javicorvi/pretoxtm-ner
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19
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PRETOX_REL | At 3 mg / kg , a pronounced decrease of terminal body weight and of absolute and relative thymus and spleen weights were found in one male . | [
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PRETOX_REL | The main finding was atrophy of epithelium in various organs , often accompanied by inflammation . | [
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NO_PRETOX_REL | _ The evaluation of blood pressure and of heart rates ( for individual and mean values see â € ™ appendix of the report ) showed no adverse effects up to and including group ltl . | [
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NO_PRETOX_REL | No relevant changes were found in females . | [
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PRETOX_REL | Adverse treatment - related effects were limited to slight , reversible degenerative changes in the sciatic nerve of female rats at all dose levels . | [
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PRETOX_REL | Increases in aspartate aminotransferase were present at doses of 1.0 mg / kg / occasion but lacked any microscopic correlate . | [
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NO_PRETOX_REL | There were no test article - related effects on clinical pathology parameters ( hematology , serum chemistry or urinalysis ) . | [
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PRETOX_REL | Peripheral neuropathy has been observed in rats subjected to a continuous 72 hour insulin infusion in which glucose levels of approximately 2.5 mM ( 45 mg / dl ) were sustained [ 5 ] . | [
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PRETOX_REL | Two group III ( 30/60 mg / kg ) - males showed pigment deposition , and one group III ( 30/60 mg / kg ) - male a small area of acute myocardial necrosis . | [
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PRETOX_REL | Additionally , after the high dose of 100 mg / kg COMPOUND_XXX per day : - At necropsy , cystic dilatation of the mesovarium was noted in one animal ( suspected compound - related ) . | [
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NO_PRETOX_REL | Toxicokinetic evaluations were conducted on plasma samples collected on study days 1 and during week 13 at 5 minutes , 0.5 , 2 , 4 , and 24 hours post dose . | [
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PRETOX_REL | Uterus , ovaries and mammary glands exhibited vacuolations . | [
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NO_PRETOX_REL | A comparison of C max at the different dose levels shows a linear increase with a dose proportionality factor exceeding the dose increase ( TF 2 ) . | [
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PRETOX_REL | The overall mean cumulative body weight gain on Day 28 was reduced by 12 % compared with the control females . | [
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NO_PRETOX_REL | Protocol - specified organs were weighed , tissues were collected , processed and microscopically examined . | [
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NO_PRETOX_REL | Although there was no consistent difference in exposure observed between male and female dogs , the apparently greater AUC and Cmax values in females at 45 mg / kg / day , albeit with large variations , taken together with the clinical signs noted primarily in females at 45 mg / kg / day , and body weight and food consumption effects at the same dose , supports the conclusion that there was a greater exposure in females at the high dose . | [
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PRETOX_REL | Findings after the high dose of 150/100 mg / kg COMPOUND_XXX are regarded as signs of general toxicity of the compound . | [
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PRETOX_REL | Accordingly , body weight gain was decreased by approximately 50 % ( males ) and 70 % ( females ) . | [
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NO_PRETOX_REL | All organ weight changes were observed in both relative and absolute values . | [
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PRETOX_REL | These changes were similarly noted from day 3 to day 15 , with the exception of minimal hypertrophy of Paneth cells in the ileal crypts , which was most obvious on day 3 . | [
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PRETOX_REL | Minimal to slight focal and / or macular erythema affecting parts of the application area was evident during several days in two females treated with the reference item , in one male and one female at 100 mg / kg and in two males at 200 mg / kg from weeks 4 to 9 . | [
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PRETOX_REL | One female from the high dose group developed emaciation and exsiccosis . | [
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PRETOX_REL | - The effects in the male genital organs were of progressive nature leading to complete loss of spermatogenesis , occurrence of tubular giant cells in the testes , and reduced secretion in the prostate gland with dense , inactive epithelia . | [
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NO_PRETOX_REL | COMPOUND_XXX ( hydrochloride , batch no . | [
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NO_PRETOX_REL | After the end of the treatment period , the surviving recovery animals were observed for at least a further 8 weeks to investigate the reversibility of possible treatment related effects . | [
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PRETOX_REL | The alterations were associated with the appearance of antinucleolar antibodies in the liver . | [
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PRETOX_REL | The acute nearly complete necrosis of the liver parenchyma ( red dystrophy ) was responsible for the premature death or of the moribund condition of the female animals . | [
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NO_PRETOX_REL | Transmission electron microscopy was performed on livers from selected animals . | [
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PRETOX_REL | A dose - dependent , statistically significant inhibition of the DAO activity in the jejunal mucosa was evident in both treated groups at all 8 time points . | [
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NO_PRETOX_REL | Five groups of 6 male and 6 female rats for the toxicity study and five groups of 10 male and 10 female rats for the toxicokinetic study were given 0 , 30 , 100 , 300 or 600 mg / kg / day for five days . | [
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PRETOX_REL | The degree of inhibition was similar during the course of the last treatment day at 600 mg / kg , but showed a variation at 60 mg / kg / day with a higher enzyme inhibition during the night . | [
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NO_PRETOX_REL | Ophthalmoscopic assessments were undertaken on all animals during pretrial and on Control and High dose animals after approximately 26 weeks of dosing . | [
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PRETOX_REL | The body weight loss noted at 1.0 mg / kg / occasion correlated with an observed decrease in food consumption . | [
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PRETOX_REL | Summary of results The following treatment - related finding were observed at the low dose of 0.2 mg / kg COMPOUND_XXX and higher : - hepatocellular hypertrophy in the liver with increased incidence and severity ; - acinar hypertrophy of the parotid gland . | [
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NO_PRETOX_REL | The tables give the counts of ASAT , ALAT , APh , GLDH , GGT , LDH , CK , GLUCOSE , CHOL , TRIGL , CREA , UREA , BILI - t , PROT , ALBUMIN , Na , K , Ca , Cl , P , Fe , Mg , T3 , 14 , and from the liver tissue the parameters N - DEM , O - DEM , P 450 , and TRIGL ( for the use of abbreviations see List of methods in the appendix of the report ) 22 COMPOUND_XXX T 1071175 eS ETT As can be seen from the tables , no changes were detected up to and including group Ul . | [
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"group",
"Ul",
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] | [
"O",
"O",
"O",
"O",
"O",
"O",
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"O",
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"O",
"O",
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"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
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"O",
"O",
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"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
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"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
"O",
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NO_PRETOX_REL | Exposures were generally higher in females than in males , especially in the low dose group . | [
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PRETOX_REL | At this same dose , animals exhibited skin anomalies such as desquamations traducing as hyperplasia and hyperkeratosis histologically , indurations and increased vulnerability . | [
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NO_PRETOX_REL | Conclusion No NOEL could be established in this study . | [
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NO_PRETOX_REL | Animals were dosed for 4 cycles , receiving doses of 0 ( control ) , 0.06 , 0.2 and 0.6 mg / kg per day at a dose volume of 2 mL / kg . | [
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NO_PRETOX_REL | In Weeks 1 , 12 , 25 , 38 and 51 heparinized whole blood was collected from 5 animals / sex / group for determination of blood drug levels . | [
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PRETOX_REL | - decrease in heart rate was noted in male animals on day 8 . | [
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PRETOX_REL | Haemorrhages and infarcts were found in a large number of organs . | [
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NO_PRETOX_REL | All animals survived the 13 - week dosing period . | [
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] | [
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NO_PRETOX_REL | No sex effect was observed except on the first day when measurable levels appeared later in the females than in males . | [
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NO_PRETOX_REL | This study was designed to establish a no toxic effect level , to estimate the toxicokinetic profile , and to estimate the potential for reversal of any toxic effects within a 4 - week recovery phase . | [
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NO_PRETOX_REL | When compared to controls the administration of COMPOUND_XXX , daily , for 4 weeks produced the following treatment - related changes . | [
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NO_PRETOX_REL | One high - dose recovery animal was terminated prior to the end of study in response to a condition suspected to be due to an error in dosing . | [
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NO_PRETOX_REL | However , systemic exposure , as indicated by maximum concentrations and a limited number of samples above the lower limit of quantification ( LLOQ , 0.1 ng / mL ) , increased with the dose and with the time period of treatment . | [
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NO_PRETOX_REL | Blood was collected at various time points for toxicokinetic analysis on days 1 and 15 . | [
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NO_PRETOX_REL | Theses dermal findings are deemed related to treatment with the test substance . | [
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NO_PRETOX_REL | Water consumption showed no treatment - related changes in males at any dose level compared to control . | [
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PRETOX_REL | Three males and one female receiving 1.5 / 1.0 mg / kg / occasion were noted as being thin in appearance from Week 7 of the study onwards . | [
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NO_PRETOX_REL | The degree of thickening was dose - dependant up to 1000 mg / kg / day , when a plateau was reached . | [
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NO_PRETOX_REL | The lists of individual data are given in Appendix 2 . | [
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NO_PRETOX_REL | The purpose of this study was to establish the toxicologic effects of COMPOUND_XXX , a protein - tyrosine kinase inhibitor , when administered to rats for at least 26 weeks . | [
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NO_PRETOX_REL | No test article related microscopic findings were noted in the animals that were dosed twice weekly . | [
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NO_PRETOX_REL | XXXX ) and Placebo to COMPOUND_XXX ( patches , batch no . | [
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NO_PRETOX_REL | III ) , resp . | [
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NO_PRETOX_REL | The rats received daily doses of 0 ( CMC - vehicle control ) , 0 ( distilled water control ) , 10 , 40 , 180 , and 800 of Ro mg / kg / day 24-7429/002 at a constant volume of 5 ml / kg / day . | [
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PRETOX_REL | Minimal to moderate liver alterations were present in both treated groups with substantial individual variations in occurrence and severity . | [
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NO_PRETOX_REL | Female animals appeared to be exposed to higher levels of COMPOUND_XXX compared to males . | [
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PRETOX_REL | Total food consumption was slightly low for males at 50 mg / kg / day and for males and females during treatment at 75 mg / kg / day . | [
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NO_PRETOX_REL | Systemic exposure to COMPOUND_XXX was generally dose proportional . | [
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PRETOX_REL | Decedent : On study day 13 , one satellite female at 30 mg / kg / day was sacrificed due to animal welfare reasons and selected for necropsy . | [
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PRETOX_REL | Analogously , hyperinsulinemia as a consequence of an insulin - secreting tumor has also been associated with development of peripheral nerve pathology [ 6 ] . | [
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PRETOX_REL | None of the observed effects apart from the vomiting is regarded as adverse . | [
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NO_PRETOX_REL | individual body weights and food consumption were recorded weekly . | [
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NO_PRETOX_REL | Food consumption was unchanged during the treatment period in both genders , and in females during the recovery period . | [
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NO_PRETOX_REL | XXXXX . | [
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NO_PRETOX_REL | The reversibility from the effects was also assessed during a 2 - week recovery period . | [
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PRETOX_REL | Only very slight erythema was noted in animals dosed twice weekly . | [
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NO_PRETOX_REL | Organ Weights The comparison of mean values of absolute and relative organ weights of the test article treated animals to the corresponding values of the control animals and a statistical analysis by using the DUNNETT test showed a compound - related difference between the test article treated animals and the controls ( see Text Tables in the appendix Several other partly statistically significant differences in group mean absolute and / or relative organ weights were considered incidental and not compound - related as they were slight , not dose - related , observed only in one sex and / or unaccompanied by correlated morphologic findings . | [
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NO_PRETOX_REL | The No Observed Effect Level in this study was 50 ppm in both sexes , equating approximately to 3.5 mg / kg / day in males and 4.1 mg / kg / day in females . | [
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PRETOX_REL | At necropsy all group III ( 30/60 mg / kg ) - males showed a reddish discoloration of the mesenteric lymph nodes . | [
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NO_PRETOX_REL | It is deemed related to treatment with the test substance . | [
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NO_PRETOX_REL | The details can be taken from the pathology report in the appendix of the report . | [
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PRETOX_REL | In females , mean absolute liver weight , liver to body weight and liver to brain weight ratios were increased by 20 % , 24 % and 18 % , respectively . | [
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NO_PRETOX_REL | There were no consistent differences in exposure to COMPOUND_XXX or YYYYY between males and females . | [
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NO_PRETOX_REL | All organ weight changes were reversible following the recovery period . | [
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PRETOX_REL | Laboratory diagnostics : - decrease in index of erythropoiesis / granulopoiesis , decrease in the number of erythropoietic cells and an increase in the number of neutrophilic cells was observed in the bone marrow examination in male animals ( interim sacrifice on day 10 ) . | [
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PRETOX_REL | In all high - dose rats , the ear pinnae , xiphoid cartilages , and skin were discolored yellow . | [
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PRETOX_REL | In conclusion , oral administration of COMPOUND_XXX by gavage to rats for 4 weeks resulted in test article - related statistically significant decreases in mean body weight and mean body weight gain in males at 60 mg / kg / day , organ weight changes in both sexes at 60 mg / kg / day and renal changes in males at doses ≥ 6 mg / kg / day . | [
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PRETOX_REL | Otherwise only background findings common to Füllinsdorfer Albino - rats were seen . | [
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NO_PRETOX_REL | The relevance of these findings remains unclear . | [
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PRETOX_REL | Microscopic examination of the joints revealed growth plate thickening , indicating pharmacological activity , without any adverse changes . | [
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NO_PRETOX_REL | ( ~ ~ Microscopic investigation of the urinary sediments involving differentiation into bacteria , epithelial cells , leucocytes , erythrocytes and amorphous salts did not bring to light any notable quantitative or qualitative differences between the control groups and the treatment groups up to and including group Ill as regards the composition of the sediments . | [
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NO_PRETOX_REL | There were no COMPOUND_XXX - related changes at 40 mg / kg / day . | [
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NO_PRETOX_REL | The following investigations were performed : mortality , clinical signs , body weight , urinalysis , toxicokinetic investigations , necropsy , macroscopic and microscopic examinations ( including immunohistochemistry ) , and pharmacogenomic investigations . | [
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NO_PRETOX_REL | The study was designed to establish a no - observed - adverse - effect level ( NOAEL ) , to estimate the toxicokinetic profile , and to estimate the potential for reversal of any toxic effects within a 4 - week postdosing phase . | [
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PRETOX_REL | COMPOUND_XXX - related reductions in neutrophil , lymphocyte , monocyte and eosinophil counts at 30 and 75 mg / kg were associated with myeloid series changes ( maturation arrest ) observed during bone marrow cytological evaluation . | [
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NO_PRETOX_REL | No treatment - related effects on hematological parameters , organ weights , macroscopic or microscopic findings were observed at either 100 or 300 mg / kg / day . | [
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PRETOX_REL | Adrenal cortical hypertrophy noted at the high dose as well as reductions in thymus and spleen weights were attributed to a stress - like response to hypoglycemia . | [
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NO_PRETOX_REL | a. Clinical observations The table for the evaluation of the nutritional state can be found in the appendix of the report . | [
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NO_PRETOX_REL | Blood samples for hematology and clinical chemistry were collected at pretest , and on day 14 . | [
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PRETOX_REL | In histopathology treatment related findings were observed in the hemolymphatic system , gastrointestinal tract , female reproductive tract , kidney , bone , salivary glands , lung , trachea and thyroid gland . | [
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PRETOX_REL | 8 ) Increased weight of the salivary glands was noted in females in the 50 mg / kg group . | [
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NO_PRETOX_REL | The reversibility of treatment - related effects was assessed following a four - week recovery period . | [
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NO_PRETOX_REL | Toxicokinetic analysis revealed a dose - dependent systemic exposure . | [
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NO_PRETOX_REL | All findings showed a tendency to normalization by the end of the recovery period . | [
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PRETOX_REL | The number of neutrophilic granulocytes was slightly increased ( statistically significant ) , whereas the absolute basophil number was slightly decreased ( statistically significant ) . | [
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