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EC number: 215-222-5
CAS number: 1314-13-2
Groups of 20 male and 20 female
Sprague-Dawley rats were fed zinc monoglycerolate at dietary levels of
0, 0.05 or 0.2% (equal to 0, 31.52 or 127.52 mg/kg for
males and 0, 35.78 or 145.91 mg/kg bw for females, respectively) for a
period of 13 weeks in a study performed according to OECD 408. A similar
group was fed 1% (equal to 719 and 805 mg/kg bw/day for males and
females, respectively) of zinc monoglycerolate up to day 58 of the study
when a deterioration in their clinical condition (poor physical health
and reduced food intake) necessitated reducing the dietary level to 0.5%
(equal to 632 and 759 mg/kg bw/day for males and females, respectively).
However, as no improvement occurred these rats were killed on humane
grounds on day 64 of the study. These rats developed hypocupremia
manifested as a hypochromic microcytic regenerative type anaemia (low
haemoglobin and haematocrit, decreased MCV and MCH, and increased MCHC,
red blood cell and reticulocyte count). Enlargement of the mesenteric
lymph nodes and slight pitting of the surface of the kidneys were noted.
Severe pancreatic degeneration and pathological changes in the spleen,
kidneys, incisors, eyes and bones were observed. The testes of all males
showed hypoplasia of the seminiferous tubules to a varying degree and in
addition the prostate and seminal vesicles showed hypoplasia. In all but
one female the uterus was hypoplastic.
All other rats survived to the end of the 13
weeks treatment. At a dietary level of 0.2% increases in plasma ALAT,
alkaline phosphatase and creatine kinase were observed in males and in
plasma creatine kinase in females. Total plasma cholesterol was reduced
in both males and females. The changes were statistically significant
but small in absolute terms. No changes in haematological parameters
were seen at 0.05 and 0.2%. A dose related reduction in the quantity of
abdominal fat was noted in male rats at 0.05 and 0.2%. Enlargement of
the mesenteric lymph nodes was apparent in 6 out of 20 rats fed 0.2% and
in one male fed 0.05%. Microscopic examination showed a reduction in the
number of trabeculae in the metaphysis of the tibia of 5 male and 3
female rats fed 0.2%, 4 males and 1 female had a similar reduction in
the metaphysis of the femur. Pancreatic cell necrosis was seen in both
sexes at 0.2% and a slight, but statistically not significant increase
could be noted at 0.05% (3 males and 1 female). This pancreatic cell
necrosis was seen also in 1 control male. A reduction in the number of
pigmentated macrophages in the red pulp of the spleen was observed in
both sexes at 0.2% and a marginal reduction was also seen in males at
0.05%. In the animals given 0.05 and 0.2% no effects were found on the
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