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Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Additional information

In a 90-day repeated oral dose toxicity study with the test item (N-Morpholinomethyl)triethoxysilan groups of 10 male and female Wistar rats were exposed to 0, 100, 300 and 1000 mg/kg bw/day by gavage with corn oil as the vehicle. (N-Morpholinomethyl)triethoxysilan had no effect on epididymal sperm motility or testicular sperm count analyzed at the end of the treatment or recovery period of this study. Neither in the percentage of motile, static or rapidly moving epididymal sperms nor in testicular number of sperms/g testis was there any statistically significance between control and any of the dose groups.

(N-Morpholinomethyl)triethoxysilan had also no effect on the oestrus cycle analyzed in study weeks 5 or 9 or at the end of the treatment or recovery period. Considering individual values, there was no considerable difference in cycle length or sequence of cycle stages between dose groups and the control group.

As no reproduction toxicological effect was found in this study, the dose level of 1000 mg/kg/day marks the NOEL for reproductive effects.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Species:
rat
Additional information

In order to detect effects on the pregnant rat and development of the embryo and fetus, (N-Morpholinomethyl) triethoxysilan was administered orally by gavage once daily to pregnant females from day 6 through to day 20 post coitum at dose levels of 100, 300 and 1000 mg/kg/day according to OECD 414.

Test item did not show any toxic potential on pregnant females up to and including the dose level of 1000 mg/kg bw/day.

(N-Morpholinomethyl)triethoxysilan had no influence on the relevant reproduction data (postimplantation loss and the mean number of fetuses per dam) up to and including the dose level of 1000 mg/kg bw/day.

Based on these observations, NOEL (No Observed Effect Level) for pregnant rat was considered to be 1000 mg/kg body weight/day.

NOEL for embryo and fetal development was considered to be 1000 mg/kg body weight/day.

Consequently, under the conditions described for this study, (N-Morpholinomethyl)triethoxysilan did not reveal any teratogenic potential up to and including the dose level of 1000 mg/kg/day.

Justification for classification or non-classification

Based on the NOEL (No Observed Effect Level) for pregnant rats of 1000 mg/kg body weight/day and the

NOEL for embryo and fetal development of 1000 mg/kg body weight/day in a study according OECD 414 (N-Morpholinomethyl)triethoxysilane is not classified as teratogenic or harmful after repeated exposure.

Based on the NOEL of 1000 mg/kg/day

for reproductive effects in a 90 -day repeated oral dose toxicity study according OECD 408 (N-Morpholinomethyl)triethoxysilan is not classified as reprotoxic after repeated exposure.