Registration Dossier

Toxicological information

Endpoint summary

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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 for (3-chloropropyl)dimethoxymethylsilane. Therefore data have been read across from the structurally related (3-chloropropyl)diethoxymethylsilane The key study is the only skin sensitisation study available for the read across substance.

The registered substance and the read-across substance share a common 3-chloropropyl sidechain, and are members of a small analogue group containing this functional group and other chloroalkyl groups. They also share a common silanol hydrolysis product, (3-chloropropyl)methylsilanediol. The non-silanol hydrolysis products, methanol and ethanol respectively, are not skin sensitisers therefore any observed effect could be attributed to the (3-chloropropyl)methylsilanediol part of the molecule. Dermal uptake of the read-across substance is likely to be slightly greater due to its anticipated slower hydrolysis rate and higher log Kow, so this is a worst-case approach. None of the substances in this analogue group have been identified as skin sensitisers in available studies. Further information is given in a supporting report attached to Section 13 of the IUCLID 5 dossier.(PFA, 2013s).


Migrated from Short description of key information:
There are no skin sensitisation data for (3-chloropropyl)dimethoxymethylsilane. Therefore data have been read across from the structurally related (3-chloropropyl)diethoxymethylsilane.

In a skin sensitisation study (Buehler test) conducted to OECD 406 and to GLP (Hüls AG, 1997e) (3-chloropropyl)diethoxymethylsilane was not sensitising to the skin of guinea pigs. No local or systemic effects were observed in this study.

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

Justification for classification or non-classification

Based on read across data from (3 -chloropropyl)diethoxymethylsilane,

(3 -chloropropyl)dimethoxymethylsilane is not classified as a skin sensitiser according to Regulation 1272/2008/EC.