Registration Dossier

Administrative data

Description of key information

The acute oral and acute dermal toxicity was investigated in studies performed comparable to the relevant guidelines (OECD420 and Hill, Ass. Food and Drug Off. 18, 1954), resulting in an LD50 of 4.9 mg/kg bw, and 12.45 mg/kg bw, respectively (BASF AG, 1967; BASF AG, 1965). The acute inhalation toxicity was investigated in a study according to internal BASF guidelines, an LC50 was not determined in this study (BASF AG, 1966).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
4.9 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
12.45 mg/kg bw

Additional information

There are no human data on acute toxicity of ethyleneimine available.

The acute toxicity of ethyleneimine in animals is high. The available BASF studies on acute oral, inhalation and dermal toxicity were selected as the key studies as they were performed using methods comparable to relevant guidelines.

The oral LD50 was 4.9 mg/kg bw in rats in a well conducted study (BASF AG, 1967).

In a whole body inhalation study performed with rats the LC50 was not determined. 1 of 5 rats died 6 days after exposure to the test substance vapour (BASF AG, 1966).

The dermal LD50 was 12.45 mg/kg bw in rats in a well conducted study (BASF AG, 1965).

Justification for classification or non-classification

According to Annex I of Directive 67/548/EEC, the substance is classified as T+; R26/27/28.

According to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, the classification is H300, Cat. 2, H310, Cat. 2 and H330, Cat. 1.