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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

In vitro

Triethylamine was tested for mutagenicity in the Salmonella/microsome preincubation assay at doses of 0, 100, 333, 1000, 3333, and 10,000 µg/plate in four Salmonella typhimurium strains (TA98, TA100, TA1535, and TA1537) in the presence and absence of Aroclor-induced rat or hamster liver S9 (Zeiger et al., 1987). Triethylamine was negative in these tests and the highest ineffective dose level tested (not causing a clearing of the background lawn) in any Salmonella tester strain was 3333 µg/plate. Triethylamine did not induce sister chromatide exchange in Chinese hamster ovary (CHO) cells (Sorsa et al., 1988).

In vivo

In an in vivo Mammalian Chromosome Damage Assay (Isakova et al., 1971), Wistar rats were exposed to vapours of TEA by inhalation in concentrations of 1 mg/m³ and 10 mg/m³ during 30 and 90 days. The incidence of structural chromosome breakages and aneuploidy, recorded in metaphases of marrow cells, was used as the criterion of a mutagenic effect. The control was provided by the incidence of similar breakages in the marrow of intact rats of the same age and sex, maintained under identical conditions. 50 to 100 metaphases were analyzed for each experimental and control animal.

The incidence of cells with structural chromosome breakages did not exceed the control incidence (2%) in any experimental variant, but the incidence of aneuploid cells in the rats exposed to a concentration of 1 mg/m³ was significantly higher than in the controls 30 days after the beginning of poisoning (p<0.01). There were no increases in the incidence of aneuploidy in the high dose group (10 mg/m³) neither after 30 days nor after 90 days of exposure.The incidence of hyperploid cells was similar to the control values in all the experimental groups except those subjected to long-term poisoning with 1 mg/m³ TEA for 30 days (p<0.01). Increased aneuploidy and hyperploidy in the low dose group after 30 days is considered to be incidental because of absence of the same response in the high dose group. Futhermore, since only 50 to 100 metaphases from the bone marrow of each animal were evaluated, the increased aneuploidy and hyperploidy can not be evaluated.

Rats poisoned with TEA did not exhibit any decrease of mitotic activity in the marrow during the observation period.

 

Short description of key information:
Zeiger et al. (1987), Salmonella mutagenicity tests: III. Results from the testing of 255 chemicals. Environ Mutagen 9: 1-110 (1987).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Triethylamine is negative in in vitro genetic toxicity assays. In in vivo Mammalian Chromosome Aberration Assay, TEA does not induced structural breakages in chromosomes of bone marrow cells of rats.

Based on these study results, TEA is considered to be non-mutagenic and therefore 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.