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Administrative data

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
Short description of key information:
No references were found to any studies on reproductive effects of DEGDN. The value NOAEL obtained from 3-generation study for TNG was used for DEGDN.

In a 3-generation reproduction study for TNG, rats received dietary nitroglycerin for 6 months prior to mating of the F0 generation with treatment continuing through successive F1 and F2 generations. The high dose was associated with decreased feed intake and body weight gain in both sexes at all matings. No specific effect on the fertility of the F0 generation was seen. Fertility in the F1 and F2 generation of high-dose males were severely impacted. These effects appeared to result from the decreased feed intake and consequent poor nutritional status of the females and decreased spermatogenesis (due to interstitial tumors) in the males. No other reproductive effects were identified.

Effects on developmental toxicity

Description of key information
One reference was found to study on teratogenic effects of DEGDN. But the quality of scanned report is very low and it seems that pages are not in proper order. Preparation of robust study summary in required quality is impossible at this moment. Due to the value NOAEL for TNG was used for DEGDN. 
In 3-generation study for TNG there was no clear evidence of teratogenicity. The incidences of unossified and incompletely ossified hyoid bone 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. These diaphragmatic hernias may have been at least partially responsible for the poor reproductive performance of the group dosed at the 1.0% (w/w) dietary level in the 3-generation reproduction test.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
6.4 mg/kg bw/day
Additional information

In 3-generation study for TNG there was no clear evidence of teratogenicity. Based on results for TNG is supposed DEGDN is no teratogenic.

Justification for classification or non-classification

The results obtained from 3-generation study for TNG was used for DEGDN. Information on reproductive effects are not sufficient to meet classification criteria for reproductive toxicity.