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EC number: 701-394-3
CAS number: 1782069-81-1
In the plasma samples taken on days 1 and 90/91 after the start of
treatment both the parent test item and its two major metabolites were
Mean AUCs of the test item were dose-proportional on days 1 and 90/91
and no apparent sex-related differences were observed. AUCs measured on
day 90/91 remained in the same range as on day 1 suggesting no potential
The plasma levels of both metabolites showed apparent sex differences.
Topical administration of the test material at a dose of 100, 400 or
2000 mg/kg/day by a daily 6 -hour semi-occlusive application during 90
or 91 days (100 and 400 mg/kg/day) or 11 days (2000 mg/kg/day), resulted
in no systemic clinical signs of toxicity. A slight decrease in
bodyweight was observed in Group 4 at week 2 and Group 4 had to be
terminated early on test day 15 due to severe skin reactions. Signs of
local dermal reaction were recorded for many of the animals treated with
the test substance comprising transient signs of irritation such as
erythema, scab formation, scaling and epidermal lesions. The formation
of wounds, general oedema, necrosis fissures and watery discharge were
observed in the group treated at 2000 mg/kg/day. The severity as well as
the incidence of general erythema, scaling, scabs and epidermal lesions
aggravated with increasing dosage and, in general, the males appeared to
be less sensitive than the females.
There were no other treatment related changes observed in any parameters
The test item was found to be absorbed in a dose-dependent manner and
metabolised into its two major metabolites after dermal application.
Based on the results of this study, 400 mg/kg/day of the test material
was established as the no-observed-adverse-effect level (NOAEL) and 100
mg/kg/day of the test material was established as the
no-observed-effect-level (NOEL). This study was assigned a reliability
rating of 1: reliable without restrictions.
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