IJT - CIR - February 2024 - 68S

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International Journal of Toxicology 43(Supplement 1)
glycosides (quercetin and kaempferol) with a molar mass of
756.7 (quercetin glycoside) and 740.7 (kaempferol glycoside);
5%-7% terpene lactones of which 2.8%-3.4% consists of
ginkgolides A, B, and C and 2.6%-3.2% bilobalide; and less
than 5 ppm (.0005%) ginkgolic acids.14
Ginkgolic acid is a salicylic acid derivative with a C15 side
chain that is related to the pentadecylcatechols (i.e., urushiol)
found in poison ivy.15 One analysis found crude aqueous extracts
ofGinkgo biloba leaf contained up to a total of 30 ppm
urushiols, while the process described in Scheme 1 (i.e., production
of a particular standardized GBE) removed long chain
alkylphenols to below detection levels.5 Other extraction
processes have been seen to result in a specificstandardized
extract material containing 10.45 ppm (.001%) urushiols.9
A cosmetic ingredient supplier reported that a Ginkgo
Biloba LeafExtract produced with ethanol/water and sold in a
tradename mixture with butylene glycol contains .51% flavonol
glycosides, .16% terpene lactones (.08% bilobalide,
.04% ginkgolide A, .02% ginkgolide B, and .02% ginkgolide
C), .21% quercetin, and less than .1 ppm ginkgolic acid.6
A certificate ofanalysis from a cosmetic ingredient supplier
on a Ginkgo Biloba Leaf Extract (solvent not specified) described
the sample as a light tan powder that contained 25.3%
ginkgo flavonol, 6.4% ginkgolides (bilobalide, ginkgolide A,
ginkgolide B, ginkgolide C), 2.3 ppm ginkgolic acid, 100 ppm
free quercetin, 200 ppm free kaempferol, 200 ppm free isorhamnetin,
and less than 20 ppm heavy metals.8
A cosmetic ingredient supplier for a tradename mixture of
Ginkgo Biloba Leaf Extract in an alcohol base reported that
heavy metals were below reporting limits and no residual
pesticides were detected.16 This supplier also reported the 26
allergens defined by the seventh amendment to the EU
Cosmetic Directive were below testing thresholds.
Ginkgo Biloba Meristem Cell. A supplier has reported that
Ginkgo Biloba Meristem Cell is distinctly different from
general GBEs, with major constituents being catechin, gallocatechin,
epigallocatechin, and bilobalide.17,18
UV Absorption
Ginkgo Biloba LeafExtract. In a spectral analysis provided by a
supplier of a Ginkgo Biloba Leaf Extract (ethanol: water:
butylene glycol extract), no maximum UV absorption peaks
were observed in the 280 to 450 nm range.19
Use
Cosmetic
The safety of the cosmetic ingredients included in this assessment
is evaluated based on data received from the US
Food and Drug Administration (FDA) and the cosmetics
industry on the expected use ofthese ingredients in cosmetics.
Use frequencies of individual ingredients in cosmetics are
Non-Cosmetic
GBE is used extensively as an herbal supplement for antiinflammatory,
cognitive-promoting, antioxidant, and vascular
effects at daily doses of120 to 240 mg.2,3,32 In Germany, GBE is
an approved herbal medicine for use for treatment of memory
collected from manufacturers and reported by cosmetic
product category in the FDAVoluntary Cosmetic Registration
Program (VCRP) database. Use concentration data are submitted
by the cosmetics industry in response to surveys,
conducted by the Personal Care Products Council (Council),
ofmaximum reported use concentrations by product category.
According to 2018 VCRP survey data, Ginkgo Biloba Leaf
Extract has the most reported uses in cosmetic products, with a
total of 712; the majority of the uses are in leave-on eye
makeup preparations and skin care products (Table 4).20 Two
other Ginkgo-derived ingredients, Ginkgo Biloba Leaf
Powder and Ginkgo Biloba Nut Extract, are reported to be in
use, with 27 or fewer uses reported in the VCRP. However, the
results of a concentration of use survey conducted by the
Council in 2014 (and those of an updated survey for Ginkgo
Leaf Cell Extract conducted in 2018) indicate use for only
Ginkgo Biloba Leaf Extract, at a maximum rinse-off concentration
of.25%, as reported in skin cleansing products, and
at a maximum leave-on concentration of .24%, as reported in
manicuring preparations.21-23 Ingredients with no reported
uses in the VCRP or by the Council are listed in Table 5.
Ginkgo Biloba LeafExtract may be used in products that can
be incidentally ingested or come into contact with mucous
membranes; for example, use is reported in a lipstick at up to
.2%.20,22 Additionally, Ginkgo Biloba Leaf Extract has been
reported to be used in products that may come into contact with
the eyes, such as eye shadows and eye lotions at up to .01%.20,22
Moreover, Ginkgo Biloba Leaf Extract was reported to be
used in spray products that could possibly be inhaled, like
pump spray suntan products at a maximum concentration of
.05%.22 In practice, 95% to 99% of the droplets/particles
released from cosmetic sprays have aerodynamic equivalent
diameters >10 μm, with propellant sprays yielding a greater
fraction ofdroplets/particles below 10 μm compared with pump
spray.24-27 Therefore, most droplets/particles incidentally inhaled
from cosmetic sprays would be deposited in the nasopharyngeal
and bronchial regions and would not be respirable (i.e., they
would not enter the lungs) to any appreciable amount.24,26
Ginkgo Biloba Leaf Extract is also used in powders, and
these products could possibly be inhaled; for example, it is used
in face powders at a maximum concentration of .05%. Conservative
estimates ofinhalation exposures to respirable particles
during the use ofloose powder cosmetic products are 400-fold to
1000-fold less than protective regulatory and guidance limits for
inert airborne respirable particles in the workplace.28-30
The Ginkgo biloba-derived ingredients described in this
report are not restricted from use in any way under the rules
governing cosmetic products in the European Union.31

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
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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
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IJT - CIR - February 2024 - 20S
IJT - CIR - February 2024 - 21S
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IJT - CIR - February 2024 - 23S
IJT - CIR - February 2024 - 24S
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IJT - CIR - February 2024 - 51S
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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
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IJT - CIR - February 2024 - 88S
IJT - CIR - February 2024 - 89S
IJT - CIR - February 2024 - 90S
IJT - CIR - February 2024 - 91S
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IJT - CIR - February 2024 - 101S
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IJT - CIR - February 2024 - 103S
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IJT - CIR - February 2024 - 105S
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IJT - CIR - February 2024 - Cover3
IJT - CIR - February 2024 - Cover4
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