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

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.

Justification for classification or non-classification

As all studies show LD50 > 5000 mg/kg, LD50 > 2000 mg/kg and LC50> 5000 mg/m3 by oral, dermal and inhalation routes, respectively. Substances in this category do not need to be classified for acute oral and dermal toxicity according to the criteria of Annex VI of Directive 67/548/EEC and CLP Regulation 1272/2008.