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EC number: 217-316-1
CAS number: 1809-19-4
The chronic toxicity of the substance via
inhalation was evaluated in an experimental study conducted in a manner
which was equivalent to the OECD Guideline 453, in a Combined Chronic
Toxicity and Carcinogenicity study. Groups of 20 male and 20 female
Fischer 344/DuCrj rats were exposed to test item concentrations of 10,
100 and 1000 ppm (corresponding to 0.013, 0.13 and 1.3 mg/L air)
continuously (ca. 20 hours per day) for 12 months (males: 7318-7341
hours; females: 7474 - 7496 hours) via inhalation chambers. Negative
control animals were tested in parallel.
No mortality during the study period was
associated with toxicity due to the absence of a dose-depended
relationship: one high-dose and one low-dose animal was eiher sacrificed in
extremis or found dead. Very slight (less than 5 % difference from
controls), transient suppression of body weight gain was observed among
high-dose males and females between weeks 27 and 44, which was
attributed to the temporary occurrence of slight diarrhea. High-dose
males demonstrated a minimal, but significant, decrease in food
consumption from week 30 to end of study; however this differed by less
than 5 % from the controls. A dose-related increase in the ratio between
liver and spleen weights and body weight was observed among female
animals, but this difference was less than 5 %. Swelling of the
chromophobic cells of the pituitary was also observed.
According to the authors, only the
observations of the 1.3 mg/L dose group could be considered
treatment-related. Based on the minor degree and severity (less than 5 %
from control values), these changes have no pathological meaning and it
cannot be excluded that these findings are toxicologically irrelevant.
Levels of 0.13 mg/L or less did not produce any effect (NOEC),
therefore, 1.3 mg/L is adopted as LOAEC, although it may be considered
as a NOAEC.
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