IJT - CIR - February 2024 - 89S

Burnett et al.
89S
pups surviving, and by measuring body weights at birth and at
weaning on day 21. Skeletal evaluation using X-ray, clinical
pathology and macroscopic examination were performed on
F1 rats. Parental animal parameters assessed were body
weight, food consumption, clinical pathology, organ weights
and macroscopic examination. Fatty acids and hydrocarbon
levels were measured, and various tissues were evaluated in F0
animals for lipogranulomata in Study 2.
Slightly decreased body weight gain, reduced cholesterol,
and increased alkaline phosphatase activities were observed in
rats treated with either shea oleine or hydrogenated shea
oleine. No adverse effects on reproduction from any shea
materials were observed in either study for any parameter.
Results showed that shea oleine, hydrogenated shea oleine,
and Butyrospermum Parkii (Shea) Oil were toxicologically
comparable to the other commercially available materials used
in this study. The authors concluded that there was no evidence
of reproductive toxicity following dietary exposure to
shea oleine, hydrogenated shea oleine, and Butyrospermum
Parkii (Shea) Oil in rats at concentrations equating to 15%
(7.5 g/kg/day).36
Genotoxicity
In Vitro
Butyrospermum Parkii (Shea) Butter and Butyrospermum Parkii
(Shea) Butter Unsaponifiables. A material containing Butyrospermum
Parkii (Shea) Butter (70%) and Butyrospermum
Parkii (Shea) Butter Unsaponifiables (30%) was not mutagenic
in an Ames test.17 The material was tested at 50 to
5000 µg/plate, with and without metabolic activation. No
further details were provided.
Carcinogenicity
Oral
Butyrospermum Parkii (Shea) Oil and Shea Oleine. The carcinogenic
potential of shea oleine and Butyrospermum Parkii
(Shea) Oil were evaluated in a dietary study in ColworthWistar
rats for 104 weeks.16 The study also evaluated palm oil.
Groups of 50 male and 50 female rats received diets containing
15% (w/w; approximately equivalent to 7.5 g/kg/day)
shea oleine, 15% (w/w) Butyrospermum Parkii (Shea) Oil, or
15% (w/w) palm oil. The rats were the offspring ofthe animals
used in the reproduction study described above (study 2) and
the test diets began at weaning (21 days ofage). The following
parameters were assessed: mortality, clinical signs of toxicity,
body weight, feed intake, clinical pathology, organ weights
and macroscopic and histopathological changes plus tumor
type and incidence evaluation.
Final mortality rates for both sexes for shea oleine and
Butyrospermum Parkii (Shea) Oil were in the range of 28 to
30% each, while the mortality rates for both sexes exposed to
palm oil was 40%. No clinical signs of toxicity were found
after exposure to either shea test material. Decreased body
weight gain and increased feed intake were observed in rats of
both sexes fed either shea diets, while reduced cholesterol was
observed in females fed the shea oleine diet. Increased alkaline
phosphatase levels were observed in both sexes fed the Butyrospermum
Parkii (Shea) Oil diet, but this value was only
increased in females fed the shea oleine diet. Decreased heart
weights and an increased incidence of pulmonary lipidosis
were observed in rats of both sexes fed either shea diet. In
females fed either shea diet, an increase in the number of
hepatomas was observed, while in males fed shea oleine,
increases in pancreatic exocrine adenomas and skin keratoacanthomas
were observed. The increase in the incidence of
hepatomas was thought to be related to the high fat content of
the diets and were interpreted to be consistent with previous
tumor data in high fat fed rats. The authors concluded that
none ofthe findings in this study were adverse effects and that
shea oleine and Butyrospermum Parkii (Shea) Oil showed no
tumorigenic potential in the rat at 15% in the diet (7.5 g/kg/
day).16
Dermal Irritation and Sensitization Studies
Irritation
Dermal irritation studies are summarized in Table 5.17,19,37-39
A material containing Butyrospermum Parkii (Shea) Butter
(70%) and Butyrospermum Parkii (Shea) Butter Unsaponifiables
(30%) was non-irritating in an EpiSkin™ assay
when tested undiluted and in a human primary cutaneous
tolerance test at a 30% dilution in paraffin oil. Butyrospermum
Parkii (Shea) Butter Extract at 5% in a moisturizer and Butyrospermum
Parkii (Shea) Seedcake Extract at up to .14%
were not irritating in human studies.
Butyrospermum Parkii (Shea) Butter. In an EpiSkin™ in vitro
assay, 24.1% Butyrospermum Parkii (Shea) Butter in a lip wax
was not an irritant.2 In a rabbit study, Butyrospermum Parkii
(Shea) Butter (concentration not reported) produced very
slight erythema with or without edema in 2/3 rabbits exposed
to the test material for 4 h in an irritation study utilizing
occlusive patches. The erythema was resolved 3 or 4 days after
patching. Butyrospermum Parkii (Shea) Butter did not cause
primary cutaneous irritation when tested at up to 2%. No
irritation to Butyrospermum Parkii (Shea) Butter was observed
in human volunteers for in-use studies of lip gloss or
body/hand massage oils at concentrations up to 45%.
Sensitization
Dermal sensitization studies are summarized in Table 6.17,19,40-45
A material containing Butyrospermum Parkii (Shea) Butter
(70%) and ButyrospermumParkii (Shea) Butter Unsaponifiables
(30%) was negative in a direct peptide reactivity assay (DPRA)

IJT - CIR - February 2024

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IJT - CIR - February 2024 - Cover3
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