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EC number: 807-935-0 | CAS number: 1244733-77-4
There were no treatment-related mortalities. No clinical observations were considered to be related to treatment. A slight, but statistically significant (p<0.05) reduction in mean body weight was apparent from day 22 of the study until termination in the high dose males (7.75% less than controls at day 80) and from day 35 in high dose females (11.8% less than controls on day 80). The mean absolute and relative liver weights were statistically significantly (p<0.05) increased in all male groups given TCPP and in females given 7,500 ppm and 20,000 ppm. In males given 800 ppm the group mean relative hepatic weight exceeded the control group mean by 16%. The absolute liver weight in this low dose group was also 16% greater than control. Relative liver weight of males given 20,000 ppm exceeded the control mean by 41% (absolute liver weight was 31% greater than controls for this group). In females given 7500 and 20,000 ppm, the mean relative liver weight exceeded that of controls by 20% and 30% respectively. The only histopathological finding related to this was periportal hepatocyte swelling (hypertrophy) in the high dose groups (9/20 males and 8/20 females). 0/20 male and 5/20 female control animals showed liver periportal swelling. Relative kidney weights were statistically significantly (p<0.05) increased in males at the two highest doses (13% and 16% greater than control, respectively). There was some evidence of histopathological change in the renal cortical tubule with the finding of mild degenerative change (hyaline droplet formation) in the two highest dose groups in males (12 animals and 7 animals, respectively) and vacuolation in females dosed with the highest dose (4 animals, compared to 1 control animal). The hyaline droplet formation is a male rat specific nephropathy and is not relevant for humans. Mild thyroid follicular cell hyperplasia was recorded in males at all doses (0/20, 2/20, 2/20, 5/20, and 8/20 at 0, 800, 2,500, 7,500 or 20,000 ppm respectively). This was seen in 5/20 females of the 20,000 ppm group, compared to 0/20 in the control group. There were no significant alterations in clinical chemistry, haematology or urinalysis parameters and no treatment-related changes in plasma, erythrocyte or brain cholinesterase activity. A slightly excessive fatty infiltration indicative of mild bone marrow hypoplasia was seen in three high dose females.
In an oral repeated dose toxicity study the test substance was axdministered to rats (20/sex/group) at dietary concentrations of 0, 800, 2500, 7500 or 20000 ppm for three months. Rats given 20000 ppm showed significantly (p<0.05) reduced body weight at most weekly intervals from weeks 4 through 12 in the males and weeks 6 through 12 in the females. No other treatment related clinical signs were noted. Significantly (p<0.0.5) higher absolute and relative liver weights were found in male rats of all groups fed the test substance and female groups given 7500 and 20000 ppm. In this study, the toxicologic significance of this observation cannot be ascertained. mean relative kidney weights of male groups given 2500, 7500 and 20000 ppm were significantly (p<0.05) greater than that of controls. hepatic morphologic change considered related to treatment was found only in rats given 20000 ppm, and was characterized by very mild swelling of cells located in the peroportal region of the hepatic lobule. Very mild cortical tubular degenerative changes were found in kidneys of male rats given 7500 ppm and in both sexes given 20000 ppm. Sternal bone marrow of three female rats given 20000 ppm was very mildly hypoplastic. Very mild thyroid follicular hyperplasia was found in male rats in all groups given the test substance and in females given 20000 ppm. Evaluation of hematological and clinical chemistry data, as well as cholinesterase activity in the brain, plasma and erythrocytes showed no change related to treatment. There were no deaths attributed to treatment with the test substance.
Based on the increase in absolute and relative liver weights, accompanied by mild thyroid follicular cell hyperplasia, observed in males of all dose groups a LOAEL of 800 ppm (equivalent to 52 mg/kg/day) is derived from this study for males. A NOAEL of 2500 ppm (equivalent to 171 mg/kg/day) is derived for females, based on increased absolute and relative liver weights observed in females dosed at 7500 ppm and above.
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