IJT - CIR - February 2024 - 78S

78S
International Journal of Toxicology 43(Supplement 1)
Discussion
This report assesses the safety of cosmetic ingredients derived
from the plant Ginkgo biloba. Because final product formulations
may contain multiple botanicals, each possibly containing
the same constituents of concern, formulators are
advised to be aware ofthese constituents and to avoid reaching
levels that may be hazardous to consumers. For Ginkgo bilobaderived
ingredients, the Panel was concerned about the presence
of ginkgolic acid in cosmetics, which is a known dermal
sensitizer. Therefore, when formulating products, manufacturers
should avoid reaching levels of plant constituents that
may cause sensitization or other adverse health effects.
The Panel determined that the available safety test data,
methods of manufacturing, and composition and impurities
data on Ginkgo Biloba Leaf Extract are sufficient, and reasonable
inferences to the safety of the 4 other leaf-derived
ingredients can be made. The Panel considered the findings of
the carcinogenicity studies performed by the NTP on a Ginkgo
biloba leaf extract where positive carcinogenic effects were
observed in animals, especially in the high-dose groups. The
Ginkgo biloba leaf extract evaluated by the NTP contained
unusually high concentrations of certain constituents that are
markedly different from those found in the leafextracts used in
dietary supplements. The NTP study administered this specific
leaf extract at high doses by gavage, allowing for concentrations
in the blood that would not be expected through
cosmetic use. Additionally, the leaf extract used in dietary
supplements did not produce increased incidences ofcancer in
a dietary study. This result, combined with a long history of
use of Ginkgo biloba leaf extracts in folk medicine, indicate
that the findings of the NTP carcinogenicity study are not
relevant to cosmetic use in humans.
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.
Ginkgo Biloba LeafExtract was reported to be used in spray
and powder products that could possibly be inhaled, such as
pump spray suntan products at a maximum concentration of
.05%, and face powders at a maximum concentration of .05%.
There were no inhalation toxicity data available. Although 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 ofthe 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.
After reviewing this safety assessment, the Panel determined
that although a conclusion of safety could be made for
five Ginkgo biloba leaf-derived ingredients, the data are insufficient
to determine the safety of the remaining five ingredients:
Ginkgo Biflavones, Ginkgo Biloba Meristem Cell,
Ginkgo Biloba Nut Extract, Ginkgo Biloba Root Extract, and
Ginkgo Leaf Terpenoids. The data needed to issue a conclusion
of safety for these cosmetic ingredients are:
· Method of manufacturing, composition, and impurities
data for each ofthese ingredients, except Ginkgo Biloba
Meristem Cell;
· 28 Day dermal toxicity data for each of these
ingredients,
(a) Dependent on the results of these studies, additional
data on other toxicological endpoints, such
as developmental and reproductive toxicity and
carcinogenicity, may be needed;
· Dermal irritation and sensitization data at leave-on use
concentrations; and
· Ocular irritation data, if available.
Conclusion
The Expert Panel for Cosmetic Ingredient Safety concluded
that the following Ginkgo biloba-derived ingredients are safe
in cosmetics in the present practices of use and concentration
described in this safety assessment when formulated to be
non-sensitizing:
Ginkgo Biloba Leaf Extract
Ginkgo Biloba Leaf*
Ginkgo Biloba Leaf Powder
Ginkgo Biloba Leaf Water*
Ginkgo Biloba Leaf Cell 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.
The Panel also concluded that the available data are insufficient
to make a determination that the following Ginkgo
biloba-derived ingredients are safe under the intended conditions
of use in cosmetic formulations:
Ginkgo Biflavones**
Ginkgo Biloba Meristem Cell**
Ginkgo Biloba Root Extract**
Ginkgo Leaf Terpenoids**
Ginkgo Biloba Nut Extract
**Not reported to be in current use.
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.
https://www.cir-safety.org/cir-findings

IJT - CIR - February 2024

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IJT - CIR - February 2024 - Cover3
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