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Administrative data

Description of key information

Acute Toxicity-Oral LD50 > 5000 mg/kg in rats (OECD TG 401)
Acute Toxicity-Dermal LD50 > 2000 mg/kg in rabbits and rats (OECD TG 402)
Acute Toxicity-Inhalation LC50 > 5000 mg/m3 (OECD TG 403)

Key value for chemical safety assessment

Additional information

The acute toxicity of Paraffins (petroleum), normal C>10 has been fully evaluated by a read across from substances from two categories: C9 -C14, aliphatics, < 2% aromatics and C14 -C20, aliphatics, < 2% aromatics.  All of the animal studies were performed in a manner similar or equivalent to currently established OECD guidelines.  Based on the provided data, Paraffins (petroleum), normal C>10 are expected to have a low order of acute toxicity by the oral, dermal, and inhalation routes of exposure.

Justification for classification or non-classification

Paraffins (petroleum), normal C>10 is a substance minimally toxic via ingestion where the LD50 is >5000 mg/kg, via dermal exposure where the LD50 is >2000mg/kg, and by inhalation where the LC50 > 5000 mg/m3.  These findings do not warrant classification of Paraffins (petroleum), normal C>10 under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) and under the Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations (DSD/DPD). However, C9-C14 aliphatic, < 2% aromatic hydrocarbons (category on which is based the read across for the substance C10 -C17, n-alkanes), and consequently, the substance "Paraffins (petroleum), normal C>10" 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.