IJT - CIR - February 2024 - 88S

88S
International Journal of Toxicology 43(Supplement 1)
shea extracts potentially have anti-inflammatory, antioxidant,
and anti-tumor effects.30-33
ToxicoKinetic Studies
Absorption, Distribution, Metabolism, and
Excretion (ADME)
Animal
Oral. In an oral absorption and excretion study, groups of
Colworth Wistar male rats were fed shea oleine in a
semisynthetic diet.34 In a low-dose experiment, groups of
24 rats received control feed, feed containing .5% shea
oleine, or feed containing 5% shea oleine for 1 week, with
controlfeedadministeredtoall rats the week prior and the
week following the exposure week. In a high-dose experiment,
2 groups of 15 male and 15 female rats received
either 10 or 20% shea oleine in the feed for 3 weeks. In the
first experiment, feces were collected and pooled weekly for
each treatment group throughout weeks 2 and 3. In the
second experiment, feces were collected and pooled for
each treatment group in week 3 only. The dried fecal matter
of the rats was then analyzed with thin-layer and gas-liquid
chromatography for fecal lipid, total sterol, differential
sterol levels, and, specifically, 4,4-dimethylsterols (the
main sterol fraction (∼97%) of shea oleine). Excretion of
4,4-dimethylsterols increased with the consumption of shea
oleine. Apparent absorption was 27 to 52% and was estimated
from the disappearance of 4,4-dimethylsterols from
the feces. The majority of the 4,4-dimethylsterols was
excreted unchanged.
Human
Oral. The oral absorption and excretion of shea oleine was
studied in 4 male volunteers.34 On day 3 ofan 8 day period, the
subjects consumed a single 25 g portion (approximately .4 g/
kg) ofshea oleine in mayonnaise. No other vegetable fats were
consumed during the course ofthe study. Feces were collected
on days 3 to 8 inclusively, freeze-dried, and weighed. The
dried fecal matter was analyzed in the manner described
above. Excretion of 4,4-dimethylsterols increased with the
consumption of shea oleine, with a marked increase from
baseline on days 4 and 5 and a return to approximate baseline
on day 8. Absorption of 4,4-dimethylsterols was estimated to
be 13 to 49%. The majority of the 4,4-dimethylsterols was
excreted unchanged.
Toxicological Studies
Acute Toxicity Studies
No relevant published acute toxicity studies on Butyrospermumparkii
(shea)-derived ingredients were identified in
a literature search for these ingredients, and no unpublished
data were submitted.
Subchronic Toxicity Studies
Shea Oleine. In a 13-week rat feeding study, groups of15 male
and 15 female Colworth-Wistar rats received a diet containing
20% (w/w; 10 to 15 g/kg/day) shea oleine or hydrogenated
shea oleine.35 Additional groups of15 male and 15 female rats
were fed either 20% (w/w) palm oil, soy bean oil, or the
hydrogenated equivalents. During the exposure period, body
weight, food and water consumption, urine chemistry, and
clinical pathology were assessed. Gross necropsy and microscopic
examination of select tissues and organs were
performed at study completion.
Results showed that shea oleine diets produced biological
effects similar to those of palm oil and soy bean oil diets.
Slightly reduced body weight gain was observed in rats fed
either of the shea oleine diets when compared to diets with
palm oil and soy bean oil. No significant differences in body
weight gains were observed between rats fed hydrogenated
shea oleine versus non-hydrogenated shea oleine. Slightly
reduced cholesterol levels, increased aminotransferase levels,
and lower triglyceride and alanine aminotransferase values
were observed in rats fed non-hydrogenated diets, as were
increased liver weights and reduced liver-lipid values. These
changes were not considered to be biologically significant.
Also considered biologically insignificant by the authors were
raised alkaline phosphatase levels and increased food consumption
in rats fed hydrogenated shea oleine. The authors
concluded that all diets were well tolerated in the rats and
considered none of the findings in this study to be adverse.35
Chronic Toxicity Studies
Butyrospermum Parkii (Shea) Oil and Shea Oleine. See Carcinogenicity
section below.
Developmental and Reproductive Toxicity
(DART) Studies
Oral
Butyrospermum Parkii (Shea) Oil and Shea Oleine. The reproductive
toxicity potential of shea oleine and hydrogenated
shea oleine was assessed in two dietary studies in rats.36 In
study 1, groups of20 male and 20 female Colworth-Wistar rats
received 7% (w/w; 3.5 g/kg/day) of either type of shea oleine
in their diet for 20 weeks (breeding began at week 12 and
lasted for 2 weeks). In study 2, groups of 50 male and 50
female Colworth-Wistar rats received 15% (w/w; 7.5 g/kg/
day) of either type of shea oleine or Butyrospermum Parkii
(Shea) Oil in their diets for 10 weeks (breeding began at week
2 and lasted for 1 week). Both studies also evaluated other
commercially available materials, such as palm oil and cocoa
butter. The rats received the test materials during pre-mating,
mating, pregnancy and offspring weaning. Reproduction was
assessed by counting the number of litters, pups born, and

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