Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

A test proposal based on read-across is included for a proposed EOGRT test on the analogue substance, triethoxy(octyl)silane. See attachment to test proposal and Section 5.9.3 of the Chemical Safety Report for read-across justification and possible read-across or testing options.

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

In a guideline, GLP, OECD 422 study (DCC, 2010) for the related substance triethoxy(octyl)silane, reproductive effects (increased duration of gestation, dystocia, decreased pup viability on PND 0 and 4, mean litter weights, average pup body weights and body weight gain decreased on PND 4) were only observed at the highest dose of 1000 mg/kg bw/day and were considered to be secondary to the systemic toxicity in dams (including dragging of hindlimbs) by the study authors. There were no effects on fertility. The NOAEL is therefore 1000 mg/kg bw/day.



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 (the highest dose tested) triethoxy(2,4,4-trimethylpentyl)silane for the oral route (Harlan Laboratories, 2009).

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

The key study for developmental toxicity 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, the NOEL for embryo and fetal development was considered to be 100 mg/kg body weight/day whereas the NOAEL was considered to be 1000 mg/kg body weight/day.

This is supported by a reliable OECD 422 study with the related substance triethoxy(octyl)silane in which the NOAEL was 1000 mg/kg bw/day (Dow Corning Corporation, 2010).

Justification for classification or non-classification

Based on the available developmental toxicity study, triethoxy (2,4,4 -trimethylpentyl)silane is not classified for reproductive or developmental toxicity according to Regulation (EC) No. 1272/2008.