IJT - CIR - February 2024 - 55S

Cherian et al.
55S
According to 2020 VCRP survey data, Adenosine has
the highest frequency of use, with a total of 905 formulations
(Table 3).11 Adenosine is most commonly used in
face and neck products (313 formulations) and moisturizing
products (262 formulations). Disodium Adenosine Triphosphate
is reported to be used in 116 formulations, 100 of
which are leave-on formulations. The remaining in-use
ingredients are reported to be used at 96 formulations or
less. The results of the concentration of use survey conducted
by the Council indicate that Adenosine has the
highest concentration of use; it is used at up to 1% in body
and hand products.12 Disodium Adenosine Phosphate is not
reportedtobeinuse.
These ingredients have been reported to be used around
the eyes (e.g., at up to .5% Adenosine Phosphate in mascara).
In addition, Adenosine could result in incidental ingestion as
it is used in lipstick and dentifrices (concentrations ofuse not
reported). Some of the adenosine ingredients are used in
cosmetic sprays and could possibly be inhaled; for example,
Adenosine is reported to be used at .041% in spray moisturizing
formulations, and Adenosine Phosphate is used in
aerosol hair spray formulations at up to .04%. In practice,
most droplets/particles released from cosmetic sprays have
aerodynamic equivalent diameters >10 μm, with propellant
sprays yielding a greater fraction of droplets/particles
<10 μmcomparedwithpump sprays.13,14 Therefore, most
droplets/particles incidentally inhaled from cosmetic sprays
would be deposited in the nasopharyngeal and thoracic regions
ofthe respiratory tract and would not be respirable (i.e.,
would not enter the lungs) to any appreciable amount.15,16
Adenosineisreportedtobeusedin face powdersatconcentrations
up to .1% and could be incidentally inhaled.
Conservative estimates of inhalation exposures to respirable
particles during the use of loose powder cosmetic products
are 400-fold to 1000-fold less than protective regulatory and
guidance limits for inert airborne respirable particles in the
workplace.17-19
All ofthe adenosine ingredients named in this report are not
restricted from use in any way under the rules governing
cosmetic products in the European Union.20
Non-Cosmetic
Adenosine. According to the US FDA, Adenosine is used for
the treatment of paroxysmal supraventricular tachycardia and
approved for use in nuclear stress testing in patients who
cannot exercise adequately.21 Adenosine is typically given
intravenously at a dose of .84 mg/kg.22 In 2013, the FDA
issued a warning informing health care professionals of the
rare but serious risk ofheart attack with the use ofAdenosinecontaining
drugs in nuclear stress testing. Health care professionals
are advised to avoid using this ingredient in patients
with signs or symptoms of unstable angina or cardiovascular
instability. In addition, Adenosine is used to treat surgical and
nerve pain, and pulmonary hypertension.23,24
Adenosine Phosphate and Adenosine Triphosphate. According to
21 CFR 216.24, all drug products containing Adenosine
Phosphate or Adenosine Triphosphate were withdrawn or removed
from the market because the product or product components
were found to be neither safe nor effective for its
intended use as a vasodilator and anti-inflammatory. Adenosine
Phosphate is used in the therapeutic treatment ofherpes, postherpetic
neuralgia, photosensitivity, and porphyria cutanea
tarda.25-27 Adenosine Triphosphate has been previously reported
to treat acute kidney failure, high blood pressure, cystic
fibrosis, and lung cancer.28,29 Adenosine Triphosphate has
also been reported to be used as an ergogenic aid used by
athletes.30
Toxicokinetic Studies
Dermal Penetration
In vitro
Adenosine. In a dermal penetration study, human skin
samples (500 μm thick) were mounted in stainless steel doubly
jacketed diffusion cells.31 The acceptor solution consisted of
phosphate buffered saline and the test substance consisted of
Adenosine (1.5 or 3%) in propionic acid, (.5%) in hexanoic
acid, or (1.5%) in a binary vehicle of propionic and hexanoic
acid. A volume of 450 μL of the test substance was pipetted
into the donor reservoir. Perfusate samples were collected after
25 or 30 min, and analyzed. The observed optimal permeability
coefficients (Kp) ofAdenosine from the binary vehicle,
propionic acid solution, and hexanoic acid solution were
.0004, .00012, and .00016 cm/min, respectively.
Absorption, Distribution, Metabolism, and
Excretion (ADME)
Animal
Oral
Adenosine Phosphate. Male and female Wistar rats
(number of animals not stated) were given a single dose of
10 mg/kg [14C]Adenosine Phosphate dissolved in 9% aqueous
sodium chloride via gavage.32 The specific activity of the
[14C]Adenosine Phosphate was reported to be 46 mCi/mmol.
Within 72 h of administration, 28% of the administered activity
was excreted in the urine and 6% was recovered in the
feces. Plasma levels of Adenosine Phosphate were maximal
approximately 30 min after oral administration. Adenosine
Phosphate was considered to be rapidly absorbed by the intestinal
mucosa and quickly distributed 2 h after absorption;
only 20% of the maximal concentration remained in the
plasma.
Human
Oral
Adenosine Triphosphate. Eight volunteers were given
single doses of5000mgAdenosine Triphosphate or placebo via

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IJT - CIR - February 2024 - Cover3
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