Registration Dossier

Administrative data

Description of key information

Acute oral toxicity (OECD 401): LD50 = 2890 mg/kg bw (BASF 82/265; 1982)

Acute dermal toxicity (OECD 402 & GLP): LD50 > 2000 mg/kg bw (SafePharma 1691/003; 2002)

Key value for chemical safety assessment

Additional information

Acute oral toxicity:

To assess acute oral toxicity of ethylenediamine, +4PO, (BASF, 82/265, 1982) Wistar rats were dosed with 2610; 3830 and 5000 mg/kg bw test substance (vehicle: water) by gavage using the standard acute method according to OECD 401. Clinical signs observed throughout all dose groups included dyspnoe, apathy, staggering, diarhea and a bad general condition. These symptoms completely regressed max. within 1 h in males and max. within 5 h in females. All observed mortalities occured within the first 24 h after dosing. Female mortalities were observed at the lowest dose level (1/5 females; whereas male mortalities initially emerged at 3830 mg/kg bw (3/5 males). Necropsy of deceased animals confirmed the observed diarhea. Necropsy of survivors did not reveal any abnormalities. Overall, this study can be considered as reliable for assessment. Under the chosen testing conditions, ethylenediamine, +4PO showed significant acute toxicity only at higher dosages:

Oral LD50 = 2890 mg/kg bw

Acute dermal toxicity:

To assess acute dermal toxicity of ethylenediamine, +4PO, (Safe Pharm 1691/0003; 2002) Wistar rats were dosed with 2000 mg/kg bw undiluted test substance in a limit test according to OECD 402. No mortality and no signs of systemic toxicity occured. Female animals displayed erythemas at the test site. Overall, this study can be considered reliable for assessment. Under the chosen testing conditions, the test substance did not show significant acute toxicity:

Dermal LD50 > 2000 mg/kg bw

Acute inhalative toxicity:

In accordance with column 2 of REACH Annex VIII-X, in addition to the oral route, for substances other than gases, an acute toxicity study for at least one other route is required. The choice of the second route will depend on the nature of the substance and the likely route of human exposure. In the case of ethylenediamine, +4PO the dermal route was selected.

Justification for classification or non-classification

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC and 1272/2008/EEC. In conclusion, ethylenediamine, +4PO does not require classification for acute toxicity.