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EC number: 700-990-0
CAS number: -
A three week repeated dose dermal
toxicity study, comparable
to OECD Guideline 410, was
performed to determine the toxicological potential of Santicizer-154.
New Zealand White rabbits were randomly distributed into four groups of
10 animals/sex/group. The test material Santicizer-154, at dose levels
of 10, 100 and 1000 mg/kg/day, was applied to the clipped dorsal surface
of New Zealand White rabbits daily, 5 days per week for three weeks.
Group I (distilled water, 1 ml/kg) served as the control group for the
Santicizer-154 low-, mid- and high-dose groups (Groups II, III and IV).
The skin of the first 5 rabbits of each sex in each group was abraded
twice weekly. Skin reponses (erythema, edema, atonia, desquamation,
fissuring, eschar formation, and exfoliation) were graded daily, seven
days per week. Hematology and clinical chemistry studies were performed
on all animals pretest and at the termination of the study.
Cholinesterase determinations were also performed on all rabbits pretest
(RBC and plasma) and at termination (RBC, plasma and brain). Complete
gross postmortem examinations were performed on all animals dying
spontaneously, killed in extremis and killed at the termination of the
study. Microscopic examinations of selected tissues were performed on
all rabbits in the Santicizer-l54 control and high-dose groups. One
rabbit died spontaneously and one was killed in extremis during the
course of the study. There did not appear to be a treatment related
effect in the deaths of these animals. A higher incidence of edema,
atonia, desquamation and fissuring was observed in the Santicizer-154
treated males and females than was observed in their respective
controls. Mean terminal blood urea nitrogen values of the Santicizer-154
high-dose males and females were significantly greater than control
values. A dose response depression of RBC and brain cholinesterase was
evident in the Santicizer-l54 treated males and females, which was
significant in the mid and high dose. All other parameters evaluated
(daily physical observations, body weights, hematology and clinical
chemistry data, organ weights and organ/body weight ratios) were
considered either comparable to control values or unremarkable. Gross
postmortem examinations of all animals in all groups did not reveal any
gross changes attributable to the administration of Santicizer-154.
There were no apparent microscopic changes in the tissues evaluated
which were considered to be related to treatment with high-dose
Based on the evident dose response
depression of terminal cholinesterase in the Santicizer-l54 treated
males and females, which was significant in the mid and high dose, a
NOAEL of 10 mg/kg bw/day was derived.
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