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EC number: 259-134-5
CAS number: 54381-16-7
study was designed to evaluate the skin sensitisation potential of
N,N-Bis-(2-hydroxyethyl)-p-phenylenediamine sulfate (A050) when applied
to human skin in the human repeat insult patch test.
total of 116 Caucasian female subjects (18-65 years) were involved in
the study. 104/116 subjects completed the study.
study enrollment group participated over a 6-week period involving 3
phases: (1) Induction, (2) Rest, and (3) Challenge. Test substance (3%)
was applied under occlusive condition at a dose level of 0.1 mL (applied
to each patch).
the induction phase, patches (Closed, from Parke-Davis Readi bandage)
were applied to infrascapular area of the back, either to the right or
left of the midline. The subjects were required to remove the patches
approx. 24 h after application. Subjects returned to the facility at
48-h intervals (72 h after a weekend if applied on Friday) to have the
sites evaluated and identical patches applied to the same sites. A total
of 9 Induction patches were applied during the period of 3 weeks.
induction phase, subjects rested for 14 d prior to challenge.
challenge phase was initiated during the sixth week of the study, with
identical patches applied to sites previously unexposed to the test
substance. These patches were removed after 24 h. The sites were graded
48 and 72 h after challenge patch application.
subjects were instructed to notify the staff if they experienced any
discomfort beyond mild itching or observed any adverse changes at the
evaluation sites while on the study or within two weeks of completing
subjects developed reactions after induction and/or challenge.
first subject developed definite erythema with minimal or doubtful edema
(+*) at 48 h and definite erythema and no edema (+) at 72 h after
challenge application. These results were probably irritation, although
low level sensitization cannot be entirely ruled out.
second subject developed definite erythema, definite edema and
vesiculation (+++) reactions at both 48 and 72 h, with some spreading of
the reactions beyond the application site. The reactions were indicative
of definite sensitisation.
third subject developed reactions during induction indicative of
possible pre-sensitisation. The pre-sensitisation was confirmed by
challenge testing to both the test substance and vehicle. These
reactions were interpreted as evidence of pre-sensitisation to the
A definite evidence of sensitization was found in one subject, and
possibly in a second subject, to the test substance. In addition, one
individual developed reactions to all three materials (two other
substances were tested in parallel), which were interpreted as
pre-sensitization, probably to the vehicle.
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