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EC number: 200-772-0
CAS number: 72-17-3
This study was conducted to evaluate the contact dermal sensitization
potential of the test article, SY-83, using a method described in the
EPA Guidelines, 1982 (modification of the Buehler Closed Patch
Technigue) as described in American Biogenics Corporation (ABC) protocol
A330. No mortalities occurred and all animals gained body weight. The
test article (100%) produced very slight erythema at 3 sites and very
slight edema at l site after the Ist induction. Erythema grades
increased in severity after the 2nd induction application. One site was
graded as severe erythema, however, this grade was given a 4 due to
pinpoint pitting of the skin and scab formation, not for redness. Due to
the increase of severity of the reactions, the concentration of the test
article was reduced to 30% and the induction site was changed to the
left flank. Very slight erythema was noted after the 5th induction
application. Grades ranging from very slight to severe erythema were
noted from the 7th to the 9th induction applications. Again, the severe
(grade 4) reactions were given this grade due to pinpoint pitting of the
skin and the eschar formation, not for redness.
After the challenge application, the test article (100%) produced grade
4 erythema in up to 6 test animals. These gradings were very sirnilar in
character as those seen during the induction pplications, that is,
pinpoint pitting of the skin and eschar formation, very little redness.
These reactions were considered to be irritation reactions, not
sensitization reactions. Other reactions noted at challenge for the test
animals were very slight to moderate erythema, and very slight to
moderate edema. The test article (100%) produced grade 4 erythema in up
to 8 naive control animals. These gradings were also pinpoint pitting of
skin and eschar formation with very little redness. These reactions were
considered to be irritation reactions, not sensitization reactions.
Other reactions noted for the naive control animals were very slight to
moderate erythema and very slight to moderate edema. The reactions seen
in the naive control animals at the challenge application were similar
to the reactions seen for the test group animals and the test article,
SY-83, was not considered to be a contact dermal sensitizer.
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