Registration Dossier

Administrative data

Description of key information

Albino rats in groups of ten (5M:5F), weighing between 150 and 300 g, were dosed with 5000 mg/kg lanolin fatty acids once using an oral method, and observed for fourteen days (Lewis 1977). The LD50 of the test material has been determined to be greater than 5 g/kg/bw.

A study to determine the oral toxicity of Lanolin alcohols was conducted following the OECD Guidelne 401 and EC guideline B1 (Leuschner 2001). Under the test conditions (a single oral dose of the test material at 2000 mg/kg bw) to rats revealed no toxic symptoms. The LD50 is > 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
No study on the ester of lanolin alcohols and fatty acids is available, as the substance is expected to be hydrolysed by esterases, the acute toxicity of the hydrolysis products lanolin alcohols and lanolin fatty esters is representative for the acute toxicity of the substance

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

No studies on the ester of lanolin alcohols and fatty acids are available, as the substance is expected to be hydrolysed by esterases, the acute toxicity of the hydrolysis products lanolin alcohols and lanolin fatty esters is representative for the acute toxicity of the substance

Justification for classification or non-classification

Based on the available information, the substance does not need to be classified for acute toxicity according to Regulation (EC) No 1272/2008 (CLP).