Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

There are no reproductive toxicity data for 3-(trimethoxysilyl)propiononitrile or its hydrolysis product, 3-(trihydroxysilyl)propiononitrile. There was no evidence of any adverse effects on the reproductive system in a 90-day oral repeated dose toxicity study with the registered substance.




Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

There are no reproductive toxicity data for 3-(trimethoxysilyl)propiononitrile or its hydrolysis product, 3-(trihydroxysilyl)propiononitrile. There was no evidence of any adverse effects on the reproductive system in a 90-day oral repeated dose toxicity study with the registered substance.

The OECD 422 study on the structural analogue, 3-(triethoxysilyl)propiononitrile (CAS 919-31-3), is included in support of read-across for the genetic toxicity endpoint.


Effects on developmental toxicity

Description of key information

In a prenatal developmental toxicity test conducted according to OECD TG 414 and in compliance with GLP, there were no adverse effects on prenatal development; therefore, the NOAEL was concluded to be at least 1000 mg/kg bw/day (the highest dose tested).

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

In a prenatal developmental toxicity test conducted according to OECD TG 414 and in compliance with GLP, pregnant Wistar rats were exposed to 3 -(trimethoxysilyl)propiononitrile at doses of 100, 300, and 1000 mg/kg bw/day administered on GD 5 to 19. There was no mortality observed during the treatment period.

All clinical signs observed in terminally sacrificed females were incidental or non-adverse in nature.

No treatment-related effect on body weight development, food consumption, prenatal data parameters, litter data parameters and gross pathology of terminally sacrificed females was observed up to highest dose tested.

Furthermore, no treatment-related and toxicologically relevant external, visceral or craniofacial findings were observed in the HD group. All findings were either marginally higher or within the historical control data range and not considered to be adverse.

No adverse effects of 3-(trimethoxysilyl)propiononitrile on females and foetuses were found for dose up to 1000 mg/kg bw/day. The NOAEL for both maternal toxicity and foetal toxicity of 3-(trimethoxysilyl)propiononitrile in this study is considered to be at least 1000 mg/kg bw/day.

The OECD 422 study on the structural analogue, 3-(triethoxysilyl)propiononitrile (CAS 919-31-3) is included in support of read-across for the genetic toxicity endpoint.


Justification for classification or non-classification

Based on the available data, 3-(trimethoxysilyl)propiononitrile is not classified for reproductive or developmental toxicity according to Regulation (EC) No 1272/2008.