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EC number: 700-684-7
CAS number: 80793-17-5
Discussion of the
No death occurred in
the dosing and recovery periods.
transiently observed in males of all treatment groups and females of the
40 and 200 mg/kg bw groups; however, it was not considered to be
toxicologically significant since animals salivated just after dosing
and there were no related changes to this.
Food consumption was
decreased in females of the 40 and 200 mg/kg groups on day 22 of the
dosing period. This was transient and not dose-related, and there were
not body weight changes related to the decreased food intake on the same
day. Therefore this change was not considered to be treatment-related.
In blood chemistry,
decreased cholinesterase in females of the 40 and 200 mg/kg groups and
decreased total cholesterol and albumin in males of the 200 mg/kg group,
were noted, and these were not considered related to the test article,
since they were slight changes within the background value of the
laboratory and lesion of the liver in males was more severe than that in
In organ weights,
relative liver weights were increased in males and females of the 200
mg/kg bw/day groups. In necropsy, enlargement of the liver was observed
in males and females of the 200 mg/kg bw/day groups. In
histopathological examinations, centrilobular hypertrophy of the
hepatocytes was observed in males of the 200 mg/kg bw/day group.
kidney weights without kidney lesion in males of the 200 mg/kg group
were considered to be treatment related. Pelvic dilatation in female and
solitary cyst in the medullar and subcapsular solitary cyst in males
were noted in the kidney in the 200 mg/kg groups, and they were single
occurrences and observed spontaneously.
No abnormalities were
noted in the FOB, body weights and urinalysis.
In the recovery
groups, mottled teeth were observed in males of the 200 mg/kg group,
This was considered related to dysplasia of the enamel. In an animal
which has brown teeth like a rat, decreased iron pigments in the
ameloblast, impaired iron-pigment secretion to the enamel and
degeneration or necrosis of the enamel are generally observed by
fluoride ingestion (Dokusci Byori Soshiki Gaku, 2000). In this study,
these signs were not observed in histopathological examinations at the
end of the dosing and recovery periods. Therefore, the mottled teeth
were considered to be slight and reversible changes, and considered
disappeared with the growing of teeth because of no histopathological
changes. Decreased MCV in males, decreased eosinophils, decreased total
cholesterol, increased absolute and relative kidney weights and
increased relative ovary weights were considered to be not
treatment-related since they were slight changes within the background
values in our laboratory. No abnormalities were noted in body weights,
food consumption, FOB, urinalysis and histopathological examinations.
In a 28-day repeated oral dose toxicity GLP study according to OECD guideline 407 and EU method B.7, groups of five male and five female Crl: CD(SD) rats were dosed with AC-6000. The high dose was set at 200 mg/kg bw/day, and altogether 3 doses including 40 and 8 mg/kg bw/day were employed. Recovery groups were also set for the 200 mg/kg bw/day and vehicle control groups.
No death occurred in the dosing and recovery periods. In organ weights, relative liver weights were increased in males and females of the 200 mg/kg bw/day groups. In necropsy, enlargement of the liver was observed in males and females of the 200 mg/kg bw/day groups. In males of the 200 mg/kg bw/day group increased relative kidney weights were observed. In histopathological examinations, centrilobular hypertrophy of the hepatocytes was observed in males of the 200 mg/kg bw/day group. No treatment-related/ toxicologically significant abnormalities were noted in clinical signs, FOB, body weights, food consumption, hematology, blood chemistry and urinalysis.
In the recovery groups, mottled teeth were observed in males of the 200 mg/kg bw/day group. No abnormalities were noted in FOB, body weights, food consumption, hematology, blood chemistry, urinalysis and histopathology.
In conclusion, the effects of AC-6000 were observed in the liver. Even though these effects are reversible, the NOAEL was considered to be 40 mg/kg bw/day due to increased relative liver weights and enlargement of the liver in males and females and centrilobular hypertrophy of the hepatocytes in males of the 200 mg/kg bw/day groups.
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