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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.
Labelling, and Packaging Regulation (EC) No 1272/2008
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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