Registration Dossier

Administrative data

Description of key information

In the key acute oral toxicity study (DCC, 1995a) an LD50 >2000 mg/kg was determined for male and female rats in a study that was conducted according to OECD 401 and in compliance with GLP. Clinical signs were limited to soft stools and anogenital staining. No abnormalities were detected at necropsy. 
In the key acute dermal study (DCC, 1995b) an LD50 >2000 mg/kg was determined for rats. There were no clinical signs of toxicity or necropsy findings.
No data are available for the inhalation route.

Key value for chemical safety assessment

Additional information

The key acute oral toxicity study (DCC, 1995a) was selected from five studies of reliability 1 or 2. Three other studies (at higher dose levels than current guidelines require) support the conclusion of the key study that LD50(oral) for rats is >2000 mg/kg (Degussa 1980; Consultox Labs 1976; Osi, 1996). In the fifth study, which was limited in respect of the amount of experimental detail available, an LD50of 1297 mg/kg was reported (Unknown, 1975). However, since four more recent studies clearly show LD50values in excess of 2000 mg/kg, this result has not been used for classification.

The key acute dermal toxicity study was selected from three Reliability 1 guideline studies, all in compliance with GLP and OECD 402 or similar. All studies gave LD50>2000 mg/kg bw for rats or rabbits.

Justification for classification or non-classification

Based on the available data for the oral and dermal routes, (3 -chloropropyl)triethoxysilane is not classified for acute toxicity according to EU Directive 67/548/EEC and Regulation 1272/2008. No data are available for the inhalation route.