IJT - CIR - February 2024 - 91S

Burnett et al.
91S
Table 6. Dermal Sensitization Studies for Butyrospermum Parkii (Shea)-Derived Ingredients.
Test Article
Concentration/
Dose
70% Butyrospermum Parkii (Shea)
Butter and 30%
Butyrospermum Parkii (Shea)
Butter Unsaponifiables
undiluted
Test
Population
In Vitro
N/A
Direct peptide reactivity assay
(DPRA); performed in accordance
with the European Centre for the
Validation of Alternative Methods
(ECVAM) protocol; reactivity of test
material evaluated by monitoring
peptide depletion following 24-h
contact between test material and
synthetic cysteine and lysine
peptides; no further details were
provided
Human
Butyrospermum Parkii (Shea)
Butter Extract
2% in a body
lotion
28 healthy
subjects
Maximization test; .05 mL test material
applied neat under an occlusive
dressing to a sodium lauryl sulfate
(SLS) pre-treated site on the upper
arm; five 48-h induction patches
were followed 7-10 days later with
challenge on na¨ıve site
Butyrospermum Parkii (Shea)
Butter Extract
2% in a body
lotion
26 healthy
subjects
Maximization test; .05 mL test material
applied neat under an occlusive
dressing to a SLS pre-treated site on
the upper arm; five 48-h induction
patches were followed 7-10 days
later with challenge on na¨ıve site
Butyrospermum Parkii (Shea)
Butter Extract
5% in a face
cream
25 healthy
subjects
Maximization test; .05 mL test material
applied neat under an occlusive
dressing to a SLS pre-treated site on
the upper arm; five 48-h induction
patches were followed 7-10 days
later with challenge on na¨ıve site
Butyrospermum Parkii(Shea)
Butter Extract
Butyrospermum Parkii (Shea)
Seedcake Extract (supplied as
2.8% in 47.2% water and 50.0%
butylene glycol)
1.7975% in a
lipstick
product diluted
to 5%
104 subjects HRIPT; .2 g test material applied to
area 1 in2 on upper back; semioccluded
15
subjects Subjects were those of the cutaneous
tolerance study described above, in
which 48 h patch test was
considered the induction phase of
the sensitization test; after a 6-8
week rest period, subjects were
challenged with a single occlusive
patch for 48 h; no further details
provided
Butyrospermum Parkii (Shea)
Seedcake Extract (supplied as
2.8% in 47.2% water and 50.0%
butylene glycol)
Butyrospermum Parkii (Shea)
Seedcake Extract
.006% in a SPF 50
cream
103 subjects HRIPT; .02 mL test material applied
over a 50 mm2 area via occlusive
patch (Finn Chambers on Scanpor)
on back
Not irritating or
sensitizing
44
product diluted
to 15%
104 subjects HRIPT; occlusive patch; no further
details provided
Not sensitizing
40
Non-reactive and
considered
non-sensitizing
17
Procedure
Results
References
Not sensitizing
41
Not sensitizing
42
Not a dermal
irritant or
dermal
sensitizer
No reactions
were observed
43
19
Not irritating or
sensitizing; test
score = .01
45

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