IJT - CIR - February 2024 - 58S

58S
International Journal of Toxicology 43(Supplement 1)
OECD TG 439.2 Ten mg of Adenosine (in powder form;
concentration not provided) were applied to the epidermal
surface. (The epidermal surface was first moistened with
5 μL deionized water to improve contact between the
powder and the epidermis). Phosphate buffered saline and
sodium dodecyl sulfate (5%) were used as the negative and
positive controls, respectively. The test substance did not
significantly reduce cell viability compared to the negative
control. The test substance was predicted to be nonirritating
to the skin.
Animal
Adenosine. According to a risk profile from the Norwegian
Food Safety Authority (NFSA), Adenosine was non-irritating
to animal skin in multiple conventional tests.33 No other
details regarding these studies were provided.
Human
Adenosine. A 48-h patch test was performed on 10 subjects.43
Each subject received an occlusive patch with 15 μLof
a cosmetic ingredient containing .2% Adenosine on the inside
upper arm. Skin reactions were evaluated 1, 24, and 48 h after
patch removal. One hour after patch removal, slight erythema
was observed on one volunteer. However, after 24 and 48 h, no
skin reaction was observed in any subject.
Sensitization
Animal
Adenosine. According to a risk profile from the NFSA,
Adenosine was non-sensitizing in a Magnusson and Kligman
maximization study.33 No other details regarding this study
were provided.
Disodium Adenosine Triphosphate. A Magnusson-Kligman
test was performed on Pirbright white guinea pigs (number of
animals not stated).44 The test substance was a trade name
mixture containing 15% mannitol and 15% Disodium
Adenosine Triphosphate. A .5% aqueous dilution of the test
substance (i.e., .075% mannitol and .075% Disodium
Adenosine Triphosphate) was used for the intracutaneous
induction, and a 10% aqueous dilution of the test substance
(i.e., 1.5% mannitol, 1.5% Disodium Adenosine Triphosphate)
was used for the epicutaneous induction and challenge.
No signs ofirritation or skin reactions indicative ofan immune
response were observed.
Human
Adenosine. A human repeated insult patch test (HRIPT)
was completed in 205 subjects using a test material containing
.2% Adenosine.43 Each of the subjects received .2 mL of the
test substance on the upper back area under a semi-occlusive
patch. After a 24-h exposure period, the patches were removed
and sites were evaluated. A series of 9 test patches were
applied followed by a 2-wk non-treatment period. Challenge
patches were applied to previously unexposed sites and allowed
to remain in skin contact for 24 h. Challenge sites were
scored at 24 and 72 h post patching. No signs of sensitization
were observed.
Disodium Adenosine Triphosphate. An HRIPT was completed
on 50 volunteers using a trade name material consisting
of 15% mannitol and 15% Disodium Adenosine Triphosphate.44
A 10% aqueous dilution of the trade name material
(i.e., 1.5% mannitol, 1.5% Disodium Adenosine Triphosphate)
was applied to the backs ofsubjects under an occlusive
patch for a total of 9 applications within a 3-wk period. A
challenge patch was applied 2 wk later to the previously
exposed area, as well as an unexposed area. Readings were
taken 24, 48, and 96 h after patch removal. No skin reactions
were noted in any volunteers.
Phototoxicity/Photosensitization
Human
Disodium Adenosine Triphosphate. A phototoxicity study
was conducted with a trade name mixture consisting of 15%
mannitol and 15% Disodium Adenosine Triphosphate in 10
volunteers.44 A 10% aqueous solution of the trade name
mixture (i.e., 1.5% mannitol, 1.5% Disodium Adenosine
Triphosphate; .2 mL) was applied under an occlusive patch to
two different areas ofthe forearm, one irradiated and one nonirradiated.
After a 24-h exposure, one site was irradiated with
long-wave ultraviolet light (UVA; 320-400 nm) for 15 min;
the other test site served as a non-irradiated control. Skin
reactions were scored immediately after light exposure as well
as 24 and 48 h later. No reactions were noted on either the
irradiated or non-irradiated test site in any subject.
A photosensitization test was completed on 34 subjects
with a trade name mixture consisting of 15% mannitol and
15% Disodium Adenosine Triphosphate .44 For 3 wk, six 24h
induction patches were applied containing a 2% aqueous
solution (i.e., .3% mannitol, .3% Disodium Adenosine Triphosphate)
of the trade name mixture. Applications were
performed in duplicate; one site was subsequently irradiated
with UV light (260-400 nm) for 15 min each session. After
2 wk, a challenge patch was applied at virgin sites with and
without irradiation. At the challenge phase, no skin reactions
were exhibited at either the irradiated site or the nonirradiated
site.
Ocular Irritation Studies
In Vitro
Adenosine. According to a risk profile from the NFSA,
Adenosine was predicted to be slightly irritating to the eyes
in an in vitro hen's egg test-chorioallantoic membrane
(HET-CAM) assay.33 No other details were provided for
this study.

IJT - CIR - February 2024

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IJT - CIR - February 2024 - Cover3
IJT - CIR - February 2024 - Cover4
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