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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
500 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

In a reproduction/developmental toxicity screening test (OECD 421) with 4-ethylmorpholine, rats were exposed to 0, 50, 150, 500 mg /kg. Following general toxicity was observed: no deaths were found in males of any group. One female at 500 mg/kg bw/day died on day 2 of lactation. Tremor was observed in the female which died, and transient salivation after dosing was observed in males and females at 150 mg/kg bw/day and higher. Decrease in body weight gain was accompanied by reduced food consumption in males at 500 mg/kg bw/day and females at 150 mg/kg bw/day and higher. Based on the findings, the male parental NOAEL for general toxicity was established as being 150 mg/kg/day and the female parental NOAEL for general toxicity was established as being 50 mg/kg/day based on reduced body weight gain and food consumption.

Reproductive and developmental toxicity observed: slight decreases in numbers and rate of implantation were detected in the 500 mg/kg group. There were, however, no adverse effects on estrous cycle, copulation, fertility, gestation length, gestation index or number of corpora lutea. Slight decreases in numbers of pups and numbers of live pups, presumably related to decrease in implantation, were detected in the 500 mg/kg group. There were no treatment-related changes in the body weight, external appearance, general conditions or necropsy findings in offspring of rats. The reproductive and developmental NOAEL was established as being 500 mg/kg/day.


Short description of key information:
A screening reproduction test with 4-ethylmorpholine in male/female Crj:CD(SD) IGS rats was performed according to OECD Guideline 421. Based on the findings, the male parental NOAEL for general toxicity was established as being 150 mg/kg/day and the female parental NOAEL for general toxicity was established as being 50 mg/kg/day based on reduced body weight gain and food consumption. The reproductive and developmental NOAEL was established as being 500 mg/kg/day.

Justification for selection of Effect on fertility via oral route:
General toxic adverse effects are observed in the parental generation. However, at the highest dose tested (500 mg/kg bw/d) no adverse effects were observed on fertility.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the criteria of the CLP Regulation, NEM should not be classified as reproductive toxicant.

Additional information