Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Genetic toxicity in vitro, gene mutation in bacteria

An Ames assay is available where the mutagenic potential of triethyl phosphite was assessed (Bayer AG, 1989). The study was similar to OECD TG 471 (adopted 1983) and was performed under GLP regulations. In comparison with actual guideline requirements (OECD TG 471, adopted 1997), some restrictions are apparent. Only four strains of S. typhimurium (TA 1535, TA 1537, TA 98 and TA 100) were used and no second positive control for experiments with metabolic activation in addition to 2 -Aminoanthracene was used. The test substance was tested up to 12500 µg/plate in a plate incorporation assay, which was performed twice. Cytotoxicity was observed at >775 µg/plate. None of the tested strains showed a dose-related and biologically relevant increase in mutant counts over those of the negative controls, both with and without the metabolic activation.

Genetic toxicity in vivo, MNT in mice

A micronucleus test according to OECD TG 474 (adopted 1983) and under GLP regulations was performed in NMRI mice. The animals were dosed by gavage with 1500 mg/kg bw triethyl phosphite. Sixteen, 24, and 48 h after treatment the animals were sacrificed and the blood smears were prepared out of the femur bone marrow of the rats. All treated animals showed the following symptoms of toxicity after administration of 1500 mg/kg bw triethyl phosphite until sacrifice: apathy, semi-anaesthetised state, roughened fur, pallor, staggering gait, sternal position, spasm, twitching, shivering and difficulty in breathing. No symptoms were recorded for the control group. All animals survived until the end of the test. There was an altered ratio between normochromatic and polychromatic erythrocytes with relevant variations noted for the 16 hours group. There was no increase in the incidence of micronucleated polychromatic erythrocytes in the triethyl phosphite treated groups, whereas the positive control showed a significant increase.

Endpoint Conclusion:

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

- Classification for mutagenicity/genetic toxicity: Data lacking


Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008:

- Classification for germ cell mutagenicity: Data lacking