Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

The oral LD50 in rats was 6150 mg/kg bw. 
The LC50 (4 h) in rats is > 21 mg/L or 7200 ppm.
The dermal LD50 in rabbits is >15100 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
6 150 mg/kg bw

Additional information

Acute toxicity data in experimental animals

Oral

The LD50 in male Wistar rats was 8.16 mL/kg bw corresponding to 6150 mg/kg bw; the post exposure observation period was 14 days (Smyth et al., 1969; limited documentation).

Inhalation

In the Limit test (BASF 1988) in 5 male and 5 female Wistar rats (according to OECD Guideline 403) no mortality was found but clinical signs (sedation) at a concentration of 21 mg/L (7200 ppm) and an exposure duration of 4 h. Apathy, closed lids and depressed breathing were noted during exposure, these clinical signs were absent the following day. No effects were detected at necropsy 2 weeks after exposure.

Promising anaesthetic properties of EVE were noted in various species. Narcotic potency of EVE was larger than that of diethylether (Krantz et al., 1947).

Dermal

In 4 male New Zealand White rabbits the maximum applied dose volume of 20 mL/kg bw did not induce lethal effects after an exposure period of 24 h (occlusive; post exposure period 14 days), therefore the LD50 is >20 mL/kg bw, i.e. > 15080 mg/kg bw (Smyth et al., 1969; limited documentation).

Acute inhalation toxicity in humans

In a female volunteer narcosis was induced by the open drop method. The blood pressure and pulse were not significantly altered. She reported no irritation of the respiratory tract after acute inhalation of presumably saturated vapour (Krantz et al., 1947).

Side effects of EVE in anaesthesia like nausea, vomiting, and ECG changes were documented during and after anaesthesia (Sadove et al., 1955); in another study (Dornette et al., 1955) also obstruction, hypoxia, coughing, deficient relaxation as well as fatal cases (respiratory or ciculatory arest) were reported.

Justification for classification or non-classification

Classification for acute toxicity is not warranted according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

EVE is classified with H336 ("May cause drowsiness or dizziness") based on human data (abandoned historical use of EVE as human anesthetic agent).