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Administrative data

Description of key information

In the key acute oral study (Degussa, 1993) the LD50 (rat) was greater than 2000 mg/kg bw (limit test). Clinical signs observed after dosing were abnormal gait, squatting, staggering, salivation and lacrimation, hypothermia, and uncontrolled movements. These had fully resolved by the 24 hour observation. No abnormalities were detected at necropsy.
No acute inhalation data are available which meet current guideline requirements. However, supporting studies in which rats were exposed to substantially saturated vapour for 6-8 hours showed no mortality, indicating a low potential for acute inhalation toxicity.
In the key acute dermal study (Degussa, 1993), the LD50 (rat) was greater than 2000 mg/kg bw (limit test). There were no clinical signs or necropsy findings.

Key value for chemical safety assessment

Additional information

The key acute oral study was selected as the most recent, reliable study available (Degussa, 1993). The study followed the now deleted OECD 401 (limit test) and was conducted in compliance with GLP. The LD50 (rat) was determined to be >2000 mg/kg day. Three older studies support this conclusion, although much higher dose levels were tested than required by current guidelines.

The key acute dermal study was selected as the most recent, reliable study available (Degussa, 1993). The study followed the OECD 402 limit test and was conducted in compliance with GLP. The LD50(rat) was determined to be >2000 mg/kg day. Two older studies support this conclusion, although much higher dose levels were tested than required by current guidelines.

No reliable acute inhalation data are available.

Justification for classification or non-classification

On the basis of reliable data for the oral and dermal routes, and supporting data for the inhalation route, 3 -chloropropyltrimethoxysilane is not classified for acute toxicity according to the criteria set out in EU Directive 67/548/EEC or Regulation 1272/2008.