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EC number: 442-300-8 | CAS number: -
Waiving arguments were applied referring to the absence of adverse effects up to 1000 mg/kg/day in a 90-day oral toxicity study in rats.
In a guideline compliant prenatal developmental toxicity study no relevant effects were reported and the maternal and developmental No Observed Adverse Effect Level (NOAEL) was established as being at least 1000 mg/kg bw/day.
In a GLP-compliant prenatal developmental toxicity study following OECD guideline 414, mated female Wistar Han rats were assigned to four dose groups, each containing 22 animals. The test item was administered once daily by gavage from Day 6 to Day 19 post-coitum, inclusive, at doses of 100, 300 or 1000 mg/kg bw/day (Groups 2, 3 and 4, respectively). The rats of the control group received the vehicle, polyethylene glycol 400, alone. Accuracy, homogeneity and stability of formulations were demonstrated by analyses.
No maternal toxicity was observed in the 100, 300 and 1000 mg/kg bw/day groups. No developmental toxicity was observed in the 100, 300 and 1000 mg/kg bw/day groups. At 1000 mg/kg bw/day, mean fetal body weights for females were significantly lower than controls (3.3 gram versus 3.5 gram). Also for male fetuses in the high dose group there was a trend towards slightly lower body weights as compared to controls (3.5 gram versus 3.7 gram). This difference was at least in part caused by the lower litter size in controls as compared to the high dose group (group mean of 10.7 versus 12.0 fetuses/litter). As for fetal body weights the difference from controls was only slight and group mean litter weights per sex remained within the available historical data range (i.e. minimum values of 3.1 and 3.3 gram for females and males, respectively), no toxicologically relevance was attached to the fetal body weight findings.
In conclusion, based on the results in this prenatal developmental toxicity study the maternal and developmental No Observed Adverse Effect Level (NOAEL) was established as being at least 1000 mg/kg bw/day.
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008 The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The NOAEL was greater than 1000 mg/kg bw/d. As a result the substance is not considered to be classified for toxicity to reproduction under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/218.
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