IJT - CIR - February 2024 - 90S

90S
International Journal of Toxicology 43(Supplement 1)
Table 5. Dermal Irritation Studies for Butyrospermum parkii (Shea)-Derived Ingredients.
Test Article
Concentration/
Dose
70% Butyrospermum Parkii
(Shea) Butter and 30%
Butyrospermum Parkii
(Shea) Butter
Unsaponifiables
Butyrospermum Parkii (Shea)
Butter Extract
undiluted
Test
Population
N/A
Procedure
In Vitro
EpiSkin™ assay in accordance
with OECD TG 439; no
further details provided
Human
5% in a
moisturizer
46 subjects Single-blind, 4-week clinical use
study; test material applied
twice daily in place of regular
moisturizer; study supervised
by a dermatologist who
conducted baseline, 2-week
interim, and final exams
Butyrospermum Parkii (Shea)
Butter Extract
70% Butyrospermum Parkii
(Shea) Butter and 30%
Butyrospermum Parkii
(Shea) Butter
Unsaponifiables
Butyrospermum Parkii (Shea)
Seedcake Extract (supplied
as 2.8% in 47.2% water and
50.0% butylene glycol)
Butyrospermum Parkii (Shea)
Seedcake Extract
5% in a
moisturizer
30% diluted in
paraffin oil
18 subjects 24-h single insult patch test;
undiluted; occluded
(Blenderm patch); no further
details provided
10 subjects 48-h primary cutaneous
tolerance test; single patch;
treated sites examined
30 min and 24 h post-patch
removal; no further details
provided
product diluted
to 5%
23 subjects 48-h primary cutaneous
tolerance test; single
occlusive patch; no further
details provided
.006% in a SPF 50
cream
41 subjects 4-week cutaneous " in-use " test;
once daily application to face,
neck, and neckline; no sun
exposure; study supervised
by a dermatologist who
conducted baseline and final
exams
No irritation
37
Non-irritating
17
Results
Reference
No irritation
38
No irritation
17
48-h after application, one skin
reaction observed on the
treated site and one on the
control site; mean irritation
index = .04; product was
considered non-irritating
Good cutaneous acceptability
19
39
when tested undiluted, thereby indicating a lack of sensitizing
potential. Butyrospermum Parkii(Shea)ButterExtract was nonsensitizing
in human patch tests at up to 5% in formulation.
Butyrospermum Parkii (Shea) Seedcake Extract at .14% did not
produce sensitization reactions in 15 human subjects in a nonstandard
sensitization study where a 48-h cutaneous patch test
was followed 6-8 weeks later with another 48-h patch test.
ButyrospermumParkii (Shea) Seedcake Extract was not irritating
or sensitizing in human repeat insult patch tests (HRIPTs) at
concentrations up to .42%.
Butyrospermum Parkii (Shea) Butter. Butyrospermum Parkii
(Shea) Butter was not sensitizing in a guinea pig maximization
study.2 The induction concentration was 75% and the challenge
concentrations were 20 and 50%. No sensitization was
observed in multiple HRIPTs with products containing Butyrospermum
Parkii (Shea) Butter. Concentrations tested were
up to 60%.
Phototoxicity and Photosensitization
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 considered
non-phototoxic in a 3T3 NRU assay when tested at .005 to
1 mg/mL.17 This study was performed in accordance to Organization
for Economic Co-operation and Development's
(OECD) TG 432. No further details were provided.

IJT - CIR - February 2024

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