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EC number: 235-826-2 | CAS number: 12788-93-1
- Life Cycle description
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- Endpoint summary
- Appearance / physical state / colour
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- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Toxicological Summary
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- Acute Toxicity
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- Additional toxicological data

Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Sept 2017 - May 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Phosphoric acid, butyl ester (mono and di ester)
- IUPAC Name:
- Phosphoric acid, butyl ester (mono and di ester)
- Test material form:
- other: liquid
- Details on test material:
- no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animal Breeding, RCC Laboratories India Private Limited, Genome Valley, Turkapally, Shameerpet (Mandal), Ranga Reddy District, Hyderabad -500 078 India.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 7-8 weeks
- Weight at study initiation: Male: 164.5 to 198.9 g, Female: 132.6 to 158.2 g
- Housing: In groups of two animals of same sex in Polycarbonate cages (Approximate internal dimensions of 365 mm x 202 mm x 180 mm height) with corncob bedding.
- Diet (e.g. ad libitum): Teklad Certified Global 14% Protein Rodent Maintenance Diet (Lot No. 2014C-082417MA) from ENVIGO was provided ad libitum.
- Water (e.g. ad libitum): Aquaguard filtered tap water was provided ad libitum.
- Acclimation period: 9 days
DETAILS OF FOOD AND WATER QUALITY:
Results of analyses for contaminants are archived at RCC Laboratories India Private
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.9 to 22.8°C
- Humidity (%): 57 to 65%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
From: 4.25. Sept. 2017 To: 1. Feb. 2018
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- The test item was administered to the test system, for the period of 90 consecutive days by oral route using oral gavage needle.
- Vehicle:
- corn oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
VEHICLE
- Justification for use and choice of vehicle (if other than water): based on preliminary solubility testing which was performed in the test facility before the study initiation date
- Concentration in vehicle: 5 mg/mL, 20 mg/mL, 40 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Gas chromotography
Samples of the dose formulations were taken immediately after dilution of the test item with the diluent (vehicle) on treatment start date and last week of treatment for homogeneity (mean of homogeneity was given as dose concentration) analyses. On week 7, samples of all dose formulations were assayed for the applied dose in triplicates. The method was developed and validated prior to analysis. The method was either matrix assisted validation or external standard method of validation. The validation and analysis was carried out as per SANCO/3029/99 rev.4.
The test item in corn oil was assayed on three occasions
01 Stability of test item at 0th, 2nd and 4th hour in corn oil matrix for the fortified concentrations of 5 mg/mL and 40 mg/mL.
02 Initial homogeneity test on Top, mid and bottom layers of corn oil fortified with of test item Viz., 5 mg/mL (Low dose), 20 mg/mL (Intermediate dose), and 40 mg/mL (High dose)
03 Dose concentration of test item in corn oil fortified with 5 mg/mL (Low dose), 20 mg/mL (Intermediate dose), and 40 mg/mL (High dose).
04 Final homogeneity test on Top, mid and bottom layers of corn oil fortified with of test item Viz., 5 mg/mL (Low dose), 20 mg/mL (Intermediate dose), and 40 mg/mL (High dose). Calibration solution, CS5 was used as bracketing standard. - Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 200 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 400 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The doses to be employed for this study were selected, based on the 28 days repeated dose toxicity dose range finding study
- Post-exposure recovery period in satellite groups: 28 days - Positive control:
- n.a.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
twice daily for mortality and on the first 3 days of treatment for clinical observations
once daily for clinical observations
DETAILED CLINICAL OBSERVATIONS: Yes
Once prior to the first exposure and weekly thereafter
BODY WEIGHT: Yes
once weekly
FOOD CONSUMPTION AND COMPOUND INTAKE:
once weekly
OPHTHALMOSCOPIC EXAMINATION: Yes
Prior to the administration of the test item (in 20% of total population) and during week 13 in all animals of group 1 and 4. animals during week 17. Tropicamide was used as a mydriatic agent.
HAEMATOLOGY: Yes
- Time schedule for collection of blood: week 13 (main groups), week 17 (recovery groups)
- Anaesthetic used for blood collection: Yes, isoflurane inhalation anaesthesia
- Animals fasted: Yes
- How many animals: all animals
- Parameters checked:
erythrocyte count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular concentration, platelet count, total leukocyte count, differential leukocyte count, reticulocytes, prothrombin time, activated partial thromboplastin time
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: week 13 (main groups), week 17 (recovery groups)
- Animals fasted: Yes
- How many animals: all animals
- Parameters checked:
glucose, urea, blood urea nirtogen, creatinine, cholesterol, triglycerides. aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyltransferase, bilirubin, sodium, potassium, chloride, protein total, albumin, globulin, A G ratio
URINALYSIS: Yes
- Time schedule for collection of urine: week 13 (main groups), week 17 (recovery groups)
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
- Parameters checked:
volume, specific gravitiy, colour, clarity, pH, erythrocytes, leukocytes, bilirubin, urobiliongen, ketone bodies, proteins and glucose
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations:during week 12 and 17
- Dose groups that were examined: all
- Battery of functions tested: sensory activity / grip strength / motor activity - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
Necropsy: all animals
organ weight (all animals): brain ,heart, liver, thymus, kidneys, adrenals, spleen, testes, epididymides, oavaries, uterus, prostate and seminal vescles with coagulating glands
HISTOPATHOLOGY: Yes
in control and high dose animals (main groups)
addtionally organs that revealed changes in low, mid dose (main groups) and all recovery groups
Adrenal glands, Aorta, Bone marrow (Sternum), Brain (cerebrum, cerebellum, medulla/ pons), Cecum, Cervix, Colon, Duodenum, Epididymides, Eye, Heart, Ileum with Peyer's patches, Jejunum, Kidneys, Liver, Lungs (inflated with NBF at necropsy), Lymph nodes (mesenteric, axillary), Oesophagus, Ovaries, Pancreas, Peripheral nerve (sciatic or tibial), Pituitary, Prostate, Rectum, Salivary gland, Seminal vesical with coagulating glands, Skeletal muscle, Skin with Mammary gland, Spinal cord (cervical, midthoracic, lumbar), Spleen,stomach, Testes, Thymus, Thyroid with parathyroid, Trachea, Urinary bladder (inflated with NBF at necropsy), Uterus, Vagina, All Gross lesions
- Statistics:
- The following statistical methods were used to analyze the body weight, feed consumption, functional observation battery parameters,organ weights as well as clinical pathology data.
• Data was summarized in tabular form. Statistical analysis was performed using statplus program.
• All the data was checked for normality with Shapiro-Wilk W test
• Statistical significances of differences was calculated with one-way analysis of variance(ANOVA). Values were given as mean ± standard deviation (SD).
• t-test/ all ANOVA with group variables were used to compare the difference between treated and control groups.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- No test item related clinical signs of illness were observed in any of the animals during treatment in groups of control (G1), Low dose (G2), Intermediate dose (G3) and recovery period (G1R). However, Dullness was obesrved in high dose (G4) in one male and one female, similarly one male and two females exhibited dullness in high dose recovery (G4R).
- Mortality:
- no mortality observed
- Description (incidence):
- Animals treated with test item at dose levels of 50, 200 and 400 mg/kg bw/d did not show any mortality in both males and females during the experimental period of 90 days and the recovery period.
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The body weight of male animals of all treatment groups were comparable with the control group animals during the dosing period and recovery period.
In females, significant decreases in body weight gain were observed for (G4) on day 85 when compared to the vehicle treated animals. The body weight gain of female animals of recovery high dose group was comparable with the recovery control group animals during the dosing period and recovery period.
The changes observed were considered to be as biological variation commonly recorded for this species, strain and age. - Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- During the 90 consecutive days of dosing period, the quantity of feed consumed by animals across different dose groups was found to be no significantly different as compared with the control animals.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Males: Significant increase of NEU and decrease of lymph in intermediate dose (G3) and high dose (G4) as compared with control dose (G1). Significant increase of mono in high (G4), intermediate dose (G3) low dose (G2) as compared with control group (G1). Significant decrease of EOS in low dose (G2) as compared with control group (G1).
Females: There was significant increase in Neut and decrease in Lymph in (G4) as compared with (G1).
In recovery males, there was significant increase of PCV in G4R as compared with control recovery (G1R). In recovery females, there was significant decrease of white blood cell count (WBC) in female as compared with control recovery (G1R). The changes observed in the hematological parameters are marginal and could not be attributed to the test item administration as these values were within biological variation. - Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Males: Significant increase of ALP and AST in intermediate (G3) and high (G4) dose as compared with control (G1) group. Significant increase of ALT in high (G4) dose as compared with control (G1).
Females: there was significant increase of AST in intermediate (G3) as compared with control (G1). Significant increase of CREA in intermediate (G3) dose as compared with (G1) dose.
In recovery males, there was significant decrease in ALP (G4R) when compared with control recovery (G1R). In recovery females, there was significant increase in UREA, BUN, CREA and ALB in (G4R) when compared with control recovery (G1R). The changes observed in the clinical biochemistry parameters are marginal and could not be attributed to the test item administration as these values were within biological variation. - Urinalysis findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- In males, there was significant decrease of volume in high (G4) dose as compared with control (G1). In females there was significant increase of SG in intermediate (G3) ) and low (G2) as compared with control (G1). The changes observed in the urine analysis parameters are marginal and could not be attributed to the test item administration as these values were within biological variation.
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There was no significance changes observed in absolute and relative organ weights of treatment and recovery groups. In relative organ weights of males, there was significant increase of liver in high (G4) dose as compared with control (G1).
Despite this macroscopical difference, no test item related change was observed in these organs from treatment groups. Hence, the changes observed in organ weight were considered to be as biological variation. - Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Treatment related histopathological findings included chronic inflammation in the non glandular region of stomach observed in treated males and females. Additionally hyperplasia and hyperkeratosis of squamous epithelium of non glandular stomach was also observed in a few animals in these groups. There was single incidence of erosion in glandular stomach in one male treated at 400 mg/kg bw. Chronic inflammation in non glandular stomach consisted of infiltration in lamina propria and/or submucosa with mostly mononuclear cells and occasional polymorphonuclear cells. Edema or/and necrosis of the squamous epithelium was observed in a few cases. The distribution of the lesion was focal or multifocal. The lesion in non glandular stomach was observed in all the treated groups. The severity of the lesion was minimal to mild in all the treated groups. . The incidence and severity of the lesion in females treated at 400mg/kg was higher when compared to males treated with the same dose. The lesions observed in the forestomach may be attributed to direct local effects of the test item administered orally. In the recovery high dose groups, all the stomach tissues were within normal histological limits indicating complete recovery. The lesion was considered non adverse as the incidence and severity of the lesion was low and complete recovery was at the end of 28 day recovery period.
Incidence of stomach effects
- Males:
Inflammation: 0/10 (0 mg/kg bw/d), 4/10 (50 mg/kg bw/d), 4/10 (200 mg/kg bw/d), 2/10 (400 mg/kg bw/d), 0/10 (0 mg/kg bw/d recovery group), 0/10 (400 mg/kg bw/d recovery group)
Hyperpalsia/Hyperkeratosis: 0/10 (0 mg/kg bw/d), 1/10 (50 mg/kg bw/d), 1/10 (200 mg/kg bw/d), 2/10 (400 mg/kg bw/d), 0/10 (0 mg/kg bw/d recovery group), 0/10 (400 mg/kg bw/d recovery group)
Erosion (glandular, focal): 0/10 (0 mg/kg bw/d), 0/10 (50 mg/kg bw/d), 0/10 (200 mg/kg bw/d), 1/10 (400 mg/kg bw/d), 0/10 (0 mg/kg bw/d recovery group), 0/10 (400 mg/kg bw/d recovery group)
- Females:
Inflammation: 0/10 (0 mg/kg bw/d), 3/10 (50 mg/kg bw/d), 4/10 (200 mg/kg bw/d), 6/10 (400 mg/kg bw/d), 0/10 (0 mg/kg bw/d recovery group), 0/10 (400 mg/kg bw/d recovery group)
Hyperpalsia/Hyperkeratosis: 0/10 (0 mg/kg bw/d), 0/10 (50 mg/kg bw/d), 2/10 (200 mg/kg bw/d), 6/10 (400 mg/kg bw/d), 0/10 (0 mg/kg bw/d recovery group), 0/10 (400 mg/kg bw/d recovery group)
Single incidence of microscopic findings observed in other organs in various groups were considered incidental. - Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 400 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: local irritation in stomach related to irrtant properties of test item
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
- Lowest effective dose / conc.:
- 400 mg/kg bw/day (actual dose received)
- System:
- gastrointestinal tract
- Organ:
- stomach
Any other information on results incl. tables
FEED CONSUMPTION (G/ANIMAL/DAY)
MALES
TREATMENT |
Group 1 |
Group 2 |
Group 3 |
Group 4 |
|
Week 1 |
Mean |
19.15 |
19.48 |
19.84 |
17.55 |
SD |
1.018 |
0.346 |
0.816 |
3.400 |
|
Week 2 |
Mean |
20.26 |
18.31 |
17.31 |
20.25 |
SD |
3.435 |
1.397 |
2.147 |
1.541 |
|
Week 3 |
Mean |
22.58 |
20.68 |
20.17 |
19.93 |
SD |
1.740 |
2.347 |
2.173 |
2.585 |
|
Week 4 |
Mean |
20.18 |
19.87 |
16.46 |
17.54 |
SD |
1.448 |
3.768 |
1.238 |
2.397 |
|
Week 5 |
Mean |
18.83 |
17.17 |
17.07 |
19.22 |
SD |
2.033 |
1.440 |
0.901 |
2.938 |
|
Week 6 |
Mean |
17.42 |
15.25 |
15.42 |
17.36 |
SD |
1.546 |
0.801 |
1.323 |
4.212 |
|
Week 7 |
Mean |
16.71 |
15.67 |
14.68 |
15.76 |
SD |
1.635 |
0.918 |
0.730 |
1.610 |
|
Week 8 |
Mean |
16.79 |
16.20 |
16.49 |
15.79 |
SD |
1.423 |
1.852 |
1.205 |
1.844 |
|
Week 9 |
Mean |
17.75 |
16.70 |
16.96 |
16.26 |
SD |
1.346 |
1.471 |
1.374 |
1.693 |
|
Week 10 |
Mean |
16.11 |
15.99 |
15.24 |
14.87 |
SD |
1.202 |
1.483 |
0.617 |
1.380 |
|
Week 11 |
Mean |
17.50 |
17.62 |
17.56 |
16.87 |
SD |
0.395 |
1.680 |
1.425 |
1.681 |
|
Week 12 |
Mean |
18.18 |
18.72 |
18.55 |
17.41 |
SD |
1.619 |
1.219 |
1.073 |
2.447 |
|
Week 13 |
Mean |
15.37 |
15.98 |
15.93 |
15.87 |
SD |
1.046 |
1.991 |
1.351 |
0.729 |
FEED CONSUMPTION (G/ANIMAL/DAY) (CONTD.)
MALES
Recovery (R) |
Group 1R |
Group 4R |
|
Recovery (R) |
Group 1R |
Group 4R |
||
Week 1 |
Mean |
17.77 |
17.18 |
|
Week 10 |
Mean |
17.99 |
17.06 |
SD |
2.256 |
2.757 |
|
SD |
1.000 |
0.700 |
||
Week 2 |
Mean |
21.57 |
20.22 |
|
Week 11 |
Mean |
17.78 |
17.36 |
SD |
1.711 |
1.194 |
|
SD |
1.175 |
0.916 |
||
Week 3 |
Mean |
21.55 |
21.25 |
|
Week 12 |
Mean |
18.98 |
18.70 |
SD |
2.132 |
2.176 |
|
SD |
0.373 |
0.563 |
||
Week 4 |
Mean |
17.68 |
17.65 |
|
Week 13 |
Mean |
19.28 |
17.99 |
SD |
1.097 |
1.107 |
|
SD |
1.405 |
1.265 |
||
Week 5 |
Mean |
18.40 |
18.41 |
|
Week 14 |
Mean |
19.41 |
19.22 |
SD |
1.468 |
1.364 |
|
SD |
0.238 |
0.959 |
||
Week 6 |
Mean |
16.98 |
16.76 |
|
Week 15 |
Mean |
19.43 |
19.13 |
SD |
0.822 |
0.691 |
|
SD |
0.227 |
0.455 |
||
Week 7 |
Mean |
16.39 |
16.49 |
|
Week 16 |
Mean |
19.52 |
19.24 |
SD |
3.537 |
1.029 |
|
SD |
0.245 |
0.293 |
||
Week 8 |
Mean |
16.56 |
15.88 |
|
Week 17 |
Mean |
21.44 |
21.79 |
SD |
0.927 |
0.834 |
|
SD |
0.174 |
1.147 |
||
Week 9 |
Mean |
18.80 |
18.57 |
|
|
|
|
|
SD |
0.377 |
0.691 |
|
|
|
|
|
FEED CONSUMPTION (G/ANIMAL/DAY) (CONTD.)
FEMALES
TREATMENT |
Group 1 |
Group 2 |
Group 3 |
Group 4 |
|
Week 1 |
Mean |
13.28 |
12.57 |
11.93 |
10.70 |
SD |
0.631 |
1.286 |
2.569 |
2.459 |
|
Week 2 |
Mean |
13.37 |
11.46 |
12.84 |
13.13 |
SD |
2.122 |
1.356 |
1.356 |
1.491 |
|
Week 3 |
Mean |
16.69 |
13.41* |
14.24 |
12.42* |
SD |
1.260 |
2.296 |
1.679 |
1.635 |
|
Week 4 |
Mean |
11.87 |
11.54 |
11.33 |
9.79*#& |
SD |
0.774 |
1.041 |
0.819 |
0.496 |
|
Week 5 |
Mean |
12.06 |
11.56 |
12.35 |
12.10 |
SD |
0.694 |
1.102 |
1.081 |
1.580 |
|
Week 6 |
Mean |
12.12 |
10.97 |
12.07 |
10.37 |
SD |
0.801 |
2.383 |
0.558 |
1.316 |
|
Week 7 |
Mean |
11.88 |
10.67 |
11.90 |
11.76 |
SD |
0.650 |
1.193 |
0.658 |
2.780 |
|
Week 8 |
Mean |
12.99 |
11.82 |
12.22 |
11.05 |
SD |
1.143 |
2.046 |
1.538 |
2.076 |
|
Week 9 |
Mean |
13.07 |
12.14 |
12.81 |
11.58 |
SD |
1.206 |
1.391 |
1.240 |
1.147 |
|
Week 10 |
Mean |
12.44 |
10.53 |
11.05 |
9.53 |
SD |
1.870 |
1.939 |
1.893 |
1.193 |
|
Week 11 |
Mean |
13.93 |
11.39 |
13.50 |
10.21* |
SD |
1.127 |
1.645 |
3.353 |
1.295 |
|
Week 12 |
Mean |
15.57 |
11.99* |
13.24 |
11.98* |
SD |
1.686 |
0.726 |
0.916 |
1.597 |
|
Week 13 |
Mean |
13.61 |
10.94 |
11.94 |
11.15 |
SD |
1.490 |
1.727 |
1.428 |
1.643 |
*-Significant at p ≤ 0.05 with Group 1, # - Significant at p ≤ 0.05 with Groups 2, & - Significant at p ≤ 0.05 with Group 3
FEED CONSUMPTION (G/ANIMAL/DAY) (CONTD.)
FEMALES
Recovery (R) |
Group 1R |
Group 4R |
|
Recovery (R) |
Group 1R |
Group 4R |
||
Week 1 |
Mean |
11.36 |
10.65 |
|
Week 10 |
Mean |
11.58 |
10.13 |
SD |
2.607 |
2.559 |
|
SD |
1.067 |
1.306 |
||
Week 2 |
Mean |
15.15 |
13.57 |
|
Week 11 |
Mean |
12.32 |
10.74 |
SD |
2.458 |
0.936 |
|
SD |
1.051 |
1.233 |
||
Week 3 |
Mean |
15.43 |
14.77 |
|
Week 12 |
Mean |
13.25 |
12.14 |
SD |
1.916 |
1.502 |
|
SD |
0.739 |
1.384 |
||
Week 4 |
Mean |
12.65 |
12.36 |
|
Week 13 |
Mean |
15.35 |
13.21 |
SD |
0.408 |
1.016 |
|
SD |
1.074 |
2.537 |
||
Week 5 |
Mean |
12.69 |
12.99 |
|
Week 14 |
Mean |
14.40 |
14.57 |
SD |
0.944 |
1.038 |
|
SD |
0.662 |
0.573 |
||
Week 6 |
Mean |
11.39 |
10.82 |
|
Week 15 |
Mean |
13.98 |
13.78 |
SD |
0.841 |
0.608 |
|
SD |
0.532 |
1.285 |
||
Week 7 |
Mean |
11.95 |
11.65 |
|
Week 16 |
Mean |
13.78 |
14.04 |
SD |
1.156 |
1.172 |
|
SD |
0.812 |
1.410 |
||
Week 8 |
Mean |
11.15 |
12.25 |
|
Week 17 |
Mean |
15.23 |
14.77 |
SD |
1.357 |
0.862 |
|
SD |
0.619 |
0.722 |
||
Week 9 |
Mean |
13.56 |
12.39 |
|
|
|
|
|
SD |
2.170 |
1.407 |
|
|
|
|
|
1.1 BODY WEIGHTS (G)
MALES
TREATMENT |
Group 1 |
Group 2 |
Group 3 |
Group 4 |
|
Day 1 |
Mean |
178.0 |
181.4 |
182.4 |
179.0 |
SD |
5.28 |
3.16 |
7.30 |
4.88 |
|
Min |
170.5 |
178.4 |
172.9 |
171.4 |
|
Max |
187.3 |
189.0 |
198.9 |
188.8 |
|
N |
10 |
10 |
10 |
10 |
|
Day 8 |
Mean |
211.2 |
209.4 |
217.0 |
214.5 |
SD |
10.91 |
10.20 |
8.69 |
11.50 |
|
Min |
197.2 |
190.7 |
206.6 |
196.1 |
|
Max |
229.3 |
223.4 |
234.3 |
229.7 |
|
N |
10 |
10 |
10 |
10 |
|
Day 15 |
Mean |
240.2 |
237.5 |
239.9 |
236.6 |
SD |
15.56 |
8.32 |
8.93 |
18.79 |
|
Min |
219.8 |
224.9 |
227.5 |
215.1 |
|
Max |
270.1 |
254.2 |
252.5 |
267.0 |
|
N |
10 |
10 |
10 |
10 |
|
Day 22 |
Mean |
264.4 |
257.6 |
259.4 |
253.6 |
SD |
18.55 |
8.62 |
11.09 |
22.02 |
|
Min |
246.5 |
243.3 |
237.6 |
224.5 |
|
Max |
302.2 |
273.2 |
273.4 |
292.3 |
|
N |
10 |
10 |
10 |
10 |
|
Day 29 |
Mean |
288.6 |
276.5 |
277.1 |
273.8 |
SD |
19.44 |
11.87 |
13.94 |
25.40 |
|
Min |
265.0 |
254.6 |
249.3 |
238.7 |
|
Max |
325.9 |
301.2 |
296.4 |
320.7 |
|
N |
10 |
10 |
10 |
10 |
TREATMENT |
Group 1 |
Group 2 |
Group 3 |
Group 4 |
|
Day 36 |
Mean |
307.0 |
290.0 |
291.1 |
293.3 |
SD |
26.28 |
18.65 |
16.38 |
28.65 |
|
Min |
272.5 |
260.8 |
263.9 |
257.7 |
|
Max |
362.0 |
334.3 |
317.0 |
345.4 |
|
N |
10 |
10 |
10 |
10 |
|
Day 43 |
Mean |
322.8 |
308.3 |
305.5 |
303.3 |
SD |
26.48 |
19.24 |
18.31 |
32.64 |
|
Min |
287.5 |
280.4 |
274.4 |
258.1 |
|
Max |
367.7 |
354.1 |
332.6 |
361.5 |
|
N |
10 |
10 |
10 |
10 |
|
Day 50 |
Mean |
332.2 |
320.1 |
317.5 |
316.6 |
SD |
29.26 |
20.37 |
20.93 |
37.44 |
|
Min |
292.7 |
289.3 |
281.8 |
260.4 |
|
Max |
379.1 |
367.8 |
349.9 |
382.3 |
|
N |
10 |
10 |
10 |
10 |
|
Day 57 |
Mean |
343.2 |
331.4 |
328.3 |
325.4 |
SD |
33.77 |
23.73 |
23.29 |
36.23 |
|
Min |
293.8 |
300.6 |
292.5 |
273.9 |
|
Max |
391.1 |
389.8 |
365.7 |
385.2 |
|
N |
10 |
10 |
10 |
10 |
|
Day 64 |
Mean |
353.1 |
343.3 |
340.6 |
336.8 |
SD |
34.42 |
26.55 |
24.15 |
38.57 |
|
Min |
303.2 |
306.3 |
307.0 |
284.9 |
|
Max |
399.1 |
404.6 |
381.7 |
399.6 |
|
N |
10 |
10 |
10 |
10 |
TREATMENT |
Group 1 |
Group 2 |
Group 3 |
Group 4 |
|
Day 71 |
Mean |
363.1 |
352.8 |
352.9 |
347.9 |
SD |
37.12 |
29.17 |
26.84 |
39.29 |
|
Min |
308.8 |
314.6 |
311.6 |
297.5 |
|
Max |
417.2 |
422.2 |
397.2 |
416.3 |
|
N |
10 |
10 |
10 |
10 |
|
Day 78 |
Mean |
370.8 |
362.6 |
364.1 |
358.9 |
SD |
37.21 |
30.89 |
26.86 |
41.69 |
|
Min |
316.6 |
320.9 |
327.4 |
296.8 |
|
Max |
429.1 |
430.2 |
412.9 |
431.7 |
|
N |
10 |
10 |
10 |
10 |
|
Day 85 |
Mean |
376.7 |
371.2 |
371.8 |
359.3 |
SD |
39.46 |
31.04 |
29.82 |
43.68 |
|
Min |
320.9 |
328.9 |
331.8 |
294.8 |
|
Max |
434.9 |
438.9 |
420.3 |
429.7 |
|
N |
10 |
10 |
10 |
10 |
|
Day 90 |
Mean |
384.1 |
378.0 |
379.0 |
370.1 |
SD |
39.17 |
32.20 |
27.96 |
44.67 |
|
Min |
331.9 |
337.4 |
340.5 |
305.5 |
|
Max |
443.9 |
451.6 |
426.4 |
446.9 |
|
N |
10 |
10 |
10 |
10 |
MALES (Recovery)
RECOVERY (R) |
Group 1R |
Group 4R |
|
RECOVERY (R) |
Group 1R |
Group 4R |
||
Day 1 |
Mean |
180.6 |
177.8 |
|
Day 36 |
Mean |
297.2 |
294.6 |
SD |
5.01 |
7.87 |
|
SD |
17.46 |
18.29 |
||
Min |
172.1 |
164.5 |
|
Min |
254.7 |
256.7 |
||
Max |
189.1 |
189.0 |
|
Max |
316.8 |
318.1 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 8 |
Mean |
212.6 |
209.3 |
|
Day 43 |
Mean |
313.7 |
313.3 |
SD |
7.89 |
11.72 |
|
SD |
19.34 |
20.33 |
||
Min |
198.7 |
196.1 |
|
Min |
273.9 |
272.7 |
||
Max |
224.0 |
226.5 |
|
Max |
336.9 |
343.9 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 15 |
Mean |
236.5 |
236.3 |
|
Day 50 |
Mean |
327.8 |
322.5 |
SD |
9.46 |
11.46 |
|
SD |
21.69 |
23.41 |
||
Min |
214.6 |
220.6 |
|
Min |
284.8 |
275.9 |
||
Max |
249.9 |
257.4 |
|
Max |
352.8 |
359.4 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 22 |
Mean |
261.0 |
259.0 |
|
Day 57 |
Mean |
338.3 |
332.5 |
SD |
12.75 |
14.34 |
|
SD |
23.93 |
27.96 |
||
Min |
232.2 |
237.8 |
|
Min |
294.1 |
285.4 |
||
Max |
280.8 |
280.1 |
|
Max |
368.6 |
372.9 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 29 |
Mean |
281.5 |
278.0 |
|
Day 64 |
Mean |
349.8 |
344.5 |
SD |
14.56 |
15.18 |
|
SD |
24.35 |
26.92 |
||
Min |
246.3 |
252.9 |
|
Min |
304.4 |
296.7 |
||
Max |
301.1 |
296.5 |
|
Max |
382.6 |
380.5 |
||
N |
10 |
10 |
|
N |
10 |
10 |
RECOVERY (R) |
Group 1R |
Group 4R |
|
RECOVERY (R) |
Group 1R |
Group 4R |
||
Day 71 |
Mean |
360.1 |
356.9 |
|
Day 98 |
Mean |
386.7 |
385.5 |
SD |
24.83 |
26.86 |
|
SD |
26.17 |
28.46 |
||
Min |
313.7 |
311.0 |
|
Min |
338.1 |
329.4 |
||
Max |
396.6 |
391.7 |
|
Max |
426.7 |
412.6 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 78 |
Mean |
367.6 |
362.6 |
|
Day 105 |
Mean |
394.6 |
394.5 |
SD |
24.78 |
28.60 |
|
SD |
27.87 |
29.04 |
||
Min |
321.3 |
311.0 |
|
Min |
342.9 |
337.2 |
||
Max |
402.9 |
401.7 |
|
Max |
437.5 |
421.3 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 85 |
Mean |
373.8 |
363.1 |
|
Day 112 |
Mean |
405.0 |
404.9 |
SD |
26.40 |
30.75 |
|
SD |
28.67 |
29.22 |
||
Min |
325.0 |
310.2 |
|
Min |
352.1 |
349.6 |
||
Max |
413.8 |
409.3 |
|
Max |
451.8 |
436.8 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 91 |
Mean |
381.7 |
379.5 |
|
Day 118 |
Mean |
410.9 |
411.2 |
SD |
26.10 |
28.33 |
|
SD |
31.05 |
29.69 |
||
Min |
337.7 |
328.7 |
|
Min |
355.9 |
356.7 |
||
Max |
425.7 |
410.4 |
|
Max |
464.1 |
443.5 |
||
N |
10 |
10 |
|
N |
10 |
10 |
BODY WEIGHTS (G)
FEMALES
TREATMENT |
Group 1 |
Group 2 |
Group 3 |
Group 4 |
|
Day 1 |
Mean |
142.7 |
143.1 |
142.5 |
141.0 |
SD |
5.75 |
4.32 |
6.97 |
4.73 |
|
Min |
132.6 |
136.9 |
133.7 |
135.2 |
|
Max |
153.2 |
149.1 |
158.2 |
150.6 |
|
N |
10 |
10 |
10 |
10 |
|
Day 8 |
Mean |
160.8 |
160.7 |
158.7 |
155.1 |
SD |
8.33 |
6.72 |
6.46 |
6.78 |
|
Min |
147.5 |
148.8 |
146.3 |
146.1 |
|
Max |
172.5 |
170.5 |
170.2 |
168.8 |
|
N |
10 |
10 |
10 |
10 |
|
Day 15 |
Mean |
171.4 |
172.5 |
170.5 |
168.2 |
SD |
7.85 |
6.56 |
6.55 |
6.88 |
|
Min |
159.7 |
165.3 |
159.2 |
154.7 |
|
Max |
184.0 |
185.7 |
181.1 |
181.8 |
|
N |
10 |
10 |
10 |
10 |
|
Day 22 |
Mean |
182.1 |
183.6 |
182.9 |
178.5 |
SD |
7.63 |
9.12 |
7.35 |
6.63 |
|
Min |
168.4 |
173.2 |
171.0 |
166.7 |
|
Max |
193.3 |
201.6 |
194.0 |
189.2 |
|
N |
10 |
10 |
10 |
10 |
|
Day 29 |
Mean |
191.8 |
191.6 |
191.2 |
184.2 |
SD |
9.63 |
11.77 |
8.25 |
6.00 |
|
Min |
177.8 |
178.5 |
180.4 |
176.5 |
|
Max |
202.6 |
219.8 |
203.7 |
195.3 |
|
N |
10 |
10 |
10 |
10 |
TREATMENT |
Group 1 |
Group 2 |
Group 3 |
Group 4 |
|
Day 36 |
Mean |
195.5 |
197.9 |
197.4 |
187.4 |
SD |
10.33 |
13.76 |
14.21 |
7.91 |
|
Min |
180.3 |
178.8 |
175.3 |
177.7 |
|
Max |
206.1 |
224.1 |
217.9 |
203.5 |
|
N |
10 |
10 |
10 |
10 |
|
Day 43 |
Mean |
203.6 |
205.0 |
206.2 |
191.6* |
SD |
8.63 |
15.85 |
13.37 |
8.80 |
|
Min |
185.7 |
184.7 |
183.6 |
181.6 |
|
Max |
212.1 |
236.7 |
225.3 |
208.2 |
|
N |
10 |
10 |
10 |
10 |
|
Day 50 |
Mean |
211.2 |
211.2 |
212.3 |
199.0 |
SD |
9.88 |
16.82 |
15.44 |
9.84 |
|
Min |
193.3 |
189.3 |
192.9 |
187.1 |
|
Max |
221.0 |
240.9 |
238.9 |
217.2 |
|
N |
10 |
10 |
10 |
10 |
|
Day 57 |
Mean |
213.9 |
215.4 |
214.6 |
200.5 |
SD |
9.51 |
16.66 |
16.37 |
11.49 |
|
Min |
195.5 |
191.8 |
193.1 |
186.8 |
|
Max |
225.8 |
246.3 |
244.5 |
218.1 |
|
N |
10 |
10 |
10 |
10 |
|
Day 64 |
Mean |
216.3 |
217.6 |
216.4 |
203.0 |
SD |
8.83 |
16.20 |
17.62 |
11.03 |
|
Min |
202.9 |
197.3 |
196.4 |
188.3 |
|
Max |
230.7 |
246.9 |
252.9 |
221.1 |
|
N |
10 |
10 |
10 |
10 |
* Significant at p ≤ 0.05 with Group 3,
TREATMENT |
Group 1 |
Group 2 |
Group 3 |
Group 4 |
|
Day 71 |
Mean |
219.8 |
222.8 |
219.6 |
208.7 |
SD |
7.42 |
20.63 |
18.07 |
12.81 |
|
Min |
210.2 |
197.5 |
197.8 |
190.3 |
|
Max |
233.4 |
270.8 |
257.2 |
229.4 |
|
N |
10 |
10 |
10 |
10 |
|
Day 78 |
Mean |
222.0 |
224.9 |
220.7 |
208.6 |
SD |
7.33 |
21.17 |
19.66 |
11.54 |
|
Min |
212.6 |
197.8 |
198.2 |
192.1 |
|
Max |
235.4 |
274.3 |
262.9 |
226.4 |
|
N |
10 |
10 |
10 |
10 |
|
Day 85 |
Mean |
226.1 |
226.5 |
223.8 |
206.2* |
SD |
8.76 |
21.09 |
19.26 |
13.37 |
|
Min |
214.5 |
199.3 |
202.9 |
194.3 |
|
Max |
242.0 |
275.4 |
266.1 |
229.3 |
|
N |
10 |
10 |
10 |
10 |
|
Day 90 |
Mean |
228.3 |
228.3 |
226.2 |
212.8 |
SD |
8.70 |
21.19 |
19.34 |
11.67 |
|
Min |
215.3 |
200.2 |
203.8 |
199.1 |
|
Max |
242.3 |
276.6 |
267.4 |
231.0 |
|
N |
10 |
10 |
10 |
10 |
Significant at p ≤ 0.05 with Groups 1, 2 and 3
BODY WEIGHTS (G) (Recovery)
FEMALES
RECOVERY (R) |
Group 1R |
Group 4R |
|
RECOVERY (R) |
Group 1R |
Group 4R |
||
Day 1 |
Mean |
141.1 |
141.8 |
|
Day 36 |
Mean |
194.5 |
193.2 |
SD |
4.46 |
5.58 |
|
SD |
10.05 |
10.45 |
||
Min |
133.2 |
133.3 |
|
Min |
182.3 |
174.7 |
||
Max |
146.2 |
150.8 |
|
Max |
210.2 |
212.0 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 8 |
Mean |
159.4 |
156.9 |
|
Day 43 |
Mean |
202.7 |
199.9 |
SD |
8.07 |
6.82 |
|
SD |
11.53 |
8.43 |
||
Min |
146.4 |
144.3 |
|
Min |
184.1 |
188.8 |
||
Max |
168.7 |
167.7 |
|
Max |
221.3 |
215.7 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 15 |
Mean |
172.4 |
167.5 |
|
Day 50 |
Mean |
211.6 |
206.0 |
SD |
8.21 |
5.53 |
|
SD |
7.90 |
10.94 |
||
Min |
164.1 |
156.0 |
|
Min |
197.6 |
189.4 |
||
Max |
191.2 |
175.2 |
|
Max |
223.1 |
224.8 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 22 |
Mean |
182.7 |
181.4 |
|
Day 57 |
Mean |
214.1 |
209.2 |
SD |
8.71 |
6.65 |
|
SD |
9.64 |
14.64 |
||
Min |
174.6 |
169.3 |
|
Min |
198.3 |
188.4 |
||
Max |
199.5 |
190.5 |
|
Max |
228.4 |
238.2 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 29 |
Mean |
190.6 |
187.0 |
|
Day 64 |
Mean |
215.6 |
210.2 |
SD |
10.05 |
7.01 |
|
SD |
8.47 |
15.02 |
||
Min |
175.1 |
174.7 |
|
Min |
201.6 |
189.2 |
||
Max |
207.3 |
197.1 |
|
Max |
229.0 |
238.4 |
||
N |
10 |
10 |
|
N |
10 |
10 |
RECOVERY (R) |
Group 1R |
Group 4R |
|
RECOVERY (R) |
Group 1R |
Group 4R |
||
Day 71 |
Mean |
218.0 |
214.6 |
|
Day 98 |
Mean |
228.5 |
219.5 |
SD |
8.04 |
17.24 |
|
SD |
11.30 |
16.21 |
||
Min |
202.5 |
196.2 |
|
Min |
207.6 |
200.7 |
||
Max |
230.0 |
249.9 |
|
Max |
250.1 |
252.1 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 78 |
Mean |
220.8 |
213.2 |
|
Day 105 |
Mean |
231.3 |
221.2 |
SD |
9.31 |
15.77 |
|
SD |
11.36 |
17.27 |
||
Min |
202.9 |
192.6 |
|
Min |
209.6 |
201.3 |
||
Max |
234.8 |
246.1 |
|
Max |
251.2 |
257.2 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 85 |
Mean |
221.4 |
210.6 |
|
Day 112 |
Mean |
234.2 |
223.0 |
SD |
10.34 |
18.01 |
|
SD |
12.05 |
17.97 |
||
Min |
204.3 |
188.6 |
|
Min |
210.2 |
202.9 |
||
Max |
235.1 |
248.1 |
|
Max |
252.6 |
260.2 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 91 |
Mean |
224.6 |
217.3 |
|
Day 118 |
Mean |
236.4 |
225.5 |
SD |
13.15 |
16.76 |
|
SD |
12.30 |
17.82 |
||
Min |
206.4 |
198.7 |
|
Min |
211.7 |
205.2 |
||
Max |
249.4 |
251.9 |
|
Max |
255.2 |
261.9 |
||
N |
10 |
10 |
|
N |
10 |
10 |
BODY WEIGHT GAIN (%)
MALES
TREATMENT |
Group 1 |
Group 2 |
Group 3 |
Group 4 |
|
Day 1 |
Mean |
0.0 |
0.0 |
0.0 |
0.0 |
SD |
0.00 |
0.00 |
0.00 |
0.00 |
|
Min |
0.0 |
0.0 |
0.0 |
0.0 |
|
Max |
0.0 |
0.0 |
0.0 |
0.0 |
|
N |
10 |
10 |
10 |
10 |
|
Day 8 |
Mean |
18.6 |
15.4 |
19.0 |
19.8 |
SD |
3.08 |
5.29 |
2.76 |
4.70 |
|
Min |
12.4 |
6.5 |
16.5 |
14.4 |
|
Max |
22.4 |
22.8 |
25.7 |
27.1 |
|
N |
10 |
10 |
10 |
10 |
|
Day 15 |
Mean |
34.8 |
30.9 |
31.6 |
32.1 |
SD |
5.64 |
4.27 |
5.90 |
9.10 |
|
Min |
26.4 |
24.7 |
22.9 |
22.5 |
|
Max |
44.2 |
39.7 |
43.4 |
47.7 |
|
N |
10 |
10 |
10 |
10 |
|
Day 22 |
Mean |
48.4 |
42.0 |
42.3 |
41.6 |
SD |
6.68 |
4.78 |
7.20 |
10.88 |
|
Min |
40.4 |
35.8 |
28.4 |
29.9 |
|
Max |
61.3 |
50.2 |
55.3 |
61.7 |
|
N |
10 |
10 |
10 |
10 |
|
Day 29 |
Mean |
62.0 |
52.4 |
52.0 |
52.8 |
SD |
7.28 |
6.26 |
7.76 |
12.62 |
|
Min |
53.5 |
42.2 |
34.7 |
39.3 |
|
Max |
74.0 |
65.6 |
61.3 |
77.4 |
|
N |
10 |
10 |
10 |
10 |
TREATMENT |
Group 1 |
Group 2 |
Group 3 |
Group 4 |
|
Day 36 |
Mean |
72.3 |
59.9 |
59.7 |
63.7 |
SD |
11.78 |
10.06 |
9.13 |
14.24 |
|
Min |
56.3 |
45.6 |
42.6 |
47.3 |
|
Max |
93.3 |
83.8 |
71.7 |
91.0 |
|
N |
10 |
10 |
10 |
10 |
|
Day 43 |
Mean |
81.3 |
69.9 |
67.7 |
69.3 |
SD |
13.13 |
10.62 |
11.13 |
16.52 |
|
Min |
58.5 |
56.6 |
48.2 |
48.3 |
|
Max |
96.3 |
94.7 |
83.6 |
99.9 |
|
N |
10 |
10 |
10 |
10 |
|
Day 50 |
Mean |
86.6 |
76.4 |
74.2 |
76.7 |
SD |
14.82 |
11.27 |
12.26 |
19.31 |
|
Min |
61.4 |
61.5 |
52.2 |
51.9 |
|
Max |
103.3 |
102.2 |
93.1 |
111.4 |
|
N |
10 |
10 |
10 |
10 |
|
Day 57 |
Mean |
92.7 |
82.7 |
80.2 |
81.7 |
SD |
17.52 |
13.33 |
14.11 |
18.73 |
|
Min |
62.0 |
67.8 |
58.0 |
58.2 |
|
Max |
112.9 |
114.3 |
101.8 |
113.1 |
|
N |
10 |
10 |
10 |
10 |
|
Day 64 |
Mean |
98.3 |
89.3 |
86.9 |
88.0 |
SD |
17.87 |
14.99 |
14.32 |
19.85 |
|
Min |
67.1 |
71.0 |
65.9 |
61.8 |
|
Max |
118.2 |
122.4 |
110.7 |
121.0 |
|
N |
10 |
10 |
10 |
10 |
TREATMENT |
Group 1 |
Group 2 |
Group 3 |
Group 4 |
|
Day 71 |
Mean |
103.9 |
94.5 |
93.7 |
94.2 |
SD |
19.06 |
16.31 |
16.01 |
20.06 |
|
Min |
70.2 |
75.7 |
68.3 |
66.4 |
|
Max |
123.6 |
132.1 |
119.2 |
130.3 |
|
N |
10 |
10 |
10 |
10 |
|
Day 78 |
Mean |
108.2 |
99.9 |
99.9 |
100.4 |
SD |
19.20 |
17.35 |
16.61 |
21.33 |
|
Min |
74.5 |
79.2 |
76.9 |
64.4 |
|
Max |
129.4 |
136.5 |
127.9 |
138.8 |
|
N |
10 |
10 |
10 |
10 |
|
Day 85 |
Mean |
111.6 |
104.7 |
104.1 |
100.5 |
SD |
20.41 |
17.46 |
17.95 |
21.84 |
|
Min |
76.9 |
83.6 |
79.3 |
70.0 |
|
Max |
132.8 |
141.3 |
132.0 |
137.7 |
|
N |
10 |
10 |
10 |
10 |
|
Day 90 |
Mean |
115.7 |
108.4 |
108.1 |
106.6 |
SD |
19.96 |
17.97 |
17.61 |
22.45 |
|
Min |
83.0 |
88.4 |
84.0 |
74.2 |
|
Max |
137.0 |
148.3 |
135.3 |
147.2 |
|
N |
10 |
10 |
10 |
10 |
MALES
RECOVERY (R) |
Group 1R |
Group 4R |
|
RECOVERY (R) |
Group 1R |
Group 4R |
||
Day 1 |
Mean |
0.0 |
0.0 |
|
Day 36 |
Mean |
64.5 |
65.8 |
SD |
0.00 |
0.00 |
|
SD |
8.55 |
9.37 |
||
Min |
0.0 |
0.0 |
|
Min |
48.0 |
55.4 |
||
Max |
0.0 |
0.0 |
|
Max |
76.3 |
80.2 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 8 |
Mean |
17.7 |
17.8 |
|
Day 43 |
Mean |
73.7 |
76.5 |
SD |
3.82 |
5.54 |
|
SD |
10.36 |
12.11 |
||
Min |
12.5 |
6.9 |
|
Min |
59.2 |
64.2 |
||
Max |
23.5 |
27.4 |
|
Max |
91.3 |
94.8 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 15 |
Mean |
30.9 |
33.1 |
|
Day 50 |
Mean |
81.5 |
81.6 |
SD |
3.83 |
6.58 |
|
SD |
11.37 |
13.43 |
||
Min |
23.9 |
20.3 |
|
Min |
64.9 |
67.0 |
||
Max |
36.4 |
44.8 |
|
Max |
100.3 |
99.8 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 22 |
Mean |
44.4 |
45.7 |
|
Day 57 |
Mean |
87.3 |
87.3 |
SD |
4.83 |
6.59 |
|
SD |
12.86 |
16.23 |
||
Min |
34.9 |
31.5 |
|
Min |
67.8 |
64.0 |
||
Max |
49.8 |
57.5 |
|
Max |
109.3 |
107.7 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 29 |
Mean |
55.8 |
56.5 |
|
Day 64 |
Mean |
93.7 |
94.0 |
SD |
6.49 |
8.27 |
|
SD |
13.22 |
15.06 |
||
Min |
43.1 |
37.9 |
|
Min |
73.6 |
69.6 |
||
Max |
65.0 |
68.0 |
|
Max |
117.3 |
113.6 |
||
N |
10 |
10 |
|
N |
10 |
10 |
RECOVERY (R) |
Group 1R |
Group 4R |
|
RECOVERY (R) |
Group 1R |
Group 4R |
||
Day 71 |
Mean |
99.4 |
100.9 |
|
Day 98 |
Mean |
114.2 |
117.0 |
SD |
13.77 |
14.49 |
|
SD |
14.66 |
14.59 |
||
Min |
79.5 |
76.6 |
|
Min |
94.0 |
92.7 |
||
Max |
125.2 |
117.7 |
|
Max |
142.3 |
133.8 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 78 |
Mean |
103.5 |
104.0 |
|
Day 105 |
Mean |
118.5 |
122.0 |
SD |
13.55 |
14.14 |
|
SD |
15.76 |
14.94 |
||
Min |
84.4 |
79.8 |
|
Min |
97.5 |
95.8 |
||
Max |
128.8 |
123.3 |
|
Max |
148.4 |
138.5 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 85 |
Mean |
107.0 |
104.3 |
|
Day 112 |
Mean |
124.3 |
127.9 |
SD |
14.42 |
14.84 |
|
SD |
16.39 |
15.54 |
||
Min |
86.7 |
77.5 |
|
Min |
103.5 |
99.6 |
||
Max |
135.0 |
127.5 |
|
Max |
156.6 |
148.1 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 91 |
Mean |
111.4 |
113.6 |
|
Day 118 |
Mean |
127.6 |
131.5 |
SD |
14.93 |
14.69 |
|
SD |
18.05 |
16.06 |
||
Min |
90.5 |
86.1 |
|
Min |
106.0 |
102.8 |
||
Max |
141.7 |
129.6 |
|
Max |
163.5 |
152.3 |
||
N |
10 |
10 |
|
N |
10 |
10 |
BODY WEIGHTS GAIN (%)
FEMALES
TREATMENT |
Group 1 |
Group 2 |
Group 3 |
Group 4 |
|
Day 1 |
Mean |
0.0 |
0.0 |
0.0 |
0.0 |
SD |
0.00 |
0.00 |
0.00 |
0.00 |
|
Min |
0.0 |
0.0 |
0.0 |
0.0 |
|
Max |
0.0 |
0.0 |
0.0 |
0.0 |
|
N |
10 |
10 |
10 |
10 |
|
Day 8 |
Mean |
12.7 |
12.3 |
11.5 |
10.0 |
SD |
4.58 |
4.60 |
5.14 |
5.05 |
|
Min |
6.0 |
3.8 |
4.4 |
1.1 |
|
Max |
20.9 |
16.9 |
18.7 |
15.8 |
|
N |
10 |
10 |
10 |
10 |
|
Day 15 |
Mean |
20.2 |
20.6 |
19.8 |
19.3 |
SD |
4.76 |
5.52 |
5.55 |
4.84 |
|
Min |
11.3 |
10.9 |
10.9 |
9.3 |
|
Max |
28.1 |
31.1 |
29.1 |
25.1 |
|
N |
10 |
10 |
10 |
10 |
|
Day 22 |
Mean |
27.7 |
28.4 |
28.5 |
26.7 |
SD |
4.60 |
7.27 |
5.96 |
5.27 |
|
Min |
17.3 |
16.2 |
15.9 |
17.8 |
|
Max |
34.6 |
42.4 |
34.7 |
32.6 |
|
N |
10 |
10 |
10 |
10 |
|
Day 29 |
Mean |
34.5 |
34.0 |
34.3 |
30.7 |
SD |
5.11 |
9.01 |
5.72 |
4.10 |
|
Min |
23.8 |
21.8 |
22.2 |
24.7 |
|
Max |
40.8 |
55.2 |
40.4 |
36.3 |
|
N |
10 |
10 |
10 |
10 |
TREATMENT |
Group 1 |
Group 2 |
Group 3 |
Group 4 |
|
Day 36 |
Mean |
37.1 |
38.4 |
38.7 |
32.9 |
SD |
6.27 |
10.38 |
9.64 |
3.32 |
|
Min |
28.6 |
22.0 |
18.8 |
25.6 |
|
Max |
46.7 |
58.3 |
52.1 |
37.6 |
|
N |
10 |
10 |
10 |
10 |
|
Day 43 |
Mean |
42.9 |
43.4 |
44.9 |
35.9 |
SD |
7.20 |
12.64 |
9.53 |
4.95 |
|
Min |
32.8 |
26.0 |
29.5 |
28.3 |
|
Max |
52.9 |
67.2 |
58.1 |
44.1 |
|
N |
10 |
10 |
10 |
10 |
|
Day 50 |
Mean |
48.2 |
47.7 |
49.1 |
41.1 |
SD |
7.05 |
12.69 |
10.02 |
4.21 |
|
Min |
34.6 |
29.1 |
32.4 |
35.5 |
|
Max |
57.0 |
70.1 |
67.6 |
46.9 |
|
N |
10 |
10 |
10 |
10 |
|
Day 57 |
Mean |
50.0 |
50.7 |
50.8 |
42.2 |
SD |
7.07 |
12.84 |
10.98 |
5.36 |
|
Min |
36.1 |
30.8 |
32.9 |
33.4 |
|
Max |
60.7 |
73.9 |
71.6 |
49.1 |
|
N |
10 |
10 |
10 |
10 |
|
Day 64 |
Mean |
51.7 |
52.1 |
52.0 |
43.9 |
SD |
7.01 |
11.95 |
11.85 |
5.66 |
|
Min |
41.7 |
34.6 |
33.8 |
35.8 |
|
Max |
64.2 |
74.4 |
77.5 |
51.2 |
|
N |
10 |
10 |
10 |
10 |
TREATMENT |
Group 1 |
Group 2 |
Group 3 |
Group 4 |
|
Day 71 |
Mean |
54.2 |
55.8 |
54.3 |
48.0 |
SD |
6.86 |
15.72 |
12.36 |
6.46 |
|
Min |
43.4 |
34.7 |
36.9 |
37.2 |
|
Max |
66.1 |
91.2 |
80.5 |
58.5 |
|
N |
10 |
10 |
10 |
10 |
|
Day 78 |
Mean |
55.8 |
57.3 |
55.0 |
47.9 |
SD |
7.07 |
15.83 |
13.40 |
5.50 |
|
Min |
44.3 |
34.9 |
37.9 |
38.5 |
|
Max |
67.5 |
93.7 |
84.5 |
55.8 |
|
N |
10 |
10 |
10 |
10 |
|
Day 85 |
Mean |
58.6 |
58.4 |
57.3 |
46.1* |
SD |
7.56 |
15.95 |
13.59 |
6.22 |
|
Min |
48.0 |
35.9 |
37.7 |
39.9 |
|
Max |
72.2 |
94.5 |
86.7 |
58.5 |
|
N |
10 |
10 |
10 |
10 |
|
Day 90 |
Mean |
60.2 |
59.7 |
59.0 |
50.9 |
SD |
7.56 |
16.06 |
14.14 |
5.52 |
|
Min |
49.8 |
36.6 |
38.1 |
43.5 |
|
Max |
72.5 |
95.3 |
87.6 |
61.0 |
|
N |
10 |
10 |
10 |
10 |
* Significant at p ≤ 0.05 with Groups 1, 2 and 3
FEMALES (Recovery)
RECOVERY (R) |
Group 1R |
Group 4R |
|
RECOVERY (R) |
Group 1R |
Group 4R |
||
Day 1 |
Mean |
0.0 |
0.0 |
|
Day 36 |
Mean |
37.9 |
36.3 |
SD |
0.00 |
0.00 |
|
SD |
8.00 |
6.49 |
||
Min |
0.0 |
0.0 |
|
Min |
25.2 |
29.2 |
||
Max |
0.0 |
0.0 |
|
Max |
49.8 |
47.6 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 8 |
Mean |
13.0 |
10.6 |
|
Day 43 |
Mean |
43.8 |
41.1 |
SD |
4.65 |
1.66 |
|
SD |
9.95 |
6.82 |
||
Min |
4.8 |
8.3 |
|
Min |
25.9 |
31.1 |
||
Max |
18.7 |
13.5 |
|
Max |
57.7 |
50.2 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 15 |
Mean |
22.2 |
18.2 |
|
Day 50 |
Mean |
50.1 |
45.4 |
SD |
6.41 |
2.16 |
|
SD |
7.03 |
6.97 |
||
Min |
15.8 |
13.9 |
|
Min |
37.7 |
37.5 |
||
Max |
37.2 |
21.4 |
|
Max |
59.0 |
56.5 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 22 |
Mean |
29.5 |
28.0 |
|
Day 57 |
Mean |
51.8 |
47.5 |
SD |
7.46 |
2.83 |
|
SD |
7.59 |
8.60 |
||
Min |
20.2 |
23.5 |
|
Min |
41.2 |
39.9 |
||
Max |
43.1 |
31.3 |
|
Max |
62.8 |
65.9 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 29 |
Mean |
35.2 |
31.9 |
|
Day 64 |
Mean |
52.9 |
48.2 |
SD |
8.03 |
4.04 |
|
SD |
7.00 |
8.28 |
||
Min |
27.5 |
25.5 |
|
Min |
41.7 |
37.4 |
||
Max |
47.8 |
37.3 |
|
Max |
63.2 |
66.0 |
||
N |
10 |
10 |
|
N |
10 |
10 |
RECOVERY (R) |
Group 1R |
Group 4R |
|
RECOVERY (R) |
Group 1R |
Group 4R |
||
Day 71 |
Mean |
54.6 |
51.3 |
|
Day 98 |
Mean |
62.1 |
54.8 |
SD |
7.19 |
10.08 |
|
SD |
10.74 |
9.16 |
||
Min |
43.1 |
38.3 |
|
Min |
42.0 |
43.9 |
||
Max |
65.2 |
74.0 |
|
Max |
78.3 |
75.6 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 78 |
Mean |
56.6 |
50.3 |
|
Day 105 |
Mean |
64.1 |
56.0 |
SD |
8.08 |
9.37 |
|
SD |
11.09 |
9.85 |
||
Min |
43.8 |
40.4 |
|
Min |
43.4 |
44.1 |
||
Max |
68.7 |
71.4 |
|
Max |
79.6 |
79.1 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 85 |
Mean |
57.1 |
48.5 |
|
Day 112 |
Mean |
66.2 |
57.2 |
SD |
9.38 |
10.47 |
|
SD |
11.67 |
10.20 |
||
Min |
40.8 |
38.5 |
|
Min |
43.8 |
44.5 |
||
Max |
71.3 |
72.8 |
|
Max |
84.8 |
81.2 |
||
N |
10 |
10 |
|
N |
10 |
10 |
||
Day 91 |
Mean |
59.3 |
53.2 |
|
Day 118 |
Mean |
67.7 |
59.0 |
SD |
11.19 |
9.64 |
|
SD |
11.87 |
10.04 |
||
Min |
41.2 |
41.4 |
|
Min |
44.8 |
47.2 |
||
Max |
77.8 |
75.4 |
|
Max |
86.5 |
82.4 |
||
N |
10 |
10 |
|
N |
10 |
10 |
FUNCTIONAL OBSERVATION BATTERY
MALES
TREATMENT(WEEK -13) |
Grip Strength |
Rotarod |
IR Activity |
||||
Fore limb |
In seconds |
S - Movement |
F - Movement |
S - Steriotypic |
F - Steriotypic |
||
Group 1 |
Mean |
469.1 |
63 |
54.0 |
133.0 |
22.9 |
111.9 |
SD |
31.60 |
4.0 |
9.83 |
38.59 |
10.77 |
29.45 |
|
Group 2 |
Mean |
462.3 |
63 |
53.4 |
71.0 |
21.7 |
89.7 |
SD |
96.44 |
4.5 |
13.36 |
45.30 |
1.67 |
30.15 |
|
Group 3 |
Mean |
442.0 |
62 |
65.1 |
105.8 |
20.3 |
102.2 |
SD |
57.44 |
5.7 |
9.98 |
56.93 |
2.52 |
29.89 |
|
Group 4 |
Mean |
478.1 |
65 |
56.9 |
119.7 |
20.7 |
103.2 |
SD |
80.85 |
4.0 |
11.39 |
71.62 |
2.04 |
29.75 |
|
Group 1R |
Mean |
585.9 |
58 |
54.9 |
161.3 |
38.7 |
106.8 |
SD |
42.19 |
9.72 |
11.20 |
55.05 |
23.26 |
33.45 |
|
Group 4R |
Mean |
602.1 |
64 |
80.6 |
180.4 |
39.2 |
124.8 |
SD |
62.81 |
2.96 |
35.20 |
63.33 |
29.06 |
26.77 |
FEMALES
TREATMENT(WEEK -13) |
Grip Strength |
Rotarod |
IR Activity |
||||
Fore limb |
In seconds |
S - Movement |
F - Movement |
S - Steriotypic |
F - Steriotypic |
||
Group 1 |
Mean |
506.3 |
65 |
53.2 |
145.3 |
20.8 |
122.3 |
SD |
99.43 |
4.8 |
10.53 |
42.91 |
2.62 |
23.81 |
|
Group 2 |
Mean |
509.6 |
63 |
61.5 |
186.2 |
21.1 |
133.1 |
SD |
89.24 |
7.3 |
9.79 |
42.69 |
3.16 |
16.45 |
|
Group 3 |
Mean |
460.8 |
63 |
58.4 |
177.4 |
20.3 |
119.9 |
SD |
40.00 |
3.0 |
10.70 |
108.63 |
3.82 |
40.53 |
|
Group 4 |
Mean |
460.3 |
65 |
63.1 |
193.5 |
21.7 |
136.2 |
SD |
90.85 |
5.0 |
8.54 |
30.51 |
2.91 |
19.65 |
|
Group 1R |
Mean |
612.8 |
62 |
49.1 |
180.7 |
41.9 |
114.2 |
SD |
50.12 |
8.44 |
10.99 |
40.03 |
25.88 |
30.67 |
|
Group 4R |
Mean |
593.9 |
63 |
54.5 |
171.4 |
42.4 |
118.0 |
SD |
28.09 |
6.64 |
14.53 |
76.45 |
33.41 |
35.66 |
MALES (Recovery)
TREATMENT(WEEK -17) |
Grip Strength |
Rotarod |
IR Activity |
||||
Fore limb |
In seconds |
S - Movement |
F - Movement |
S - Steriotypic |
F - Steriotypic |
||
Group 1R |
Mean |
604.1 |
59 |
47.4 |
99.3 |
50.4 |
88.7 |
SD |
55.03 |
6.5 |
14.73 |
36.07 |
27.06 |
27.13 |
|
Group 4R |
Mean |
630.6 |
64 |
85.7 |
109.1 |
64.5 |
94.4 |
SD |
43.63 |
4.6 |
18.80 |
12.96 |
26.75 |
17.87 |
FEMALES (Recovery)
TREATMENT(WEEK -17) |
Grip Strength |
Rotarod |
IR Activity |
||||
Fore limb |
In seconds |
S - Movement |
F - Movement |
S - Steriotypic |
F - Steriotypic |
||
Group 1R |
Mean |
597.6 |
63 |
58.5 |
134.4 |
21.2 |
120.5 |
SD |
50.64 |
7.0 |
8.96 |
48.79 |
3.12 |
27.58 |
|
Group 4R |
Mean |
602.8 |
64 |
56.2 |
134.5 |
23.4 |
105.9 |
SD |
64.14 |
5.8 |
9.03 |
66.72 |
4.77 |
23.82 |
HEMATOLOGY
MALES
TREATMENT(WEEK -13) |
RBC |
Hb |
PCV |
MCV |
MCH |
MCHC |
|
x106Cells/µL |
g/dL |
% |
fL |
pg |
g/dL |
||
Group 1 |
Mean |
8.67 |
15.93 |
48.12 |
55.62 |
18.44 |
33.14 |
SD |
0.596 |
0.638 |
2.312 |
1.936 |
0.847 |
0.806 |
|
Group 2 |
Mean |
8.60 |
15.48 |
47.56 |
55.28 |
18.02 |
32.59 |
SD |
0.292 |
0.516 |
1.506 |
0.675 |
0.551 |
0.764 |
|
Group 3 |
Mean |
8.73 |
15.90 |
48.23 |
55.26 |
18.21 |
32.95 |
SD |
0.493 |
0.899 |
2.733 |
1.034 |
0.614 |
0.789 |
|
Group 4 |
Mean |
8.56 |
15.62 |
47.10 |
55.04 |
18.26 |
33.15 |
SD |
0.397 |
0.509 |
2.085 |
1.004 |
0.576 |
0.737 |
TREATMENT(WEEK -13) |
PLT |
WBC |
RET |
DC (%) |
PT |
APTT |
|||||
x103cells/µL |
x103cells/ µL |
% |
NEUT |
LYMPH |
MONO |
EOS |
BASO |
Sec |
Sec |
||
Group 1 |
Mean |
718.20 |
5.66 |
2.07 |
17.29 |
77.93$ |
1.86 |
1.42 |
0.36 |
15.76 |
12.16 |
SD |
74.730 |
1.622 |
0.285 |
4.176 |
4.898 |
0.643 |
0.447 |
0.107 |
1.009 |
1.709 |
|
Group 2 |
Mean |
706.50 |
6.01 |
1.91 |
21.30 |
73.65 |
2.77* |
0.83* |
0.30 |
15.67 |
12.81 |
SD |
86.314 |
1.839 |
0.259 |
6.391 |
6.094 |
0.538 |
0.320 |
0.067 |
0.990 |
1.717 |
|
Group 3 |
Mean |
624.10 |
6.94 |
1.84 |
29.37*# |
65.03*# |
2.95* |
1.13 |
0.32 |
14.71 |
11.89 |
SD |
181.323 |
1.527 |
0.273 |
6.484 |
6.872 |
0.610 |
0.633 |
0.092 |
0.940 |
1.225 |
|
Group 4 |
Mean |
770.80& |
5.77 |
2.17 |
26.31* |
68.22* |
2.78* |
1.29 |
0.26 |
15.26 |
12.78 |
SD |
87.519 |
1.322 |
0.321 |
6.552 |
6.697 |
0.786 |
0.522 |
0.084 |
0.650 |
1.495 |
*Significant at p ≤ 0.05 with Group 1, #- Significant at p ≤ 0.05 with Group 2, &-Significant at p ≤ 0.05 with Group 3
MALES
RECOVERY (WEEK 17) |
RBC |
Hb |
PCV |
MCV |
MCH |
MCHC |
|
x106Cells/µL |
g/dL |
% |
fL |
pg |
g/dL |
||
Group 1R |
Mean |
8.31 |
14.77 |
44.85 |
54.45 |
17.81 |
32.95 |
SD |
0.568 |
0.556 |
2.227 |
1.258 |
0.759 |
0.664 |
|
Group 4R |
Mean |
8.63 |
15.19 |
47.38* |
54.25 |
17.63 |
32.48 |
SD |
0.289 |
0.341 |
1.056 |
0.755 |
0.414 |
0.339 |
RECOVERY (WEEK 17) |
PLT |
WBC |
RET
|
DC (%) |
PT |
APTT |
|||||
x103cells/µL |
x103cells/ µL |
% |
NEUT |
LYMPH |
MONO |
EOS |
BASO |
Sec |
Sec |
||
Group 1R |
Mean |
808.40 |
4.55 |
2.13 |
26.58 |
68.11 |
2.69 |
1.08 |
0.23 |
15.72 |
12.08 |
SD |
96.212 |
1.138 |
0.299 |
7.319 |
7.226 |
0.805 |
0.457 |
0.309 |
1.165 |
1.067 |
|
Group 4R |
Mean |
811.80 |
4.39 |
2.04 |
23.96 |
70.26 |
2.93 |
1.63 |
0.19 |
15.93 |
12.72 |
SD |
77.334 |
1.193 |
0.205 |
6.263 |
6.861 |
0.558 |
0.862 |
0.099 |
1.012 |
1.173 |
*Significant at p ≤ 0.05 with Group 1R
FEMALES
TREATMENT(WEEK -13) |
RBC |
Hb |
PCV |
MCV |
MCH |
MCHC |
|
x106Cells/µL |
g/dL |
% |
fL |
pg |
g/dL |
||
Group 1 |
Mean |
8.08 |
14.92 |
45.80 |
56.76 |
18.47 |
32.58 |
SD |
0.468 |
0.464 |
2.076 |
1.213 |
0.633 |
0.705 |
|
Group 2 |
Mean |
7.90 |
14.69 |
44.62 |
56.49 |
18.57 |
32.88 |
SD |
0.234 |
0.493 |
1.352 |
0.656 |
0.467 |
0.620 |
|
Group 3 |
Mean |
8.00 |
15.09 |
45.67 |
57.10 |
18.88 |
33.05 |
SD |
0.295 |
0.314 |
1.432 |
1.140 |
0.663 |
0.776 |
|
Group 4 |
Mean |
7.90 |
15.02 |
45.34 |
57.43 |
19.02 |
33.12 |
SD |
0.279 |
0.421 |
1.490 |
1.059 |
0.555 |
0.668 |
TREATMENT(WEEK -13) |
PLT |
WBC |
RET
|
DC (%) |
PT |
APTT |
|||||
x103cells/µL |
x103cells/ µL |
% |
NEUT |
LYMPH |
MONO |
EOS |
BASO |
Sec |
Sec |
||
Group 1 |
Mean |
823.80 |
3.39 |
1.97 |
15.77 |
79.65 |
2.05 |
1.16 |
0.27 |
15.70 |
12.74 |
SD |
177.020 |
0.615 |
0.398 |
4.606 |
4.918 |
0.357 |
0.237 |
0.125 |
0.738 |
1.695 |
|
Group 2 |
Mean |
874.80 |
3.80 |
2.25 |
16.73 |
78.68 |
2.15 |
0.98 |
0.28 |
15.17 |
12.42 |
SD |
123.591 |
0.973 |
0.368 |
3.823 |
4.102 |
0.562 |
0.249 |
0.140 |
0.962 |
1.040 |
|
Group 3 |
Mean |
834.90 |
3.39 |
2.13 |
19.29 |
76.10 |
2.28 |
0.96 |
0.25 |
15.43 |
12.83 |
SD |
66.542 |
0.684 |
0.350 |
6.391 |
6.784 |
0.625 |
0.227 |
0.085 |
0.538 |
1.491 |
|
Group 4 |
Mean |
804.20 |
3.46 |
2.30 |
23.41*# |
71.28*# |
2.61 |
1.25 |
0.26 |
15.15 |
13.03 |
SD |
78.816 |
1.787 |
0.530 |
5.895 |
5.780 |
0.465 |
0.631 |
0.324 |
0.682 |
1.411 |
*Significant at p ≤ 0.05 with Group 1, #-Significant at p ≤ 0.05 with Group 2
FEMALES
RECOVERY (WEEK 17) |
RBC |
Hb |
PCV |
MCV |
MCH |
MCHC |
|
x106Cells/µL |
g/dL |
% |
fL |
pg |
g/dL |
||
Group 1R |
Mean |
7.96 |
14.81 |
45.02 |
56.55 |
18.57 |
32.88 |
SD |
0.290 |
0.463 |
1.521 |
0.848 |
0.490 |
0.598 |
|
Group 4R |
Mean |
8.15 |
14.99 |
46.65 |
56.63 |
18.20 |
32.52 |
SD |
0.476 |
0.456 |
1.434 |
1.821 |
0.876 |
0.611 |
RECOVERY (WEEK 17) |
PLT |
WBC |
RET |
DC (%) |
PT |
APTT |
|||||
x103cells/µL |
x103cells/ µL |
% |
NEUT |
LYMPH |
MONO |
EOS |
BASO |
Sec |
Sec |
||
Group 1R |
Mean |
833.10 |
2.78 |
1.78 |
13.63 |
81.82 |
1.99 |
1.37 |
0.14 |
16.32 |
13.11 |
SD |
147.485 |
0.693 |
0.220 |
1.310 |
7.344 |
0.191 |
0.744 |
0.097 |
0.665 |
0.971 |
|
Group 4R |
Mean |
758.30 |
1.68* |
1.64 |
18.22 |
76.59 |
2.33 |
1.73 |
0.14 |
15.92 |
12.93 |
SD |
96.524 |
0.441 |
0.179 |
4.682 |
5.053 |
0.576 |
0.538 |
0.117 |
0.866 |
1.108 |
*Significant at p ≤ 0.05 with Group 1R
CLINICAL BIOCHEMISTRY (CONTD.)
MALES
TREATMENT(WEEK 13) |
GLU |
UREA |
BUN |
CREA |
CHOL |
TRIGL |
AST |
ALT |
ALP |
|
mmol/L |
mmol/L |
mmol/L |
µmol/L |
mmol/L |
mmol/L |
U/L |
U/L |
U/L |
||
Group 1 |
Mean |
9.51 |
5.48 |
2.56 |
43.06 |
1.81 |
0.53 |
62.00 |
34.13 |
77.42 |
SD |
1.754 |
1.219 |
0.570 |
8.132 |
0.350 |
0.190 |
5.219 |
4.551 |
26.735 |
|
Group 2 |
Mean |
10.21 |
5.53 |
2.59 |
37.86 |
1.97 |
0.69 |
61.70 |
34.80 |
88.55 |
SD |
2.161 |
1.512 |
0.706 |
5.190 |
0.284 |
0.245 |
5.582 |
4.177 |
21.158 |
|
Group 3 |
Mean |
9.76 |
6.01 |
2.81 |
47.12# |
2.02 |
1.03 |
75.40*# |
41.87 |
133.35* |
SD |
1.813 |
1.199 |
0.560 |
6.666 |
0.460 |
1.096 |
13.237 |
9.319 |
66.920 |
|
Group 4 |
Mean |
9.11 |
5.76 |
2.67 |
46.12 |
2.00 |
0.70 |
81.76*# |
45.30* |
122.34* |
SD |
1.129 |
0.899 |
0.401 |
9.777 |
0.407 |
0.263 |
14.515 |
13.528 |
59.983 |
TREATMENT(WEEK 13) |
BIL |
GGT |
Na |
K |
Cl |
TPO |
ALB |
GLB |
A/G |
|
µmol/L |
U/L |
mmol/L |
mmol/L |
mmol/L |
g/L |
g/L |
g/L |
_ |
||
Group 1 |
Mean |
1.48 |
0.00 |
142.26 |
3.64 |
108.03 |
67.57 |
44.74 |
22.84 |
2.04 |
SD |
0.710 |
0.00 |
1.095 |
0.141 |
0.762 |
3.973 |
2.785 |
3.824 |
0.554 |
|
Group 2 |
Mean |
0.85 |
0.00 |
141.21 |
3.70 |
107.94 |
66.82 |
43.73 |
23.09 |
1.90 |
SD |
0.620 |
0.00 |
1.526 |
0.259 |
0.991 |
3.612 |
3.176 |
1.287 |
0.158 |
|
Group 3 |
Mean |
1.03 |
0.00 |
142.07 |
3.79 |
107.87 |
67.63 |
43.83 |
24.32 |
1.86 |
SD |
0.773 |
0.00 |
1.470 |
0.348 |
0.913 |
3.246 |
1.984 |
3.275 |
0.276 |
|
Group 4 |
Mean |
1.18 |
0.00 |
141.89 |
3.84 |
108.28 |
66.10 |
44.20 |
21.90 |
2.03 |
SD |
0.719 |
0.00 |
1.265 |
0.429 |
0.399 |
2.692 |
1.213 |
1.733 |
0.125 |
*-Significant at p ≤ 0.05 with Group 1, # - Significant at p ≤ 0.05 with Group 2.
MALES
RECOVERY (WEEK 17) |
GLU |
UREA |
BUN |
CREA |
CHOL |
TRIGL |
AST |
ALT |
ALP |
|
mmol/L |
mmol/L |
mmol/L |
µmol/L |
mmol/L |
mmol/L |
U/L |
U/L |
U/L |
||
Group 1R |
Mean |
10.54 |
6.33 |
2.96 |
41.13 |
2.10 |
0.62 |
60.67 |
34.29 |
65.86 |
SD |
1.389 |
0.800 |
0.374 |
4.603 |
0.318 |
0.125 |
14.096 |
15.181 |
9.311 |
|
Group 4R |
Mean |
9.76 |
6.28 |
2.94 |
38.20 |
2.27 |
0.72 |
61.80 |
32.32 |
53.69* |
SD |
1.132 |
1.147 |
0.536 |
4.274 |
0.171 |
0.174 |
9.370 |
5.683 |
11.373 |
RECOVERY (WEEK 17) |
BIL |
GGT |
Na |
K |
Cl |
TPO |
ALB |
GLB |
A/G |
|
µmol/L |
U/L |
mmol/L |
mmol/L |
mmol/L |
g/L |
g/L |
g/L |
_ |
||
Group 1R |
Mean |
1.03 |
0.00 |
145.12 |
3.85 |
106.84 |
63.74 |
41.47 |
22.27 |
2.22 |
SD |
0.589 |
0.00 |
1.137 |
0.408 |
1.206 |
1.817 |
5.333 |
5.806 |
1.613 |
|
Group 4R |
Mean |
0.76 |
0.00 |
145.47 |
3.89 |
106.92 |
64.70 |
43.52 |
21.18 |
2.06 |
SD |
0.540 |
0.00 |
0.943 |
0.300 |
0.884 |
1.791 |
2.282 |
1.128 |
0.198 |
*-Significant at p ≤ 0.05 with Group 1R
FEMALES
TREATMENT(WEEK 13) |
GLU |
UREA |
BUN |
CREA |
CHOL |
TRIGL |
AST |
ALT |
ALP |
|
mmol/L |
mmol/L |
mmol/L |
µmol/L |
mmol/L |
mmol/L |
U/L |
U/L |
U/L |
||
Group 1 |
Mean |
7.66 |
6.28 |
2.94 |
43.85 |
1.62 |
0.48 |
60.84 |
26.78 |
40.67 |
SD |
1.816 |
2.645 |
1.236 |
11.498 |
0.387 |
0.176 |
9.058 |
6.606 |
29.926 |
|
Group 2 |
Mean |
9.18 |
6.51 |
3.04 |
45.10 |
1.77 |
0.51 |
61.47 |
29.19 |
39.15 |
SD |
1.686 |
1.475 |
0.689 |
5.859 |
0.358 |
0.089 |
7.767 |
5.150 |
14.333 |
|
Group 3 |
Mean |
8.73 |
6.89 |
3.22 |
50.84* |
1.86 |
0.59 |
79.24*# |
29.03 |
57.04 |
SD |
1.079 |
1.168 |
0.546 |
7.642 |
0.433 |
0.193 |
16.562 |
8.981 |
40.442 |
|
Group 4 |
Mean |
9.39 |
7.37 |
3.51 |
47.81 |
1.70 |
0.62 |
69.84 |
30.18 |
44.01 |
SD |
1.404 |
1.354 |
0.637 |
6.199 |
0.317 |
0.365 |
10.845 |
10.816 |
22.765 |
TREATMENT(WEEK 13) |
BIL |
GGT |
Na |
K |
Cl |
TPO |
ALB |
GLB |
A/G |
|
µmol/L |
U/L |
mmol/L |
mmol/L |
mmol/L |
g/L |
g/L |
g/L |
_ |
||
Group 1 |
Mean |
1.64 |
0.00 |
140.46 |
3.44 |
107.85 |
69.48 |
50.21 |
19.27 |
2.64 |
SD |
0.990 |
0.00 |
1.153 |
0.163 |
1.801 |
4.462 |
4.020 |
2.315 |
0.390 |
|
Group 2 |
Mean |
0.96 |
0.00 |
140.20 |
3.48 |
107.42 |
71.99 |
51.58 |
20.42 |
2.62 |
SD |
0.398 |
0.00 |
1.391 |
0.246 |
1.900 |
3.685 |
4.016 |
3.709 |
0.573 |
|
Group 3 |
Mean |
1.39 |
0.00 |
140.97 |
3.49 |
107.76 |
71.60 |
50.55 |
21.05 |
2.45 |
SD |
0.930 |
0.00 |
1.018 |
0.529 |
0.706 |
3.045 |
3.468 |
2.581 |
0.431 |
|
Group 4 |
Mean |
1.38 |
0.00 |
140.05 |
3.58 |
108.20 |
70.38 |
51.71 |
18.68 |
2.79 |
SD |
0.972 |
0.00 |
1.400 |
0.520 |
1.194 |
4.139 |
4.585 |
1.509 |
0.408 |
*- Significant at p ≤ 0.05 with Group 1,#-Significant at p ≤ 0.05 with Group 2.
FEMALES
RECOVERY (WEEK 17) |
GLU |
UREA |
BUN |
CREA |
CHOL |
TRIGL |
AST |
ALT |
ALP |
|
mmol/L |
mmol/L |
mmol/L |
µmol/L |
mmol/L |
mmol/L |
U/L |
U/L |
U/L |
||
Group 1R |
Mean |
9.58 |
8.12 |
3.80 |
40.86 |
1.53 |
0.56 |
65.66 |
31.59 |
25.98 |
SD |
1.565 |
0.903 |
0.368 |
2.538 |
0.378 |
0.074 |
23.576 |
10.057 |
10.694 |
|
Group 4R |
Mean |
9.09 |
9.33* |
4.36* |
45.81* |
2.18 |
0.47 |
61.93 |
26.50 |
23.38 |
SD |
1.623 |
0.926 |
0.433 |
4.525 |
0.355 |
0.115 |
11.343 |
5.049 |
5.666 |
RECOVERY (WEEK 17) |
BIL |
GGT |
Na |
K |
Cl |
TPO |
ALB |
GLB |
A/G |
|
µmol/L |
U/L |
mmol/L |
mmol/L |
mmol/L |
g/L |
g/L |
g/L |
_ |
||
Group 1R |
Mean |
1.31 |
0.00 |
144.31 |
3.49 |
106.33 |
68.42 |
49.61 |
18.81 |
2.68 |
SD |
0.854 |
0.00 |
1.318 |
0.199 |
1.193 |
3.014 |
3.541 |
1.981 |
0.462 |
|
Group 4R |
Mean |
1.00 |
0.00 |
144.34 |
3.50 |
106.42 |
72.16 |
53.58* |
18.58 |
3.26 |
SD |
0.566 |
0.00 |
1.582 |
0.299 |
2.126 |
7.046 |
3.022 |
4.991 |
1.698 |
*Significant at p ≤ 0.05 with Group 1R.
URINE ANALYSIS
MALES
TREATMENT (Week 13) |
Volume |
SG |
pH |
Pro |
GLU |
KET |
UBG |
BIL |
Color |
Clarity |
|
mL |
- |
- |
mg/dl |
- |
mg/dl |
mg/dl |
mg/dl |
- |
- |
||
Group 1 |
Mean |
5.97 |
1.02 |
8.50 |
37.50 |
0.00 |
5.00 |
0.00 |
0.00 |
NA |
NA |
SD |
0.691 |
0.002 |
0.527 |
39.528 |
0.000 |
4.082 |
0.000 |
0.000 |
NA |
NA |
|
Group 2 |
Mean |
5.54 |
1.01* |
8.20 |
17.50 |
0.00 |
3.00 |
0.00 |
0.00 |
NA |
NA |
SD |
0.629 |
0.003 |
1.033 |
12.076 |
0.000 |
2.582 |
0.000 |
0.000 |
NA |
NA |
|
Group 3 |
Mean |
5.43 |
1.02* |
8.15 |
17.50 |
0.00 |
3.50 |
0.00 |
0.10 |
NA |
NA |
SD |
0.519 |
0.005 |
1.375 |
12.076 |
0.000 |
4.743 |
0.000 |
0.316 |
NA |
NA |
|
Group 4 |
Mean |
5.10* |
1.02 |
8.35 |
50.00 |
0.00 |
4.00 |
0.00 |
0.00 |
NA |
NA |
SD |
0.556 |
0.003 |
0.944 |
44.096 |
0.000 |
4.595 |
0.000 |
0.000 |
NA |
NA |
TREATMENT (WEEK 13) |
ERY |
LEU |
EPI |
RBC |
PUS |
CAST |
CRY |
SPER |
|
/µL |
/µL |
/field |
/field |
/field |
/field |
/field |
/field |
||
Group 1 |
Mean |
0.00 |
117.50 |
0.90 |
0.00 |
0.00 |
0.00 |
2.30 |
0.00 |
SD |
0.000 |
138.969 |
0.316 |
0.000 |
0.000 |
0.000 |
0.823 |
0.000 |
|
Group 2 |
Mean |
0.00 |
125.00 |
0.90 |
0.00 |
0.00 |
0.00 |
2.50 |
0.00 |
SD |
0.000 |
135.401 |
0.316 |
0.000 |
0.000 |
0.000 |
0.850 |
0.000 |
|
Group 3 |
Mean |
1.00 |
67.50 |
1.00 |
0.00 |
0.00 |
0.00 |
2.20 |
0.00 |
SD |
3.162 |
42.573 |
0.000 |
0.000 |
0.000 |
0.000 |
1.033 |
0.000 |
|
Group 4 |
Mean |
1.00 |
150.00 |
1.00 |
0.00 |
0.00 |
0.00 |
2.10 |
0.00 |
SD |
3.162 |
187.824 |
0.000 |
0.000 |
0.000 |
0.000 |
0.738 |
0.000 |
Key: NA = Not Applicable,*Significant at p ≤ 0.05 with Group 1.
MALES
RECOVERY (Week 17) |
Volume |
SG |
pH |
Pro |
GLU |
KET |
UBG |
BIL |
Color |
Clarity |
|
mL |
- |
- |
mg/dl |
- |
mg/dl |
mg/dl |
mg/dl |
- |
- |
||
Group 1R |
Mean |
5.82 |
1.02 |
8.20 |
70.00 |
0.00 |
4.50 |
0.10 |
0.00 |
NA |
NA |
SD |
0.469 |
0.003 |
0.789 |
151.291 |
0.000 |
4.378 |
0.316 |
0.000 |
NA |
NA |
|
Group 4R |
Mean |
5.41 |
1.01 |
8.40 |
42.50 |
0.00 |
4.50 |
0.00 |
0.00 |
NA |
NA |
SD |
0.769 |
0.002 |
0.699 |
28.988 |
0.000 |
4.378 |
0.000 |
0.000 |
NA |
NA |
RECOVERY (Week 17) |
ERY |
LEU |
EPI |
RBC |
PUS |
CAST |
CRY |
SPER |
|
/µL |
/µL |
/field |
/field |
/field |
/field |
/field |
/field |
||
Group 1R |
Mean |
12.50 |
80.00 |
0.90 |
0.00 |
0.00 |
0.00 |
2.60 |
0.00 |
SD |
17.678 |
149.443 |
0.316 |
0.000 |
0.000 |
0.000 |
0.843 |
0.000 |
|
Group 4R |
Mean |
1.00 |
117.50 |
1.00 |
0.00 |
0.00 |
0.00 |
2.70 |
0.20 |
SD |
3.162 |
138.969 |
0.000 |
0.000 |
0.000 |
0.000 |
0.823 |
0.422 |
Key: NA = Not Applicable
FEMALES
TREATMENT (Week 13) |
Volume |
SG |
pH |
Pro |
GLU |
KET |
UBG |
BIL |
Color |
Clarity |
|
mL |
- |
- |
mg/dl |
- |
mg/dl |
mg/dl |
mg/dl |
- |
- |
||
Group 1 |
Mean |
5.36 |
1.02 |
8.60 |
85.00 |
0.00 |
2.50 |
0.10 |
0.00 |
NA |
NA |
SD |
0.602 |
0.000 |
0.516 |
153.749 |
0.000 |
4.859 |
0.316 |
0.000 |
NA |
NA |
|
Group 2 |
Mean |
5.82 |
1.02 |
8.80 |
37.50 |
0.00 |
2.00 |
0.00 |
0.00 |
NA |
NA |
SD |
0.643 |
0.003 |
0.422 |
44.49 |
0.000 |
4.830 |
0.000 |
0.000 |
NA |
NA |
|
Group 3 |
Mean |
5.41 |
1.02 |
8.90 |
20.00 |
0.00 |
3.50 |
0.00 |
0.00 |
NA |
NA |
SD |
0.540 |
0.003 |
0.316 |
22.973 |
0.000 |
4.743 |
0.000 |
0.000 |
NA |
NA |
|
Group 4 |
Mean |
5.37 |
1.02 |
8.90 |
82.50 |
0.00 |
3.50 |
0.40 |
0.00 |
NA |
NA |
SD |
0.699 |
0.003 |
0.316 |
149.560 |
0.000 |
4.743 |
1.265 |
0.000 |
NA |
NA |
TREATMENT (WEEK 13) |
ERY |
LEU |
EPI |
RBC |
PUS |
CAST |
CRY |
|
/µL |
/µL |
/field |
/field |
/field |
/field |
/field |
||
Group 1 |
Mean |
0.00 |
92.50 |
1.00 |
0.00 |
0.00 |
0.00 |
2.70 |
SD |
0.000 |
148.160 |
0.000 |
0.000 |
0.000 |
0.000 |
0.823 |
|
Group 2 |
Mean |
0.00 |
132.50 |
1.00 |
0.00 |
0.00 |
0.00 |
2.50 |
SD |
0.000 |
196.515 |
0.000 |
0.000 |
0.000 |
0.000 |
0.850 |
|
Group 3 |
Mean |
0.00 |
50.00 |
0.90 |
0.00 |
0.00 |
0.00 |
2.60 |
SD |
0.000 |
44.096 |
0.316 |
0.000 |
0.000 |
0.000 |
1.075 |
|
Group 4 |
Mean |
2.50 |
92.50 |
1.00 |
0.00 |
0.00 |
0.00 |
2.40 |
SD |
7.906 |
148.160 |
0.000 |
0.000 |
0.000 |
0.000 |
1.075 |
Key: NA = Not Applicable
FEMALES
RECOVERY (Week 17) |
Volume |
SG |
pH |
Pro |
GLU |
KET |
UBG |
BIL |
Color |
Clarity |
|
mL |
- |
- |
mg/dl |
- |
mg/dl |
mg/dl |
mg/dl |
- |
- |
||
Group 1R |
Mean |
5.13 |
1.02 |
8.40 |
72.50 |
0.00 |
2.50 |
0.00 |
0.00 |
NA |
NA |
SD |
0.457 |
0.002 |
0.699 |
151.589 |
0.000 |
2.635 |
0.000 |
0.000 |
NA |
NA |
|
Group 4R |
Mean |
5.25 |
1.02 |
8.40 |
162.50 |
0.00 |
5.00 |
0.10 |
0.00 |
NA |
NA |
SD |
0.703 |
0.003 |
0.699 |
186.059 |
0.000 |
5.774 |
0.316 |
0.000 |
NA |
NA |
RECOVERY (Week 17) |
ERY |
LEU |
EPI |
RBC |
PUS |
CAST |
CRY |
|
/µL |
/µL |
/field |
/field |
/field |
/field |
/field |
||
Group 1R |
Mean |
5.00 |
47.50 |
0.80 |
0.00 |
0.00 |
0.00 |
2.60 |
SD |
10.541 |
36.228 |
0.422 |
0.000 |
0.000 |
0.000 |
1.506 |
|
Group 4R |
Mean |
0.00 |
110.00 |
0.90 |
0.00 |
0.00 |
0.00 |
1.80 |
SD |
0.000 |
142.009 |
0.568 |
0.000 |
0.000 |
0.000 |
0.632 |
Key: NA = Not Applicable
ORGAN WEIGHTS (G)
MALES
Organs |
TREATMENT |
RECOVERY |
|||||
Group 1 |
Group 2 |
Group 3 |
Group 4 |
Group 1R |
Group 4R |
||
Body Weight (G) |
Mean |
369.47 |
360.84 |
364.16 |
355.55 |
394.22 |
396.05 |
SD |
37.01 |
32.47 |
28.26 |
42.83 |
29.22 |
29.14 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Adrenals |
Mean |
0.0882 |
0.1584 |
0.0904 |
0.0916 |
0.0879 |
0.0886 |
SD |
0.0262 |
0.2056 |
0.0220 |
0.0413 |
0.0181 |
0.0177 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Kidneys |
Mean |
2.0028 |
1.9861 |
2.0283 |
2.0210 |
2.0407 |
2.0053 |
SD |
0.2367 |
0.1940 |
0.1235 |
0.2424 |
0.1787 |
0.1864 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Liver |
Mean |
10.0878 |
10.0878 |
10.3265 |
10.4688 |
10.8801 |
11.3502 |
SD |
1.2526 |
1.2525 |
0.9455 |
1.4035 |
1.2492 |
0.8907 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Heart |
Mean |
1.1699 |
1.1751 |
1.1510 |
1.2151 |
1.2401 |
1.1954 |
SD |
0.1596 |
0.1235 |
0.1039 |
0.1373 |
0.1623 |
0.1102 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Thymus |
Mean |
0.4725 |
0.4662 |
0.4653 |
0.4646 |
0.4347 |
0.4638 |
SD |
0.0962 |
0.0700 |
0.0652 |
0.1016 |
0.0933 |
0.0683 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
Organs |
TREATMENT |
RECOVERY |
|||||
Group 1 |
Group 2 |
Group 3 |
Group 4 |
Group 1R |
Group 4R |
||
Spleen |
Mean |
0.7067 |
0.6786 |
0.6670 |
0.6829 |
0.6731 |
0.7299 |
SD |
0.1865 |
0.1228 |
0.0676 |
0.1051 |
0.0978 |
0.0997 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Testes |
Mean |
3.9717 |
3.9355 |
3.9715 |
3.9018 |
3.7815 |
4.0577 |
SD |
0.2906 |
0.2662 |
0.2892 |
0.3083 |
0.3458 |
0.2464 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Epididymides |
Mean |
1.6972 |
1.6259 |
1.6547 |
1.6242 |
1.6922 |
1.7497 |
SD |
0.1265 |
0.1590 |
0.1632 |
0.1931 |
0.1807 |
0.1652 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Prostate + Seminal vesicles with coagulating gland |
Mean |
2.8477 |
2.7193 |
2.8320 |
2.5825 |
3.0185 |
3.1790 |
SD |
0.2176 |
0.3672 |
0.4523 |
0.2898 |
0.4887 |
0.4975 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Brain |
Mean |
2.1798 |
2.1177 |
2.1717 |
2.1813 |
2.1824 |
2.1123 |
SD |
0.0894 |
0.0818 |
0.1193 |
0.0941 |
0.0653 |
0.1032 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
FEMALES
Organs |
TREATMENT |
RECOVERY |
|||||
Group 1 |
Group 2 |
Group 3 |
Group 4 |
Group 1R |
Group 4R |
||
Body Weight (G) |
Mean |
214.8 |
216.2 |
215.0 |
202.0 |
223.2 |
214.8 |
SD |
11.33 |
19.30 |
16.90 |
11.44 |
11.59 |
15.96 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Adrenals |
Mean |
0.1049 |
0.1012 |
0.1006 |
0.1022 |
0.1106 |
0.1084 |
SD |
0.0306 |
0.0397 |
0.0297 |
0.0278 |
0.0147 |
0.0213 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Kidneys |
Mean |
1.5102 |
1.4336 |
1.4582 |
1.3354 |
1.4855 |
1.3923 |
SD |
0.1102 |
0.1435 |
0.1783 |
0.1618 |
0.1164 |
0.1493 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Liver |
Mean |
7.0277 |
7.0319 |
7.2701 |
6.6108 |
6.9474 |
6.8568 |
SD |
0.5982 |
0.8065 |
0.9244 |
0.6169 |
0.8519 |
0.8777 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Heart |
Mean |
0.8961 |
0.8668 |
0.8401 |
0.8359 |
0.8643 |
0.9149 |
SD |
0.0950 |
0.0887 |
0.1118 |
0.0798 |
0.0933 |
0.2533 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
Organs |
TREATMENT |
RECOVERY |
|||||
Group 1 |
Group 2 |
Group 3 |
Group 4 |
Group 1R |
Group 4R |
||
Thymus |
Mean |
0.3618 |
0.3923 |
0.3553 |
0.3340 |
0.3215 |
0.2984 |
SD |
0.0683 |
0.0499 |
0.0726 |
0.0443 |
0.0645 |
0.0789 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Spleen |
Mean |
0.4599 |
0.4720 |
0.4976 |
0.4787 |
0.5188 |
0.4749 |
SD |
0.1710 |
0.0721 |
0.0668 |
0.0735 |
0.0700 |
0.0737 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Ovaries |
Mean |
0.1880 |
0.2528 |
0.1864 |
0.1662 |
0.1867 |
0.1719 |
SD |
0.0441 |
0.1440 |
0.0315 |
0.0378 |
0.0399 |
0.0465 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Uterus |
Mean |
0.7340 |
0.9319 |
0.7671 |
0.8519 |
0.7735 |
0.7830 |
SD |
0.0471 |
0.3839 |
0.2269 |
0.3005 |
0.1508 |
0.1130 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Brain |
Mean |
2.0723 |
2.0588 |
2.0869 |
1.9738 |
2.0267 |
2.0657 |
SD |
0.1224 |
0.1395 |
0.1025 |
0.1207 |
0.0893 |
0.1561 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
1.1 ORGAN WEIGHT RATIO (%)
MALES
Organs |
TREATMENT |
RECOVERY |
|||||
Group 1 |
Group 2 |
Group 3 |
Group 4 |
Group 1R |
Group 4R |
||
Body Weight (G) |
Mean |
369.47 |
360.84 |
364.16 |
355.55 |
394.22 |
396.05 |
SD |
37.01 |
32.47 |
28.26 |
42.83 |
29.22 |
29.14 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Adrenals |
Mean |
0.0246 |
0.0253 |
0.0249 |
0.0269 |
0.0225 |
0.0225 |
SD |
0.0097 |
0.0050 |
0.0059 |
0.0144 |
0.0053 |
0.0050 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Kidneys |
Mean |
0.5423 |
0.5507 |
0.5582 |
0.5694 |
0.5185 |
0.5066 |
SD |
0.0385 |
0.0284 |
0.0302 |
0.0354 |
0.0415 |
0.0359 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Liver |
Mean |
2.7925 |
2.7926 |
2.8364 |
2.9438* |
2.7641 |
2.8677 |
SD |
0.1806 |
0.1806 |
0.1589 |
0.1594 |
0.2920 |
0.1270 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Heart |
Mean |
0.3164 |
0.3262 |
0.3161 |
0.3408 |
0.3147 |
0.3019 |
SD |
0.0243 |
0.0281 |
0.0149 |
0.0264 |
0.0341 |
0.0181 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Thymus |
Mean |
0.1276 |
0.1292 |
0.1285 |
0.1308 |
0.1103 |
0.1174 |
SD |
0.0213 |
0.0151 |
0.0200 |
0.0243 |
0.0237 |
0.0175 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
*Significant at p ≤ 0.05 with Group 1
Organs |
TREATMENT |
RECOVERY |
|||||
Group 1 |
Group 2 |
Group 3 |
Group 4 |
Group 1R |
Group 4R |
||
Spleen |
Mean |
0.1913 |
0.1871 |
0.1833 |
0.1922 |
0.1713 |
0.1848 |
SD |
0.0465 |
0.0192 |
0.0129 |
0.0211 |
0.0250 |
0.0244 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Testes |
Mean |
1.0800 |
1.0951 |
1.0939 |
1.1063 |
0.9610 |
1.0271 |
SD |
0.0786 |
0.0854 |
0.0894 |
0.1096 |
0.0788 |
0.0620 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Epididymides |
Mean |
0.4620 |
0.4531 |
0.4555 |
0.4597 |
0.4301 |
0.4438 |
SD |
0.0421 |
0.0555 |
0.0441 |
0.0536 |
0.0428 |
0.0512 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Prostate + Seminal vesicles with coagulating gland |
Mean |
0.7749 |
0.7536 |
0.7794 |
0.7332 |
0.7727 |
0.8093 |
SD |
0.0672 |
0.0714 |
0.1166 |
0.0972 |
0.1584 |
0.1557 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Brain |
Mean |
0.5955 |
0.5905 |
0.5986 |
0.6207 |
0.5565 |
0.5359 |
SD |
0.0657 |
0.0494 |
0.0444 |
0.0699 |
0.0469 |
0.0450 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
FEMALES
Organs |
TREATMENT |
RECOVERY |
|||||
Group 1 |
Group 2 |
Group 3 |
Group 4 |
Group 1R |
Group 4R |
||
Body Weight (G) |
Mean |
214.8 |
216.2 |
215.0 |
202.0 |
223.2 |
214.8 |
SD |
11.33 |
19.30 |
16.90 |
11.44 |
11.59 |
15.96 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Adrenals |
Mean |
0.0492 |
0.0473 |
0.0472 |
0.0511 |
0.0498 |
0.0505 |
SD |
0.0156 |
0.0204 |
0.0144 |
0.0154 |
0.0081 |
0.0098 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Kidneys |
Mean |
0.7046 |
0.6634 |
0.6778 |
0.6598 |
0.6667 |
0.6487 |
SD |
0.0585 |
0.0378 |
0.0618 |
0.0535 |
0.0560 |
0.0561 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Liver |
Mean |
3.2733 |
3.2555 |
3.3861 |
3.2715 |
3.1076 |
3.1889 |
SD |
0.2270 |
0.2767 |
0.4064 |
0.2250 |
0.2989 |
0.2723 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Heart |
Mean |
0.4182 |
0.4018 |
0.3904 |
0.4139 |
0.3873 |
0.4273 |
SD |
0.0483 |
0.0358 |
0.0380 |
0.0340 |
0.0366 |
0.1243 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
Organs |
TREATMENT |
RECOVERY |
|||||
Group 1 |
Group 2 |
Group 3 |
Group 4 |
Group 1R |
Group 4R |
||
Thymus |
Mean |
0.1681 |
0.1832 |
0.1648 |
0.1649 |
0.1447 |
0.1396 |
SD |
0.0275 |
0.0314 |
0.0291 |
0.0155 |
0.0320 |
0.0389 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Spleen |
Mean |
0.2147 |
0.2186 |
0.2315 |
0.2366 |
0.2321 |
0.2209 |
SD |
0.0797 |
0.0293 |
0.0268 |
0.0296 |
0.0247 |
0.0283 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Ovaries |
Mean |
0.0881 |
0.1176 |
0.0876 |
0.0829 |
0.0831 |
0.0802 |
SD |
0.0228 |
0.0680 |
0.0184 |
0.0215 |
0.0170 |
0.0226 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Uterus |
Mean |
0.3433 |
0.4333 |
0.3587 |
0.4170 |
0.3486 |
0.3646 |
SD |
0.0371 |
0.1807 |
0.1134 |
0.1243 |
0.0769 |
0.0463 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
|
Brain |
Mean |
0.9689 |
0.9570 |
0.9736 |
0.9801 |
0.9104 |
0.9659 |
SD |
0.0975 |
0.0852 |
0.0526 |
0.0857 |
0.0642 |
0.0943 |
|
N |
10 |
10 |
10 |
10 |
10 |
10 |
Applicant's summary and conclusion
- Conclusions:
- In conclusion, under the conditions of this experiment the No Observed Adverse Effect Level (NOAEL) was 400 mg/kg body weight.
- Executive summary:
The test item Hordaphos MDB was administered daily by oral route to Wistar rats for a period of 90 consecutive days. A recovery period of 28 days without test item treatment was included in this study.
Three groups consisting of 10 male and 10 female rats each were treated at dose levels of 50, 200 and 400 mg/kg, respectively.Concurrently, vehicle control, vehicle control recovery and test item high dose recovery groups (400 mg/kg) were used in the present study.
All the animals survived up to the scheduled sacrifice.
No test item related changes in clinical signs, detailed clinical observation, functional observation battery, ophthalmic examination findings, organ weight and body weight changes were noted. The dullness observed in the in high dose (G4 & G4R) were considered to be without toxicological relevance.
Minor changes in hematological, clinical biochemistry, body weight, feed consumption and urine analysis were recorded at the end of treatment and recovery periods, but the variations were considered incidental as there was no dose dependent trend in the observed variations and the respective tissues revealed no abnormalities in macroscopic and histopathological examination.
Post-mortem examinations revealed no test item-related macroscopic findings in treated animals.
Microscopic examination revealed abnormalities in non glandular stomach attributable to the test item HORDAPHOS MDB at 50, 200 and 400 mg/kg bw in both sexes. The lesion was considered non adverse as complete recovery was observed at the end of 28 day recovery period.
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