation routes of exposure.

Justification for classification or non-classification

C14-C20 aliphatic, 2 -30% aromatic hydrocarbons is minimally toxic via ingestion where the LD50 is >4150 mg/kg, via dermal exposure where the LD50 is >1700mg/kg, and by inhalation where the LC50 > 5.28 mg/L.  These results were the highest doses tested using OECD TG and no deaths were reported. There are supporting studies with higher concentrations reported in this category. These findings do not warrant classification of C14-C20 aliphatic, 2 -30% under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) do not warrant classification under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations (DSD/DPD). C14-C20 aliphatic, 2 -30% aromatic hydrocarbons are classified under EU CLP guidelines as a Category 1 aspiration hazard based on its physical and chemical properties (hydrocarbon fluid, viscosity ≤ 20,5 mm2/s) and as an R65 aspiration hazard under the EU DSD/DPD.