Registration Dossier

Administrative data

Description of key information

In the key skin irritation/corrosion study (Allied Corporation, 1982a), which was similar to OECD 404, gamma-glycidyloxypropyltrimethoxysilane was found to be mildly irritating to the skin of rabbits. 
In the key eye irritation study (Allied Corporation, 1982b), which was similar to OECD 405, gamma-glycidyloxypropyltrimethoxysilane was found to be irritating. In unwashed eyes treated with undiluted test substance, blinking and tearing were observed in all eyes within minutes after instillation. Pannus of the cornea developed in 2 of the 6 animals. Corneal opacities, covering a minimal area of the cornea, persisted for 21 days (termination of study) in the animals which developed pannus. Conjunctival redness was also observed in several test eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

There are several studies available for skin and eye irritation that have a reliability score of 2, therefore the most recent of these were selected as the key studies.

For skin irritation there was one supporting study (DCC, 1976) that showed TMSPGE was not irritating to the skin of rabbits. Therefore this study is in agreement with the key study, which showed only minimal irritation.

For eye irritation, there is one supporting study that revealed TMSPGE to be mildly irritating to the eyes of rabbits. Therefore this study is did not show the same degree of irritation as the key study, which showed moderate irritation that was not completely reversed by day 21 days after treatment.


Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: moderately irritating

Justification for classification or non-classification

Based on the available data, TMSPGE does not require classification for skin irritation.

Based on the key study for eye irritation it is proposed that TMSPGE be classified as 'Eye Corr. Cat 1' and labelling 'R41: Risk of serious damage to the eyes' under Regulation 1272/2008.