Ethylene dinitrate

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route

Dose descriptor:

NOAEL

39 mg/kg bw/day

Additional information

The only reproductive toxicity study available was an oral feeding study conducted in rats (Ellis et al., 1978).

The weights of the high-dose females at termination and their weight changes (excluding the uterus and contents) were significantly less than those of the control group and less than those of the two groups tested at lower doses. In addition, their liver weights were significantly increased relative to their corrected body weight and increased relative to those of the two lower dose test groups. Diaphragmatic hernias occurred only in the high dose group and were believed by the investigators to be due to the test material. Their incidence was not significant (two-sample rank test), but they occurred in 4/19 of the high dose litters from this study. The incidences of unossified and incompletely ossified hyoid bones also were significantly increased compared to the controls and were increased compared to the two lower dose test groups. However, sternabrae, centra, and skull bones were not similarly affected. The investigators believe that these diaphragmatic hernias may have been at least partially responsible for the poor reproductive performance of the group dosed at the1.0 % (w/w) dietary level in the three-generation reproduction test.

Short description of key information:

Decreased food intake was observed in dams and aspermatogenesis leading to infertility was observed in the F2a generation of the high dose group in this feeding study.

Effects on developmental toxicity

Description of key information

Teratogenic effects included incomplete or unossified hyoid bones in offspring at the high dose level tested at 1.0% in diet. the NOAEL is based upon the low dose level tested at 0.01% in diet.

Effect on developmental toxicity: via oral route

Dose descriptor:

NOAEL

0.6 mg/kg bw/day

Additional information

The incidences of unossified and incompletely ossified hyoid bones also were significantly increased compared to the controls and were increased compared to the two lower dose test groups. However, sternabrae, centra, and skull bones were not similarly affected. The investigators believe that these diaphragmatic hernias may have been at least partially responsible for the poor reproductive performance of the group dosed at the1.0 % (w/w) dietary level in the three-generation reproduction test. Maternal toxicity was also observed at the high dose level (1.0% diet).