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EC number: 226-685-8 | CAS number: 5451-76-3
An acute oral toxicity test (Up-and-Down Procedure) was conducted with female Wistar rats to determine the potential of 2-butoxyethyl benzoate to produce toxicity from a single dose via the oral route.
The study was initiated with a limit test at 2000 mg/kg (step 1) with one female rat. The undiluted test substance was administered at 2000 mg/kg body weight as a single oral dose to fasted (16 - 17 hours) rats. The animal exhibited clinical signs of toxicity such as slight piloerection, lethargy and red discoloration of urine. The animal died on day 6. As per the AOT 425 statpgm, the main test was then conducted with the dose of 175 mg/kg (step 2). The rat survived with no clinical signs of toxicity, hence the next dose of 550
mg/kg (step 3) was administered to one female rat. There were no clinical signs of toxicity and the rat survived. The next dose of 2000 mg/kg (limit dose) (step 4) was then administered to one female rat. The animal exhibited clinical signs of toxicity such as moderate piloerection, lethargy and red discoloration of urine. The animal died on day 4. Hence the dosing was continued with 550 mg/kg (steps 5 and 7) and 2000 mg/kg (steps 6 and 8). There were no clinical signs of toxicity at 550 mg/kg (steps 5 and 7).
Slight piloerection, lethargy and red discoloration of urine were observed at 2000 mg/kg (steps 6 and 8) and the rats died on day 3 and day 4, respectively. The surviving rats were observed for 14 days post treatment. All the surviving rats gained body weight during the 14- day observation period. The preterminally dead rats lost weight when compared to their initial body weight.
All surviving animals were sacrificed on the scheduled Day 15 and subjected to a gross necropsy. There were no gross abnormalities detected in any of the rats at necropsy.
Liver pale; kidneys - discoloration, red multifocal; urinary bladder – distended with red colour content; stomach - glandular mucosa - erosions, discoloration red multifocal and/or stomach non glandular mucosa, discoloration red multifocal were observed in all pre-terminally dead rats at necropsy. The LD50 was determined after the 14-day observation period using the AOT 425 statpgm.
Based on the present study results, the estimated acute oral LD50 of 2-butoxyethyl benzoate was 939.8 mg/kg body weight with a 95% confidence interval of 550 to 2000 mg/kg body weight in female Wistar rats.According to Guidance to regulation (EC) No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, 2-butoxyethyl benzoate will be classified under Acute toxicty, oral, Category 4.
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