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Administrative data

Description of key information

Acute toxicity data indicate low toxicity: in rats the oral LD50 was 6400 mg/kg bw; in rabbits the dermal LD50 was > 2000 mg/kg bw. Inhalation exposure for 8 hours to vapour saturated with TEA failed to cause any deaths in rats (LC50 was not determined). 

Key value for chemical safety assessment

Additional information

Oral toxicity

In an acute oral toxicity study (BASF AG, 1966), 5 Sprague-Dawley rats/sex/dose were exposed to 200 - 6400 mg/kg bw TEA by gavage and observed for 7 days. The LD50 was determined to be 6400 mg/kg bw for males and females. No deaths occurred at doses of 5000 mg/kg bw or below. At 200 mg/kg bw, slight agitation was observed up to 4 hours after exposure; at higher doses unsteady, elevated respiration, anancasm to chew, apathy, and reduced grooming was noticed. Two days after exposure, no clinical signs were observed. Gross pathology did not reveal any abnormalities.

Dermal toxicity

In a dermal limit test, rabbits were treated with 2000 mg/kg bw TEA on the intact or abraded skin and subsequently observed for a 14 -day period (EPA, 1989a). The test substance was either derived from NH3 (92% TEA) or DEA (88% TEA), both containing approximately 6.5% DEA. Mild erythema was observed following exposure to TEA derived from NH3 on the intact or abraded skin, returning to normal on day 6. Moderate erythema was observed following exposure to TEA derived from DEA on the intact or abraded skin, returning to normal on day 10. No mortality was observed, hence the LD50 was > 2000 mg/kg bw.

Inhalation toxicity

Due to its extremely low volatility, there is a lack of data documenting the acute inhalation toxicity. As good quality data for the oral and dermal route are available, in accordance with column 2 of REACH Annex VIII, a study regarding the inhalation route is not required. One limited report stated that whole-body exposure of rats to a saturated TEA atmosphere (approximately 1.8 mg/m3) at 20°C for 8 hours failed to cause any deaths. Therefore no LC50 value has been determined for this compound (BASF AG, 1966).

Justification for classification or non-classification

Based on the results of acute oral, inhalation and dermal toxicity studies, TEA does not need to be classified according to Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.