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Administrative data

Description of key information

In the key acute oral toxicity study (WIL, 1999a), the LD50 for rats was determined to be >2000 mg/kg in a study that was carried out in accordance with OECD 401 and in compliance with GLP. A majority of the rats were  noted with various discoloured areas due to discharges/excretions. Other findings in approximately one-third of the animals included abnormal excretion, hypoactivity and tremors. One male and one female died at the 2000 mg/kg dose level. Gastrointestinal abonormalities were detected at necropsy of one of the animals that died.
In the key acute dermal toxicity study (WIL, 1999b), the LD50 for rats was determined to be >2000 mg/kg in a study that was carried out in accordance with OECD 402 and in compliance with GLP. There were no clinical signs of toxicity or abormalities at necropsy, although local desquamation was observed.

Key value for chemical safety assessment

Additional information

The key acute oral and dermal studies were selected as the only available data for these endpoints that followed OECD test guidelines and were in compliance with GLP, and hence were assigned Reliability 2 (WIL, 1999a and WIL, 1999b). Two additional acute oral toxicity studies in rats were assigned Reliability 2 since they were not GLP and pre-dated the OECD guidelines. The LD50 was determined to be >2000 mg/kg in all cases.

A second acute dermal toxicity study in rabbits is available (Mellon, 1954), which gave an LD50 of ca. 1.5 ml/kg (equivalent to ca. 1545 mg/kg based on a density of 1.03 g/cm3). However, the more recent guideline study is used for classification purposes because the older study used occlusive coverings that resulted in necrosis of the skin, so subsequent deaths and other effects may have been secondary to corrosion.

Justification for classification or non-classification

On the basis of reliable data for the oral and dermal routes, tris(2 -methoxyethoxy)vinylsilane is not classified for acute toxicity according to EU Directive 67/548/EEC and Regulation 1272/2008.

No reliable data are available for the inhalation route.