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EC number: 214-881-6
CAS number: 1205-17-0
dermal repeated dose toxicity study was performed equivalent to OECD
guideline 411 in Sprague-Dawley rats. The test item was applied dermally
once daily to male and female rats (15/sex/group) at 50, 150, or 300
mg/kg bw/day (0.043, 0.129, or 0.259 mL/kg bw/day applied neat to 5 cm²
dorsal skin) for at least 90 consecutive days. A control group (15/sex)
was given vehicle (reverse osmosis water) at 0.259 mL/kg bw/day for a
similar duration. Rats were necropsied at the end of treatment
(10/sex/group) or following a 4-week recovery period (5/sex/group). The
following parameters were evaluated: dermal irritation, estrous cycle,
ophthalmologic examinations, body weight, feed consumption, hematology,
blood coagulation, serum chemistry, organ weights, macroscopic and
histopathologic examinations, and male reproductive assessment. No test
item related mortalities or effects on estrous cycles, ophthalmic exams,
mean body weights, mean body weight change, feed consumption, absolute
or relative organ weights, macroscopic observations or male reproductive
morphology/function were observed. Test item related dermal irritation
was observed across all dose levels with increased incidence and
severity at 300 mg/kg bw/day. Dermal
irritation that initially ranged from slight to marked improved to
slight (≥ 150 mg/kg bw /day) or resolved completely (50 mg/kg bw/day)
during the recovery phase.
Based on the findings in this study,
it can be concluded that the NOEL for dermal irritation is below 50
mg/kg bw/day and the NOAEL for dermal irritation is 50 mg/kg/bw/day when
applied undiluted to 5 cm² of the dorsal skin. The NOEL as well as NOAEL
for systemic toxicity is greater than 300 mg/kg bw/day.
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