Datasets:
javicorvi
/
pretoxtm-dataset

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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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[ "O", "B-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "O", "O", "O", "B-MANIFESTATION_FINDING", "O", "B-STUDY_TESTCD", "I-STUDY_TESTCD", "I-STUDY_TESTCD", "O", "O", "O", "O", "O", "B-SPECIMEN", "O", "B-SPECIMEN", "B-STUDY_TESTCD", "O", "O", "O", "O", "B-SEX", "O" ]
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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 .
[ "No", "relevant", "changes", "were", "found", "in", "females", "." ]
[ "O", "O", "O", "O", "O", "O", "O", "O" ]
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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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[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
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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 cons...
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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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[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
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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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[ "O", "B-SEX", "O", "O", "B-GROUP", "I-GROUP", "I-GROUP", "O", "B-FINDING", "O", "B-FINDING", "O" ]
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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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[ "O", "O", "O", "O", "O", "O", "O" ]
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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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[ "O", "O", "O", "O", "O", "O", "O", "O", "B-FINDING", "I-FINDING", "O", "O", "B-SPECIMEN", "O" ]
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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 .
[ "Ophthalmoscopic", "assessments", "were", "undertaken", "on", "all", "animals", "during", "pretrial", "and", "on", "Control", "and", "High", "dose", "animals", "after", "approximately", "26", "weeks", "of", "dosing", "." ]
[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "B-DOSE_QUALIFICATION", "I-DOSE_QUALIFICATION", "O", "O", "O", "O", "O", "O", "O", "O" ]
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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 .
[ "The", "body", "weight", "loss", "noted", "at", "1.0", "mg", "/", "kg", "/", "occasion", "correlated", "with", "an", "observed", "decrease", "in", "food", "consumption", "." ]
[ "O", "B-STUDY_TESTCD", "I-STUDY_TESTCD", "B-MANIFESTATION_FINDING", "O", "O", "B-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "O", "O", "O", "O", "B-MANIFESTATION_FINDING", "O", "B-STUDY_TESTCD", "I-STUDY_TESTCD", "O" ]
[ 0, 2, 6, 1, 0, 0, 3, 4, 4, 4, 4, 4, 0, 0, 0, 0, 1, 0, 2, 6, 0 ]
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...
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NO_PRETOX_REL
Exposures were generally higher in females than in males , especially in the low dose group .
[ "Exposures", "were", "generally", "higher", "in", "females", "than", "in", "males", ",", "especially", "in", "the", "low", "dose", "group", "." ]
[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "B-GROUP", "I-GROUP", "I-GROUP", "O" ]
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 12, 13, 13, 0 ]
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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[ "O", "O", "O", "O", "O", "O", "O", "B-SPECIMEN", "O", "O", "O", "B-FINDING", "O", "O", "B-FINDING", "I-FINDING", "I-FINDING", "O", "O", "B-FINDING", "O", "B-FINDING", "I-FINDING", "O" ]
[ 0, 0, 0, 0, 0, 0, 0, 10, 0, 0, 0, 8, 0, 0, 8, 9, 9, 0, 0, 8, 0, 8, 9, 0 ]
NO_PRETOX_REL
Conclusion No NOEL could be established in this study .
[ "Conclusion", "No", "NOEL", "could", "be", "established", "in", "this", "study", "." ]
[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
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 .
[ "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", "." ]
[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "B-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
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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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[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "B-GROUP", "I-GROUP", "I-GROUP", "I-GROUP", "I-GROUP", "I-GROUP", "O", "O", "O", "O", "O", "O", "O" ]
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PRETOX_REL
- decrease in heart rate was noted in male animals on day 8 .
[ "-", "decrease", "in", "heart", "rate", "was", "noted", "in", "male", "animals", "on", "day", "8", "." ]
[ "O", "B-MANIFESTATION_FINDING", "O", "B-STUDY_TESTCD", "I-STUDY_TESTCD", "O", "O", "O", "B-SEX", "O", "O", "O", "O", "O" ]
[ 0, 1, 0, 2, 6, 0, 0, 0, 5, 0, 0, 0, 0, 0 ]
PRETOX_REL
Haemorrhages and infarcts were found in a large number of organs .
[ "Haemorrhages", "and", "infarcts", "were", "found", "in", "a", "large", "number", "of", "organs", "." ]
[ "B-FINDING", "I-FINDING", "I-FINDING", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
[ 8, 9, 9, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
NO_PRETOX_REL
All animals survived the 13 - week dosing period .
[ "All", "animals", "survived", "the", "13", "-", "week", "dosing", "period", "." ]
[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
NO_PRETOX_REL
No sex effect was observed except on the first day when measurable levels appeared later in the females than in males .
[ "No", "sex", "effect", "was", "observed", "except", "on", "the", "first", "day", "when", "measurable", "levels", "appeared", "later", "in", "the", "females", "than", "in", "males", "." ]
[ "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
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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[ "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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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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[ "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
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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[ "O", "B-DOSE_QUALIFICATION", "I-DOSE_QUALIFICATION", "I-DOSE_QUALIFICATION", "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
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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[ "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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NO_PRETOX_REL
Blood was collected at various time points for toxicokinetic analysis on days 1 and 15 .
[ "Blood", "was", "collected", "at", "various", "time", "points", "for", "toxicokinetic", "analysis", "on", "days", "1", "and", "15", "." ]
[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
NO_PRETOX_REL
Theses dermal findings are deemed related to treatment with the test substance .
[ "Theses", "dermal", "findings", "are", "deemed", "related", "to", "treatment", "with", "the", "test", "substance", "." ]
[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
NO_PRETOX_REL
Water consumption showed no treatment - related changes in males at any dose level compared to control .
[ "Water", "consumption", "showed", "no", "treatment", "-", "related", "changes", "in", "males", "at", "any", "dose", "level", "compared", "to", "control", "." ]
[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
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 .
[ "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", "." ]
[ "O", "O", "O", "O", "B-SEX", "O", "B-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "O", "O", "O", "O", "B-FINDING", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
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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 .
[ "The", "degree", "of", "thickening", "was", "dose", "-", "dependant", "up", "to", "1000", "mg", "/", "kg", "/", "day", ",", "when", "a", "plateau", "was", "reached", "." ]
[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "B-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "O", "O", "O", "O", "O", "O", "O" ]
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NO_PRETOX_REL
The lists of individual data are given in Appendix 2 .
[ "The", "lists", "of", "individual", "data", "are", "given", "in", "Appendix", "2", "." ]
[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
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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[ "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
No test article related microscopic findings were noted in the animals that were dosed twice weekly .
[ "No", "test", "article", "related", "microscopic", "findings", "were", "noted", "in", "the", "animals", "that", "were", "dosed", "twice", "weekly", "." ]
[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "B-DOSE", "I-DOSE", "I-DOSE", "O" ]
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 3, 4, 4, 0 ]
NO_PRETOX_REL
XXXX ) and Placebo to COMPOUND_XXX ( patches , batch no .
[ "XXXX", ")", "and", "Placebo", "to", "COMPOUND_XXX", "(", "patches", ",", "batch", "no", "." ]
[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
NO_PRETOX_REL
III ) , resp .
[ "III", ")", ",", "resp", "." ]
[ "O", "O", "O", "O", "O" ]
[ 0, 0, 0, 0, 0 ]
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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[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "B-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "...
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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 .
[ "Minimal", "to", "moderate", "liver", "alterations", "were", "present", "in", "both", "treated", "groups", "with", "substantial", "individual", "variations", "in", "occurrence", "and", "severity", "." ]
[ "B-MANIFESTATION_FINDING", "I-MANIFESTATION_FINDING", "I-MANIFESTATION_FINDING", "B-FINDING", "I-FINDING", "O", "O", "O", "B-GROUP", "I-GROUP", "I-GROUP", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
[ 1, 14, 14, 8, 9, 0, 0, 0, 12, 13, 13, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
NO_PRETOX_REL
Female animals appeared to be exposed to higher levels of COMPOUND_XXX compared to males .
[ "Female", "animals", "appeared", "to", "be", "exposed", "to", "higher", "levels", "of", "COMPOUND_XXX", "compared", "to", "males", "." ]
[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
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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[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
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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 .
[ "XXXXX", "." ]
[ "O", "O" ]
[ 0, 0 ]
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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[ "O", "O", "B-FINDING", "I-FINDING", "O", "O", "O", "O", "B-DOSE", "I-DOSE", "I-DOSE", "O" ]
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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 ...
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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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[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
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NO_PRETOX_REL
All organ weight changes were reversible following the recovery period .
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[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
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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...
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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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[ "O", "O", "O", "O", "O", "O", "O", "O" ]
[ 0, 0, 0, 0, 0, 0, 0, 0 ]
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...
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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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[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
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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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[ "O", "O", "O", "O", "B-FINDING", "O", "O", "O", "O", "B-SPECIMEN", "I-SPECIMEN", "O", "B-SPECIMEN", "I-SPECIMEN", "O", "B-SPECIMEN", "I-SPECIMEN", "I-SPECIMEN", "O", "B-SPECIMEN", "O", "B-SPECIMEN", "O", "B-SPECIMEN", "I-SPECIMEN", "O", "B-SPECIMEN", "I-SPECIMEN...
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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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[ "O", "O", "B-MANIFESTATION_FINDING", "B-STUDY_TESTCD", "O", "O", "B-SPECIMEN", "I-SPECIMEN", "O", "O", "O", "B-SEX", "O", "O", "B-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "O", "O" ]
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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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[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
NO_PRETOX_REL
Toxicokinetic analysis revealed a dose - dependent systemic exposure .
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[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
NO_PRETOX_REL
All findings showed a tendency to normalization by the end of the recovery period .
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[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
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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[ "O", "O", "O", "B-STUDY_TESTCD", "I-STUDY_TESTCD", "O", "O", "B-MANIFESTATION_FINDING", "O", "O", "O", "O", "O", "O", "O", "O", "B-STUDY_TESTCD", "O", "O", "O", "B-MANIFESTATION_FINDING", "O", "O", "O", "O", "O" ]
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