Datasets:
javicorvi
/
pretoxtm-dataset

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PRETOX_REL
Following the 4 week recovery period evidence of reversibility was observed for all of the clinical chemistry parameters affected during the treatment period , although , cholesterol levels were still slightly lower than those of the controls .
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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", "B-STUDY_TESTCD", "I-STUDY_TESTCD", "O", "O", "B-MANIFESTATION_FINDING", "I-MANIFESTATION_FINDING", "O", "O", "O", "O", "O", "O" ]
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NO_PRETOX_REL
This effect in the lungs is considered to be due to the amphiphilic properties of the compound , because it shows a great morphological similarity to the phospholipidosis described after amphiphilic chemicals .
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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" ]
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NO_PRETOX_REL
Exposure to COMPOUND_XXX after multiple oral doses was generally similar to that observed after a single dose .
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[ "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 ]
NO_PRETOX_REL
Animal H 937 / group III which was sacrificed prematurely showed no evidence of findings which would be attributable to dosing with COMPOUND_XXX a Further details can be taken from the pathology report in the appendix of the report .
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[ "O", "O", "O", "O", "B-GROUP", "I-GROUP", "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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PRETOX_REL
Slightly decreased mean body weights were observed in females at 50 mg / kg / day towards the end of the dosing phase .
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[ "O", "B-MANIFESTATION_FINDING", "O", "B-STUDY_TESTCD", "I-STUDY_TESTCD", "O", "O", "O", "B-SEX", "O", "B-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "O", "O", "O", "O", "O", "O", "O", "O" ]
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PRETOX_REL
Mild fibroplasia and changes in the synovial lining were seen at 1000 and 2000 mg / kg / day .
[ "Mild", "fibroplasia", "and", "changes", "in", "the", "synovial", "lining", "were", "seen", "at", "1000", "and", "2000", "mg", "/", "kg", "/", "day", "." ]
[ "B-FINDING", "I-FINDING", "O", "B-FINDING", "I-FINDING", "I-FINDING", "I-FINDING", "I-FINDING", "O", "O", "O", "B-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "O" ]
[ 8, 9, 0, 8, 9, 9, 9, 9, 0, 0, 0, 3, 4, 4, 4, 4, 4, 4, 4, 0 ]
PRETOX_REL
In addition , increases in AST and ALT were noted in 2 moribund sacrifice animals at 50 mg / kg ( Animal Nos. 03F04 and 03F10 ) , without histologic correlate .
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[ "O", "O", "O", "B-MANIFESTATION_FINDING", "O", "B-STUDY_TESTCD", "O", "B-STUDY_TESTCD", "O", "O", "O", "O", "B-FINDING", "I-FINDING", "O", "O", "B-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
Five animals / sex / group were placed on an eight week recovery phase following 52 weeks of treatment and the remaining survivors were necropsied for the one year interim necropsy .
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NO_PRETOX_REL
This inhibition was observed on days 12 and 26 for liver only .
[ "This", "inhibition", "was", "observed", "on", "days", "12", "and", "26", "for", "liver", "only", "." ]
[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "B-SPECIMEN", "O", "O" ]
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 10, 0, 0 ]
NO_PRETOX_REL
No test item was detected in the control formulations .
[ "No", "test", "item", "was", "detected", "in", "the", "control", "formulations", "." ]
[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
NO_PRETOX_REL
The lesion persisted to the recovery necropsy .
[ "The", "lesion", "persisted", "to", "the", "recovery", "necropsy", "." ]
[ "O", "O", "O", "O", "O", "O", "O", "O" ]
[ 0, 0, 0, 0, 0, 0, 0, 0 ]
NO_PRETOX_REL
Clinical signs , body weight and estimated food consumption determinations were performed on all the animals .
[ "Clinical", "signs", ",", "body", "weight", "and", "estimated", "food", "consumption", "determinations", "were", "performed", "on", "all", "the", "animals", "." ]
[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
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PRETOX_REL
Treatment resulted in decreased neutrophil , eosinophil and red blood cell counts , hematocrit , hemoglobin and platelets , and increased MCV , MCH , MCHC and red cell distribution width at 50 mg / kg / day .
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PRETOX_REL
The second interim sacrifice on day 17 of the study revealed initial degenerative alterations in the left ventricular papillary muscle of the heart in one male and one female of group II ( 30/60 mg / kg ) .
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PRETOX_REL
Hyaline droplet nephropathy is a recognized lesion of the male rat kidney that is related to the accumulation of α2μ - globulin in the proximal tubules of affected animal .
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NO_PRETOX_REL
COMPOUND_XXX suspensions in 0.5 % ( w / v ) hydroxylpropyl - methylcellulose ( 0.5 % HPMC ) were found to be stable under the conditions of use for this study .
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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" ]
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PRETOX_REL
The clinical signs observed during this study were consistent with excessive cholinergic stimulation in the peripheral and central nervous systems .
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PRETOX_REL
Autopsy " Mammary tumor " in animal No. 7096 ( F , top dose group ) histo - logically confirmed as lobular hyperplasia ( adenosis ) .
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[ "O", "O", "B-FINDING", "I-FINDING", "O", "O", "O", "O", "O", "O", "O", "O", "B-GROUP", "I-GROUP", "I-GROUP", "O", "O", "O", "O", "O", "O", "B-FINDING", "I-FINDING", "O", "B-FINDING", "O", "O" ]
[ 0, 0, 8, 9, 0, 0, 0, 0, 0, 0, 0, 0, 12, 13, 13, 0, 0, 0, 0, 0, 0, 8, 9, 0, 8, 0, 0 ]
NO_PRETOX_REL
Ophthalmoscopic examinations were performed on all animals on study in pretest week -1 and Weeks 15 , 28 , 51 and 59 ( Recovery Week 7 ) .
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PRETOX_REL
The timing of the observations in this investigation indicated that any mechanism underlying the effects of HDAC inhibition in the thyroid by COMPOUND_XXX was likely to be an early event .
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[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "B-FINDING", "I-FINDING", "O", "O", "B-SPECIMEN", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
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NO_PRETOX_REL
The incidence and severity increased with dose .
[ "The", "incidence", "and", "severity", "increased", "with", "dose", "." ]
[ "O", "O", "O", "O", "O", "O", "O", "O" ]
[ 0, 0, 0, 0, 0, 0, 0, 0 ]
PRETOX_REL
Rough coat and lacrimation were observed in the High dose group .
[ "Rough", "coat", "and", "lacrimation", "were", "observed", "in", "the", "High", "dose", "group", "." ]
[ "B-FINDING", "I-FINDING", "O", "B-FINDING", "O", "O", "O", "O", "B-GROUP", "I-GROUP", "I-GROUP", "O" ]
[ 8, 9, 0, 8, 0, 0, 0, 0, 12, 13, 13, 0 ]
PRETOX_REL
Following a two week period of recovery the treatment - related lesions in the liver of males were fully reversible .
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NO_PRETOX_REL
Inter-animal variability was medium to high , in both males and females after the first and last administration .
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[ "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
Two additional animals / sex were assigned to the control and high dose groups and served as recovery animals for a 4 - week recovery period .
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PRETOX_REL
Reproductive organs including uterus , testes and epididymides , prostate and seminal vesicles were diminished in size .
[ "Reproductive", "organs", "including", "uterus", ",", "testes", "and", "epididymides", ",", "prostate", "and", "seminal", "vesicles", "were", "diminished", "in", "size", "." ]
[ "O", "O", "O", "B-SPECIMEN", "O", "B-SPECIMEN", "O", "B-SPECIMEN", "O", "B-SPECIMEN", "O", "B-SPECIMEN", "I-SPECIMEN", "O", "B-FINDING", "I-FINDING", "I-FINDING", "O" ]
[ 0, 0, 0, 10, 0, 10, 0, 10, 0, 10, 0, 10, 11, 0, 8, 9, 9, 0 ]
PRETOX_REL
Body weight gains for both sexes showed a marked improvement often surpassing concurrent control values .
[ "Body", "weight", "gains", "for", "both", "sexes", "showed", "a", "marked", "improvement", "often", "surpassing", "concurrent", "control", "values", "." ]
[ "B-STUDY_TESTCD", "I-STUDY_TESTCD", "I-STUDY_TESTCD", "O", "B-SEX", "I-SEX", "O", "O", "O", "B-MANIFESTATION_FINDING", "O", "O", "O", "O", "O", "O" ]
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NO_PRETOX_REL
Eighty ( 80 ) Wistar rats were allocated to 8 groups ( 5 animals / sex / group ) and treated by the dermal route either once daily from Days 1 - 28 or twice weekly from Days 1 - 28 with the control article or the test articles , COMPOUND_XXX 100 mg / g Nail Lacquer ; COMPOUND_XXX 200 mg / g Nail Lacquer ; or COMPOUND_XXX 270 mg / g Nail Lacquer , at dose levels of 100 , 200 , or 270 mg / kg / day .
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NO_PRETOX_REL
Additional 2 males were included in the 120 ad 180 mg / kg COMPOUND_XXX groups as satellite animals for toxicokinetics and dosed as described above .
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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" ]
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PRETOX_REL
Four of these naturally dying animals exhibited lesions that indicated an intubation error was the probable cause of death .
[ "Four", "of", "these", "naturally", "dying", "animals", "exhibited", "lesions", "that", "indicated", "an", "intubation", "error", "was", "the", "probable", "cause", "of", "death", "." ]
[ "O", "O", "O", "O", "O", "O", "O", "B-FINDING", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
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NO_PRETOX_REL
, Cmax or Cmin ) was dose - proportional and increased 2 - to 4-fold on multiple administration of COMPOUND_XXX .
[ ",", "Cmax", "or", "Cmin", ")", "was", "dose", "-", "proportional", "and", "increased", "2", "-", "to", "4-fold", "on", "multiple", "administration", "of", "COMPOUND_XXX", "." ]
[ "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 finding showed a large decrease in incidence when the High Dose was reduced from 1.5 to 1.0 mg / kg / occasion .
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[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "B-DOSE_QUALIFICATION", "I-DOSE_QUALIFICATION", "O", "O", "O", "B-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "O" ]
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 15, 16, 0, 0, 0, 3, 4, 4, 4, 4, 4, 4, 4, 0 ]
PRETOX_REL
No changes were seen in the mean daily water consumption of treated females except for a slightly higher consumption at 225 mg / kg at the end of gestation .
[ "No", "changes", "were", "seen", "in", "the", "mean", "daily", "water", "consumption", "of", "treated", "females", "except", "for", "a", "slightly", "higher", "consumption", "at", "225", "mg", "/", "kg", "at", "the", "end", "of", "gestation", "." ]
[ "O", "O", "O", "O", "O", "O", "O", "O", "B-STUDY_TESTCD", "I-STUDY_TESTCD", "O", "O", "B-SEX", "O", "O", "O", "O", "B-MANIFESTATION_FINDING", "O", "O", "B-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "O", "O", "O", "O", "O", "O" ]
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PRETOX_REL
However , increases in ALT and AST also suggested liver damage .
[ "However", ",", "increases", "in", "ALT", "and", "AST", "also", "suggested", "liver", "damage", "." ]
[ "O", "O", "B-MANIFESTATION_FINDING", "O", "B-STUDY_TESTCD", "O", "B-STUDY_TESTCD", "O", "O", "B-SPECIMEN", "B-FINDING", "O" ]
[ 0, 0, 1, 0, 2, 0, 2, 0, 0, 10, 8, 0 ]
NO_PRETOX_REL
Clinical signs , body weight and estimated food consumption determinations were performed on all the animals .
[ "Clinical", "signs", ",", "body", "weight", "and", "estimated", "food", "consumption", "determinations", "were", "performed", "on", "all", "the", "animals", "." ]
[ "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
Females in general had higher exposure to COMPOUND_XXX than males , especially in the low dose group .
[ "Females", "in", "general", "had", "higher", "exposure", "to", "COMPOUND_XXX", "than", "males", ",", "especially", "in", "the", "low", "dose", "group", "." ]
[ "O", "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, 0, 12, 13, 13, 0 ]
NO_PRETOX_REL
COMPOUND_XXX ( Batch no .
[ "COMPOUND_XXX", "(", "Batch", "no", "." ]
[ "O", "O", "O", "O", "O" ]
[ 0, 0, 0, 0, 0 ]
PRETOX_REL
The absolute and relative weights of the spleen and thymus were decreased in both sexes .
[ "The", "absolute", "and", "relative", "weights", "of", "the", "spleen", "and", "thymus", "were", "decreased", "in", "both", "sexes", "." ]
[ "O", "O", "O", "O", "B-STUDY_TESTCD", "O", "O", "B-SPECIMEN", "O", "B-SPECIMEN", "O", "B-MANIFESTATION_FINDING", "O", "B-SEX", "I-SEX", "O" ]
[ 0, 0, 0, 0, 2, 0, 0, 10, 0, 10, 0, 1, 0, 5, 7, 0 ]
PRETOX_REL
Lesions at doses : ; : : : 15 mg / kg / day included focal fibrosis of bone marrow , atrophy of acinar cells of the Harderian gland and increased eosinophilic macrophages in mesenteric lymph nodes .
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PRETOX_REL
Other fluoride related changes were observed in the stomach in animals that died or were sacrificed early at 10 mg / kg and higher , and in the kidney at 25 and 50 mg / kg .
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[ "O", "B-STUDY_TESTCD", "O", "B-MANIFESTATION_FINDING", "O", "O", "O", "O", "B-SPECIMEN", "O", "O", "O", "B-FINDING", "O", "O", "B-FINDING", "O", "O", "B-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "O", "O", "O", "O", "O", "O", "B-SPECIMEN", "O", "B-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "O" ]
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NO_PRETOX_REL
The changes can be attributed to actions of estrogens .
[ "The", "changes", "can", "be", "attributed", "to", "actions", "of", "estrogens", "." ]
[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
PRETOX_REL
At necropsy , enlarged livers were noted in 4/5 males and 2/5 females .
[ "At", "necropsy", ",", "enlarged", "livers", "were", "noted", "in", "4/5", "males", "and", "2/5", "females", "." ]
[ "O", "O", "O", "B-FINDING", "B-SPECIMEN", "O", "O", "O", "O", "B-SEX", "O", "O", "B-SEX", "O" ]
[ 0, 0, 0, 8, 10, 0, 0, 0, 0, 5, 0, 0, 5, 0 ]
NO_PRETOX_REL
Changes unrelated to COMPOUND_XXX : Other statistically significant changes were sporadic or within the variations .
[ "Changes", "unrelated", "to", "COMPOUND_XXX", ":", "Other", "statistically", "significant", "changes", "were", "sporadic", "or", "within", "the", "variations", "." ]
[ "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
COMPOUND_XXX , batch C0062 , was intraperitoneally administered at a dosage of 50 ( group 2 , 3 males ) for 28 days , at a dosage volume of 20 mL / kg , once daily .
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[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "B-GROUP", "I-GROUP", "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
The effects of COMPOUND_XXX were evaluated using clinical , biochemical and hematological parameters , bone marrow examinations , urinalysis , coagulation studies , necropsy findings , organ weight analysis and microscopic examinations .
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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" ]
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PRETOX_REL
Animal H 944 / group | experienced a possibly false intratracheal application of application formulation in week 3 of the study with a subsequent deterioration of the health condition with rapid regeneration .
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NO_PRETOX_REL
At the initiation of dosing , the monkeys were approximately 3 to 4.5 years of age and weighed from 3.4 to 3.9 kg for males and 2.6 to 4.4 kg for females .
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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" ]
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PRETOX_REL
- atrophic lymphoid changes in thymus , in the mesenteric lymph nodes and in Peyer ’s patch were observed in both sexes at 40 mg / kg , correlated at necropsy with low organ weights and / or thymus of small size and consistent with the decrease in myeloid to erythroid ratio .
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NO_PRETOX_REL
Based on these results , both the No Effect Level ( NOEL ) and the No Adverse Effect Level ( NOAEL ) are below the lowest dose level , 30 mg / kg / day .
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PRETOX_REL
- Liver : increase in GLDH ( M > F ) , PAL ( M ) , ASAT ( M ) and ALAT ( M ) activities and increase in serum total bilirubin concentration ( M > F ) correlated at macroscopic and microscopic examination .
[ "-", "Liver", ":", "increase", "in", "GLDH", "(", "M", ">", "F", ")", ",", "PAL", "(", "M", ")", ",", "ASAT", "(", "M", ")", "and", "ALAT", "(", "M", ")", "activities", "and", "increase", "in", "serum", "total", "bilirubin", "concentration", "(", "M", ">", "F", ")", "correlated", "at", "macroscopic", "and", "microscopic", "examination", "." ]
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PRETOX_REL
Emetic changes ( emesis with food or apparent compound ) were also observed three of the high dose females generally during the last week of the dosing phase .
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[ "O", "O", "O", "B-FINDING", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "B-DOSE_QUALIFICATION", "I-DOSE_QUALIFICATION", "B-SEX", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
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NO_PRETOX_REL
Exposure to COMPOUND_XXX was approximately dose proportional from 100 to 270 mg / kg and no evidence of accumulation was found when exposures on Day 1 and Day 28 were compared .
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[ "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", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
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PRETOX_REL
At 50 mg / kg / day , red ears , squinting , swollen appendage , red feet , dry perineal staining and presence of apparent blood or dark yellow urine on cage paper were observed .
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PRETOX_REL
Drug - related effects on body weight were noted in Group IT females and Groups IV and V animals when compared to Control values .
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NO_PRETOX_REL
d. Ophthaimoscopic findings The individual data for the ophthalmoscopic investigations can be found in the appendix of the report .
[ "d.", "Ophthaimoscopic", "findings", "The", "individual", "data", "for", "the", "ophthalmoscopic", "investigations", "can", "be", "found", "in", "the", "appendix", "of", "the", "report", "." ]
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PRETOX_REL
At 3 500 ppm , clinical pathology analysis revealed lower mean total cholesterol concentrations in both sexes ( - 52 % and -51 % in males and females , respectively ) .
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PRETOX_REL
Reversible , dose - dependent increased liver weights occurred in males at doses ≥ 15 mg / kg / day while pertinent necropsy findings were observed at doses ≥ 15 mg / kg / day consisting of mucosal foci or mucosal discoloration of the gall bladder and mottled discoloration of the liver in one high - dose female .
[ "Reversible", ",", "dose", "-", "dependent", "increased", "liver", "weights", "occurred", "in", "males", "at", "doses", "≥", "15", "mg", "/", "kg", "/", "day", "while", "pertinent", "necropsy", "findings", "were", "observed", "at", "doses", "≥", "15", "mg", "/", "kg", "/", "day", "consisting", "of", "mucosal", "foci", "or", "mucosal", "discoloration", "of", "the", "gall", "bladder", "and", "mottled", "discoloration", "of", "the", "liver", "in", "one", "high", "-", "dose", "female", "." ]
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PRETOX_REL
Summary of results and discussion Treatment of cynomolgus monkeys with COMPOUND_XXX was associated with gastrointestinal symptoms such as vomiting , decreased food consumption resulting in weight loss at a daily dose of 160 μmol / kg bw .
[ "Summary", "of", "results", "and", "discussion", "Treatment", "of", "cynomolgus", "monkeys", "with", "COMPOUND_XXX", "was", "associated", "with", "gastrointestinal", "symptoms", "such", "as", "vomiting", ",", "decreased", "food", "consumption", "resulting", "in", "weight", "loss", "at", "a", "daily", "dose", "of", "160", "μmol", "/", "kg", "bw", "." ]
[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "B-FINDING", "O", "B-MANIFESTATION_FINDING", "B-STUDY_TESTCD", "I-STUDY_TESTCD", "O", "O", "B-STUDY_TESTCD", "B-MANIFESTATION_FINDING", "O", "O", "O", "O", "O", "B-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "O" ]
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NO_PRETOX_REL
The data were used to investigate the mechanism of mucosal cell proliferation in the small intestine in previous mouse studies with the test item .
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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" ]
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NO_PRETOX_REL
Gross - pathological and histopathological findings At the time of necropsy no toxicologically relevant changes were found in respect of the nutritional state of the animals up to and including group | .
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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", "B-GROUP", "I-GROUP", "O" ]
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PRETOX_REL
Changes seen at 75 mg / kg as regards pre and post natal losses were considered not compoundrelated since not confirmed at the highest dose and since the values fell within the normal range of variability of the historical control data for the laboratory .
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PRETOX_REL
With respect to course of the DAO inhibition , there was no clear correlation to the jejunal mucosa concentrations of COMPOUND_XXX and PAG .
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[ "O", "O", "O", "O", "O", "O", "B-FINDING", "I-FINDING", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
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PRETOX_REL
In conclusion , daily oral administration of COMPOUND_XXX to rats for two weeks at doses of 50 , 150 or 450 mg / kg / day resulted in dose - related decreases in serum and plasma glucose levels as well as in - life observations consistent with severe and prolonged hypoglycemia .
[ "In", "conclusion", ",", "daily", "oral", "administration", "of", "COMPOUND_XXX", "to", "rats", "for", "two", "weeks", "at", "doses", "of", "50", ",", "150", "or", "450", "mg", "/", "kg", "/", "day", "resulted", "in", "dose", "-", "related", "decreases", "in", "serum", "and", "plasma", "glucose", "levels", "as", "well", "as", "in", "-", "life", "observations", "consistent", "with", "severe", "and", "prolonged", "hypoglycemia", "." ]
[ "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", "O", "O", "O", "O", "O", "B-FINDING", "I-FINDING", "I-FINDING", "O", "B-STUDY_TESTCD", "I-STUDY_TESTCD", "I-STUDY_TESTCD", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "B-FINDING", "I-FINDING", "O" ]
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PRETOX_REL
In accordance with oral mucosa and skin lesions , white blood cell count ( WBC ) and fibrinogen was increased at 1.0 ( 1.5 ) mg / kg / day .
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NO_PRETOX_REL
The purpose of this oral study in dogs was to follow the progression and then reversibility of long - term liver toxicity .
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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" ]
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NO_PRETOX_REL
Therefore , the observation is considered treatment - related but not toxicologically relevant .
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NO_PRETOX_REL
The ano - genital distance of pups ( males and females ) belonging to the treated group was similar to those of male and female control pups respectively , either when recorded at birth or on Day 4 at necropsy and the external sex corresponded to the internal one , checked at sacrifice , in all pups .
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[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "B-GROUP", "I-GROUP", "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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PRETOX_REL
Clinically , local irritations at the snout such as reddening and / or swelling at the low dose and higher were observed .
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NO_PRETOX_REL
However , due to the isolated nature of the death , a relationship to the test article was not evident .
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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" ]
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PRETOX_REL
Food intake was sporadically decreased in 15 animals at 50 mg / kg , 11 animals at 25 mg / kg , from Day 39 and 57 , respectively .
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[ "B-STUDY_TESTCD", "I-STUDY_TESTCD", "O", "O", "B-MANIFESTATION_FINDING", "O", "O", "O", "O", "B-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "O", "O", "O", "O", "B-DOSE", "I-DOSE", "I-DOSE", "I-DOSE", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
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PRETOX_REL
Summary of results and discussion Following suspected or clear - cut compound - related findings were observed : From 35 mg / kg COMPOUND_XXX onwards : - single or repeated vomitus over several days with dose - dependently increasing frequency and incidence in two animals of group 2 and all animals of groups 3 and 4 - _ slight decrease in systolic blood pressure in individual animals of all groups From 100 mg / kg COMPOUND_XXX onwards : - sialorrhea with dose - dependently increasing frequency and incidence in one animal of group 3 and all animals of group 4 - decrease in food intake in one animal of group 3 ( no. 8566 ) and in all animals of group 4 - decrease in water consumption in one animal of group 3 ( no. 8566 ) and in all animals of group 4 - distinct loss of body weight in one animal of group 3 ( no 8566 ) and in all animals of group 4 - decrease in heart rate in one animal of group 3 ( no. 8566 ) and in all animals of group 4 ; this effect provoked a prolongation of the PQ - and QT - intervals in the above - mentioned animals - _ slight increase in alkaline phosphatase on day 27 - slight increase in fibrinogen on day 27 - slight increase in sedimentation rate in one animal only of group 3 - emaciation of one animal each in group 3 and 4 - hypocellularity of bone marrow of femur and sternum .
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NO_PRETOX_REL
The AUC ( 0 - 24 h ) values were 4840 , 5170 , 3100 , 3760 ng.h / mL for male nos. 2001 , 3001 , 4001 and 4002 at 6 , 20 and 60 mg / kg / day , respectively on days 1 - 2 .
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NO_PRETOX_REL
The change was present at all dose levels , but only in female rats .
[ "The", "change", "was", "present", "at", "all", "dose", "levels", ",", "but", "only", "in", "female", "rats", "." ]
[ "O", "O", "O", "O", "O", "B-DOSE", "I-DOSE", "I-DOSE", "O", "O", "O", "O", "O", "O", "O" ]
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NO_PRETOX_REL
The dose of 30 mg / kg / day was considered to be a no observed effect level ( NOEL ) in males .
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NO_PRETOX_REL
As can be seen from the table , feed intake showed no changes up to and including group Hl .
[ "As", "can", "be", "seen", "from", "the", "table", ",", "feed", "intake", "showed", "no", "changes", "up", "to", "and", "including", "group", "Hl", "." ]
[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "B-GROUP", "I-GROUP", "O" ]
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NO_PRETOX_REL
There was no relationship to dose and , in the absence of any similar finding in the females , this finding was considered of doubtful toxicological significance .
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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" ]
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PRETOX_REL
Administration of COMPOUND_XXX for up to 26 days resulted in a slight decrease of body weight gains ( 28 % ) and food consumption .
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PRETOX_REL
It should be noted that no off - target effects were seen in this study and that all findings resulting from severe hypoglycemia are not clinically relevant since the test species in the current study is a euglycemic model while the target population is hyperglycemic patients .
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NO_PRETOX_REL
The mean plasma levels are given in T 5 .
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[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
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PRETOX_REL
In all animals from the high dose group desquamations of the skin were observed .
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NO_PRETOX_REL
Isopropanol , soap and water were used to remove the test items .
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[ "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O", "O" ]
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PRETOX_REL
Test article - related decrease in food consumption was observed in only one high dose female during week 2 with concomitant body weight loss .
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PRETOX_REL
Phagocytic activities of tissue macrophages and foreign - body giant cells are therefore predominant in the histopathological picture .
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[ 0, 0, 0, 10, 8, 0, 0, 0, 0, 8, 9, 0, 0, 0, 0, 0, 0, 0, 0 ]
PRETOX_REL
A decrease in food consumption was observed at 30 mg / kg ( statistically significantly ) in the 2nd treatment week by 11.5 % in males and 9.1 % in females .
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NO_PRETOX_REL
An overview of the key pharmacokinetic parameters determined in this study is given in TT 1 .
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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
Urinalysis data were suggestive of urinary tract inflammation and / or kidney lesions and correlated with the changes in the histopathological examination .
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PRETOX_REL
In the female reproductive tract , minimal unilateral to bilateral ovarian cysts were seen in two rats , which were combined with minimal acute focal unilateral hemorrhages in the corpora lutea in one case .
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PRETOX_REL
In the glandular stomach , mild erosions / ulcerations , inflammation and hemorrhages were found , cytoplasmic vacuolation was shown in the epithelium of limiting ridge of the forestomach .
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PRETOX_REL
However since the magnitude of liver weight variations at 80 mg / kg was minor and not associated with any liver histomorphological changes , it was considered to be of no toxicological significance at this low dose .
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NO_PRETOX_REL
No effects on female reproductive organs were seen at postmortem examination .
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[ "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
Food consumption during the recovery period was comparable to control , for treated males and females .
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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
On days 1 - 2 , AUC ( 0 - 24h ) values were 2.48 , 9.12 , and 46.6 ng.h / mL in males and 8.50 , 20.5 , and 67.0 ng.h / mL in females at 3 , 10 , and 30 mg / kg , respectively .
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PRETOX_REL
Test article - related clinical signs were observed at all doses .
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NO_PRETOX_REL
At 1 mg / kg the maximum 89 Y plasma levels at 5 minutes after injection were 19.0 and 24.9 μg / mL on day 0 and day 27 , respectively .
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PRETOX_REL
The focal increased cytolysosomes in skeletal muscle of animal No. 56 ( COMPOUND_XXX 180 mg / kg / day ) resemble to necrotic changes of mitochondria and cytoplasm .
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NO_PRETOX_REL
No mortality was seen in the animals .
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NO_PRETOX_REL
The animals were received from Charles River Laboratories , Kingston , New York , and were approximately 6 to 8 weeks of age and weighed from 180.2 to 223.2 g for males and 151.7 to 188.5 g for females at initiation of dosing .
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NO_PRETOX_REL
Toxicokinetic evaluations were conducted on toxicokinetic subgroup animals on day 1 , and weeks 11 and 25 at 0.5 , 1 , 2 , 6 and 24 hour post dose .
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NO_PRETOX_REL
In conclusion , the identity of the test article was proved , and the COMPOUND_XXX concentrations were within the range of variation accepted ; hence , the preparations for application were done with the correct compound and at the correct concentrations .
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NO_PRETOX_REL
Clinical pathology evaluations ( hematology , clinical chemistry and urinalysis ) were conducted on all animals in weeks 1 and 4 and at the end of the recovery period .
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