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EC number: 232-800-2
CAS number: 9025-57-4
The objective of this
study was the assessment of general systemic toxic potential of Xylanase
in rats, including a screen for reproductive/development effects, after
once daily by oral (gavage) administration for at least five weeks.
Three groups, each
comprising ten male and ten female Sprague-Dawley rats received three
different doses of Xylanase. Males were treated daily for two weeks
before pairing, throughout pairing and up to necropsy after a minimum of
five consecutive weeks. Females were treated daily for two weeks before
pairing, throughout pairing, gestation and until Day 6 of
lactation. Females were allowed to litter, rear their offspring and both
females and F1 offspring were killed on Day 7 of lactation. The
F1 generation received no direct administration of the test substance,
meaning that any exposure was in utero or via the milk. A similarly
constituted control group of both sexes received the vehicle (reverse
osmosis water) at the same volume dose as treated groups, 10 mL/kg body
During the study, clinical
condition, detailed physical examination and arena observations, sensory
reactivity, grip strength, motor activity, body weight, food
consumption, haematology (peripheral blood and bone marrow), blood
chemistry, oestrous cycles, pre‑coital
interval, mating performance, fertility, gestation length, organ weight
and macroscopic pathology investigations were undertaken. Histopathology
investigations were undertaken for the first five males and first five
females from the control and high dose groups. The clinical condition,
litter size and survival, sex ratio, body weight and macropathology for
all offspring were also assessed.
General appearance and
behavior, sensory reactivity responses, grip strength and motor activity
were not affected by treatment, there were no deaths during the
treatment period and there was no effect of treatment on bodyweight gain
or on food consumption.
investigation in Week 2 indicated a small reduction of lymphocyte and
large unstained cell count in males given 100% of Xylanase, batch
PPQ38584, and the biochemical examination of the blood plasma indicated,
at 100% Xylanase, batch PPQ38584, a small reduction of creatinine
concentration in both sexes and low urea and potassium concentrations in
females; these findings were not adverse. The bone marrow composition
There were no treatment
related organ weight changes and there were no macroscopic or
histopathological findings that were attributable to treatment.
demonstrated that there was no adverse effect of Xylanase on oestrous
cycles, mating performance, fertility or gestation length. There was no
adverse effect observed on litter size, and sex ratio and offspring
survival and body weight up to Day 7 of age. There were also no
treatment related macroscopic findings in the offspring.
It was concluded that oral
administration of Xylanase to Sprague-Dawley rats at doses up to 1101.3
mg TOS/kg body weight/day for 5 weeks to males and for 2 weeks before
and during pairing throughout gestation and to Day 6 of lactation for
females was well tolerated and did not cause any adverse change. The
no-observed-adverse-effect-level (NOAEL) for systemic and
reproductive/developmental toxicity was therefore considered to be the
highest dose tested (equivalent to 1101.3 mg TOS/kg body weight/day).
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