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EC number: 203-929-1
CAS number: 112-03-8
study was conducted to determine the oral repeated dose toxicity of the
read across substance, quaternary ammonium compounds, C12-C18 (even
numbered) alkyltrimethyl chloride (C12-18 TMAC), according to OECD
Guideline 408 and EU Method B.26, in compliance with GLP. Sprague-Dawley
rats were administered the test substance at concentrations of 0, 100,
500 or 2000 ppm, corresponding to 22, 113 and 273 mg a.i./kg bw/day) in
the diet for 90 d. The highest dose of 2000 ppm was reduced to 1000 ppm
from Day 29 onwards due to deterioration in health of the test animals
at 2000 ppm. At the highest dose, the treatment-related findings were
clinical signs of toxicity, reduced body weight gain and food
efficiency, organ weight changes and microscopic changes in the spleen
and kidneys. At the mid dose, reduced body weight gain (males) and
reduced food consumption, reduced absolute heart weight and higher
incidence of haemosiderin accumulation in the kidneys of males was
observed. No treatment-related effects were observed at the lowest dose.
Hence, the NOEL was considered to be 100 ppm (i.e. equivalent to 22 mg
a.i./kg bw/day). The changes observed at 500 ppm were considered to be
minor, isolated effects associated with the reduced palatability of the
test substance and were considered not to represent an adverse health
effect. The NOAEL was therefore 500 ppm (i.e. equivalent to 113 mg
a.i./kg bw/day) (Jones, 2002).
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