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EC number: 305-748-4
CAS number: 95009-22-6
three-generation study, performed to GLP and apparently conducted in
compliance with FDA guidelines, was conducted to investigate the
reproductive toxicity of cocoa powder in Sprague-Dawley rats.
were given cocoa powder in the diet at 0, 1.5, 3.5 or 5% [corresponding
to about 0, 1110, 2670 or 3850 mg/kg bw/day in males, and 0, 1330, 3190
or 4670 mg/kg bw/day in females]. Each generation was mated twice, with
one set of offspring killed at day 21 of lactation, and the other chosen
as parents of the next generation. For the F0 generation, consisting of
35/sex/dose, males were fed for 12 weeks prior to mating. Females were
concurrently kept on a control diet for 10 weeks, then treated for the
last 2 weeks prior to mating. Subsequent females were not subject to the
10-week control diet period.
significant reductions were seen in the mean final (week 12) body weight
of male and female F1b and F2b rats, in males given at least 3.5% and in
high-dose females. No significant body weight effects were seen in the
F0 generation. Food consumption was reduced by about 10% in F2b
high-dose males.Mean plasma cholesterol levels were seen in F1b male
rats in all groups, and in high-dose F1b females, possibly an adaptive
response to a cocoa diet higher in fat than the controls[i1] .
dose-related adverse effects were seen on the fertility of parental
animals, and no significant adverse effects on the weight or
histopathology of the reproductive organs were observed. A statistically
significant increased incidence of kidney lesions was seen
in the high-dose F0 males only.
increases in gross malformations were seen in the offspring of treated
animals, but viability was modestly reduced in the high-dose F2a and F3a
pups, and also in the mid-dose F3b pups. As effects were not seen in the
F2b generation, or in the F3b high-dose pups,these
marginal effects were considered to “probably represent chance
occurrences not related to dietary [cocoa powder] exposure”.
Statistically significant decreases in birth weight were seen in all
treated F1b, F2b and F3a groups. In the low and mid-dose groups, effects
resolved within four days. The high dose was associated with reduced
birth weight for all F1, F2 and F3 groups, with effects, in the majority
of cases, persisting until at least day 21.
authors state that “exposure of rats to dietary [cocoa powder] at
concentrations of up to 5.0% of the diet for three generations caused no
consistent effect on any of the reproductive indices monitored”. The
study found no treatment-related adverse effect on fertility (NOAELs of
3850 and 4670 mg/kg bw/day for males and females, respectively), or on
the incidence of gross malformations in offspring. Reduced birth weight
was seen in the offspring of treated animals (LOAEL: 1330 mg/kg bw/day).
Maternal growth was also reduced at higher concentrations (NOAEL: 3190
mg/kg bw/day). It was suggested that these effects on growth could be
due to different protein bioavailability or utilisation, or other
nutritional or metabolic perturbations.
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