Registration Dossier
Registration Dossier
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EC number: 242-262-0 | CAS number: 18379-25-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
No reproductive toxicity data are available.
Effects on developmental toxicity
Description of key information
In a reliable study conducted according to OECD 414 and in compliance with GLP, the NOAEL for developmental toxicity in rats was determined to be 1000 mg/kg bw/day for the oral route (Adamska, 2009).
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
The key study for developmental toxicity is the only reliable study for this endpoint, based on read-across from the related substance triethoxy (2,4,4-trimethylpentylsilane). The registered substance, trichloro (2,4,4-trimethylpentylsilane), and the surrogate substance both hydrolyse in contact with water to produce the common hydrolysis product 2,4,4 -trimethylpentylsilanetriol, with the other hydrolysis products being hydrogen chloride and ethanol respectively. Although at pH 7, the triethoxy analogue hydrolyses more slowly than the trichloro (half-life 22 hours compared to <1 minute), under acidic conditions such as in the stomach following oral ingestion, the triethoxy substance is expected to hydrolyse rapidly, based on experience with other ethoxy silanes.
Since both substances generate a common hydrolysis produc it is considered appropriate to read-across the result of the reliable OECD 414 test for the oral route. At the dose levels relevant for testing and human exposure, ethanol generated in the stomach from hydrolysis of triethoxy (2,4,4 -trimethylpentyl)silane would not contribute any developmental toxicity effects.
The test was conducted in accordance with OECD 414 and in compliance with GLP. Under the conditions described for this study, the NOEL for pregnant rats was considered to be 1000 mg/kg body weight/day. Based on the variations on development of axial skeleton, NOEL for embryo and fetal development was considered to be 100 mg/kg body weight/day whereas NOAEL was considered to be 1000 mg/kg body weight/day.
Justification for classification or non-classification
Based on the available developmental toxicity study, triethoxy (2,4,4 -trimethylpentyl)silane is not classified as a developmental toxin.
There are no data to suggest that the substance should be classified for reproductive toxicity (fertility).
Additional information
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