0.2 mL or grams of each test article is applied occlusively to alternate
(right arm/left arm) contact areas that have been cellophane tape-stripped
5 times to remove the superficial horny layers. Two hours later,
the patches are removed from the forearm designated for irradiation
and the sites are subjected to 10 Joules of UV-A irradiation.
the irradiation procedure, the control arm (non-irradiated) patches
are removed. Both the test and control forearms are examined for
dermal reactivity 10 minutes following the irradiation procedure
and again 2 and 24 hours post-irradiation.
are scored according to the following 6-point scale:
evidence of any effect.
faint, uniform or spotty erythema or tanning.
uniform erythema or tanning covering most of the contact site.
erythema or tanning, uniform in the entire contact site.
red erythema or tanning with/without petechiae or papules.
red erythema with/without vesiculation and/or weeping or dark
edema (swelling) at any test site is recorded with an "e"
and described as mild, moderate or severe. Other possible dermal
sequelae are similarly recorded.
test subjects are instructed to report any delayed dermal reactivity
that might occur following the final (24-hour) examination at the
clinic. Any evidence of hyperpigmentation (tanning-like response)
and/or any evidence of erythema on the irradiated test sites which
differs significantly in either incidence or severity from the non-irradiated
control site is considered evidence of a possible phototoxic response.