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Description of key information

Acute toxicity via oral route LD50 of 2074 mg/kg bw was determined for male and female rats following the standard acute method (OECD TG 401) that were in place on the date of study report.  At 2000 mg/kg bw 3/5 males and 5/5 females died. The NOEL in this study was 1600 mg/kg bw  for male rats and 1000 mg/kg bw  for female rats. Following the acute  toxic class method (OECD TG 423) the median lethal dose was found to be greater than 200 mg/kg and less than 2000 mg/kg bw with mortality of 3/3 males at 2000 mg/kg and no mortality at 200 mg/kg bw . Similiar acute oral toxicity in rats was determined in a further study according to OECD TG 401 with a calculated LD50 value of 1400 mg/kg for both sexes. 
The dermal LD50 determined in compliance with OECD TG 402 was greater than 2000 mg/kg body weight for rats.

Key value for chemical safety assessment

Additional information

For acute toxicity via the oral route a LD50 of 2074 mg/kg bw was determined for male and female rats following the standard acute method (OECD TG 401) that was in place on the date of study report. At 2000 mg/kg bw 3/5 males and 5/5 females died. The NOEL in this study was 1600 mg/kg bw for male rats and 1000 mg/kg bw for female rats. Following the acute toxic class method (OECD TG 423) the median lethal dose was found to be greater than 200 mg/kg and less than 2000 mg/kg bw with mortality of 3/3 males at 2000 mg/kg and no mortality at 200 mg/kg bw . Similiar acute oral toxicity in rats was determined in a further study according to OECD TG 401 with a calculated LD50 value of 1400 mg/kg for both sexes. The dermal LD50 determined in compliance with OECD TG 402 was greater than 2000 mg/kg body weight for rats.

Justification for classification or non-classification

The results from testing acute toxicity via dermal route do not warrant classification.

The acute oral toxicity in rats was found to require classification as acute oral cat.4 according to GHS (EU): according to the the acute toxic class method (OECD TG 423) the median lethal dose was greater than 200 mg/kg and less than 2000 mg/kg. However subject to the dosing regime the point estimate of LD50 from valid studies in rats conducted in compliance with OECD TG 401 the LD50 is greater than 2000 mg/kg (LD50 = 2074 mg/kg bw) and less than 2000 mg/kg (LD50 = 1400 mg/kg).