Registration Dossier

Administrative data

Description of key information

There are no repeated dose oral, inhalation or dermal studies available for methylsilanetriyl triacetate. Data waivers are in place for oral, inhalation and dermal repeated dose toxicity endpoints.

In a seven-day range-finding study conducted to determine appropriate doses for administration in an OECD TG 422 study with the related substance, ethylsilanetriyl triacetate (CAS 17689-77-9), a NOAEL could not be determined due to the corrosive effects of this substance on the oesophagus and stomach (DCC, 2004).

On the basis of this result and results of the skin corrosion studies, it is considered not to be either ethical or technically feasible to perform further repeat dose toxicity testing with methylsilanetriyl triacetate by any route of exposure at toxicologically relevant doses or concentrations due to its known corrosive properties.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available
System:
gastrointestinal tract

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There are no repeated dose oral, inhalation or dermal studies available for methylsilanetriyl triacetate. Data waivers are in place for oral, inhalation and dermal repeated dose toxicity endpoints.

See attached data waiver justification and Section 5.6.3 of the Chemical Safety Report for further discussion.

Justification for classification or non-classification

The available data indicate that methylsilanetriyl triacetate does not need to be classified for specific target organ toxicity according to Regulation (EC) No 1272/2008.