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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
600 mg/kg bw/day
Study duration:
subchronic
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

A well-reported, repeated dose 90-day oral toxicity study on 3-aminopropyltriethoxysilane (CAS 919-30-2), conducted in the main according to the current guideline for that endpoint and in accordance with GLP, identified a systemic NOAEL value of 200 mg/kg bw/day in male and female rats; mortality, clinical observations and liver effects were evident at 600 mg/kg bw/day (WIL, 2001). No effects on reproductive organs, oestrus cycle or sperm parameters were evident at the highest tested dose of 600 mg/kg bw/day.

Although it is accepted that this study cannot detect all possible reproductive effects, the 90 day oral toxicity study is considered adequate to cover testing requirements for reproductive toxicity as laid out in Annex IX.

Read-across from 3-aminopropyltriethoxysilane to 3-(diethoxymethylsilyl)propylamine is discussed in Section 7.5.


Short description of key information:
A reliable 90-day oral toxicity study in rats (WIL, 2001) on the related 3-aminopropyltriethoxysilane (CAS 919-30-2), which may be used as a read-across study, reported a NOAEL for reproductive effects of 600 mg/kg bw. This study would have only limited potential to detect all possible reproductive effects.

Justification for selection of Effect on fertility via oral route:
The selected study is the only available reproductive toxicity study for a relevant surrogate substance. It was conducted in accordance with a protocol similar to OECD 418 and in compliance with GLP.

Effects on developmental toxicity

Description of key information
A study in rats (Momentive, 1998) on the related 3-aminopropyltriethoxysilane (CAS 919-30-2), which is used as a read-across study, reported a maternal and developmental NOAEL of 100 mg/kg bw. However, the author of this CSR considers that the NOAEL relevant for human hazard assessment was 600 mg/kg bw/day, the highest dose tested.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
600 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

A well reported oral study in rats, conducted according to generally accepted scientific standards (similar to OECD 414) and in accordance with GLP reported maternal toxicity (increased incidences of mortality, clinical observations, and slight decreases in body weight gain and food consumption) at 600 mg/kg bw/day (Momentive, 1998). The occurrence of maternal toxicity was accompanied by slight fetal toxicity (increased minor skeletal variations). No significant maternal or developmental effects were observed at 20 or 100 mg/kg bw/day.  However, the increased minor skeletal variation can result from maternal stress and is considered to be minor, and not a threat to normal functioning of the animals, and therefore not of significance for humans. The NOAEL for developmental toxicity (including teratogenicity) was therefore ≥600 mg/kg bw/day.

Read-across from 3-aminopropyltriethoxysilane to 3-(diethoxymethylsilyl)propylamine is discussed in Section 7.5.


Justification for selection of Effect on developmental toxicity: via oral route:
The selected study is the only available developmental toxicity study for a relevant surrogate substance. It was conducted in accordance with an appropriate OECD test guideline and in compliance with GLP.

Justification for classification or non-classification

Based on the available information on the registered substance and limited read-across data, no classification is proposed for effects on reproduction and development in accordance with Regulation (EC) No 1272/2008.

Additional information