Registration Dossier

Administrative data

Description of key information

For acute oral and dermal toxicity studies, no mortality was observed at the highest doses tested, i. e. doses equal to or greater than 5000 mg/kg bw and 2000 mg/kg bw, respectively. For acute inhalation, the LC50 was 1.85 mg/L air in males, 1.68 mg/L air for females and 1.73 mg/L air for both sexes.

Key value for chemical safety assessment

Acute toxicity: via oral route

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

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
1 730 mg/m³

Acute toxicity: via dermal route

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

Additional information

Isohexadecane was tested for acute inhalation according to OECD guideline 403 in compliance with GLP. The LC50 was 1.85 mg/L air in males, 1.68 mg/L air for females and 1.73 mg/L air for both sexes

Justification for classification or non-classification

All studies conducted on substances within the category showed LD50 > 5000 mg/kg and LD50 > 2000 mg/kg by oral and dermal 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.

In an acute inhalation study conducted on Isohexadecane, a combined LD50 equal to 1.73 mg/L was found, corresponding to a classification as harmful by inhalation according to the criteria of Annex VI to Directive 67/548/EEC and acute toxic category 4 according to criteria of CLP Regulation 1272/2008.