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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 L(+)-lactic acid using a
method described in the EPA Guidelines, 1982 (modification of the
Buehler Closed Patch Technique) 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 1 site after the 1st
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 similar in character as those seen during the
induction applications, 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 L(+)-lactic acid was not considered to be a contact
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