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EC number: 203-603-9
CAS number: 108-65-6
of male and female New Zealand White rabbits were received 15 dermal
applications of 0 mg/kg/day (water control) or 1000 mg/kg/day PGME
(colorlesss liquid) for a period of 21 days.
received from Hazelton Dutchland, Inc,,Rabbits were kept for
acclimatization 14 days. At study initiation Weight rabbit was
approximately 3.0 kg. Rabbit were housed 1/cage in stainless steel cages
with wire bottoms. A standard laboratory diet (Purina Certified
Laboratory Chow, Ralston Purina Co.) supplied to rabbits adlibitum
except and adlibitum tap water was supplied rabbits during the period of
for effects included clinical observations, body weights, food
consumption, hematology, clinical chemistry, necropsy, organ weights,
gross pathology and histopathology.
no mortalities during the course of the study which were related to
exposure to PGME.One control female died on the day prior to the
scheduled termination. Based upon gross and histopathologic examination,
the cause of death was severe inflammation of the cecum, appendix,
sacculus rotundus and proximal colon. The only clinical observation
attributed to treatment with PGME was slight exfoliation on the backs of
all rabbits at the application sight.
were no significant differences in body weights between control and
treated animals. There were no significant differences in food
consumption between control and treated animals.
no changes observed which were considered to be a result of treatment
with PGME. RBC, Hb and PCV data for female rabbits exposed to 1000
mg/kg/day PGME were statistically increased and platelets were
statistically decreased relative to concurrent values. These differences
were considered to be sporadic occurrences unrelated to treatment.
Hematology data for male rabbits were unremarkable. There were no
significant differences in clinical chemistry parameters between control
and treated animals.
significant decreases from control values were observed in both absolute
and relative kidney weights of female rabbits exposed to PGME. This
pattern was not observed in male rabbits nor were there any
histopathologic changes in the kidney suggestive of a treatment related
effect. Furthurmore, as previously stated there were no changes in
clinical chemistry data to indicate an effect on renal function.
gross lesion attributed to treatment to treatment was a slight amount
white scales present on the back at the site where PGME was applied.
This effect was noted in all rabbits, males and females treated with
1000 mg/kg/day of PGME.
histopathologic effect attributed to treatment with PGME was also noted
in the skin. All treated rabbits had a mild response at the site of
treatment characterized by very slight thickening of epidermis and very
slight accumulations of keratinized, hyperkeratosis. Additionally, 3 of
5 treated rabbits of each sex had a slight inflammatory response
characterized as accumulations of mixed inflammatory cells in the
superficial dermis. These effects were confined to the treated portion
of the skin. The non treated site had no effects attributed to PGME
applications. Some control and treated rabbits had focal skin lesions
that were attributed to the bandaging tecqniques.Typically, these were
linear, transversely oriented lesions located on the lateral or ventral
aspect of the trunk where the bandages had been secured with tape. The
skin effects attributed grossly to bandaging were examined
histopathologically and found to consist of inflammation, degeneration
and other protective effects which were generally slightly more severe
than the effects attributed to treatment with PGME at the application
site. No systemic toxicity resulted from dermally exposing male and
femalewhite rabbits to 1000 mg/kg/day PGME 15 times in a 21 day period.
Based on the
results of this study the NOAEL for systemic effects in male and female
rabbits is > 1000 mg/kg/day via dermal route.
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