Registration Dossier

Administrative data

Description of key information

Acute Toxicity:
- oral: LD50: 1320 mg/kg bw (rat);
- inhalation: 4.6 mg/L air (estimated by Haber rule from an IRT; rat);
- dermal: 855 mg/kg bw (guinea pig);

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
1 320 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
4 600 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
885 mg/kg bw

Additional information

Oral:

In a study which was in large parts equivalent to methods described in OECD guideline 401, the LD50 for oral acute toxicity in rats was calculated as ca. 1320 mg/kg body weight (BASF AG, 1969; Val. 2). Doses of 177, 708, 1106 and 1416 mg/kg bw of an aqueous solution were applied by gavage followed by a post dose observation period of 7 days. Mortality was 0/20 at 177, 1/20 at 708, 0/20 at 1106 and 14/20 at 1416 mg/ kg bw. Main clinical signs observed were apathy and dyspnea. At necropsy, hemorrhage into the gastro-intestinal tract was observed. This LD50 is essentially in the same range as the values reported earlier by Smyth et al. (LD50 = 1480 mg/kg bw; Smyth 1954; Val. 2; LD50 = ca. 1300 mg/kg bw; Smyth 1942, Val. 2). Higher values have been reported, but these were from tests conducted with the neutralized substance (LD50 = 8000 mg/kg bw; Cornish 1967; Val. 4; LD50 = 5600 mg/kg bw; Cornish 1965; Val. 2).

Inhalation:

Data was available from an inhalation risk test (IRT) which meets generally accepted scientific principles (BASF AG, 1969; Val. 2). The inhalation of a saturated vapor-air mixture for 1 hour caused no mortality but the exposure for 3 hours let to a mortality of 5/6 animals. Since the vapor pressure of the substance at 20°C is 1.9 mbar, the saturated vapor concentration is about 9.2 mg/l. Worst case graphical extrapolation from a probability sheet using the lethality rates after 1 and 3 hours of exposure results in an estimated LT50 of about 2.4 hours. From this a 4 hour LC50 of ca. 4.6 mg/l (4600 mg/m3) can be calculated using Haber's rule. Clinical signs were escape attempts, gasping, dyspnoea. At necropsy, severe signs of irritation (corroded snouts, eyes, ears and front paws) were observed. In an older IRT, no mortality occurred after 8 h of exposure (Smyth 1954; Val. 2). In a further IRT, no mortality occurred after 4 hours whereas one of five animals died after 8 hours of exposure to an atmosphere saturated with vapors of DEAE at 25 °C (Smyth 1942, Val. 2).

 

Dermal:

Data for the acute dermal toxicity of DEAE are available from 2 publications where only limited data is provided. A LD50 of 885 mg/kg bw was reported for the guinea pig and a LD50 of ca. 1100 mg/kg bw was reported for the rabbit (Smyth 1942; Val. 2).

Justification for classification or non-classification

EU classification according to Annex I of Directive 67/548/EEC: Xn, R20/21/22

EU classification according to EC/1272/2008 (CLP):

- Oral: Cat 4 (Harmful if swallowed)

- Dermal: Cat 3 (Harmful in contact with skin)

- Inhalation: Cat 3 (Toxic if inhalated)