Registration Dossier

Administrative data

Description of key information

An acute oral toxicity study was performed in mice on EP1. 
EP1 was prepared as a 20% v/v emulsion in Tween-80 (10% aqueous solution) and administered at a maximum dosage volume of 20 mL/kg. Mice treated at Tween-80 (10%) in water (20 mL/kg) served as control. During the 14 -days observation period, record was kept of all mortalities and signs of toxicity. All mice were examined macroscopically to identify target organs.
Autopsy revealed darkening of the liver and animals treated at 4 mL/kg (corresponding to 0.8 g/kg bw) showed ulceration of the stomach wall and intestine togeher with bleaching of parts of the liver.
The acute median lethal oral dose (LD50) of EP1 was calculated to be 1.2 mL/kg bw, corresponding to 0.24 g/kg bw.

Key value for chemical safety assessment

Additional information

According to regulation (EC) 1907/2006 of the European parliament and the council of 18 December 2006 (Article 17), no chemical safety assessment is required for on-site isolated intermediates. Therefore, no key values were defined for EP1.

Justification for classification or non-classification