Registration Dossier

Administrative data

Description of key information

An acute oral toxicity study has been conducted on MV31.  The result of the study was:
Acute oral toxicity is greater than 2000 mg/kg when tested according to OECD 423.

Key value for chemical safety assessment

Additional information

The acute oral toxicity of the test article was determined in Sprague Dawley rats. The study was conducted in compliance with OECD GLP (1999). The test method was based on OECD Guideline 423 (1996) and EC Method B.1 (1996). Rats (3/sex) were administered a single dose of 2000 mg/kg body weight of undiluted test article by oral gavage. Body weights (Days 1, 8, and 15) and clinical signs (twice daily) were recorded. No moratlity occurred during the study, and body weight gain was not impaired. On study Day 1, stilted gait was observed in 1 animal and a squatting posture in 2 animals. No other clinical signs were observed in any other animals at any time points. Based on the results of the study, the oral LD50 of the test article is > 2000 mg/kg body weight.

Justification for classification or non-classification

MV31 does not meet the DSD or CLP criteria for classification by the oral route.