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Administrative data

Description of key information

DEA has a moderate acute oral toxicity, while it is considered low after inhalation exposure. For the dermal route, no reliable data is available. As oral and inhalation data are available, no dermal data is required under REACH. 

Key value for chemical safety assessment

Additional information

Regarding the oral route of exposure, in the key study (BASF AG, 1966), performed to a comparable protocol as OECD guideline 401, 5 rats per sex were dosed with 200 - 3200 mg/kg bw and observed up to 14 days. No deaths occurred up to 1000 mg/kg bw dosing group. The LD50 for males and females combined was 1600 mg/kg bw. Reported clinical signs were tumbling, staggering gait, twitches, convulsions, dyspnoea, abdominal lateral position and scrubby coat. Gross pathology revealed hydrothorax, local adhesions of the gut and signs of irritation on the gastro-intestinal tract.

Smyth et al (1959, 1969 and 1970) reported a LD50 of 1820 mg/kg bw in female Wistar rats.

When male Sprague-Dawley rats received a single oral administration of aqueous DEA solutions in the range of 100 – 6400 mg/kg bw, only at the top dose 7/8 rats died. At ≥100 mg/kg bw onwards an increase in liver weight and an increase in the relative kidney weight at ≥1600 mg/kg bw was noted. Organ finding with associated changes in clinical chemistry parameters were reported for the liver at ≥200 mg/kg bw and for the kidney at ≥400 mg/kg bw (Korsrud et al., 1973).

Information from an inhalation risk test showed no mortality in rats after an 8 h exposure to an atmosphere enriched with DEA vapour (the technically highest attainable concentration is approximately 1.9 mg/m3 (0.44 ppm)) (BASF AG, 1966). In addition, no mortality was observed after an 8 h exposure to a mean substance concentration of 0.2 mg/l air (calculated by the weight loss of the test substance over the time of exposure) (BASF AG, 1956a). Acute screening studies with DEA aerosol exposure from 1.5 – 4 h and concentrations between 30 – 1476 ppm (0.13 - 6.4 mg/l) caused mortality in 5/8 rats after 105 min exposure to 6.4 mg/l. After exposure of 3.35 mg/l (768 ppm) for up to 4 h no animal died. Toxicological signs consisted predominantly of lethargy and irregular respiration. In addition, blood pressure was affected and gross pathology showed congestion in lung, liver, spleen and discoloration in kidney and thymus (Foster, 1971; Hartung et al., 1970).

No reliable acute dermal toxicity data is available. However, in accordance with column 2 of REACH Annex VIII, in addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. As an acute inhalation toxicity study is available, no dermal acute toxicity study is needed.

 

Justification for classification or non-classification

Based on the available data, DEA has to be classified for acute oral toxicity. According to Annex I of Directive 67/548/EEC, classification with Xn; R22 is warranted. According to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, the classification is H302, Cat. 4.

The substance does not need to be classified for acute dermal and inhalation toxicity according to Annex I of Directive 67/548/EEC and according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.