Registration Dossier
Registration Dossier
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EC number: 211-656-4 | CAS number: 681-84-5
Endpoint summary
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.
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