Oxirane, reaction products with ammonia, distn. residues

Endpoint summary

Description of key information

Since Amix TE (CAS 68953-70-8) is composed of at least 75 % of TEA (CAS 102-71-6) and the available data for Amix TE are limited, a read-across to TEA was conducted. Acute toxicity data indicate low toxicity: in rats the oral LD50 was 6400 mg/kg bw (for TEA) and >2000 mg/kg bw (for Amix TE); in rabbits the dermal LD50 was > 2000 mg/kg (TEA). Inhalation exposure for 8 hours to vapour saturated with TEA failed to cause any deaths in rats (LC50 was not determined). 

Additional information

Since Amix TE (CAS 68953-70-8) is composed of at least 75 % of TEA (CAS 102-71-6) and the available data for Amix TE are limited, a read-across to TEA was conducted. In addition to the acute toxicity studies for TEA mentioned below, another acute oral toxicity study with Amix TE was performed: in rats the oral LD 50 was >2000 mg/kg bw, no mortality and no abnormal clinical signs were observed (BASF AG 10A0444/951087).

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 occured 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 (TSCATS, 1989). 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. One 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, Amix TE 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.