IJT - CIR - February 2024 - 93S

Burnett et al.
93S
identified in a literature search for these ingredients and no
unpublished data were submitted.
Discussion
There are no irritation or sensitization data for Butyrospermum
Parkii (Shea) Nut Extract and Butyrospermum Parkii (Shea)
Nut Shell Powder, and no irritation or sensitization data for
Butyrospermum Parkii (Shea) Seedcake Extract and Butyrospermum
Parkii (Shea) Butter at maximum use concentrations
(5.5 and 100% in leave-on products, respectively).
However, human repeated patch tests for Butyrospermum
Parkii (Shea) Seedcake Extract and Butyrospermum Parkii
(Shea) Butter were negative at lower concentrations (.42 and
70%, respectively). Based on the Panel's clinical experience,
the absence of adverse event reports, and the available negative
safety test data (including negative results from DPRAs),
the Panel does not expect dermal irritation or sensitization
following exposure to these ingredients at reported use
concentrations.
The Panel noted that, because botanical ingredients are
complex mixtures, there is concern that multiple botanical
ingredients in one formulation may each contribute to the final
concentration of a single constituent. While there are no
specific constituents of concern detailed for the Butyrospermum
parkii (shea)-derived ingredients described in this
safety assessment, not all constituents have been identified,
especially for the nut shell and seedcake ingredients. Therefore,
when formulating products, manufacturers should avoid
reaching levels in final formulation of known botanical
constituents that may cause sensitization or other adverse
effects.
The Panel discussed the issue of incidental inhalation exposure
from hair sprays, fragrance preparations, body and hand
sprays, and face powders. There were no inhalation toxicity data
available. The Panel noted that droplets/particles from spray and
loose-powder cosmetic products would not be respirable to any
appreciable amount. The potential for inhalation toxicity is not
limited to respirable droplets/particles deposited in the lungs. In
principle, inhaled droplets/particles deposited in the nasopharyngeal
and thoracic regions of the respiratory tract may cause
toxic effects depending on their chemical and other properties.
However, coupled with the small actual exposure in the breathing
zone and the concentrations at which the ingredients are used, the
available information indicates that incidental inhalation would
not be a significant route of exposure that might lead to local
respiratory or systemic effects. A detailed discussion and summary
of the Panel's approach to evaluating incidental inhalation
exposures to ingredients in cosmetic products is available at
https://www.cir-safety.org/cir-findings.
The Panel also expressed concern about pesticide residues,
heavy metals, and other plant species that may be present in
botanical ingredients. They stressed that the cosmetics industry
should continue to use current good manufacturing
practices (cGMPs) to limit impurities.
Conclusion
The Expert Panel for Cosmetic Ingredient Safety concluded
that the following 13 ingredients are safe in cosmetics in the
present practices of use and concentration described in this
safety assessment when formulated to be non-sensitizing.
Butyrospermum Parkii (Shea) Butter Hydrogenated Shea Butter
Butyrospermum Parkii (Shea) Oil
Hydrogenated Shea Oil*
Butyrospermum Parkii (Shea) Butter
Extractrowhead
Butyrospermum Parkii (Shea) Butter
Unsaponifiables
Butyrospermum Parkii (Shea) Nut
Extract
Butyrospermum Parkii (Shea) Nut Shell
Powder
Butyrospermum Parkii (Shea) Seedcake
Extract
*Not reported to be in current use. Were ingredients in this
group not in current use to be used in the future, the expectation
is that they would be used inproduct categories and
at concentrations comparable to others in this group.
Author's Note
Unpublished sources cited in this report are available from the Director,
Cosmetic Ingredient Review, 1620 L Street, NW, Suite 1200,
Washington, DC 20036, USA.
Author Contributions
The articles in this supplement were sponsored by the Cosmetic
Ingredient Review.
Declaration of Conflicting Interests
The author(s) declared the following potential conflicts of interest
with respect to the research, authorship, and/or publication of this
article: The articles in this supplement were sponsored by the
Cosmetic Ingredient Review.
Funding
The author(s) disclosed receipt of the following financial support for
the research, authorship, and/or publication ofthis article: The articles
in this supplement were sponsored by the Cosmetic Ingredient Review.
The Cosmetic Ingredient Review is financially supported by the
Personal Care Products Council.
References
1. Nikitakis J, Lange B. International Cosmetic Ingredient Dictionary
andHandbook. 16th ed.Washington, DC: Personal Care
Products Council, 2016.
2. Burnett CL, Fiume MM, Bergfeld WF, et al. Final report on
plant-derived Fatty acid oils as used in cosmetics. Int JToxicol.
2017;36(Suppl. 3):51S-129S.
Hydrolyzed Shea Seedcake
Extract*
Shea Butter Glyceride
Shea Butter Glycerides
Shea Oleine
https://www.cir-safety.org/cir-findings

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
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IJT - CIR - February 2024 - 93S
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IJT - CIR - February 2024 - Cover3
IJT - CIR - February 2024 - Cover4
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