Registration Dossier

Administrative data

Description of key information

The key study for skin irritation, conducted according to a protocol comparable to guideline but not compliant with GLP found the test material not irritating to rabbit skin (Consultox 1976). The key study for eye irritation, conducted according to current guideline and in compliance with GLP found the test material not irritating to rabbit eyes (Hoechst 1991).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

The key study for skin irritation found the test material not irritating to the skin of rabbits in a study conducted according to a protocol equivalent to current guideline but not compliant with GLP (Consultox 1976). There were no signs of erythema or oedema at any time point.

The Primary Irritation Index was 0.0 so the test material was considered a non-irritant under these conditions.

A reliable supporting study was also available that was similar to a guideline study, but not compliant with GLP (BRRC 1984). Trimethoxyvinylsilane was judged to be moderately irritating under the conditions tested, however, based on the available information, the substance would not meet the current EU criteria for classification as a skin irritant. Two reliability 4 studies were also available which support the key data, reporting mild or no irritation (Marhold 1986, Dow Corning Corporation 1973).

 

The key study for eye irritation found the test material not irritating to the eyes of rabbits in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP (Hoechst 1991). The conjunctiva of the animals showed marked hyperaemia and redness. Slight conjunctival swelling was evident. Irritation was only observed 30 - 60 minutes post application; all effects were reversible within 1 day. Two reliable supporting studies also found the test material not irritating to rabbit eyes (BRRC 1984, Consultox 1976). Two reliability 4 studies for eye irritation were also available (Dow Corning Corporation 1973, Mellon 1962).


Justification for classification or non-classification

Based on the available data, trimethoxyvinylsilane does not require classification for irritation according to Regulation (EC) 1272/2008.