Registration Dossier

Administrative data

Description of key information

The key study for skin irritation finds the test material irritating to skin, reporting a mean value of 2 for erythema, and 4 for oedema based on  three test animals (SafePharm, 2001). The study was conducted according to OECD 404 and in compliance with GLP.
No key study was available for eye irritation. However, three reliability 4 studies indicate severe effects to the eye and have been used as weight of evidence (HSDB, Mellon Institute 1951a and 1951b).

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Only one skin irritation study is available for tetramethyl orthosilicate (SafePharm, 2001). This was conducted according to OECD test guideline 404 and in compliance with GLP, and was therefore selected as a key study.

There are no reliable eye irritation studies for tetramethylorthosilicate. Information on effects on the eye are available from three sources to which reliability could not be assigned (reliability 4) as insufficient details were available to assess the test methods used. These sources report varying degrees of severe effects to the eye including marked oedema and necrosis of the lid (American Conference of Governmental Industrial Hygienists, 1986), corneal burns to the rabbit eye from a 1% dilution of the test substance (Mellon Institute 1951a) as well as delayed burn and progressive injury (Mellon Institute 1951b). In view of the reported effects it is not considered to be appropriate to perform any further testing for eye irritation and the substance is considered to be a severe eye irritant.


Justification for selection of skin irritation / corrosion endpoint:
The selected study is the only skin irritation study available for the registered substance. It was conducted in accordance with an appropriate OECD test guideline and in compliance with GLP.

Justification for selection of eye irritation endpoint:
No key study is selected. The assessment of eye irritation is based on a weight of evidence approach.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Based on the available in vivo data, tetramethyl orthosilicate is classified for Skin Irritation Category 2, H315: Causes skin irritation and Eye Damage Category 1, H318: Causes serious eye damage, in accordance with Regulation (EC) No 1272/2008.