IJT - CIR - February 2024 - 75S

Burnett et al.
75S
fraction of the crude GBE, or diphenylhydantoin (positive
control group) at doses of 2 mg each. The negative control
yielded small enlargement ofthe lymph nodes, while the crude
ethanolic-aqueous GBE resulted in statistically significant
lymphoproliferative reaction (LPR) in the ipsilateral popliteal
lymph node. A massive lymph node hyperplasia that was
almost comparable to the positive control was observed in the
heptane solution fraction of the crude GBE. Chemical analyses
of the crude extract and the heptane fraction found
ginkgolic acid at 5.5% and 24.6%, respectively, which were
theorized to be responsible for the LPR observed in this study.
Dermal Irritation and Sensitization Studies
Irritation
Human. No irritation was observed in a 24-h human patch test
of a Ginkgo Biloba Leaf Extract (100%; ethanol:water: butylene
glycol extract) in 20 subjects.6 No further details were
provided.
Sensitization
Animal. The sensitizing potential ofginkgolic acid and a GBE
was studied in 10 female albino guinea pigs using a modified
Freund's complete adjuvant (FCA) technique.56 The pure
ginkgolic acid was extracted from Ginkgo biloba fruit and the
GBE was a prepared through water:acetone extraction and
contained 24% flavone glycosides and ∼1000 ppm (∼.1%)
ginkgolic acid. The animals received intradermal injections
(up to .15 mL) of an emulsion containing 4 mL physiological
saline, 4 mL FCA, 15 mg of the pure ginkgolic acid, and
30 mg ginkgolic acid-containing leaf extract on to the clipped
and shaved shoulder area on days 1, 5, and 9 ofthe study. After
an 11-d rest period, the animals were challenged with .1% and
1% ginkgolic acid and 10% GBE in acetone on the clipped and
shaved right flank. All animals exhibited sensitization to pure
ginkgolic acid, while none were sensitized to the GBE that
contained 1000 ppm ginkgolic acid.
Number of
Subjects
Human. Human dermal sensitization studies are summarized
in Table 6. No dermal irritation or sensitization was observed
in human repeat insult patch tests (HRIPTs) of products
containing up to .2% Ginkgo Biloba Leaf Extract.57-60
Cross-Reactivity
Guinea pig sensitization studies of crude Ginkgo biloba fruit
extract, the main aromatic components of the fruit, and
urushiol found no cross-reactions among the compounds.61 It
was also determined that ginkgolic acid was the main allergen
in Ginkgo biloba.
Phototoxicity/Photosensitization. No phototoxicity or photosensitization
was reported to a lip product containing .0072%
Ginkgo Biloba Leaf Extract in a study of 29 subjects.59 The
test material was applied neat under semi-occlusive patches.
No further details were provided.
Ocular Irritation Studies
In an EpiOcular in vitro assay of an eye product containing
.013% Gingko Biloba Leaf Extract, it was predicted that the
test substance had no potential for eye irritation.59 No further
details were provided.
Clinical Studies
Case Studies
The fruit pulp of the Ginkgo biloba tree has been reported to
cause contact dermatitis, with several cases reported after
patients handled the fruit pulp during extraction of the edible
nut center.3,15,62 Symptoms include intense itching, edema,
papules, and pustules that usually resolve in 7-10 d.
A 66-yr-old woman presented with progressive erythematous
eruption over the face, neck, trunk, and extremities that
started approximately 1 week after the patient had ingested
two 60 mg doses of a GBE supplement.63 No other new
medications or changes in behavior were reported. A physical
Table 6. Human Dermal Sensitization Studies on Ginkgo Biloba Leaf Extract.
Concentration
Method
.0005% in a test article
.0085% in a cream
.0072% in a lip product
.2% in a lotion
52 HRIPT, approximately .05 mL/cm2 applied to the back of
subjects with occlusive patch
48 HRIPT, tested neat under occlusive patch
109 HRIPT, tested neat under occlusive patch
.1% in a leave-on product 201 HRIPT, 4 cm2 semi-occlusive patches; dose density =
.05 mg/cm2
208 HRIPT, .2 mL applied with a 2 cm2 Webril pad and semioccluded
Results
No
dermal irritation or
sensitization
No dermal irritation or
sensitization
No dermal irritation or
sensitization
No sensitization
No sensitization
References
60
59
59
58
57

IJT - CIR - February 2024

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