Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There are no skin sensitisation data on tetramethyl orthosilicate, so good quality data on the structurally-related substance, tetraethyl orthosilicate have been used for read-across.

In the absence of measured data for tetramethyl orthosilicate, it is considered appropriate to use this result in support of the skin sensitisation endpoint. The read-across substance is moderately lipophilic (log Kow 3.0) for which dermal uptake is favourable. The registered substance is hydrophilic (log Kow -0.5), therefore the read-across substance represents a worst-case with respect to potential for dermal absorption. After uptake both substances hydrolyse rapidly with half-lives of ca. 1 minute (tetramethyl orthosilicate) and 2.5 hours (tetraethyl orthosilicate) at pH 7 and 37.5°C, forming methanol or ethanol and silicic acid. Neither methanol nor ethanol is sensitising to skin (OECD, 2004a, OECD 2004b), therefore read-across based on the common hydrolysis product is relevant.


Migrated from Short description of key information:
There are no skin sensitisation data on tetramethyl orthosilicate, so good quality data on the structurally-related substance, tetraethyl orthosilicate have been read-across.

In a skin sensitisation study (Buehler test) conducted to OECD 406 (except only ten test animals and no positive control) DYNASIL A (tetraethyl orthosilicate) was not sensitising to the skin of guinea-pigs (Degussa-Huls, 1992).

Justification for selection of skin sensitisation endpoint:
The selected study is the only skin sensitisation study available for a relevant surrogate substance. It was conducted in accordance with an appropriate OECD test guideline and in compliance with GLP.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on read-across data on tetraethyl orthosilicate, tetramethyl orthosilicate is not classified as a skin sensitiser according to Regulation (EC) No 1272/2008.