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EC number: 500-051-3
CAS number: 26780-96-1
Analytical verification of stability of the test material, homogeneity
and concentration of test material in the diet with satisfactory results.
Compared with their respective controls, survival at the end of the
study was greater at the high level in both males (61 ves 40%) and
females (59 vs 48%). These results are not indicative of toxicity.
Clinical signs: no compound related findings.
Body weight: significant lower weight was observed for high dose females
from week 11 to week 77; no effect in males.
Food consumption: no consistent effect except a statistically
significant decrease was observed during the first week of the study.
Ophthalmic examinations: no abnormalities
Clinical pathology:there were no abnormalities in urinanalysis
parameters which were attributed to the test material.
Gross pathology: absolute liver weight were increased in high dose males
and females; liver weight relative to brain weight was increased in mid
dose females; there were no other organ weights attributed to
administration of the test material.There were no gross necropsy
alterations attributed to administration of the test material.
The following oservations were reported; statistically significant
observations are indicated by an asterics(*)
Organ sex control low mid and high dose group
Cystic degen. cortex M 2/60 4/60 4/60 9/60*
Sinusoidalectasia/cyst M 0/60 3/60 3/60 6/60*
Hyperblasis medulla M 12/60 11/60 22/60* 19/60
Bile duct prolif. cholangiofibros. M 31/60 33/60 30/60 43/60*
Fucus of celular alteration M 17/60 12/60 22/60 30/60*
centriiobular M 1/60 0/60 0/60 13/60*
F 0/60 0/59 0/59 11/60*
Hepathocell. vacuol. centriiobular F 1/60 3/59 2/59 16/60*
Sinus dilatation F 2/60 3/59 10/59* 17/60*
cystadenoma M 5/60 2/60 4/60 10/60 (not statistically significant)
F 1/60 3/58 0/60 9/59*
hyperblasia M 1/60 2/60 2/60 5/60 (no statistics done)
Additional lesions observed were considered to occur spontaneously and,
due to the lack of a dose response relationship and/or lack of
consistency in the incidences across the various death categories in
this study, were not considered related to administration of thetest
Cellular proliferation assay:
The mean positive hepathic nuclei/microscopic field was slightly, but
statistically significantly, increased in the high dosefemales after 4
days of exposure. The toxicological significanc, if any, of this
difference is not known. There were no significant differences in
females at one or six months nor there were any differences in males at
any time interval.
The following effects were considered to be test materia related:
effects on body weight of females in the high dose group;
histopathologic effects on adrenals in the high dose males; effects on
liver weight and liver histopathology in the high dose males and in the
mid and high dose females.
The increased incidence of thyroid follicular adenoma/cystadenomas in
the high level males and females was considered to have resulted from
compound administration, but may have resulted from compensatory
mechanisms as a result of the hepathic changes; see discussion of this
study in chapter 7.7 carcinogenicity.
The NOAEL for systemic toxicity was considered to be 250 ppm in males
and 50 ppm in females.
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