Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
1 000 mg/kg bw/day
Additional information

Only one reproductive toxicity study is available. This is considered to be a good quality study, which is adequate to support the fertilty endpoint.

Short description of key information:
In a good quality one-generation reproductive toxicity study (Becker et al., 2004) conducted to OECD 415 and GLP, the parental and reproductive NOAELs for [3-(2,3-epoxypropoxy)propyl]trimethoxysilane were 500 and ≥ 1000 (the highest dose tested) mg/kg bw/d, in rats. Treatment with the test substance resulted in signs of discomfort after dosing (noted for P females from early /mid gestation onwards), decreased body weight gain of males, and increased absolute and relative liver and kidney weights in P males and females. Histopathology revealed effects on livers and kidneys of males.

Effects on developmental toxicity

Description of key information
In a well conducted study (BRRC, 1993), conducted using a protocol similar to OECD 414 and GLP, the NOAELs for maternal toxicity and developmental toxicity were 200 and ≥400 (the highest dose tested) mg/kg bw/day, respectively, in rabbits. No developmental effects were observed at the highest dose, in the presence of maternal toxicity. 
Effect on developmental toxicity: via oral route
Dose descriptor:
400 mg/kg bw/day
Additional information

Three developmental studies with a reliability score of 1 are available for [3 -(2,3 -epoxypropoxy)propyl]trimethoxysilane. The most recent of these was selected as the key study.


Justification for classification or non-classification

The available data do not suggest that [3 -(2,3 -epoxypropoxy)propyl]trimethoxysilane should be classified for reproductive toxicity.