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Administrative data

Description of key information

MDEA has a low acute oral, inhalation and dermal toxicity. The oral LD50 is 4680 mg/kg bw in rats, in inhalation risk tests with rats no mortality was observed after 6 and 8 hours exposure to a saturated MDEA vapour atmosphere. The LD50 for the dermal route is > 2000 mg/kg bw in rabbits.

Key value for chemical safety assessment

Additional information

Oral toxicity

In an acute oral toxicity study (BASF AG, 1969) comparable to an OECD TG 401 study, 10 rats/sex/dose were exposed to 208 - 6656 mg/kg bw MDEA by gavage and observed for 7 days. The LD50 was determined to be 4680 mg/kg bw for males and females. No deaths occurred at doses of 1664 mg/kg bw or below.

Inhalation toxicity

Information from an inhalation risk test showed no mortality in rats after an 8 h exposure to a saturated MDEA vapour atmosphere (BASF AG, 1969). In addition, also no mortality was observed after a 6 h exposure to a saturated atmosphere of the test substance (Ballantyne and Leung, 1996). Due to its low vapour pressure (0.0027 hPa, at 25 degrees Celsius), exposure by inhalation can be regarded as negligible. Therefore, acute toxicity is considered low after inhalation exposure.

Dermal toxicity

The available data which was assessed using a weight of evidence (WoE) approach showed that the acute dermal toxicity of MDEA was low. All studies (Ballantyne and Leung, 1996a; Smyth, 1954; The Dow Chemical Company 1983) report a LD50 of > 2000 mg/kg bw.

Justification for classification or non-classification

Based on the available acute toxicity data, classification is not needed for acute toxicity according to Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.