Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

Oral administration of read-across substance trimethoxy(methyl)silane to male and female Sprague-Dawley rats at doses of 50, 250 or 1000 mg/kg/day did not result on any effects on reproductive parameters and the No-Observed-Adverse-Effect-Level (NOAEL) for reproductive performance was considered to be 1000 mg/kg/day.

Effect on fertility: 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 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 on tripotassium propylsilanetriolate, and testing is not technically feasible due to the corrosive nature of the test substance, so good quality data for the surrogate substance trimethoxy(methyl)silane (CAS 1185-55-3) have been used to assess the systemic toxicity of tripotassium propylsilanetriolate. A Test Plan for alkyl trialkoxysilanes is attached in Section 13. The read-across strategy for tripotassium propylsilanetriolate will be reviewed when test results are available, particular in respect of trimethoxy(propyl)silane (CAS 1067 -25 -0). The current approach is presented to enable interim risk characterisation.

Refer to Section 5.6.3 of the Chemical Safety Report for further details on read-across justification.

Oral administration of read-across substance trimethoxy(methyl)silane to male and female Sprague-Dawley rats at doses of 50, 250 or 1000 mg/kg/day did not result on any effects on reproductive parameters and the No-Observed-Adverse-Effect-Level (NOAEL) for reproductive performance was considered to be 1000 mg/kg/day.


Effects on developmental toxicity

Description of key information

Oral administration of read-across substance trimethoxy(methyl)silane to male and female Sprague-Dawley rats at doses of 50, 250 or 1000 mg/kg/day did not result in any effects on developmental parameters and the No-observed-Adverse-Effect-Level (NOAEL) for developmental toxicity was considered to be 1000 mg/kg/day.

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

There are no developmental toxicity data on tripotassium propylsilanetriolate, and testing is not technically feasible due to the corrosive nature of the test substance, so good quality data for the surrogate substance trimethoxy(methyl)silane (CAS 1185-55-3) have been used to assess the systemic toxicity of tripotassium propylsilanetriolate. A Test Plan for alkyl trialkoxysilanes is attached in Section 13. The read-across strategy for tripotassium propylsilanetriolate will be reviewed when test results are available, particular in respect of trimethoxy(propyl)silane (CAS 1067 -25 -0). The current approach is presented to enable interim risk characterisation.

Refer to Section 5.6.3 of the Chemical Safety Report for further details on read-across justification.

Oral administration of read-across substance trimethoxy(methyl)silane to male and female Sprague-Dawley rats at doses of 50, 250 or 1000 mg/kg/daydid not result in any effects on developmental parameters and the No-Observed-Adverse-Effect-Level (NOAEL) for developmental toxicity was considered to be 1000 mg/kg/day.

Justification for classification or non-classification

Based on the available data with read-across substance trimethoxy(methyl)silane, tripotassium propylsilanetriolate is not classified for adverse effects on reproductive or developmental toxicity according to Regulation (EC) No 1272/2008.