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EC number: 938-793-9
CAS number: -
Average Dermal Irritation Score
Induction Phase Average
Challenge Phase Average
In a skin sensitisation study, ten young
adult male albino rabbits were exposed to 0.5 mL of undiluted test
material in the treatment group and ten
ten young adult male albino rabbits were
exposed to 0.05% (w/v) dilution of chlorodinitrobenzene in ethanol in
the positive control group. Both groups were shaved in an area on their
backs approximately 3" x 3" in size. On the day of application, test
material or positive control was placed on a gauze patch which was put
on the shaved exposure site, covered with plastic wrap and wrapped with
elastic bandaging. Bandaging and wrapping was removed 6 hours after
application. The same procedure was replicated 3 times a week for 3
weeks (10 treatments in total). Two weeks after the last induction dose,
a single challenge dose was administered following the same methods as
used during the induction period, in both the treatment and positive
control groups. Scoring of erythema and oedema was made at 24 hours
after each application.
Results indicated no statistically
significant differences between the mean of the averages of the ten
sensitising treatments and the mean of the challenge treatment for
wither erythema or oedema in the test or control group. Based on this
data, the test material is considered non-sensitising.
This study received a Klimisch score of 2 and
is classified as reliable with restriction because it was conducted
similar to guideline study OECD 406.
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