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Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via inhalation route
Dose descriptor:
NOAEC
182 mg/m³
Additional information

An OECD 422 Guideline study, Combined Repeated Dose Toxicity Study with the Reproductive/Developmental Toxicity Screen Test, was conducted on Sprague Dawley rats at doses of 0, 25, 50, 100 ppm. There were no treatment related effects at any exposure level on reproductive indices, time to mating, gestation length,post-implantation loss, pup survivial, or pup sex ratio.There was no effect of exposure on histopathology of sperm or any reproductive organ examined (in the 100 ppm group, relative testes weights were increased).

The only effect seen in the Reproductive/Developmental screen was a slight decrease in litter size between the high dose group and the control group. In the high exposure, the mean number of pups on day 1 and 4 postpartum were less than controls. Although these differences were not statistically significant, each of these values was outside the range of the historical control data at the time. Data indicates that 3 of 10 dams in this group had litter sizes of fewer than 12 pups, Conversely, in the control, 25, and 50 ppm groups, the number of dams producing fewer than 12 pups was 1/12, 1/12, and 0/10, respectively. The toxicological significance of this finding is equivocal since there were no apparent effects on any other reproductive parameter examined, or any corroborating histopathological findings. These results suggest that the slightly reduced litter size in animals exposed to 100 ppm 1 -nitropropane was likely secondary to maternal toxicity and/or stress associated with nasal irritation. However, the NOEC was set at 50 ppm (or 182 mg/m3)


Short description of key information:
The key reproductive study is a GLP, OECD 422 guideline study, Combined Repeated Dose Toxicity Study with the Reproductive/Developmental Toxicity Screen Test.

Effects on developmental toxicity

Description of key information
The key reproductive study is a GLP, OECD 422 guideline study, Combined Repeated Dose Toxicity Study with the Reproductive/Developmental Toxicity Screen Test.
Effect on developmental toxicity: via inhalation route
Dose descriptor:
NOAEC
364 mg/m³
Additional information

An OECD 422 guideline study, "Combined Repeated Dose Toxicity Study with the Reproductive/Developmental Toxicity Screen Test, was conducted on Sprague Dawley rats at doses of 0, 25, 50, and 100 ppm. No teratological effects were seen at any dose level. Therefore the NOAC for developmental effects was 100 ppm ( 364 mg/m3).

Justification for classification or non-classification

There were no developmental effects observed in the OECD 422 study. For reproductive effects, the reduce litter size observed between the high dose group and the control was likely secondary to maternal toxicity or stress in dams exposed to 100 ppm of 1 -nitropropane. Therefore, 1 -nitropropane is not classifiable as a reproductive or developmental toxicant.