Triethylamine

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Additional information

There is sufficient information from an inhalation 28 -week repeated dose toxicity study with rat (Lynch et al., 1990), performed with triethylamine. No effects on gonads were observed in this study. Two related substances, whose functional groups belong to alkyl homologues series, trimethylamine and tri-n-butylamine did not possess reprotoxic potential. In a combined oral repeated dose and reproductive/developmental toxicity screening test (OECD 422) performed with trimethylamine at dose levels of 8, 40, 200 mg/kg/day the no observed effect level (NOEL) for reproductive and developmental toxicity was 200 mg/kg/day in male and female rats, and 200 mg/kg/day in pups. No abnormality which can be considered the effects of trimethylamine administration was observed in the reproductive organs, and no effect on the observation results of estrous cycle was found. Also no effect was found on the mating rate, conception rate, the birth rate, pregnancy period, nursing state, the number of corpora lutea, the number and rate of implantation.

In a OECD 414 study performed with tri-n-butylamine, transiently reduced food consumption and body weight were signs of toxicity observed. The NOAEL for maternal toxicity was 45 mg/kg bw.

Short description of key information:
1. Waiver for 2-generation study;
2. Read-across of fertility data from a structural analogue of TEA (trimethylamine): OECD 422 study.

Effects on developmental toxicity

Description of key information

1.Read-across for developmental toxicity from data of structural analogues tri-n-butylamine (OECD 414 study) and trimethylamine (OECD 422 study).

Additional information

In the oral developmental/teratogenicity study (OECD 414) performed with tri-n-butylamine, there were no significant prenatal adverse effects. A slight and dose related increase in the mean foetal body weight was observed, which was statistically significant in the high dose group. Observed malformations were of spontaneous nature with respect to number and type. The NOAEL for maternal toxicity was 45 mg/kg bw and for developmental effects 135 mg/kg bw, the highest dose level tested. In the OECD 422 study performed with trimethylamine, the viability of the delivered pups, sex ratio, body weight and form were not affected. The NOAEL for developmental effects was 200 mg/kg bw.

Justification for classification or non-classification

Classification is not warranted according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.