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EC number: 931-292-6
CAS number: 308062-28-4
The following gonadal tissues were examined for all
control and high dose group animals at 4 and 13 weeks: testes, ovaries,
prostate, uterus, vagina, seminal vesicles, inguinal mammary gland. No
test substance-related microscopic or macroscopic changes were seen in
any of these tissues at any dose level.
Additionally, organ weights were performed for each
animal for the testes and ovaries; absolute and relative (to body) organ
weights were determined. Absolute and relative organ weights for the
high dose animals sacrificed at 4, 13, and 14 weeks were significantly
altered when compared to control animals. These findings likely reflect
the effect of suppressed body weight gain in the high dose group, as a
result of the animals' reluctance to consume the diet mixture.
A 13-week repeated dose toxicity study was conducted
where C10-C16 alkyldimethyl, N-oxide was administered by oral
administration in the diet daily to three groups of 20 male and 20
female Charles River CD Sprague-Dawley rats at dosage levels of 0.02,
0.1, and 0.5%. A fourth group of 20 male and 20 female rats received the
basal diet only and served as the control. Five males and five females
from each treatment group (including untreated control group) were
sacrificed at 4 weeks, 10 males and 10 females were sacrificed after 13
weeks, and the remaining animals, after review of the previous necropsy
findings, were sacrificed at the end of week 14.
The effect of C10-C16 alkyldimethyl, N-oxide on the rats
was evaluated according to physical appearance, behavior, growth
(weekly), food consumption (weekly), survival, clinical laboratory
studies (blood and urine), microscopic eye examinations, organ weights,
and gross and microscopic pathology. No adverse effects were observed in
rats consuming diets containing 0.02 or 0.1% C10-C16 alkyldimethyl,
N-oxide. Male and female rats receiving diets containing 0.5% test
substance generally consumed less diet (grams of diet/kg body weight),
and a depression in the average body weight gain was observable by the
end of the first week. This sign continued throughout the 14 weeks with
growth rates, food consumption, and terminal body weights for these
animals being significantly affected. The alterations observed in the
absolute and relative organ weights (including the testes and ovaries)
in the 0.5% treatment group probably were secondary to body weight
effects. Clinical laboratory findings for the high dose group animals
generally remained within acceptable limits; however, slight electrolyte
imbalance and slight elevation of alkaline phosphatase and blood urea
nitrogen values were evident in some animals. Subsequent histopathology
failed to confirm an indication of alterations in organ morphology and
these findings may be related to the decrease in food consumption.
Gonadal tissues were examined for both gross pathology and
histopathology and no treatment-related effects were detected.
Significantly, 2/20 males and 2/20 females in the 0.5%
treatment group developed moderate to severe bilateral cataracts. The
incidence and early appearance of these cataracts in only the high dose
group suggests that these ocular changes may be an effect of test
substance treatment. This effect could be a direct effect of C10-C16
alkyldimethyl, N-oxide or an indirect effect caused by the effect of the
test substance on food consumption and nutrient absorption or
utilization. Based on these results, the NOAEL for the C10 -C16
alkyldimethyl, N-oxide was 0.1% (in the diet) or 1000 mg DDAO/kg diet.
Using a food consumption factor of 0.088 kg food/kg bw/day for rats of
this strain and age, this translates into a delivered dose of 88 mg
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