Registration Dossier

Administrative data

Description of key information

For acute oral, dermal and inhalation toxicity studies, no mortality was observed at the highest doses tested, i. e. doses equal to or greater than 5000 mg/kg bw, 2000 mg/kg bw and 5000 mg/m3, respectively.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
5 000 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

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

Four studies were available for acute oral toxicity, dealing with the toxicity of C5-C20 normal paraffins, C14-C17 n-alkanes, C14-C16 paraffins and isohexadecane. All studies were conducted similarly to OECD guideline 401 without GLP compliance. All studies show no mortality at concentrations up to 5000 mg/kg bw.

Three studies were available for acute dermal toxicity, dealing with the toxicity of C5-C20 normal paraffins,

C14-C17 n-alkanes

and C14-C16 paraffins. All studies were conducted similarly to OECD guideline 402 without GLP compliance. All studies show no mortality at concentrations equal to or higher than 2000 mg/kg bw.

A reliable study and a non-reliable study were available for acute inhalation, dealing with the toxicity of Hydrocarbons, C10-C12, isoalkanes, < 2% aromatics and C14-C16 n-paraffins, respectively. All studies were conducted similarly to OECD guideline 403. They all show no mortality at concentrations equal to or higher than 5000 mg/m3.

These acute toxicity results are read across to Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics.

Justification for classification or non-classification

As all available read-across studies show LD50 > 5000 mg/kg, LD50 > 2000 mg/kg and LC50> 5000 mg/m3 by oral, dermal and inhalation routes, respectively. Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics does not need to be classified for acute oral and dermal toxicity according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC.

Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics has a measured viscosity of 3.3 mm²/s at 40°C and therefore is classified under Regulation (EC) No 1272/2008 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 Directive 67/548/EEC.