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EC number: 916-916-7
CAS number: -
Bayscript Blaukomponente (konserviert) was administered orally by gavage
to 5 male and 5 female Wistar rats per dose group using tap water as
vehicle, in daily doses of 0, 100, 300, 1000 mg/kg bw/day for a period
of four weeks. This GLP study was performed according to OECD guideline
Treatment with Bayscript Blaukomponente resulted in several findings
which were related to the color of the test substance. The whole body
and several organs of animals treated with 1000 mg/kg bw/day appeared
discolored. The kidneys were also discolored in the lower dose groups.
In the kidneys, beneath findings associated with the color of the test
substance (starting at 300 mg/kg b.w./day), corticotubular degeneration
and increased incidence and/or severity of cortical basophilic
(regenerative) tubules were noted at 1000 mg/kg b.w./day. Furthermore,
demyelinated fibers in nerve roots at the spinal cord were seen in both
sexes at 1000 mg/kg b.w./day.
At 1000 mg/kg b.w./day, histopathological findings in the mesenteric
lymph node, the interstitium of the testis, and in the Peyer's patch
were related to the colored test item and not accompanied by other
structural changes of the organs.
Minor changes in red blood cell parameters observed for males and
females at 1000 mg/kg b.w./day were associated with appearing of
golden-brown pigment deposition in the spleen in females. In males, the
thrombocyte count was increased at 1000 mg/kg b.w./day.
Despite this general toxic effects no pathological changes were observed
at the reproductive organs in amle and female rats
Under the conditions described the no adverse observed effect level
(NOAEL) for administration of BAYSCRIPT Blaukomponente (konserviert) to
male and female Wistar rats was 300 mg/kg b.w./day mainly due to
degenerative effects on kidneys and nerve roots. With respect to
reproductive organ toxitcity a NOAEL of 1000 mg/kgbw/day is established
for male and female rats
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