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EC number: 204-847-9
CAS number: 127-52-6
1. RESULTS OF HISTOPATHOLOGICAL FINDINGS IN MALES
Number of examined animals
Without histopathological changes
Heart: pres. valvular endocardiosis
Heart: valvular endocardiosis
Kidney: pres. mesangial cell proliferation
Kidney: mesangial cell proliferation
Kidney: hyaline droplets
Kidney: hyaline casts
Kidney: presumptive glomerulonephrosis
Kidney: glomerulonephrosis 1st degree
Liver: focal inflammation
Liver: extramedullary haemopoiesis
Liver: pres. oval cell proliferation
Lymph nodes: presumptive atrophy of cortex
Lymph nodes: mild atrophy of cortex
Lymph nodes: lymphostasis
Lymph nodes: histiocytosis
Prostate gland: interstitial inflammation
Prostate gland: oedema of interstitium
Prostate gland: pres. hyperplasia of epithelium
Prostate gland: hyperplasia of epithelium
Prostate gland: alveolar dilatation
Spleen: atrophy of PALS
Stomach: pres. atrophy of phundal glands
Stomach: atrophy of phundal glands
Stomach: oedema of submucosa
Testes: dystrophy of germinal epithelium
Testes: pres. atrophy of germinal epithelium
Testes: atrophy of germinal epithelium
Thymus: tubular structures
Thymus: hyperaemia of medulla
Thymus : hyperplasia of stroma of epithelium
Thyroid gland: pres. inspissation of colloid
2. RESULTS OF HISTOPATHOLOGICAL FINDINGS IN FEMALES
Kidney: glomerulonephrosis 1stdegree
Liver: oval cell proliferation
Lymph nodes: pres. atrophy of cortex
Ovaries: persistent corpus luteum
Ovaries: hyperplasia of interstitial glands
The oral administration of Chloramin B trihydrate
to rats by gavage for period of 90 consecutive days at dose levels 20,
60, 180 mg/kg bw/day produced no significant changes in functional
observations, ophthalmological examination and did not cause mortality.
Overall assessment of results showed, that the test
substance, after 90-day oral application caused reversible decrease in
body weight increments in both sexes (more marked in males) in all dose
levels. It was connected with reversible decrease of food consumption
and food conversion in both sexes.
Reversible changes of health status (piloerection)
and clinical changes immediately after application (excited behavior)
were recorded in both sexes of the highest dose level.
Haematological examination showed an effect on
leukocyte differential count in both sexes without dependence on dose
level. Portion of lymphocytes was increased and portion of monocytes and
granulocytes was decreased. In females of the highest dose level also
the increase of number of leucocytes and platelets was observed.
During biochemical examination of blood the
statistically significant changes were detected at the highest dose
level: increased value of urea in both sexes, increased value of
chloride ions in males, decreased value of AST, creatinine and potassium
ions in males, increased value of bilirubin and ALT in females and
decreased value of creatinine and sodium ions in females. Increase of
bilirubin was irreversible.
Statistically significantly decreased volume of
urine was detected in males especially at highest dose level. It was
connected with increase of specific gravity of urine. Increased value of
pH of urine was recorded in satellite males of the dose level 180 mg/kg
bw/day and females of the dose levels 60 and 180 mg/kg bw/day. Decreased
volume of urine accompanied by higher specific gravity of urine occurred
also in females of the dose level 180 mg/kg bw/day.
The most important histological affections were
diagnosed in kidneys of males of the highest dose level –hyaline
droplets in renal tubules and mesangial cell proliferation in renal
glomeruli. In the same treated group also the increase of incidence of
histiocytosis of lymph nodes and involution of thymus was registered.
In females the increased incidence of hydrometra of
uterus was found out in all treated groups irrespective of dose level.
The LOAEL (Lowest Observed Adverse Effect Level)
for males and females was established as 60 mg/kg bw/day. The changes however
were mild and did not indicate specific target organ toxicity. The NOAEL
(No Observed Adverse Effect Level) for males and females is 20 mg/kg
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