IJT - CIR - February 2024 - 92S

92S
International Journal of Toxicology 43(Supplement 1)
Animal
Butyrospermum Parkii (Shea) Butter. Butyrospermum Parkii
(Shea) Butter was not phototoxic in guinea pigs when tested at
10 and 20% in acetone.2 The test sites were irradiated with
UV-B light for 80 seconds followed by UV-A light for 80 min.
Ocular Irritation Studies
Animal
Butyrospermum Parkii (Shea) Butter. While mild conjunctival
reactions were observed, undiluted Butyrospermum Parkii
(Shea) Butter was considered not irritating when tested in the
eyes of male rabbits.2
Mucous Membrane Irritation Studies
In Vitro
Butyrospermum Parkii (Shea) Butter and Butyrospermum Parkii
(Shea) Butter Unsaponifiables. A balm containing 1.5% of the
mixture Butyrospermum Parkii (Shea) Butter (70%) and
Butyrospermum Parkii (Shea) Butter Unsaponifiables (30%)
was considered non-irritating in a SkinEthic™ reconstituted
mucous membrane model.17 Approximately 10 µl ofthe balm
was applied undiluted for 24 h. The negative control was
phosphate buffer saline and the positive control was .1 and 3%
sodium dodecyl sulfate. No further details were provided.
Summary
The 13 Butyrospermum parkii (shea)-derived ingredients
detailed in this report function mainly as skin and hair conditioning
agents in personal care products. Studies on Butyrospermum
Parkii (Shea) Butter and Butyrospermum Parkii
(Shea) Butter Unsaponifiables included in the 2011 safety
assessment ofplant-derived fatty acid oils are not included this
this summary. The original safety assessment found these
ingredients to be safe as used in cosmetics.
According to 2017 VCRP data, Butyrospermum Parkii
(Shea) Butter has the most reported uses of the ingredients
listed in this safety assessment in cosmetic products, with a
total of 5447; nearly three-fourths of the uses are in leave-on
formulations. Butyrospermum Parkii (Shea) Butter Extract
has the second greatest number ofoverall reported, with a total
of 560; about two-thirds of the uses are in leave-on formulations.
The results of the concentration of use survey conducted
in 2016 by the Council indicate Butyrospermum Parkii
(Shea) Butter has the highest reported maximum concentration
of use; it is used at up to 100% in moisturizers. Butyrospermum
Parkii (Shea) Oil is used at up to 11% in a lipstick.
No uses were reported for Hydrogenated Shea Oil or Hydrolyzed
Shea Seedcake Extract.
Butyrospermum Parkii (Shea) Oil is a GRAS direct food
additive in the U.S. It is used as a cocoa butter substitute in
confections and frostings, coatings of soft candy, and sweet
sauces and toppings. It is also used as a margarine or shortening.
Components of shea extracts reportedly have potential
anti-inflammatory, antioxidant, and anti-tumor effects.
Oral absorption and excretion studies ofrats fed up to 20%
shea oleine in a semisynthetic diet found excretion of 4,4dimethylsterols
increased with the consumption of shea
oleine. Apparent absorption of shea oleine was 27 to 52%, as
measured by 4,4-dimethylsterols. The majority of the 4,4dimethylsterols
was excreted unchanged. The findings for the
absorption and excretion of approximately .4 g/kg in a single
dose study of human volunteers were similar, with the absorption
ofshea oleine estimated to be 13 to 49%, as measured
by 4,4-dimethylsterols.
In a 13-week rat feeding study, shea oleine or hydrogenated
shea oleine (20% w/w, equivalent to 10-15 g/kg/day, for both
test materials) did not produced adverse effects. No reproductive
effects were observed in rats fed shea oleine, hydrogenated
shea oleine, or Butyrospermum Parkii (Shea) Oil
(up to 15% w/w, equivalent to 7.5 g/kg/day, for all test materials)
for up to 20 weeks. No tumorigenic potential or adverse
effects to shea oleine or Butyrospermum Parkii (Shea)
Oil (15% w/w, equivalent to 7.5 g/kg/day) were observed in a
carcinogenicity study in the offspring of the rats from the
reproductive study.
A material containing Butyrospermum Parkii (Shea) Butter
(70%) and Butyrospermum Parkii (Shea) Butter Unsaponifiables
(30%) was not mutagenic in an Ames test.
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 tested 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 irritation studies.
A material containing Butyrospermum Parkii (Shea) Butter
(70%) and Butyrospermum Parkii (Shea) Butter Unsaponifiables
(30%) was considered non-sensitizing in a
DPRA when tested undiluted. Butyrospermum Parkii (Shea)
Butter Extract was non-sensitizing in human patch tests at up
to 5% in formulation. Butyrospermum Parkii (Shea) Seedcake
Extract did not produce sensitization reaction in humans in a
non-standard sensitization study (at .14%) or in HRIPTs (at up
to .42%).
A material containing Butyrospermum Parkii (Shea) Butter
(70%) and Butyrospermum Parkii (Shea) Butter Unsaponifiables
(30%) was considered non-phototoxic in a 3T3
NRU assay when tested at .005 to 1 mg/mL.
A balm containing 1.5% of the mixture Butyrospermum
Parkii (Shea) Butter (70%) and Butyrospermum Parkii (Shea)
Butter Unsaponifiables (30%) was considered non-irritating in
a SkinEthic™ reconstituted mucous membrane model.
No relevant published acute toxicity or case reports on
Butyrospermum parkii (shea)-derived ingredients were

IJT - CIR - February 2024

Table of Contents for the Digital Edition of IJT - CIR - February 2024

Contents
IJT - CIR - February 2024 - Cover1
IJT - CIR - February 2024 - Cover2
IJT - CIR - February 2024 - 1S
IJT - CIR - February 2024 - 2S
IJT - CIR - February 2024 - Contents
IJT - CIR - February 2024 - 4S
IJT - CIR - February 2024 - 5S
IJT - CIR - February 2024 - 6S
IJT - CIR - February 2024 - 7S
IJT - CIR - February 2024 - 8S
IJT - CIR - February 2024 - 9S
IJT - CIR - February 2024 - 10S
IJT - CIR - February 2024 - 11S
IJT - CIR - February 2024 - 12S
IJT - CIR - February 2024 - 13S
IJT - CIR - February 2024 - 14S
IJT - CIR - February 2024 - 15S
IJT - CIR - February 2024 - 16S
IJT - CIR - February 2024 - 17S
IJT - CIR - February 2024 - 18S
IJT - CIR - February 2024 - 19S
IJT - CIR - February 2024 - 20S
IJT - CIR - February 2024 - 21S
IJT - CIR - February 2024 - 22S
IJT - CIR - February 2024 - 23S
IJT - CIR - February 2024 - 24S
IJT - CIR - February 2024 - 25S
IJT - CIR - February 2024 - 26S
IJT - CIR - February 2024 - 27S
IJT - CIR - February 2024 - 28S
IJT - CIR - February 2024 - 29S
IJT - CIR - February 2024 - 30S
IJT - CIR - February 2024 - 31S
IJT - CIR - February 2024 - 32S
IJT - CIR - February 2024 - 33S
IJT - CIR - February 2024 - 34S
IJT - CIR - February 2024 - 35S
IJT - CIR - February 2024 - 36S
IJT - CIR - February 2024 - 37S
IJT - CIR - February 2024 - 38S
IJT - CIR - February 2024 - 39S
IJT - CIR - February 2024 - 40S
IJT - CIR - February 2024 - 41S
IJT - CIR - February 2024 - 42S
IJT - CIR - February 2024 - 43S
IJT - CIR - February 2024 - 44S
IJT - CIR - February 2024 - 45S
IJT - CIR - February 2024 - 46S
IJT - CIR - February 2024 - 47S
IJT - CIR - February 2024 - 48S
IJT - CIR - February 2024 - 49S
IJT - CIR - February 2024 - 50S
IJT - CIR - February 2024 - 51S
IJT - CIR - February 2024 - 52S
IJT - CIR - February 2024 - 53S
IJT - CIR - February 2024 - 54S
IJT - CIR - February 2024 - 55S
IJT - CIR - February 2024 - 56S
IJT - CIR - February 2024 - 57S
IJT - CIR - February 2024 - 58S
IJT - CIR - February 2024 - 59S
IJT - CIR - February 2024 - 60S
IJT - CIR - February 2024 - 61S
IJT - CIR - February 2024 - 62S
IJT - CIR - February 2024 - 63S
IJT - CIR - February 2024 - 64S
IJT - CIR - February 2024 - 65S
IJT - CIR - February 2024 - 66S
IJT - CIR - February 2024 - 67S
IJT - CIR - February 2024 - 68S
IJT - CIR - February 2024 - 69S
IJT - CIR - February 2024 - 70S
IJT - CIR - February 2024 - 71S
IJT - CIR - February 2024 - 72S
IJT - CIR - February 2024 - 73S
IJT - CIR - February 2024 - 74S
IJT - CIR - February 2024 - 75S
IJT - CIR - February 2024 - 76S
IJT - CIR - February 2024 - 77S
IJT - CIR - February 2024 - 78S
IJT - CIR - February 2024 - 79S
IJT - CIR - February 2024 - 80S
IJT - CIR - February 2024 - 81S
IJT - CIR - February 2024 - 82S
IJT - CIR - February 2024 - 83S
IJT - CIR - February 2024 - 84S
IJT - CIR - February 2024 - 85S
IJT - CIR - February 2024 - 86S
IJT - CIR - February 2024 - 87S
IJT - CIR - February 2024 - 88S
IJT - CIR - February 2024 - 89S
IJT - CIR - February 2024 - 90S
IJT - CIR - February 2024 - 91S
IJT - CIR - February 2024 - 92S
IJT - CIR - February 2024 - 93S
IJT - CIR - February 2024 - 94S
IJT - CIR - February 2024 - 95S
IJT - CIR - February 2024 - 96S
IJT - CIR - February 2024 - 97S
IJT - CIR - February 2024 - 98S
IJT - CIR - February 2024 - 99S
IJT - CIR - February 2024 - 100S
IJT - CIR - February 2024 - 101S
IJT - CIR - February 2024 - 102S
IJT - CIR - February 2024 - 103S
IJT - CIR - February 2024 - 104S
IJT - CIR - February 2024 - 105S
IJT - CIR - February 2024 - 106S
IJT - CIR - February 2024 - 107S
IJT - CIR - February 2024 - 108S
IJT - CIR - February 2024 - 109S
IJT - CIR - February 2024 - 110S
IJT - CIR - February 2024 - 111S
IJT - CIR - February 2024 - 112S
IJT - CIR - February 2024 - 113S
IJT - CIR - February 2024 - 114S
IJT - CIR - February 2024 - 115S
IJT - CIR - February 2024 - 116S
IJT - CIR - February 2024 - 117S
IJT - CIR - February 2024 - 118S
IJT - CIR - February 2024 - Cover3
IJT - CIR - February 2024 - Cover4
https://www.nxtbookmedia.com