Registration Dossier

Administrative data

Description of key information

The rat oral LD50 for hexadecanol and octadecanol is >2000 mg/kg. At this dose level there were no signs of toxicity (Hempstock 1996, Hempstock 1991). Administration of a single oral dose of lanolin alcohol at 2000 mg/kg bw) to rats revealed no toxic symptoms (Leushner 2001).

The oral LD50 of acetic acid in rats > 2000mg/kg bw (HSDB database)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The dermal study is waived based on the fact that the substance is not classified for acute oral toxicity or STOT3.

The information on the hydrolysis products is expected to be representative for effects of the substance. The ester will hydrolyse in the gastro-intestinal tract and systemic exposure is expected to be related to the hydrolysis products.

Justification for classification or non-classification

Based on the information available the substance does not need to be classified for acute toxicity according to EC Regulation 1272/2008 (CLP).