Document Jxno2J9E1NbX8ZOZrMXXEreX
AR226-3186
TRADE SECRET
Study Title H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
Volume 3 of 5
Laboratory Project ID: DuPont-4739
DuPont-4739
TEST GUIDELINES: U.S. EPA Health Effects Test Guidelines OPPTS 870.3100 (1998)
AUTHOR: Don A. Delker, Ph.D. STUDY COMPLETED ON: October 23, 2001
PERFORMING LABORATORY:
E.I. du Pont de Nemours and Company Haskell Laboratory for Health and Environmental Sciences
Elkton Road, P.O. Box 50 Newark, Delaware 19714-0050
jHf^ WORK REQUEST NUMBER:!
y ^
ij^B SERVICE CODE NUMBER:
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SPONSOR STUDY NUMBER: )fl----B i
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
APPENDIX F INDIVIDUAL FORELIMB AND fflNDLIMB GRIP STRENGTH ASSESSMENTS
608 Company Sanitized. Does s
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL PORELIMB AND fflNDLIMB GRIP STRENGTH ASSESSMENTS FOR MALE RATS
BASELINE
FORELIMBGR[PSTRENiGTHCke)
HINDIJMBGRD'STREW3TH (kg)
ANIMAL
MEAN OF
NUMBER 'TRIAL 1 TRIAL2 TRIAL 3 TRIALS
MEAN OF TRIAL 1 TRIAL2 TRIAL 3 TRIALS
GROUP 1:0 mg/kg/daiy
641083 641084 641085 641101 641105 641123 641154 641159 641165 641215
0.71 0.55 0.86 0.94 0.62 0.86 0.46 0.70 0.46 0.66
0.75 0.68 0.93 0.75 0.84 0.84 0.68 0.85 0.54 0.63
GROUP ffl: 50 mg/kg/day
0.75 0.74 0.77 1.01 0.61 0.86 0.74 0.86 0.40 0.37
0.73667 0.65667 0.85333 0.90000 0.69000 0.85333 0.62667 0.80333 0.46667 0.55333
0.20 0.22 0.52 0.44 0.29 0.31 0.30 0.20 0.24 0.37
0.23 0.27 0.22 0.45 0.30 0.28 0.31 0.19 0.25 0.41
0.41 0.44 0.45 0.44 0.32 0.34 0.37 0.17 0.34 0.33
0.28000 0.31000 0.39667 0.44333 0.30333 0.31000 0.32667 0.18667 0.27667 0.37000
641055 641056 641073 641081 641144 641146 641178 641198 641218 641224
0.45 0.51 0.66 0.82 0.56 0.52 0.64 0.63 0.61 0.61
0.89 0.72 0.79 0.84 0.57 0.91 0.71 0.77 0.76 0.57
GROUP V: 250 mg/kg/dav
641061 641089 641102 641134 641137 641162 641190 641197 641200 641202
0.76 0.59 0.93 0.66 0.61 0.56 0.50 0.39 0.66 0.81
0.95 0.63 0.88 0.53 0.75 0.80 0.65 0.87 0.80 0.80
0.55 0.47 0.62 0.60 0.67 0.58 0.40 0.56 0.78 0.79
0.94 0.70 0.85 0.69 0.56 0.93 0.63 0.85 0.73 0.74
0.63000 0.56667 0.69000 0.75333 0.60000 0.67000 0.58333 0.65333 0.71667 0.65667
0.88333 0.64000 0.88667 0.62667 0.64000 0.76333 0.59333 0.70333 0.73000 0.78333
0.30 0.29 0.34 0.22 0.19 0.41 0.27 0.28 0.26 0.33
0.35 0.24 0.24 0.20 0.13 0.27 0.20 0.25 0.24 0.41
0.46 0.30 0.26 0.36 0.17 0.17 0.27 0.37 0.36 0.31
0.37000 0.27667 0.28000 0.26000 0.16333 0.28333 0.24667 0.30000 0.28667 0.35000
0.33 0.42 0.31 0.24 0.34 0.36 0.31 0.45 0.31 0.52
0.40 0.27 0.31 0.26 0.27 0.45 0.34 0.25 0.44 0.40
0.37 0.29 0.30 0.48 0.22 0.43 0.30 0.38 0.53 0.37
0.36667 0.32667 0.30667 0.32667 0.27667 0.41333 0.31667 0.36000 0.42667 0.43000
609
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL FORELIMB AND HINDUMB GRIP STRENGTH ASSESSMENTS FOR MALE RATS
BASELINE
FORELIMB GRIP STRENGTH (kg)
fflNDLIMB GRIP STRENGTH (kg)
ANIMAL
MEAN OF
NUMBER TRIAL 1 TRIAL 2 TRIAL 3 TRIALS
MEAN OF TRIAL 1 TRIAL 2 TRIAL 3 TRIALS
GROUP Vn: 1000 me/kg/day
641064 641092 641143 641153 641167 641185 641189 641203 641213 641216
0.78 0.89 0.71 0.37 0.71 0.92 0.59 0.36 0.89 0.52
0.63 0.53 0.74 0.55 0.79 0.87 0.32 0.76 0.79 0.74
0.59 0.77 0.61 0.58 0.75 0.80 0.65 0.51 0.58 0.66
0.66667 0.73000 0.68667 0.50000 0.75000 0.86333 0.52000 0.54333 0.75333 0.64000
0.22 0.39 0.27 0.16 0.33 0.27 0.30 0.31 0.35 0.36
0.22 0.25 0.17 0.32 0.33 0.45 0.31 0.35 0.38 0.35
0.20 0.38 0.19 0.32 0.42 0.37 0.33 0.40 0.43 0.46
0.21333 0.34000 0.21000 0.26667 0.36000 0.36333 0.31333 0.35333 0.38667 0.39000
610 Company SanStized. Does not eonSain TSCA CB1
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL PORELIMB AND HENDLIMB GRIP STRENGTH ASSESSMENTS FOR MALE RATS
WEEK 12
FORELIMB GRIP STRENGTH (kg)
HINDLIMB GRIP STRENGTH (kg)
ANIMAL
MEAN OF
NUMBER TRIAL 1 TRIAL2 TRIALS TRIALS
MEAN OF TRIAL 1 TRIAL2 TRIAL3 TRIALS
GROUP I: C1mg/kg/daiy
641083 641084 641085 641101 641105 641123 641154 641159 641165 641215
1.28 1.02 1.29 1.66 1.54 1.66 2.01 1.27 1.29 1.19
1.09 1.57 1.06 2.07 1.22 1.87 1.53 1.10 1.22 1.00
GROUP III 50 mg/kg/day
1.11 0.96 1.20 2.37 1.49 1.71 1.95 1.24 1.53 1.08
1.16000 1.18333 1.18333 2.03333 1.41667 1.74667 1.83000 1.20333 1.34667 1.09000
0.29 0.50 0.85 0.66 0.76 0.56 0.57 0.55 0.27 0.69
0.37 0.47 0.69 0.40 0.77 0.62 0.80 0.44 0.37 0.62
0.56 0.66 0.75 0.36 0.77 0.67 0.64 0.30 0.57 0.70
0.40667 0.54333 0.76333 0.47333 0.76667 0.61667 0.67000 0.43000 0.40333 0.67000
641055 641056 641073 641081 641144 641146 641178 641198 641218 641224
1.30 1.56 0.76 2.16 1.69 1.40 1.49 1.05 1.78 0.70
0.98 1.44 1.07 1.98 1.18 1.02 1.35 1.71 1.95 1.01
GROUP V: 250 mg/kg/day
0.84 1.34 0.86 1.48 2.06 0.67 1.37 1.18 1.47 0.82
1.04000 1.44667 0.89667
.87333 .64333 .03000 .40333 .31333 1.73333 0.84333
0.86 0.48
0.73 0.25 0.58 0.51 0.42 0.52 0.83 0.66
0.47 0.48 0.42 0.27 0.66 0.59 0.43 0.45 0.80 0.45
0.38 0.56 0.54 0.47 0.53 0.64 0.42 0.39 0.82 0.51
0.57000 0.50667 0.56333 0.33000 0.59000 0.58000 0.42333 0.45333 0.81667 0.54000
641061 641089 641102 641134 641137 641162 641190 641197 641200 641202
1.30 1.22 1.41 1.51 0.98 2.12 1.45 0.94 1.82 1.83
0.63 0.77 1.28 1.03 0.89 1.82 1.32 0.76 1.47 1.41
0.66 0.67 1.10 0.56 1.02 2.23 1.41 0.70 1.05 1.23
0.86333 0.88667 1.26333 1.03333 0.96333 2.05667 1.39333 0.80000 1.44667 1.49000
0.65 0.82 0.75 0.46 0.83 0.64 0.94 0.64 0.58 0.59
1.00 0.75 0.52 0.60 0.59 0.79 0.76 0.50 0.38 0.90
0.87 0.90 0.41 0.70 0.66 0.44 1.13 0.61 0.40 0.95
0.84000 0.82333 0.56000 0.58667 0.69333 0.62333 0.94333 0.58333 0.45333 0.81333
611
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL FORELIMB AND fflNDUMB GRIP STRENGTH ASSESSMENTS FOR MALE RATS
WEEK 12
FORELIMB GRIP STRENGTH (kg)
ANIMAL
MEAN OF
NUMBER TRIAL 1 TRIAL 2 TRIALS TRIALS
fflNDLIMB GRIP STRENGTH te)
MEAN OF TRIAL 1 TRIAL2 TRIALS TRIALS
GROUP VII: 1000 mg/kg/day
641064 641092 641143 641153 641167 641185 641189 641203 641213 641216
1.28 0.82 1.56 0.87 1.47 1.54 0.80 1.52 1.14 1.62
1.00 0.92 1.17 0.47 1.54 1.75 1.05 1.17 1.26 1.45
1.64 0.84 0.81 0.26 1.86 0.90 1.72 1.03 1.98 1.78
1.30667 0.86000 1.18000 0.53333 1.62333 1.39667 1.19000 1.24000 1.46000 1.61667
0.46 0.68 0.31 0.41 0.54 0.53 0.75 0.52 0.59 0.76
0.51 0.64 0.41 0.61 0.64 0.88 0.61 0.57 0.79 0.95
0.41 0.78 0.60 0.40 0.70 0.81 0.41 0.64 0.50 0.72
0.46000 0.70000 0.44000 0.47333 0.62667 0.74000 0.59000 0.57667 0.62667 0.81000
612 Company Sanitized. Does noS contain TSCA CBl
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL FORELIMB AND fflNDLIMB GRIP STRENGTH ASSESSMENTS FOR MALE RATS
RECOVERY
FORELIMB GRIP STRENGTH (kg)
fflNDLIMB GRIP STRENGTH (kg)
ANIMAL
MEAN OP
NUMBER TRIAL 1 TRIAL2 TRIALS TRIALS
MEAN OP TRIAL 1 TRIAL2 TRIALS TRIALS
GROUP 1:01ng/kg/day
641083 641084 641085 641101 641105 641123 641154 641159 641165 641215
2.42 1.37 1.00 2.12 1.88 1.57 1.19 1.58 1.40 1.26
2.40 1.45 1.16 1.53 1.17 1.38 0.95 0:91 1.83 0.66
GROUP VII: 1000 mg/kg/day
2.19 1.17 1.24 2.37 1.60 1.30 1.05 1.55 1.85 1.05
2.33667 1.33000 1.13333 2.00667 1.55000 1.41667 1.06333 1.34667 1.69333 0.99000
0.99 1.00 0.94 1.05 0.96 0.65 1.06 0.75 0.70 0.61
0.72 0.74 0.81 0.77 0.99 0.77 0.94 0.69 0.47 0.70
0.73 0.61 0.97 0.70 0.99 0.51 0.86 0.73 0.38 0.60
0.81333 0.78333 0.90667 0.84000 0.98000 0.64333 0.95333 0.72333 0.51667 0.63667
641064 641092 641143 641153 641167 641185 641189 641203 641213 641216
1.56 1.72 1.45 1.76 1.12 0.99 0.71 1.48 1.82 1.54
1.76 1.60 1.19 1.29 1.10 1.67 1.62 1.14 2.08 1.71
0.91 1.36 1.77 0.70 0.97 1.53 1.22 1.54 2.18 1.11
1.41000 1.56000 1.47000 1.25000 1.06333 1.39667 1.18333 1.38667 2.02667 1.45333
0.64 0.84 0.38 0.63 0.55 0.77 0.72 0.86 0.66 0.56
0.59 0.82 0.70 0.51 0.77 0.45 0.90 0.51 0.75 0.55
0.48 0.64 0.84 0.67 0.69 0.61 0.69 0.62 0.69 0.64
0.57000 0.76667 0.64000 0.60333 0.67000 0.61000 0.77000 0.66333 0.70000 0.58333
613
Company Sanitized. Does not contain T8CA CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL FORELIMB AND fflNDLIMB GRIP STRENGTH ASSESSMENTS FOR FEMALE RATS
BASELINE
FORE3LIMBGR]PSTRENCmince)
ANIMAL
MEAN OF
NUMBER 1FRIAL1 TRIAL2 TRIAL 3 TRIALS
HINDIJMBGRII'STRENGrTHfke)
MEAN OF
rRIALl TRIAL2 TRIAL 3 TRIALS
GROUPn: ()mg/kg/d ay
641253 641281 641266 641294 641325 641331 641359 641364 641383 641400
0.75 0.78 0.87 0.54 0.76 0.45 0.67 0.72 0.44 0.60
0.83 0.53 0.52 0.69 0.73 0.44 0.93 0.50 0.71 0.47
GROUP IV: 50 mg/kg/day
0.54 0.88 0.85 0.56 0.61 0.79 0.76 0.61 0.76 0.58
0.70667 0.73000 0.74667 0.59667 0.70000 0.56000 0.78667 0.61000 0.63667 0.55000
0.38 0.40 0.31 0.23 0.30 0.28 0.27 0.29 0.21 0.36
0.50 0.31 0.40 0.31 0.30 0.26 0.33 0.21 0.22 0.27
0.37 0.29 0.33 0.41 0.25 0.19 0.40 0.27 0.15 0.37
0.41667 0.33333 0.34667 0.31667 0.28333 0.24333 0.33333 0.25667 0.19333 0.33333
641260 641298 641311 641312 641313 641336 641355 641361 641369 641396
0.30 0.89 0.99 0.60 0.73 0.47 0.87 0.53 0.47 0.49
0.57 0.47 0.76 0.39 0.69 0.77 0.75 0.85 0.54 0.36
GROUP VI: 250 mg/kg/day
0.80 0.69 0.50 0.51 0.52 0.78 0.62 0.78 0.74 0.48
0.55667 0.68333 0.75000 0.50000 0.64667 0.67333 0.74667 0.72000 0.58333 0.44333
0.29 0.26 0.20 0.28 0.31 0.32 0.31 0.29 0.28 0.21
0.34 0.27 0.26 0.21 0.35 0.45 0.33 0.26 0.32 0.34
0.21 0.35 0.23 0.33 0.29 0.43 0.23 0.40 0.22 0.48
0.28000 0.29333 0.23000 0.27333 0.31667 0.40000 0.29000 0.31667 0.27333 0.34333
641244 641251 641269 641292 641302 641362 641363 641375 641379 641398
0.59 0.88 0.57 0.81 0.66 0.53 0.44 0.58 1.02 0.36
0.47 0.80 0.80 0.84 0.58 0.67 0.81 0.68 1.19 0.47
0.48 0.65 0.65 0.73 0.75 0.70 0.67 0.85 1.04 0.80
0.51333 0.77667 0.67333 0.79333 0.66333 0.63333 0.64000 0.70333 . 1.08333 0.54333
0.24 0.33 0.35 0.31 0.63 0.39 0.27 0.25 0.39 0.51
0.31 0.54 0.36 0.52 0.25 0.43 0.20 0.24 0.37 0.38
0.25 0.37 0.33 0.46 0.26 0.27 0.35 0.30 0.27 0.42
0.26667 0.41333 0.34667 0.43000 0.38000 0.36333 0.27333 0.26333 0.34333 0.43667
614 Company Sanitized.
not eonstaEn TSCA CB1
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL FORELIMB AND HINDLIMB GRIP STRENGTH ASSESSMENTS FOR FEMALE RATS
BASELINE
FORELIMB GRIP STRENGTH (kg)
HINDLIMB GRIP STRENGTH (kg)
ANIMAL
MEAN OF
NUMBER TRIAL 1 TRIAL 2 TRIALS TRIALS
MEAN OF TRIAL 1 TRIAL2 TRIALS TRIALS
GROUP Vin: 1000 mg/kg/day
641234 641256 641282 641352 641356 641366 641377 641385 641387 641399
0.45 0.85 0.63 0.58 0.95 0.71 0.45 0.44 0.46 0.51
0.64 1.05 0.84 0.56 0.83 0.67 0.58 0.43 0.80 0.67
0.61 1.01 0.65 0.76 0.77 0.73 0.71 0.83 0.61 0.65
0.56667 0.97000 0.70667 0.63333 0.85000 0.70333 0.58000 0.56667 0.62333 0.61000
0.36 0.32 0.47 0.21 0.30 0.21 0.29 0.49 0.39 0.31
0.21 0.39 0.37 0.20 0.27 0.32 0.48 0.32 0.25 0.33
0.21 0.50 0.37 0.24 0.44 0.30 0.32 0.24 0.30 0.40
0.26000 0.40333 0.40333 0.21667 0.33667 0.27667 0.36333 0.35000 0.31333 0.34667
615
Company Sanitized. Does not contain TSCA CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL FORELIMB AND fflNDLIMB GRIP STRENGTH ASSESSMENTS FOR FEMALE RATS
WEEK 12
ANIMAL NUMBER
FOREELIMBGR]OPSTRENCmnks)
MEAN OP 1FRIAL1 TRIAL 2 TRIAL 3 TRIALS
HINDIJMBGRII'STRENG.THfke)
MEAN OF TRIAL 1 TRIAL2 TRIAL3 TRIALS
GROUP n: <)mg/kg/d ay
641253 641266 641281 641294 641325 641331 641359 641364 641383 641400
1.24 1.00 1.59 1.17 0.89 0.53 1.66 1.15 0.58 1.22
1.36 1.33 1.29 1.42 1.20 0.73 1.14 0.85 0.88 1.49
GROUP IV: 50 mg/kg/day
0.81 0.64 1.17 1.72 1.19 0.54 0.81 0.94 0.87 1.16
1.13667 0.99000 1.35000 1.43667 1.09333 0.60000 1.20333 0.98000 0.77667 1.29000
0.59 0.59 0.53 0.35 0.56 0.58 0.38 0.50 0.33 0.73
0.51 0.53 0.51 0.54 0.62 0.38 0.47 0.51 0.46 0.49
0.59 0.58 0.57 0.61 0.53 0.47 0.38 0.67 0.33 0.42
0.56333 0.56667 0.53667 0.50000 0.57000 0.47667 0.41000 0.56000 0.37333 0.54667
641260
0.91
0.56
0.86
0.77667
0.63
0.30
0.56
0.49667
641298
0.70
0.66
0.56
0.64000
0.66
0.71
0.42
0.59667
641311
0.95
1.42
1.59
1.32000
"0.49
0.29
0.26
0.34667
^11
641312
0.60
0.71
0.74
0.68333
0.51
0.51
0.51
0.51000
641313
1.34
0.65
0.86
0.95000
0.60
0.51
0.50
0.53667
641336
0.86
1.02
0.83
0.90333
0.23
0.70
0.50
0.47667
641355
1.27
0.69
0.35
0.77000
0.32
0.41
0.48
0.40333
641361
1.43
0.89
1.18
1.16667
0.37
0.46
0.57
0.46667
641369
0.60
1.14
0.96
0.90000
0.34
0.31
0.28
0.31000
641396
1.35
1.11
1.26
1.24000
0.42
0.26
0.70
0.46000
GROUP VI: 250 mg/kg/day
641244 641251 641269 641292 641302 641362 641363 641375 641379 641398
0.99 0.35 0.56 0.97 1.23 1.08 0.99 1.64 1.52 1.03
1.14 0.40 0.32 0.95 0.66 1.56 0.85 1.52 0.76 1.73
1.32 0.35 0.62 0.85 0.66 1.59 0.71 1.60 0.52 1.82
1.15000 0.36667 0.50000 0.92333 0.85000 1.41000 0.85000 1.58667 , 0.93333 1.52667
0.45 0.56 0.39 0.53. 0.43 0.58 0.33 0.66 0.34 0.20
0.84 0.48 0.43 0.61 0.52 0.54 0.64 0.73 0.56 0.35
0.74 0.63 0.51 0.41 0.68 0.45 0.58 0.58 0.36 0.41
0.67667 0.55667 0.44333 0.51667 0.54333 0.52333 0.51667 0.65667 0.42000 0.32000
616
Company Sanitized. Does not contain TSCA C^
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL FORELIMB AND fflNDLIMB GRIP STRENGTH ASSESSMENTS FOR FEMALE RATS
WEEK 12
FORELIMB GRIP STRENGTH (kg)
fflNDLIMB GRIP STRENGTH (kg)
ANIMAL
MEAN OF
NUMBER TRIAL 1 TRIAL 2 TRIALS TRIALS
MEAN OF TRIAL 1 TRIAL2 TRIALS TRIALS
GROUP Vni: 1000 nig/kg/day
641234 641256 641282 641352 641356 641366 641377 641385 641387 641399
0.74 1.10 0.76 1.21 0.96 1.32 0.95 0.75 1.30 1.24
0.46 1.32 1.83 1.29 0.54 1.60 1.56 0.90 1.46 0.86
0.32 0.40 1.29 1.42 0.75 1.43 0.48 0.79 1.51 1.40
0.50667 0.94000 1.29333 1.30667 0.75000 1.45000 0.99667 0.81333 1.42333 1.16667
0.43 0.50 0.65 0.57 0.56 0.35 0.45 0.36 0.27 0.61
0.51 0.54 0.62 0.40 0.49 0.36 0.53 0.56 0.26 0.58
0.34 0.40 0.51 0.40 0.61 0.32 0.47 0.65 0.38 0.50
0.42667 0.48000 0.59333 0.45667 0.55333 0.34333 0.48333 0.52333 0.30333 0.56333
617 Company Sanitized. Does not congaim TSCA CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INTWIDVAiLFORE:LIMB AN1OfflNDLD*ffi GRIPS'TRENGTH ASSES SMENTS F ORFEMA]LERATS
RECO'VERY
FORIiLIMBGR][P STRENGirH(kp)
HIND]-JMBGRD' STRENGI"H(kR)
ANIMAL
MEAN OF
NUMBER TRIAL1 TRIAL2 TRIAL3 TRIALS
MEAN OF TRIAL1 TRIAL2 TRIAL3 TRIALS
GROUP II: 0 nig/kg/day
641253 641266 641281 641294 641325 641331 641359 641364 641383 641400
1.44 0.97 0.84 1.12 1.64 0.46 1.48 0.87 0.91 1.10
1.33 1.00 0.69 1.43 1.62 0.49 1.18 0.71 0.83 0.93
1.41 0.85 0.63 1.04 1.35 0.44 1.25 0.88 0.8 0.46
1.39333 0.94000 0.72000 1.19667 1.53667 0.46333 1.30333 0.82000 0.84667 0.83000
0.58 0.48 0.80 0.65 0.66 0.52 0.43 0.68 0.44 0.46
0.44 0.37 0.53 0.80 0.86 0.52 0.48 0.52 0.63 0.49
0.54 0.43 0.51 1.07 0.58 0.65 0.42 0.56 0.66 0.59
0.52000 0.42667 0.61333 0.84000 0.70000 0.56333 0.44333 0.58667 0.57667 0.51333
GROUP VIII: lOOOmg/kg/day
641234 641256 641282 641352 641356
641366 641377 641385 641387 641399
0.62 1.42 1.39 1.19
a
1.04 0.82 0.97 0.91 1.34
0.47 0.72 1.11
a
-
1.17 0.68 0.61 0.50 1.08
0.4 0.89 1.22 0.60
-
0.61 0.90 0.64 1.49 1.42
0.49667 1.01000 1.24000 0.89500
-
0.94000 0.80000 0.74000 0.96667 1.28000
0.55 0.75 0.45 0.46
-
0.95 0.45 0.56 0.47 0.58
0.41 0.61 0.77 0.61
-
0.95 0.39 0.67 0.34 0.81
0.47 0.68 0.68 0.56
-
0.76 0.51 0.60 0.53 0.72
0.47667 0.68000 0.63333 0.54333
-
0.88667 0.45000 0.61000 0.44667 0.70333
618 .Company Sanitized. Does not contain TSCA CBB
H-24616: Subchromc Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
APPENDIX G INDIVIDUAL FUNCTIONAL OBSERVATIONAL BATTERY ASSESSMENTS
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL FUNCTIONAL OBSERVATIONAL BATTERY ASSESSMENTS FOR MALE RATS
Group I: 0 mg/kg/day
Animal Number Time Point
I Iaiupulatioi1
Approach and Touch
Auditory Stimulus
Tail Pinch
Ini Motor Activity
Pupillary Response
Defecation
Urination
641083 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
0
1
Recovery
0
0
0
0
1
1
641084 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
1
1
Recovery
0
0
0
0
1
1
641085 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
1
1
Recovery
0
0
0
0
1
1
641101 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
0
1
Recovery
0
0
0
0
1
1
641105 Baseline
0
0
0
0
0
1
Week 12
0
0
-1
0
0
0
Recovery
0
0
0
0
0
1
641123 Baseline
0
0
0
0
1
1
Week 12
0
0
-1
0
1
1
Recovery
0
0
0
0
1
1
641154 Baseline
0
0
0
0
0
1
Week 12
0
0
0
0
1
1
Recovery
0
0
1
0
1
1
641159 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
1
1
Recovery
0
0
0
0
1
1
641165 Baseline
0
0
0
0
0
1
Week 12
0
0
0
0
0
1
Recovery
0
0
0
0
1
1
641215 Baseline
0
0
0
0
0
1
Week 12
0
0
0
0
1
1
Recovery
0
0
0
0
0
1
620 CompMSf Sanitized. Does not co"Wn TSCA CSl!
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUA.LFUNCTK)NALOB SERVATKONALBATTERY A55SESSMENTS FO]RMALERATS
Group ffl : 50mg/kg/day
i Aanipulatioli
In[ Motor Activity
Animal Number Time Point
Approach and Touch
Auditory Stimulus
Tail Pinch
Pupillary Response
Defecation
Urination
641055 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
1
1
641056 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
1
1
641073 Baseline
0
0
0
0
0
1
Week 12
0
0
0
0
1
1
641081 Baseline
0
0
0
0
1
1
Week 12
0
-1
0
0
0
1
641144 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
0
1
641146 Baseline
0
0
0
0
0
1
Week 12
0
0
0
0
0
0
641178 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
0
1
641198 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
0
1
641218 Baseline
0
0
0
0
0
1
Week 12
0
-1
-1
0
0
1
641224 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
1
1
621
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAJLFUNCTK)NALOB SERVATK3NALBA.TTERY AS1SESSMENTS FO]RMALERATS
Group V: 250 mg/kg/d;iy
i tianipulatfoii
In. Motor Activi ty
Animal Number Time Point
Approach and Touch
Auditory Stimulus
Tail Pinch
Pupillary Response
Defecation
Urination
641061 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
1
1
641089 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
0
1
641102 Baseline
0
0
0
0
1
1
Week 12
0
-1
-1
0
1
1
641134 Baseline
1
0
0
0
0
1
Week 12
0
0
0
0
0
1
641137 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
0
1
641162 Baseline
0
0
0
0
0
1
Week 12
0
0
0
0
1
1
641190 Baseline
0
0
0
0
1
1
Week 12
0
0
-1
0
1
1
641197 Baseline
0
0
0
0
0
1
Week 12
0
0
0
0
1
1
641200 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
0
1
641202 Baseline
0
0
0
0
1
0
Week 12
0
0
0
0
0
1
622
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL FUNCTIONAL OBSERVATIONAL BATTERY ASSESSMENTS FOR MALE RATS
Group Vn: 1000
mg/kg/day___1^_la_ni_pu_la_ti_or_1 _____________In_M_<_at_or_A_c_tiv_ii_ty______
Animal Number Time Point
Approach and Touch
Auditory Stimulus
Tail Pinch
Pupillary Response
D efecation
Urination
641064 Baseline
0
0
0
0
1
1
Week 12
0
0
-1
0
1
1
Recovery
0
0
0
0
1
1
641092 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
0
1
Recovery
0
0
0
0
1
1
641143 Baseline
1
1
1
0
1
1
Week 12
0
0
0
0
1
1
Recovery
0
0
0
0
1
1
641153 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
0
1
Recovery
0
0
0
0
0
1
641167 Baseline
0
0
0
0
1
1
Week 12
0
0
-1
0
1
1
Recovery
0
0
0
0s
0
1
641185 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
1
1
Recovery
0
0
0
0
1
1
641189 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
0
0
Recovery
0
0
0
0
1
1
641203 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
0
1
Recovery
0
0
0
0
1
1
641213 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
1
1
Recovery
0
0
0
0
1
1
641216 Baseline
0
0
0
0
Week 12
0
0
0
0
Recovery
0
0
0
0
0
1
1
1
1
0
623
f*V>f
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL FUNCTIONAL OBSERVATIONAL BATTERY ASSESSMENTS FOR FEMALE RATS
Group II: Omg/kg/day
Animal Number Time Point
I ^[anipuladol1
Approach and Touch
Auditory Stimulus
Tail Pinch
In1Motor Activity
Pupillary Response
Defecation
Urination
641253 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
0
1
Recovery
0
0
0
0
0
1
641266 Baseline
0
0
0
0
0
1
Week 12
0
0
0
0
1
1
Recovery
0
0
0
0
0
1
641281 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
1
1
Recovery
0
0
0
0
0
1
641294 Baseline
0
0
0
0
0
1
Week 12
0
0
0
0
1
1
Recovery
0
0
0
0
1
1
641325 Baseline
0
0
0
0
0
1
Week 12
0
0
0
0
1
1
Recovery
0
0
0
0
1
1
641331 Baseline
0
0
-1
0
0
1
Week 12
0
0
0
0
1
1
Recovery
0
0
0
0
0
1
641359 Baseline
0
0
0
0
0
1
Week 12
0
0
0
0
1
1
Recovery
0
0
0
0
0
1
641364 Baseline
0
0
0
0
0
1
Week 12
0
0
0
0
1
1
Recovery
0
0
0
0
0
1
641383 Baseline
0
Week 12
0
Recovery
0
0
0
0
0
-1
0
0
0
0
1
1
1
1
1
1
641400 Baseline
0
0
0
0
0
1
Week 12
0
0
0
0
1
1
Recovery
0
0
0
0
1
1
624
Company Santfeed. Does not contain TSCA CB^
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAI.FUNCTK3NALOBSSERVATHONALBATTERY ASSSESSMENTS FOR FEMALE RATS
Group IVr: 50mg/kg/day
i klanipulatfoi1
Animal Number Time Point
Approach and Touch
Auditory Stimulus
Tail Pinch
Ini Motor Activity
Pupillary Response
Defecation
Urination
641260 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
1
1
641298 Baseline
1
1
1
0
0
1
Week 12
0
0
0
0
0
1
641311 Baseline
0
0
0
0
0
1
Week 12
0
0
0
0
0
1
641312 Baseline
0
0
0
0
0
1
Week 12
0
0
0
0
0
1
641313 Baseline
0
0
0
0
0
1
Week 12
0
0
0
0
0
1
641336 Baseline
0
0
0
0
0
1
Week 12
0
0
0
0
0
1
641355 Baseline
0
0
0
0
0
1
Week 12
1
1
0
0
0
1
641361 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
0
0
641369 Baseline
0
0
0
0
0
1
Week 12
0
0
-1
0
0
I
641396 Baseline
0
1
0
0
1
1
Week 12
0
0
0
0
0
1
625
G0mpalv santetl ^ not contain TSCA CK
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAI.FUNCTK3NALOB.SERVATKONALBATTERYASSSESSMENTS FOR FEMALE RATS
Group VIE: 250mg/kg/d[ay
I ^lanipulatiol1
Ini Motor Activity
Animal Number Time Point
Approach and Touch
Auditory Stimulus
Tail Pinch
Pupillary Response
Defecation
Urination
641244 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
0
1
641251 Baseline
0
0
0
0
0
1
Week 12
0
0
0
0
0
1
641269 Baseline
0
0
0
0
0
1
Week 12
0
0
-1
0
1
1
641292 Baseline
0
0
0
0
0
1
Week 12
0
0
0
0
0
0
641302 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
1
1
641362 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
0
1
641363 Baseline
0
0
0
0
0
1
Week 12
0
0
0
0
1
1
641375 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
1
1
641379 Baseline
0
0
-1
0
0
1
Week 12
0
0
0
0
0
1
641398 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
0
1
626
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL FUNCTIONAL OBSERVATIONAL BATTERY ASSESSMENTS FOR FEMALE RATS
Group VIOH: 1000 mg/k'day
I klanipulatfoi1
In1Motor Activity
Animal Number Time Point
Approach and Touch
Auditory Stimulus
Tail Pinch
Pupillary Response
Defecation
Urination
641234 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
0
1
Recovery
0
0
0
0
0
1
641256 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
0
1
Recovery
0
0
0
0
1
1
641282 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
0
1
Recovery
0
0
0
0
1
1
641352 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
1
1
Recovery
0
0
0
0
0
1
641356 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
0
0
Recovery a
-
-
-
-
641366 Baseline
0
0
0
0
0
1
Week 12
0
0
0
0
0
1
Recovery
0
0
0
0
0
1
641377 Baseline
0
0
0
0
0
1
Week 12
0
0
0
0
0
1
Recovery
0
0
0
0
0
1
641385 Baseline
0
1
0
0
Week 12
0
0
0
0
Recovery
0
0
0
0
1
0
1
1
1
1
641387 Baseline
0
0
0
0
1
1
Week 12
0
0
0
0
1
1
Recovery
0
0
0
0
0
1
641399 Baseline
0
0
0
0
0
1
Week 12
0
0
0
0
0
1
Recovery
0
0
0
0
1
1
627
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
APPENDIX H
-'III
INDIVIDUAL MOTOR ACTIVITY ASSESSMENT: DURATION OF MOVEMENT
628
Sotted. Doe. not contain TSCACBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL MOTOR ACTIVITY ASSESSMENT: DURATION OF MOVEMENT (sec) FOR MALE RATS
ANIMAL NUMBER
BASELINE SUCCESSIVE 10-MINUTE INTERVALS
TOTAL
GROUP I: Omg/kg/day
641083
332
274
264
76
6
641084
497
494
426
387
296
641085
395
304
241
127
0
641101
354
353
254
64
8
641105
458
456
303
162
4
641123
362
233
104
245
1
641154
372
277
196
195
95
641159
413
318
370
317
158
641165
345
340
165
31
0
641215
441
444
293
121
6
2
954
90
2190
0
1067
14
1047
13
1396
2
947
96
1231
12
1588
0
881
0
1305
GROUP III: 50mg/kg/day
641055
477
433
150
0
0
641056
381
348
83
2
0
641073
401
375
255
202
57
641081
388
330
267
76
5
641144
380
362
148
7
12
641146
404
350
303
182
0
641178
433
272
140
2
2
641198
419
276
44
27
249
641218
368
328
281
271
74
641224
430
245
27
2
33
2
1062
38
852
8
1298
0
1066
0
909
0
1239
0
849
24
1039
0
1322
0
737
GROUP V: 250mg/kg/day
641061
429
337
300
158
125
9
1358
641089
361
215
0
18
2
0
596
641102
403
310
292
85
94
0
1184
641134
359
246
129
257
188
19
1198
641137
410
336
409
336
287
306
2084
641162
388
337
20
5
3
54
807
641190
349
343
166
4Q
6
5
909
641197
335
236
214
92
22
2
901
641200
360
256
34
21
2
0
673
641202
335
251
93
1
11
9
700
629 Dae nnf e'-wfafn TSCA CBt
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL MOTOR ACTIVITY ASSESSMENT: DURATION OP MOVEMENT (sec) FOR MALE RATS
BASELINE
ANIMAL NUMBER
SUCCESSIVE 10-MINUTE INTERVALS
TOTAL
GROUP VII: 1000 mg/kg/day
641064
452
258
240
8
2
4
964
641092
392
289
269
29
7
7
993
641143
445
383
339
312
300
147
1926
641153
394
281
213
5
13
3
909
641167
387
365
199
6
I
2
960
641185
348
138
306
111
0
0
903
641189
368
271
121
40
16
0
816
641203
344
341
285
17
II
641213
399
273
126
54
0
0
998
0
852
641216
250
329
173
66
0
0
818
630
^PySrtteADoes.otco^TOCACB
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL MOTOR ACTIVITY ASSESSMENT: DURATION OF MOVEMENT (sec) FOR MALE RATS
ANIMAL NUMBER
1
WEEK 12
SIJCCESSIVE 10-MINUTE;INTERVA1^S
2
3
4
5
6
TOTAL
GROUP I: 0 mg/kg/day
641083
364
312
194
47
0
25
942
641084
455
337
347
111
1
139
1390
641085
428
192
187
179
199
150
1335
641101
369
311
264
254
18
142
1358
641105
473
438
402
288
282
200
2083
641123
331
384
251
258
224
130
1578
641154
368
320
294
228
193
168
1571
641159
442
383
315
290
213
2
1645
641165
407
339
214
184
44
4
1192
641215
514
424
409
357
350
242
2296
GROUP III: 50mg/kg/day
641055
367
256
150
176
128
197
1274
641056
477
402
301
185 . 223
194
1782
641073
394
418
314
220
7
163
1516
641081
402
424
369
406
236
11
1848
641144
417
329
312
74
21
87
1240
641146
405
247
209
111
11
14
997
641178
397
295
334
260
224
131
1641
641198
414
314
23
23
5
43
822
641218
353
334
348
300
325
46
1706
641224
460
409
290
329
151
5
1644
GROUP V: 250 mg/kg/day
641061
404
343
287
203
75
42
1354
641089
353
207
183
22
2
5
772
641102
465
384
273
6
3
5
1136
641134
341
166
250
255
39
10
1061
641137
443
363
318
159
225
183
1691
641162
305
190
206
4
19
160
884
641190
400
356
256
265,
255
241
1773
641197
404
289
92
6
10
114
915
641200
447
329
409
185
126
0
1496
641202
341
300
151
153
50
83
1078
631 fssi. D@e "*!* *;--,>,;.-> y>^*8
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL MOTOR ACTIVITY ASSESSMENT: DURATION OF MOVEMENT (sec) FOR MALE RATS
ANIMAL NUMBER
WEEK 12 SUCCESSIVE 10-MINUTE INTERVALS
TOTAL
GROUP VII: 1000 mg/kg/day
641064
491
309
89
220
4
10
1123
641092
488
329
44
9
14
4
888
641143
452
405
389
330
289
245
2110
641153
449
354
257
71
10
15
1156
641167
337
117
32
15
112
46
659
641185
349
291
152
363
370
264
1789
641189
386
179
I
12
0
3
581
641203
411
154
II
11
40
641213
455
311
328
131
2
14
641
2
1229
641216
353
264
212
186
219
21
1255
632
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL MOTOR ACTIVITY ASSESSMENT: DURATION OF MOVEMENT (sec) FOR MALE RATS
ANIMAL NUMBER
RECOVERY SUCCESSIVE 10-MINUTE INTERVALS
TOTAL
GROUP I: Omg/kg/day
641083
346
186
64
239
11
41
887
641084
360
258
223
121
41
0
1003
641085
407
219
229
125
20
118
1118
641101
297
263
152
99
146
74
1031
641105
332
289
182
196
60
8
1067
641123
383
304
213
89
51
7
1047
641154
492
323
307
105
413
359
1999
641159
489
389
378
312
283
151
2002
641165
493
386
243
148
252
76
1598
641215
328
216
162
74
9
142
931
ROUP VII: 1000 n
641064
401
222
123
139
31
144
1060
641092 .- 403
319
211
143
246
56
1378
641143
373
297
248
205
188
120
1431
641153
360
244
166
68
168
50
1056
641167
362
304
99
110
76
14
965
641185
236
104
123
113
50
63
689
641189
349
256
146
147
179
196
1273
641203
371
232
125
129
114
75
1046
641213
324
85
260
147
18
52
886
641216
329
262
105
106
72
116
990
633
Company ganISfeed. Dees not ewtafn JSCA cm
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL MOTOR ACTIVITY ASSESSMENT: DURATION OF MOVEMENT (sec) FOR FEMALE RATS
ANIMAL NUMBER
BASELINE SUCCESSIVE 10-MINUTE INTERVALS
TOTAL
GROUP II: Omg/kg/day
641253
438
271
237
122
2
197
1267
641266
385
355
199
144
166
81
1330
641281
369
292
310
132
135
0
1238
641294
344
294
40
3
109
3
793
641325
395
289
65
164
137
0
1050
641331
494
346
78
35
24
2
979
641359
310
239
137
255
174
167
1282
641364
282
192
128
4
12
2
620
641383
423
327
106
2
I
6
865
641400
350
235
158
45
II
5
804
ROUPIV: ;iOmg/1
641260
395
308
236
263
81
21
1304
641298
431
361
281
33
225
209
1540
641311
411
379
150
1
32
0
973
641312
561
519
499
485
471
403
2938
641313
306
300
219
198
208
97
1328
641336
353
262
282
229
225
40
1391
641355
353
280
260
240
215
131
1479
641361
437
375
387
137
0
0
1336
641369
255
162
145
81
0
2
645
641396
333
283
284
266
244
291
1701
ROUPVI:
2ISO ~Jv/
mlil^e
641244
343
22
74
0
3
0
442
641251
401
313
294
187
219
104
1518
641269
343
377
267
211
384
365
1947
641292
361
237
256
292
43
11
1200
641302
482
376
331
300
275
130
1894
641362
353
271
82
4
84
4
798
641363
341
71
2
0
6
,
0
420
641375
439
336
90
251
160
109
1385
641379
414
323
229
344
149
15
1474
641398
436
250
46
326
90
7
1155
634
Company Santfad. Does not eonteM TSCA CB^
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL MOTOR ACTIVITY ASSESSMENT: DURATION OF MOVEMENT (sec) FOR FEMALE RATS
BASELINE
ANIMAL NUMBER
GROUP Vin:
641234 641256 641282 641352 641356 641366 641377 641385 641387 641399
SUCCESSIVE 10-MINUTE INTERVALS
1 2 3 4 5 6 1000 mg/kg/day
372
244
258
203
371
204
341
217
185
120
192
169
308
202
163
79
0
0
308
208
137
15
2
1
357
197
6
90
132
104
393
326
210
46
17
2
468
259
2
3
9
10
383
272
230
255
201
34
408
353
365
185
19
0
396
289
284
53
2
1
TOTAL
1652 1224 752 671 886 994 751 1375 1330 1025
635 Company SaiiStfced. Does not contain TSCA CBt
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL MOTOR ACTIVITY ASSESSMENT: DURATION OP MOVEMENT (sec) FOR FEMALE RATS
ANIMAL NUMBER
WEEK 12 SUCCESSIVE 10-MINUTE INTERVALS
TOTAL
GROUP II: Omg/kg/day
641253
362
299
143
41
2
25
872
641266
467
414
207
8
1
145
1242
641281
414
304
153
168
179
25
1243
641294
352
370
326
223
136
7
1414
641325
391
271
132
212
235
213
1454
641331
414
353
230
82
124
93
1296
641359
358
183
183
132
154
164
1174
641364
343
276
205
29
16
136
1005
641383
449
374
327
280
144
8
1582
641400
367
280
164
207
327
169
1514
ROUPIV: 50 mg/1
641260
410
317
203
220
128
16
1294
641298
426
363
393
333
171
0
1686
641311
384
307
252
154
2
3
1102
641312
425
362
123
303
173
4
1390
641313
366
303
205
79
7
208
1168
641336
368
284
244
149
233
179
1457
641355
373
333
289
242
210
67
1514
641361
486
455
272
13
17
0
1243
641369
349
211
36
153
54
0
803
641396
326
289
238
195
53
152
1253
"KDU/~\UTT.Dr \Vf I: 250 mg
641244
308
199
79
1
13
0
600
641251
298
174
118
187
78
86
941
641269
381
334
246
253
263
147
1624
641292
321
317
217
51
5
13
924
641302
523
401
277
352
96
60
1709
641362
328
225
158
120
40
11
882
641363
369
238
72
55
242
34
1010
641375
423
304
234
227
144
17
1349
641379
473
237
53
360
207
25
1355
641398
373
315
126
150
55
40
1059
636
A Does not eonW.R TSCA CBJ
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL MOTOR ACTIVITY ASSESSMENT: DURATION OF MOVEMENT (sec) FOR FEMALE RATS
ANIMAL NUMBER
WEEK 12 SUCCESSIVE 10-MINUTE INTERVALS
TOTAL
GROUP VDI: 1000 mg/kg/day
641234
422
275
267
129
237
85
1415
641256
346
84
80
289
86
57
942
641282
279
201
119
37
60
2
698
641352
376
317
311
267
187
227
1685
641356
357
162
25
17
204
25
790
641366
405
383
174
15
5
197
1179
641377
400
264
107
20
11
2
804
641385
404
314
65
113
9
14
919
641387
415
304
8
177
172
18
1094
641399
374
352
173
55
174
228
1356
637
, Does not cortaSn TSCA CB8
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL Mm'OR ACTTVUY A5SSESSME1STT: DURymoN o:F MOVEMENT (sec)
FOR FEMALE RATS
ANIMAL NUMBER
1
RECO VERY
SlICCESSIVE 10-MINUTIiINTERVAlLS
2
3
4
5
6
TOTAL
GROUP n: 0 mg/kg/day
641253
328
141
182
86
27
144
908
641266
390
308
202
217
283
99
1499
641281
363
193
114
114
112
87
983
641294
389
194
129
269
98
229
1308
641325
387
177
145
249
83
77
1118
641331
373
294
129
87
50
122
1055
641359
359
218
107
202
113
118
1117
641364
271
164
49
138
48
22
692
641383
378
167
182
120
100
85
1032
641400
270
172
117
238
130
91
1018
GROUP VIII: 1000 mg/kg/day
641234
327
233
88
118
92
103
961
641256 . 236 129 98 65 101 66 695
641282
346
127
56
115
2
14
660
641352
364
641356
a
237
-
126
-
200
-
210
-
122
-
1259
-
641366
429
164
167
105
134
177
1176
641377
414
126
74
37
48
244
943
641385
328
178
192
144
38
1
881
641387
411
144
169
40
94
228
1086
641399
398
210
185
127
118
71
1109
638
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
APPENDIX I INDIVIDUAL MOTOR ACTIVITY ASSESSMENT; NUMBER OF MOVEMENTS
639
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL MOTOR ACTIVITY ASSESSMENT: NUMBER OF MOVEMENTS FOR MALE RATS
ANIMAL NUMBER
1
BASELINE
SIICCESSIVE 10-MINm'E INTERVA]^
2
3
4
5
6
TOTAL
GROUP I: 0 mg/kg/day
641083
133
125
155
36
6
641084
76
67
66
73
65
641085
122
116
125
95
0
641101
123
128
145
47
8
641105
114
126
129
92
4
641123
128
122
82
111
3
641154
118
123
127
129
76
641159
133
136
124
138
98
641165
147
125
116
38
4
641215
100
102
122
87
6
5
460
33
380
1
459
12
463
11
476
6
452
81
654
14
643
3
433
2
419
GROUP III: 50mg/kg/day
641055
80
87
75
0
0
1
243
641056
143
140
71
7
-
3
25
389
641073
125
116
132
96
36
8
513
641081
111
137
109
55
8
3
423
641144
130
131
100
10
25
1
397
641146
138
131
164
117
2
0
552
641178
109
142
90
5
2
3
351
641198
123
129
55
14
126
33
480
641218
144
148
136
165
86
2
681
641224
112
91
21
5
12
2
243
GROUP V: 250 mg/kg/day
641061
122
140
117
117
77
9
582
641089
141
127
0
12
3
1
284
641102
137
139
127
81
82
3
569
641134
125
138
97
135
94
26
615
641137
103
128
158
162
160
155
866
641162
127
132
15
3
7
34
318
641190
118
125
100
28,
5
13
389
641197
133
137
156
108
30
6
570
641200
135
129
31
17
2
2
316
641202
136
160
90
8
10
15
419
640
j^OIBponjBf aRlffisad. Does ''""9 c'''"?^ TSCA CBS
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL MOTOR ACTIVITY ASSESSMENT: NUMBER OF MOVEMENTS FOR MALE RATS
ANIMAL NUMBER
BASELINE SUCCESSIVE 10-MINUTE INTERVALS
TOTAL
GROUP VII: 1000 mg/kg/day
641064
114
107
81
17
5
6
330
641092
126
123
128
43
6
10
436
641143
119
142
136
132
173
132
834
641153
121
137
130
8
18
8
422
641167
144
139
125
11
3
2
424
641185
143
95
138
57
0
3
436
641189
155
136
93
27
20
0
431
641203
146
134
125
20
21
2
448
641213
137
160
117
52
0
0
466
641216
128
148
130
50
0
0
456
641
SSoispemsgaatod. Doss noS contain JSOA CB8
H-24616; Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL MOTOR ACTIVITY ASSESSMENT: NUMBER OF MOVEMENTS FOR MALE RATS
ANIMAL NUMBER
1
WEEK 12
SIICCESSIVE 10-MINimi INTERVALS
2
3
4
5
6
TOTAL
GROUP I: 0 nig/kg/day
641083
162
145
122
40
3
28
500
641084
121
135
138
62
4
90
550
641085
125
88
91
120
89
97
610
641101
139
150
136
148
17
59
649
641105
111
115
125
129
131
100
711
641123
121
123
118
113
128
95
698
641154
140
130
117
129
114
104
734
641159
143
151
140
126
115
2
677
641165
138
133
149
112
26
7
565
641215
96
109
110
121
154
97
687
GROUP III: 50mg/kg/day
641055
132
129
80
99
73
106
619
641056
113
134
134
120
99
114
714
641073
128
103
144
98
8
88
569
641081
120
105
113
122
109
8
577
641144
118
139
162
34
15
66
534
641146
122
139
100
94
10
20
485
641178
137
129
152
126
116
94
754
641198
130
140
13
17
7
31
338
641218
135
138
153
130
161
53
770
641224
109
138
136
99
58
5
545
GROUP V: 250 mg/kg/day
641061
139
147
149
142
81
54
712
641089
151
139
82
18
4
7
401
641102
121
152
144
6
7
13
443
641134
147
87
121
119
35
9
518
641137
129
148
144
87
116
108
732
641162
133
101
100
8
26
85
453
641190
106
130
111
124
161
90
722
641197
152
167
62
6
17
110
514
641200
108
134
150
118
97
0
607
641202
140
150
114
111
48
71
634
642 QissusisssySanitized. Da not eontain TSCA W
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL MOTOR ACTIVITY ASSESSMENT: NUMBER OF MOVEMENTS FOR MALE RATS
ANIMAL NUMBER
WEEK 12 SUCCESSIVE 10-MINUTE INTERVALS
TOTAL
GROUP Vn: lOOOmg/kg/day
641064
96
106
50
82
8
13
355
641092
117
116
12
12
14
10
281
641143
115
116
137
150
138
122
778
641153
122
127
136
44
9
12
450
641167
160
97
31
16
98
43
445
641185
125
132
61
144
142
125
729
641189
162
141
8
23
2
8
344
641203
151
65
15
10
33
17
291
641213
118
141
160
76
2
6
503
641216
136
138
98
114
136
20
642
643 Company SanRked. B@ not eantafn TSCA CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
iNDnmXJALI^[OTOR ftiCTIVITY ASSESS^IENT: N1JMBERO:F MOVEMENTS FO]RMALEDIATS
ANIMAL NUMBER
1
RECO VERY
SlrccEssrvE 10-MINUTEEINTERVAI^5
2
3
4
5
6
TOTAL
GROUP I: 0]mg/kg/day
641083
141
122
39
114
16
39
471
641084
130
142
147
57
33
2
511
641085
120
121
120
76
25
55
517
641101
111
132
89
75
78
65
550
641105
148
150
86
125
36
12
557
641123
144
138
121
59
28
9
499
641154
62
62
44
16
53
57
294
641159
119
135
130
155
145
90
774
641165
113
115
96
61
115
45
545
641215
129
147
121
59
12
119
587
GROUP VII: 1000 mg/kg/day
641064
133
86
47
78
24
79
447
641092
117
115
122
80
96
30
560
641143
125
124
113
116
114
94
686
641153
157
167
125
70
125
58
702
641167
127
149
52
80
49
20
477
641185
129
87
110
40
50
74
490
641189
144
149
132
89
89
148
751
641203
158
134
93
84
97
86
652
641213
127
67
126
94
16
49
479
641216
141
141
79
75
62
71
569
644 SanBked. Does noS ecmfain TSCA CB
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL MOTOR ACTIVITY ASSESSMENT: NUMBER OP MOVEMENTS FOR FEMALE RATS
ANIMAL NUMBER
1
BASELINE
SIrCCESSIVE 10-MINUTE INTERVAI
2
3
4
5
6
TOTAL
GROUP n: 0 mg/kg/day
641253
117
147
135
98
5
135
637
641266
153
148
138
100
99
75
713
641281
119
151
78
73
99
0
520
641294
141
154
30
4
89
4
422
641325
132
127
72
110
79
5
525
641331
99
132
75
28
25
5
364
641359
142
125
111
137
122
110
747
641364
141
127
105
13
18
4
408
641383
109
113
47
2
4
11
286
641400
144
137
121
56
21
6
485
GROUP IV: 50 mg/kg/day
641260
119
130
144
120
66
23
602
641298
115
134
124
37
114
117
641
641311
134
133
95
2
16
1
381
641312
56
65
61
56
51
64
353
641313
135
131
132
116
129
90
733
641336
115
131
126
108
123
38
641
641355
138
151
140
155
156
123
863
641361
117
111
109
83
0
3
423
641369
139
137
114
94
3
5
492
641396
130
116
138
148
137
148
817
GROUP VI: 250 mg/kg/day
641244
133
22
46
0
5
0
206
641251
130
132
123
140
124
102
751
641269
104
108
107
99
133
125
676
641292
148
137
126
140
44
12
607
641302
119
112
137
144
154
93
759
641362
163
178
89
9
74
11
524
641363
157
72
3
6
12
0
250
,
641375
120
119
60
101
125
82
607
641379
101
110
127
131
52
13
534
641398
113
99
31
120
53
10
426
645
mpanySanitized, Does no! eonfa?n TSCA CB(
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIV IDUAL3MOTOR ALCTIVITY ASSESS^IENT: N1JMBERC)F MOVEMENTS FOR FEMALE RATS
ANIMAL NUMBER
1
BASELINE
SlICCESSIVE 10-MINUTEEINTERVAl^s
2
3
4
5
6
.
TOTAL
GROUP vm: 1000 ing/kg/day
641234
115
135
144
136
138
162
830
641256
134
128
120
95
156
141
774
641282
166
138
94
73
2
4
477
641352
141
126
103
24
5
3
402
641356
148
105
5
49
75
91
473
641366
137
144
113
38
19
5
456
641377
117
122
5
2
10
7
263
641385
129
115
132
139
159
59
733
641387
126
135
142
147
20
3
573
641399
105
144
146
54
6
2
457
646
,
not eontain TSCA CB)
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL MOTOR ACTIVITY ASSESSMENT: NUMBER OF MOVEMENTS FOR FEMALE RATS
ANIMAL NUMBER
1
WEEK 12
sue;CESSIVE 10-MINUTE; INTERVALSi
2
3
4
5
6
TOTAL
GROUP n: 0 mg/kg/day
641253
144
113
125
46
6
24
458
641266
107
137
115
15
9
75
458
641281
150
142
83
106
105
35
621
641294
134
154
141
184
129
9
751
641325
152
129
88
139
128
146
782
641331
131
139
120
82
97
79
648
641359
142
147
164
129
122
118
822
641364
127
166
133
38
23
95
582
641383
120
132
128
120
114
5
619
641400
135
139
92
98
161
127
752
GROUP IV: 50 mg/kg/day
641260
111
133
136
130
109
12
631
641298
140
138
124
128
75
1
606
641311
158
140
135
121
6
3
563
641312
114
153
93
139
103
9
611
641313
127
157
142
57
12
146
641
641336
133
112
116
99
159
118
737
641355
144
127
145
154
130
56
756
641361
115
115
133
14
13
2
392
641369
151
159
35
123
70
4
542
641396
138
136
131
112
49
131
697
GROUP VI: 250 mg/kg/day
641244
130
102
53
4
17
0
306
641251
133
127
84
114
94
83
635
641269
129
120
110
93
107
81
640
641292
147
138
145
62
8
10
510
641302
104
128
122
149
64
43
610
641362
167
154
167
129
42
13
672
641363
157
124
70
52
155
39
597
,
641375
126
136
123
135
108
23
651
641379
116
118
41
133
123
32
563
641398
131
144
90
132
68
40
605
647
Sompasy Sanitfced. Does no! contain TSCA CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL MOTOR ACTIVITY ASSESSMENT: NUMBER OF MOVEMENTS FOR FEMALE RATS
ANIMAL NUMBER
WEEK 12 SUCCESSIVE 10-MINUTE INTERVALS
TOTAL
GROUP Vm: 1000 mg/kg/day
641234
127
132
128
102
154
74
717
641256
152
81
63
135
66
45
542
641282
152
145
88
27
54
3
469
641352
131
163
148
151
137
122
852
641356
152
136
29
28
132
31
508
641366
147
152
123
15
7
95
539
641377
142
111
86
18
21
6
384
641385
149
131
70
104
19
25
498
641387
130
107
12
85
86
27
447
641399
123
159
135
62
112
143
734
648
^eeapaeySsaVSxsSB. o noSsontaIn VSW cw
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
IND rvrouALMOTOR AiCTTvTTY ASSESS]^IENT: N1JMBERC)F MOVEMENTS
FOR FEMALE RATS
ANIMAL NUMBER
1
RECO VERY
SlrCCESSIVE 10-MINUTEiINTERVAl.S
2
3
4
5
6
TOTAL
GROUP II: 0 mg/kg/day
641253
166
126
97
61
28
121
599
641266
137
126
134
134
133
77
741
641281
158
116
95
97
120
102
688
641294
131
131
106
141
92
130
731
641325
138
148
96
158
63
84
687
641331
136
122
90
78
62
82
570
641359
130
129
83
132
113
67
654
641364
141
124
51
100
62
24
502
641383
128
104
95
94
77
63
561
641400
168
132
86
121
92
88
687
GROUP VIII: 1000 mg/kg/day
641234
146
137
63
91
85
78
600
641256
154
106
80
75
83
85
583
641282
134
108
44
69
2
18
375
641352
165
147
99
123
147
94
775
641356
a
-
-
-
-
-
-
641366
126
105
89
67
90
101
578
641377
127
96
68
44
43
156
534
641385
161
116
120
124
53
3
577
641387
140
118
119
37
81
124
619
641399
144
153
133
106
107
78
721
649
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
APPENDIX J INDIVIDUAL ANIMAL CLINICAL PATHOLOGY DATA
650 'Gasspany Sanitjzed, Boas not contain TSCA CBl
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL CLINICAL PATHOLOGY DATA
EXPLANATORY NOTES
ABBREVIATIONS:
General:
ADEQ CLOT DECK
NSR NT
NT-HEMOL OK
QNS RNV
>
<
adequate
sample clotted
decreased
no sample received for testing
not taken or not performed
not taken due to hemolysis greater than or equal to moderate sample condition OK for testing quantity not sufficient result not valid greater than less than
Individual
COMD RBC HGB HCT MCV MCH
MCHC RDW
ARET
WBC
AMEU ANPR ALYM AMON AEOS ABAS ALUC ABLT AMSC
PLT SPEC
Hematology Values:
- sample condition
- red blood cell count
- hemoglobin
- hematocrit
- mean corpuscular volume - mean corpuscular hemoglobin - mean corpuscular hemoglobin concentration
- red cell distribution width - absolute reticulocyte count - white blood cell count - absolute neutrophil (all forms)
- absolute neutrophil precursor - absolute lymphocyte
- absolute monocyte - absolute eosinophil - absolute basophil
- absolute large unstained cell - absolute blast leukocyte
- absolute miscellaneous leukocyte
- platelet count
- special observations
Individual Red Blood Cell Morphology Values:
NORM - normal
AHIS - anisocytosis
MIC - microcytes
MAC - macrocytes
POLY - polychromasia
HYPO - hypochromasia
ECHI - echinocytes
ACAN - acanfchocyfces
TARG RX -
HJB SPEC -
-
target cells
rouleaux Howell-Jolly body special observations
not observed or not examined;
see whole
blood
sample
condition
651
^n^ ewfain TSCA CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL CLINICAL PATHOLOGY DATA
EXPLANATORY NOTES
ABBREVIATIONS:
Individual
NORM SM DB PC GP BP
TOX VC
SPEC
--
White Blood Cell / Platelet Morphology Values:
- normal
- smudge white blood cells
- Dohle bodies
- platelet clumps (graded as 1 if present at any level)
- giant platelets - bizarre platelets - toxic neutrophils
- vacuolated cytoplasm - special observations - not observed or not examined; see whole blood sample
condition
Individual
PHEM
FLIP PICT
PT
APTT
Coagulation Values: - plasma hemolysis
- plasma lipemia - plasma icterus - prothrombin time - activated partial
thromboplastin
time
Individual
SHEM
SLIP SICT
AST ALT SDH ALKP
BILI
BUN CREA
CHOL TRIG GLUC
TP ALB GLOB CALC IPHS
NA
K
CL PHEM
FLIP PICT
PFLU
Serum and Plasma Chemistry Values: - serum hemolysis
- serum lipemia
- serum icterus - aspartate aminotransferase - alanine aminotransferase - sorbitol dehydrogenase - alkaline phosphatase
- total bilirubin
- urea nitrogen - creatinine - cholesterol - triglycerides - glucose - total protein - albumin
- globulin - calcium
- inorganic phosphorous
- sodium
- potassium - chloride
- plasma hemolysis from blood sample for fluoride determination - plasma lipemia from blood sample for fluoride determination - plasma icterus from blood sample for fluoride determination - plasma fluoride
652
, Doe not eonfa'n TSCA Crt
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL CLINICAL PATHOLOGY DATA
EXPLANATORY NOTES
ABBREVIATIONS:
Individual Urinalysis Values:
QUAL COL -
quality (modifies color) color
CLAR VOL -
clarity
volume
XTOSM - urine osmolalifcy
SG -
pH -
specific gravity the logarithm of the reciprocal of the hydrogen ion concentration
UGLU - urine glucose
KET - ketone
UBIL -
BLD -
urine bilirubin
blood
URO - urobilinogen
UFLU - urine fluoride
UMTP - urine protein
SPEC - special observations
Individual
EPIT
UWBC
URBC
NCRY MICR SPER SPEC
Urine Microscopic Examination
- epithelial cells - urine white blood cells - urine red blood cells - normal crystals
- microorganisms
- sperm
- special observations
Values:
KEY:
Red Blood Cell Morphology Values, White Blood Cell / Platelet Morphology Values
the exception of Platelet Clumps), and Special Observations:
1
-
trace
2
few
3
-
moderate
4
-
many
(with
Urine Microscopic Values:
EPIT/CASTS
HCRY/MICR
few moderate
many
I-10
II-50
>50
few moderate
many
l-25%/field 26-50%/field
>50%/field
SPERM/MPCUS
1
-
2
-
.3 -
1-5 6-20 >20
653
S. De """<8fl,s^ ww ^R8?
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL CLINICAL PATHOLOGY DATA
EXPLANATORY NOTES
NOTES:
When individual animal data are not reported, it may be due to one of the following
reasons or other reasons, all of which are explained in the study records:
the sample was clotted (for hematology or coagulation data) (CLOT) there was insufficient sample for analysis (QNS) a valid result could not be obtained (RNV) the sample was not suitable for evaluation the animal died prior to sample collection no sample was available for analysis (NSR)
When an individual observation was recorded as being less than a certain value,
calculations were performed on half the recorded value. For example, if bilirubin was
reported as <0.1, 0.05 was used for any calculations performed with that bilirubin
data.
654 9. Ol9P< minf gy(^,, TOpwjn <wA
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL HEMATOLOGY VALUES FOR MALE RATS
Animal Number
COND
RBC
xl0''6/HL
HGB
g/dL
Male, Group:
641069 641070 641094 641147 641149 641155 641172 641206 641214 641222
1-0 rog/kg -
CLOT OK OK OK OK OK OK OK OK OK
Day 44
NT
8.39 8.43 8.09 7.69 7.86 8.16 8.50 8.28 8.21
Male, Group: III - 50 mg/kg - Day 44
641055 641056 641073 641081 641144 641146 641178 641198 641218 641224
OK
8.07
OK
7.71
OK
8.00
OK
8.21
OK
7.79
OK
8.43
OK
8.10
OK
8.58
OK
7.55
OK
8.28
NT
15.6 14.7 15.3 14.8 14.5 14.9 15.9 14.5 15.1
15.6 14.6 14.9 14.9 15.5 15.1 14.5 14.6 14.6 14.6
HCT
%
NT
50.8 48.9 48.4 47.6 47.3 48.3 51.9 48.2 48.9
49.9 46.5 47.5 48.7 47.3 50.3 47.6 48.8 45.1 48.7
MCV
fL
NT
60.5 58.0 59.8 61.8 60.2 59.2 61.0 58.2 59.5
61.8 60.3 59.4 59.3 60.8 59.6 58,7 56.9 59.8 58.9
MCH PS
NT
18.6 17.4 18.9 19.3 18.4 18.3 18.7 17.5 18.4
19.4 18.9 18.7 18.1 19.9 18.0 18.0 17.0 19.3 17.6
MCHC
g/dL
NT.
30.7 30.0 31.5 31.2 30.6 30.9 30.6 30.1 30.9
31.3 31.4 31.4 30.6 32.8 30.1 30.6 29.9 32.4 30.0
RDW
ARET
% x!0"3/AlL xl
MT
11.2 11.9 11.2 11.3 11.5 10.6 11.4 11.9 12.5
11.2 12.1 11.3 11.6 10.8 11.6 10.9 11.9 12.4 11.1
NT 216. 261. 202. 182. 192. 199. 278. 241. 237.
198. 244. 195. 231. 203. 209. 176. 212. 268. 225.
655
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL HEMATOLOGY VALUES FOR MALE RATS
Animal Number
COND
RBC
xlO^/^L
HGB
g/dL
Male, Group: V - 250 mg/kg - Day 44
641061 641089 641102 641134 641137 641162 641190 641197 641200 641202
OK
7.93
15.1
OK
7.46
14.1
OK
7.64
14.5
OK
7.75
14.1
OK
7.89
14.1
OK
7.32
14.0
OK
8.37
14.8
OK
8.28
15.3
OK
7.94
14.9
OK
7.75
15.6
Male, Group: VII - 1000 mg/kg - Day 44
641067 641077 641086 641095 641097 641132 641157 641166 641201 641223
OK
7.87
14.4
OK
7.71
14.3
OK
8.05
15.0
OK
8.17
14.5
OK
7.28
14.2
OK
7.52
13.5
OK
7.91
14.7
OK
8.27
14.9
OK
8.10
14.3
. OK 7.71 13.9
HCT %
49.9 45.1 45.6 45.8 45.4 44.2 48.9 51.4 47.5 50.0
46.5 45.5 47.4 47.7 45.8 45.5 47.3 47.5 47.3 44.5
MCV
fL
62.9 60.4 59.7 59.1 57.5 60.4 58.4 62.1 59.9 64.4
59.1 59.0 58.9 58.4 62.8 60.6 59.8 57.4 58.4 57.7
MCH pg
19.0 18.9 19.0 18.2 17.8 19.2 17.7 18.5 18.7 20.1
18.3 18.6 18.6 17.8 19.5 17.9 18.6 18.0 17.6 18.0
MCHC
g/dL
30.2 31.3 31.8 30.8 31.0 31.8 30.3 29.8 31.3 31.2
30.9 31.5 31.6 30.5 31.0 29.6 31.2 31.3 30.2 31.2
RDW
ARET
% xl0^3/(iL xl
11.6 11.1 11.3 11.3 11.6 12.3 11.1 12.1 11.2 10.9
11.8 12.2 10.9 13.0 11.6 13.5 11.2 11.7 12.5 12.5
254. 180. 214. 176. 189. 250. 163. 201. 205. 250.
267. 228. 180. 237. 179. 333. 187. 191. 196. 187.
656
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL HEMATOLOGY VALUES FOR MALE RATS
Animal Number
ANPR
; <10"3/^L
A LYM
xlO^S /^L
K.MON
xl0 "3 /ML
A EOS
3tlO^ /111.
A BAS
>cl0"3 /HL
ALUC > :10"3/HL
ABLT x:LO~3/HL
AMSC
x]-0^3/ML
PLT > slO^/AlL
Male, Group: 1-0 mg/'kg - D ay 44
641069
NT
NT
NT
NT
NT
NT
NT
NT
NT
641070
NT
14 .59
0 .29
0 .12
0 .13
0.23
NT
NT
1133
641094
NT
10.42
0.21
0 .08
0 .14
0.25
NT
NT
RNV
641147
NT
8 .97
0 .21
0 .04
0 .05
0.15
NT
NT
RNV
641149
NT
14 .25
0 .25
0 .16
0 .14
0.16
NT
NT
1177
641155
NT
10 .97
0.25
0 .09
0 .09
0.12
NT
NT
1063
641172
NT
10 .43
0 .14
0 .33
. 0 .08
0.23
NT
NT
KNV
641206
NT
8 .59
0 .25
0 .18
0 .13
0.49
NT
NT
1271
641214
NT
8.72
0 .44
0 .53
0 .09
0.09
NT
NT
KNV
641222
NT
16 .97
0 .34
0 .12
0 .20
0.45
NT
NT
1147
Male, Group: III - 50 ing/kg - Day 44
641055
NT-
13 .62
0 .30
0 .11
0 .14
0.11
NT
NT
1080
641056
NT
14 .91
0 .45
0 .17
0 .09
0.16
NT
NT
RNV
641073
NT
17 .19
0 .29
0 .11
0 .11
0.26
NT
NT
RNV
641081
NT
14 .76
0 .31
0 .12
0 .12
0.21
NT
NT
1331
641144
NT
16 .33
0 .52
0 .17
0 .21
0.33
NT
NT
RNV
641146
NT
18 .20
0 .35
0 .21
0 .14
0.30
NT
NT
1244
641178
NT
9 .81
0 .34
0 .15
0 .06
0.20
NT
NT
1133
641198
NT
12 .05
0 .42
0 .15
0 .06
0.20
NT
NT
1095
641218
NT
10 .59
0 .25
0 .07
0 .07
0.30
NT
NT
1232
641224
NT
12 .01
0 .57
0 .22
0 .04
0.30
NT
NT
RNV
657
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL HEMATOLOGY VALUES FOR MALE RATS
Animal Number
ANPR
3<10"3/^L
AL YM
atl0"3/ IlL
A MOM
xl0/3 /IlL
A EOS
; cl0"3 /III.
A BAS
>clO'3 /HL
AL UC
; cl0^3/ AlL
ABLT
x:LO^/fiL
AMSC
x3.0"3/iUL
PLT > :10"3/(xL
Male, Group: V - 250 mg/'kg - Da}/ 44
641061 641089 641102 641134 641137 641162 641190 641197 641200 641202
NT
15. 67
NT
13. 19
NT
14. 27
NT
12. 89
NT
8. 91
NT
13. 81
NT
15. 59
MT
14. 57
NT
12. 23
MT
17. 24
0 .35 0 .31
0 .34 0 .23
0.26 0 .37 0 .50 0 .35 0 .28 0 .25
0 .12 0 .09 0 .10 0 .08
0 .08 0 .05
0 .16 0 .07 0 .08 0 .16
0 .15
0 .13 0 .09
0 .14 0 .08 0 .11 0 .11 0 .18 0 .07 0 .15
0. 33 0. 22 0. 11 0. 15 0. 14 0. 21 0. 23 0. 22 0. 19 0. 18
NT
NT
1173
NT-
NT
RMV
NT
MT
RMV
MT
NT
1082
MT
NT
1214
NT
MT
1025
MT
NT
900
NT
NT
894
NT
MT
822
MT
NT
904
Male, Group: VII - 1000 ing/kg - Day 44
641067
NT.
19. 85
0 .53
0 .12
0 .29
0. 35
MT
NT
1051
641077
NT
19. 17
0 .33
0 .12
0 .16
0. 95
NT
MT
1150
641086
MT
20. 18
0 .76
0 .15
0 .23
0. 60
NT
NT
898
641095
NT
16. 97
0 .25
0 .10
0 .14
0. 23
NT
MT
1220
641097
MT
12. 57
0 .33
0 .08
0 .10
0. 14
MT
NT
1094
641132
NT
14. 75
0 .26
0 .09
0 .16
0. 22
NT
MT
1234
641157
NT
4. 79
0 .16
0 .50
0 .04
0. 05
MT
NT
RNV
641166
NT
12. 19
0 .37
0.07
0 .08
0. 19
NT
NT
980
641201
NT
17. 79
0 .27
0 .13
0 .15
0. 16
NT
NT
995
641223
NT
18. 52
0 .29
0 .09
0 .12
0. 20
MT
NT
987
658
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL HEMATOLOGY VALUES FOR MALE RATS
Animal Number
COND
RBC
X10"6/^L
HGB
g/dL
Male, Group:
641069 641070 641094 641147 641149 641155 641172 641206 641214 641222
1-0 nig/kg -
OK OK OK OK OK OK OK OK OK OK
Day 91
8.56 8.75 8.99 8.60 8.63 8.36 8.79 9.02 9.05 8.63
Male, Group: III - 50 nig/kg - Day 91
641055 641056 641073 641081 641144 641146 641178 641198 641218 641224
OK-
8.96
OK
8.25
OK
8.93
OK
10.05
OK
8.67
OK
8.82
OK
9.33
OK
8.76
OK
7.96
OK
8.66
15.1 16.1 15.7 16.4 16.2 15.2 15.7 16.5 15.4 15.4
16.8 14.8 16.0 17.5 15.9 15.7 16.3 14.7 15.2 15.2
HCT %
48.0 50.0 49.6 49.8 50.4 47.5 49.7 52.1 49.3 48.9
52.1 47.1 49.9 55.5 50.1 48.3 51.9 47.3 45.0 47.8
MCV
fL
56.1 57.1 55.1 57.9 58.4 56.8 56.6 57.8 54.5 56.7
58.2 57.1 55.9 55.2 57.8 54.7 55.6 54.0 56.5 55.3
MCH
pg
17.7 18.4 17.5 19.1 18.7 18.2 17.8 18.3 17.0 17.9
18.7 17.9 18.0 17.4 18.3 17.7 17.4 16.7 19.1 17.6
MCHC
g/dL
31.5 32.2' 31.7 32.9 32.0 32.0 31.5 31.7 31.2 31.5
32.1 31.4 32.1 31.6 31.7 32.4 31.3 31.0 33.7 31.8
RDW
ARET
% xlO^/fiL xl
12.6 12.0 13.1 11.7 12.3 12.3 11.1 11.9 13.2 12.9
12.1 12.5 12.2 12.3 11.9 12.3 11.9 13.9 12.2 11.9
204. 147. 235. 153. 148. 178. 185. 233. 235. 205.
177. 223. 211. 215. 182. 163. 180. 243. 216. 237.
659
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL HEMATOLOGY VALUES FOR MALE RATS
Animal Number
COND
RBC x.l0"6/p.li
HGB
g/dL
Malei Group: V - 250 nig/kg - Day 91
641061 641089 641102 641134 641137 641162 641190 641197 641200 641202
OK
9.12
16.7
OK
8.16
14.8
OK
8.21
15.2
OK
8.73
15.9
OK
9.08
15.8
OK
8.36
15.2
OK
8.92
15.6
OK
9.01
16.1
OK
9.05
15.9
OK
8.66
16.7
Male, Group: VII - 1000 mg/kg - Day 91
641067 641077 641086 641095 641097 641132 641157 641166 641201 641223
OK
8.46
15.2
OK
8.05
14.1
OK
9.06
15.8
OK
8.28
14.6
OK
7.80
15.0
OK
8.30
14.8
OK
8.66
16.2
OK
9.14
15.7
OK
8.91
15.4
OK
8.33
15.0
HCT %
54.4 46.0 46.8 49.4 49.9 48.2 48.8 50.1 50.6 52.4
47.0 44.8 50.2 45.6 45.6 47.4 50.8 50.0 49.0 47.2
MCV L
59.7 56.4 57.1 56.6 55.0 57.7 54.7 55.6 55.9 60.5
55.6 55.7 55.5 55.1 58.5 57.1 58.6 54.7 54.9 56.6
MCH
P3
18.3 18.2 18.6 18.2 17.5 18.2 17.4 17.9 17.6 19.3
18.0 17.6 17.4 17.7 19.2 17.8 18.7 17.1 17.3 18.0
MCHC
g/dL
30.7. 32.2 32.5 32.2 31.8 31.6 31.9 32.1 31.4 31.9
32.4 31.5 31.4 32.1 32.8 31.2 31.9 31.3 31.5 31.7
RDW
ARET
% X.10"3 / IJ.L xl
12.7 12.3 12.0 11.3 12.2 12.3 12.5 12.3 12.1 11.3
11.7 13.9 11.6 13.0 13.2 12.7 11.5 12.6 12.3 13.5
228. 151. 125. 143. 152. 160. 110. 149. 179. 189.
76. 197. 113. 158. 168. 196. 132. 150. 102. 176.
660
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL HEMATOLOGY VALUES FOR MALE RATS
Animal Number
ANPR
xlO^/fA
ALYM
xlO^a/AtL
AMON
xl0''3/UiL
AEOS
xlO"3/^L
ABAS
xlO"3/^L
ALUC
xlO^/jltL
ABLT
xlO"3/^L
AMSC
xlO"3/tL
PLT
xlO"3/tlL
Male, Group: 1-0 ing/kg - Day 91
641069
NT
"
-
11.54
0.43
0.27
0.07
0.10
NT.
NT
1259
641070
NT
9.05
0.29
0.10
0.05
0.09
NT
NT
1133
641094
NT
7.00
0.29
0.14
0.11
0.11
NT
NT
1110
641147
NT
8.04
0.25
0.06
0.05
0.09
NT
NT
1083
641149
NT
9.57
0.35
0.09
0.04
0.05
NT
NT
1177
641155 NT . 7.36 0.25 0.17 0.03 0.06 NT NT RNV
641172
NT
11.39
0.25
0.15
0.13
0.22
NT
NT
RNV
641206
NT
7.25
0.19
0.17
0.08
0.08
NT
NT
1188
641214
NT
8.08
0.42
0.11
0.10
0.13
NT
NT
879
641222
NT
12.53
0.36
0.14
0.10
0.14
NT
NT
1221
Male, Group: III - 50 nig/kg - Day 91
641055
NT
8.96
0.21
0.17
0.13
0.15
NT
NT
1018
641056
NT
10.67
0.41
0.21
0.06
0.08
NT
NT
1022
641073
NT
12.18
0.29
0.17
0.13
0.17
NT
NT
1063
641081
NT
8.17
0.43
0.08
0.06
0.12
NT
NT
RNV
641144
NT
8.80
0.51
0.23
0.07
0.15
NT
NT
RNV
641146
NT
12.79
0.22
0.17
0.10
0.10
NT
NT
1032
641178
NT
11.05
0.41
0.13
0.11
0.14
NT
NT
1162
641198
NT
10.18
0.34
0.19
0.06
0.08
NT
NT
1006
641218
NT
9.83
0.40
0.15
0.05
0.14
NT
NT
RMV
641224 . NT 10.96 0.52 0.23 0.15 0.09 NT NT 1087
661
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL HEMATOLOGY VALUES FOR MALE RATS
Animal Number
1IMPR
xlO":1/1L
AL YM 3i:10"3/ HL
AMON
xl0"3/ liL
AEOS
xl.0"3/ML
AB AS
5clO^/ 111,
ALUC
?cl0"3/ P.L
ABLT x:1.0^3/^tL
AMSC
X]10^3/ftL
PLT > !:10"3/^L
Male, Group: V - 250 mg/'kg - Das,' 91
641061 641089 641102 641134 641137 641162 641190 641197 641200 641202
NT
9. 85
NT
11. 78
NT
7. 84
MT
9. 43
NT
8. 87
NT
12. 43
NT
15. 38
NT
7. 57
NT
10. 67
NT
12. 51
0. 21 0. 30 0. 30 0. 37 0. 28 0. 27 0. 39 0. 22 0. 37 0. 29
Male, Group: VII - 1000 ing/kg - Day 91
641067 641077 641086 641095 641097 641132 641157 641166 641201 641223
NT-
14. 44
NT
12. 86
NT
14. 35
NT
11. 17
NT
7. 44
NT
11. 58
NT
6. 69
NT
7. 53
NT
12. 14
NT
14. 10
0. 41 0. 26 0. 29 0. 45 0. 23 0. 31 0. 21
0.26 0. 31 0. 42
0.38 0.13 0.16 0.10 0.12 0.07 0.15 0.12 0.08 0.20
0.15 0.16 0.16 0.10 0.10 0.09 0.06 0.06 0.16 0.14
0. 03 0. 10 0. 03 0. 04 0. 11 0. 08 0. 09 0. 04 0. 13 0. 14
0. 16 0. 09 0. 16 0. 03 0. 11 0. 17 0. 05 0. 12 0. 15 0. 07
0. 08 0. 13 0. 09 0. 04 0. 10 0. 11 0. 14 0. 04 0. 15 0. 11
0. 23 0. 10 0. 18 0. 11 0. 11 0. 19 0. 05 0. 15 0. 12 0. 26
NT
NT
RNV
NT-
NT
1290
NT
NT
845
NT
NT
1052
NT
NT
1217
NT
NT
990
NT
NT
850
NT
NT
946
MT
NT
717
NT
NT
840
NT
NT
830
NT
NT
1137
NT
NT
815
NT
NT
RMV
NT
NT
RMV
NT
NT
1048
NT
MT
909
NT
NT
902
NT
NT
792
NT
NT
997
662
H-24616; Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL HEMATOLOGY VALUES FOR MALE RATS
Animal Number
COND
RBC
xl0''6/p.L
HGB
g/dL
Male, Group:
641083 641084 641085 641101 641105 641123 641154 641159 641165 641215
1-0 nig/kg -
OK OK OK OK OK OK OK OK OK OK
Day 123
8.67 8.96 8.24 8.67 8.47 8.80 8.93 9.07 8.42 8.29
15.5 15.4 14.9 14.5 14.7 14.6 14.6 16.2
14.7 14.7
Male, Group: VII - 1000 mg/kg - Day 123
641064 641092 641143 641153 641167 641185 641189 641203
641213 641216
OK-
8.83
OK
8.10
OK
8.72
OK
8.83
OK
8.69
OK
8.57
OK
7.92
OK
7.97
OK
8.44
OK
8.67
15.9 14.1 14.8 14.4 15.2
15.4 13.3 14.2 14.4 14.5
HCT %
48.3 47.4 45.4 45.5 45.2 45.4 45.8 48.8 46.3 45.2
50.2 44.0 46.4 43.9 46.5 47.6 41.7 44.8 44.7 45.0
MCV
fL
55.7 52.9 55.1 52.5 53.4 51.5 51.3 53.8 55.0 54.5
56.9 54.4 53.1 49.7 53.5 55.5 52.6 56.1 53.0 51.9
MCH
pg
17.8 17.2 18.1 16.7 17.3 16.6 16.4 17.8 17.5 17.7
18.1 17.4 17.0 16.4 17.4 17.9 16.8 17.8 17.1 16.8
MCHC
g/dL
32.0 32.532.8 31.8 32.5 32.3 31.9 33.2 31.8 32.5
31.7 32.0 32.0 32.9 32.6 32.3 31.9 31.7 32.3 32.3
RDW
ARET
% xl0^3/f2L xlO
12.9 13.5 12.7 13.6 13.6 14.1 13.6 13.4 13.1 13.8
13.1 14.7 14.7 14.1 13.4 13.1 13.5 13.2 12.5 14.8
228. 179. 154. 194. 175. 182. 171. 201. 166. 184.
186. 196. 158. 158. 176. 203. 154. 151. 170. 222.
663
H-24616: Subchronic Toxicity 90-Day Qavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL HEMATOLOGY VALUES FOR MALE RATS
Animal Number
ANPR
xlO''3/nL
ALYM
xlO"3/tiL
AMON
xlO"3/p.L
AEOS
x!0"3/^L
ABAS
xlO"3/A(L
ALUC
xlO^/^L
ABLT
xlO"3/ftL
AMSC
xlO^/^L
PLT
xl0^3/^L
Male, Group:
0 nig/kg - Day 123
641083
NT
7 .23
0 .32
0. 17
0.07
0. 17
NT
NT
851
641084
NT
12 .99
0 .08
0. 39
0.10
0. 57
NT
NT
1158 Sam
SIG
DIF
SPE
641085
NT
11 .97
0 .38
0. 19
0.06
0. 37
MT
NT
933
641101
NT
8 .96
0 .29
0. 10
0.14
0. 15
NT
NT
1031
641105
NT
10 .76
0 .38
0.12
0.06
0. 21
NT
NT
1206
641123
NT
10 .38
0 .22
0. 13
0.21
0. 18
NT
NT
1115
641154
NT
9 .79
0 .35
0. 07
0.17
0. 18
NT
NT
RNV
641159
NT
14 .98
0 .47
0. 09
0.17
0. 11
NT
NT
RNV
641165
NT
13 .56
0 .29
0. 17
0.22
0. 31
NT
NT
RNV
641215
NT
10 .99
0 .39
0. 11
0.21
0. 09
NT
NT
1123
Male, Group: VII 1000 mg/kg - Day 123
641064
NT
9 .43
0 .27
0.24
0.11
0. 15
NT
NT
RNV
641092
NT
11 .59
0 .36
0. 11
0.17
0. 12
NT
NT
1083
641143
NT
10 .25
0. .33
0. 12
0.42
0. 15
NT
NT
989
641153
NT
9 .81
0 .34
0. 08
0.31
0. 16
NT
NT
837
641167
NT
12 .21
0 .37
0. 12
0.29
0. 17
NT
NT
1027
641185
NT
13 .28
0 .30
0. 33
0.09
0. 11
NT
NT
1062
641189
NT
11 .67
0 .31
0. 13
0.17
0. 23
NT
NT
905
641203
NT
7 .43
0 .40
0. 07
0.26
0. 11
NT
NT
911
641213
NT
10 .31
0 .28
0. 11
0.06
0. 12
NT
NT
664
641216
NT
7 .45
0 .34
0. 14
0.12
0. 36
NT
NT
860
664
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL HEMATOLOGY VALUES FOR FEMALE RATS
Animal Muniber
COMD
RBC
xlO^/dL
HGB
g/dL
Female, Group:
641240 641245 641249 641257 641283 641290 641293 641335 641344 641384
11-0
OK OK OK OK OK OK OK OK OK OK
nig/kg - Day 44
7.92 8.48 7.86 7.97 8.46 7.91 8.29 8.52 7.49 8.25
15.3 15.9 14.9 15.2 15.6 14.9 15.3 15.6
15.1 15.6
Female, Group: IV - 50 nig/kg - Day 44
641260 641298 641311 641312 641313 641336 641355 641361 641369 641396
OK.
7.97
OK
7.62
OK
7.66
OK
7.61
OK
7.69
OK
7.85.
OK
7.63
OK
8.45
OK
8.07
OK
7.74
15.1 14.5 15.2 14.3 13.7 15.0 14.1 16.2
14.5 14.8
HCT
%
47.9 50.4 47.1 51.0 51.3 48.5 49.1 50.5 48.5 49.5
47.0 46.9 48.1 45.0 44.6 47.8 45.6 51.6 47.9 47.9
MCV
fL
60.5 59.5 59.9 64.0 60.6 61.3 59.2 59.2 64.8 60.0
58.9 61.6 62.8 59.1 58.1 60.9 59.7 61.1 59.4 61.9
MCH
pg
19.3 18.7 19.0 19.0 18.4 18.8 18.4 18.3 20.1 18.9
19.0 19.0 19.9 18.7 17.9 19.1 18.5 19.2 18.0 19.1
MCHC
g/dL
32.0 31.5. 31.7 29.7 30.4 30.7 31.1 30.9 31.1 31.4
32.2 30.8 31.6 31.7 30.8 31.3 30.9 31.3 30.2 30.8
RDW
ARET
% xlO"3/v.L xlO
11.2 10.7 11.0 11.1 10.6 11.5 10.9 11.5 10.8 10.6
11.2 12.2 10.9 11.6 10.7 11.1 10.8 12.4 11.1 11.6
251. 179. 175. 299. 244. 202. 171. 195. 250. 150.
263. 204. 174. 319. 192. 205. 194. 245. 202. 221.
665
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL HEMATOLOGY VALUES FOR FEMALE RATS
Animal Number
COND
RBC
xlO^-6/flL
HGB
g/dL
Female, Group; VI - 250 ing/kg - Day 44
641244 641251 641269 641292 641302 641362 641363 641375 641379 641398
OK
7.52
14.6
OK
7.27
14.0
OK
8.34
14.8
OK
7.75
15.0
OK
7.63
14.7
OK
7.28
14.1
OK
7.54
13.7
OK
8.14
15.3
OK
7.31
14.2
OK
8.30
15.2
Female, Group:
641237 641275 641279 641299 641300 641314 641326 641327 641380 641390
VIII -
OKOK OK OK OK OK OK OK OK OK
1000 mg/kg -
7.75 8.00 7.61 7.74 7.49 7.89 7.78 7.77 7.47 7.50
Day 44
14.7 15.2 14.9 15.5
1.4.2
14.8 15.0 14.8 14.3 15.1
HCT
%
44.7 44.2 48.1 45.1 45.5 44.1 43.7 47.3 45.4 49.2
47.1 48.8 47.7 48.0 43.4 47.1 47.7 47.1 45.9 47.4
MCV L
59.4 60.8 57.7 58.2 59.6 60.5 58.0 58.2 62.2 59.3
60.9 60.9 62.7 62.0 57.9 59.6 61.3 60.6 61.4 63.3
MCH P?
19.4 19.2 17.8 19.4 19.3 19.3 18.1 18.8 19.4 18.3
19.0 19.0 19.6 20.1 18.9 18.7 19.2 19.1 19.2 20.1
MCHC
g/dL
RDW
ARET
% xlO"3/nL xlO
32.6 31.730.8 33.3 32.4 31.9 31.3 32.3 31.1 30.9
31.1 31.1 31.2 32.4 32.7 31.4 31.4 31.5 31.3 31.8
10.1 12.1 11.9 10.8 11.0 12.1 11.3 10.2 11.9 10.9
11.0 11.1 10.9 11.1 11.2 11.1 11.5 11.5 12.0 11.2
184. 225. 238. 235. 232. 238. 251. 189. 274. 194.
187. 242. 242. 284. 230. 238. 223. 197. 312. 255.
666
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL HEMATOLOGY VALUES FOR FEMALE RATS
Animal Number
ANPR
xl ()"3/(iL
A LYM xlO^-3 /IJ.L
AM:ON
xl0''3/ 111,
A EOS
xl.0"3 /^L
A BAS
?tl0'-3 /ML
A LUC
>cl0"3 /P.L
ABLT x:l.O"3/nL
AMSC
X]-0^3/^L
PLT ? tlO'-3/nL
Female, Group: II - 0 rng/kg - Day 44
641240
MT
15 .04
0. 30
0 .12
0 .13
0 .33
NT
NT
1028
641245
NT
8 .65
0. 22
0.10
0 .08
0 .15
NT
NT
KNV
641249
NT
7 .66
0. 28
0 .14
0 .06
0 .10
NT
NT
875
641257
NT
13 .19
0. 36
0.23
0 .10
0 .28
NT
NT
RNV
641283
NT
8 .15
0. 24
0 .13
0 .16
0 .16
MT
NT
1419
641290
NT
12 .19
0. 32
0 .15
0 .12
0 .31
NT
NT
RNV
641293
NT
12 .04
0. 22
0 .24
0 .08
0 .59
NT
NT
1190
641335
NT
12 .84
0. 34
0 .20
0 .15
0 .15
NT
NT
RNV
641344
NT
15 .26
0. 23
0 .13
0 .09
0 .16
NT
NT
765
641384
NT
11 .76
0. 29
0 .26
0 .09
0 .24
NT
NT
RNV
Female, Group; IV - 50 nig/kg - Day 44
641260
NT-
9 .70
0. 44
0 .22
0 .00
0 .00
NT
NT
RMV
641298
NT
15 .03
0. 17
0 .10
0 .06
0 .12
NT
NT
1266
641311
NT
10 .17
0. 17
0 .06
0 .13
0 .17
NT
NT
RNV
641312
NT
8 .39
0. 09
0 .16
0 .04
0 .08
NT
NT
1169
641313
NT
14 .92
0. 21
0 .09
0 .11
0 .24
NT
NT
888
641336
NT
10 .73
0. 29
0 .05
0 .14
0 .20
NT
NT
917
641355
NT
10 .67
0. 24
0 .06
0 .15
0 .19
NT
NT
1208
641361
NT
12 .15
0. 40
0 .19
0 .14
0 .29
NT
NT
977
641369
NT
14 .12
0. 43
0 .12
0 .09
0 .31
NT
NT
1242
641396
. NT
8 .20
0. 28
0 .12
0 .05
0 .20
NT
NT
1007
667
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL HEMATOLOGY VALUES FOR FEMALE RATS
Animal Number
ANPR
xl()"3/(iL
A:LYM
xl0"3 /lL
AMOM
3riO"3/fiL
AEOS ? clO"3/AlL
AB A3
?ElO^/ ftL
A:LUC
>cl0"3 /II.-L,
ABLT X:LO"3/^L
AMSC
x3.0"3/AlL
PLT > ;10"3/(;L
Female, Group: VI - 2 50 nig/tog - Da;/ 44
641244
NT
13 .86
0.34
0.12
0. 10
0 .15
MT
MT
850
641251
MT
7 .33
0.20
0.39
0. 00
0 .00
NT
MT
1110
641269
MT
13 .42
0.44
0.14
0. 18
0 .45
MT
MT
1017
641292
NT
9 .72
0.20
0.20
0. 04
0 .15
MT
NT
RMV
641302
MT
10 .19
0.18
0.16
0. 12
0 .23
NT
NT
994
641362
MT
7 .22
0.20
0.08
0. 07
0 .15
MT
MT
RMV
641363
MT
9 .07
0.17
0.13
0. 05
0 .13
NT
NT
RNV
641375
NT
15 .57
0.19
0.27
0. 12
0 .28
MT
NT
RMV
641379
MT
8 .01
0.21
0.15
0. 10
0 .11
NT
MT
1128
641398
MT
16 .72
0.39
0.16
0. 12
0 .25
MT
MT
1223
Female, Group: VIII - 1000 nig/kg - Day 44
641237
MT-
7 .90
0.15
0.16
0. 08
0 .12
NT
NT
1324
641275
MT
8 .85
0.15
0.10
0. 06
0 .08
MT
MT
1363
641279
MT
12 .46
0.15
0.13
0. 06
0 .23
MT
NT
922
641299
NT
14 .15
0.29
0.13
0. 12
0 .18
NT
MT
1211
641300
MT
11 .98
0.09
0.83
0. 04
0 .19
MT
NT
RNV
641314
MT
18 .62
0.37
0.16
0. 18
0 .35
NT
NT
1217
641326
NT
9 .78
0.31
0.18
0. 11
0 .26
NT
NT
RNV
641327
NT
11 .69
0.27
0.07
0. 08
0 .24
MT
MT
RMV
641380
NT
9 .29
0.17
0.04
0. 06
0 .13
MT
NT
1297
641390
MT
9 .57
0.22
0.10
0. 16
0 .21
MT
NT
791
668
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL HEMATOLOGY VALUES FOR FEMALE RATS
Animal Number
COMD
RBC
xlO"6/^L
HGB
g/dL
Female, Group:
641240 641245 641249 641257 641283 641290 641293 641335 641344 641384
11-0 mg/kg - Day 92
OK
8.45
OK
8.87
OK
8.52
OK
8.35
OK
8.56
OK
8.09
OK
8.76
OK
8.56
OK
8.37
OK
8.58
16.0 16.3
15.5 15.9 15.9 15.2 16.2 15.8 16.5
15.9
Female, Group: IV - 50 ing/kg - Day 92
641260 641298 641311 641312 641313 641336 641355 641361 641369 641396
OK'
8" .48"
15.9
OK
8.09
15.4
OK
8.16
16.0
OK
8.01
15.1
OK
8.14
14.3
OK
8.22
15.3
OK
8.24
15.4
OK
8.50
16.3
OK
8.28
14.8
OK
8.16
15.8
HCT
%
49.3 51.6 49.5 49.7 50.5 47.6 50.8 49.0 52.5 49.8
49.4 47.9 49.4 46.3 45.3 49.4 47.5 50.1 47.1 48.8
MCV L
58.3 58.1 58.1 59.5 59.0 58.8 58.1 57.2 62.7 58.1
58.3 59.1 60.5 57.8 55.6 60.1 57.6 59.0 56.9 59.8
MCH
pg
19.0 18.4 18.1 19.1 18.5 18.7 18.4 18.5 19.7 18.6
18.7 19.1 19.6 18.8 17.6 18.6 18.7 19.2 17.9 19.4
MCHC
g/dL
32.5 31.6 31.2 32.0 31.4 31.9 31.8 32.3 31.4 31.9
32.1 32.2 32.4 32.6 31.6 30.9 32.5 32.5 31.5 32.4
RDW
ARET
% xlO"3/nL xl
10.7 10.8 11.3 10.6 10.6 11.6 10.8 10.8 10.6 10.0
10.6 11.0 10.2 10.3 10.4 10.7 10.6 11.5 10.4 10.2
155. 117. 179. 200. 215. 142. 138. 103. 187.
98.
144. 145. 117. 210129. 152. 138. 178. 127. 118.
669
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL HEMATOLOGY VALUES FOR FEMALE RATS
Animal Number
COND
RBC
xlO^/f^L
HGB
g/dL
Female, Group: VI - 250 nig/kg - Day 92
641244 641251 641269 641292 641302 641362 641363 641375 641379 641398
OK
8.40
15.5
OK
7.96
14.8
OK
9.16
16.2
OK
8.25
15.7
OK
8.41
15.7
OK
7.72
14.8
OK
7.92
14.5
OK
8.34
15.5
OK
7.89
15.2
OK
8.81
15.9
Female, Group: VIII -
641237
OK-
641275
OK
641279
OK
641299
OK
641300
OK
641314
OK
641326
OK
641327
OK
641380
OK
641390
OK
1000 ing/kg -
8.01 8.32 8.24 8.05 7.92 8.25 8.17 8.36 8.02 8.15
Day 92
1--5
.
-
2
15.9
15.8
16.2
14.4
15.5
15.8
15.8
15.7
16.2
HCT %
49.0 46.7 53.1 48.6 49.5 46.0 45.2 49.2 47.6 50.3
47.1 49.8 49.9 48.3 45.6 47.5 48.4 49.2 48.2 49.5
MCV
fL
58.4 58.7 57.9 58.8 58.9 59.6 57.0 59.0 60.3 57.1
58.7 59.8 60.5 60.0 57.6 57.6 59.3 58.9 60.1 60.7
MCH
pg
18.4 18.6 17.7 19.0 18.6 19.2 18.3 18.6 19.2 18.1
19.0 19.1 19.2 20.1 18.3 18.8 19.3 18.9 19.5 19.9
MCHC
g/dL
31.6 31.6' 30.6 32.2 31.7 32.3 32.2 31.6 31.8 31.7
32.3 31.9 31.6 33.6 31.7 32.5 32.6 32.1 32.5 32.7
RDW
ARET
% xlO"3/(A xlO
9.8 10.6 11.0 10.4 10.4 10.7 10.7 10.8 11.1 10.6
10.8 10.5 10.7 10.4 10.6 10.5 10.9 11.2 10.4 11.0
170. 160. 176. 192. 162. 179. 151. 178. 188. 170.
208. 163. 152. 246. 153. 151. 170. 158. 136. 196.
670
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL HEMATOLOGY VALUES FOR FEMALE RATS
Animal Number
ANPR
xl(1^3/UlL
AL iYM
xl0"3/ P.L
A]MON
xl0'"3 /ftL
AEOS
?clO"3/(iL
AB AS
xl0"3/ H.L
A:LUC
?clO^ /P.L
ABLT ; clO"3/ML
AMSC
a :10"3/llL
PLT
? clO^/nL
Female, Group: II - 0 I ng/kg - Day 92
641240 641245 641249 641257 641283 641290 641293 641335 641344 641384
NT
6. 76
NT
5. 90
NT
5. 24
NT
8. 98
MT
6. 86
NT
9. 08
NT
8. 18
NT
6. 45
NT
7. 40
NT
7. 16
0 .19
0 .26 0 .21
0 .20 0 .31 0 .39 0 .17 0 .20 0 .16 0 .20
Female, Group: IV - 50 ing/kg - Day 92
641260 641298 641311 641312 641313 641336 641355 641361 641369 641396
NTNT NT NT NT
0.00
NT NT NT NT
9. 33 8. 34 6. 27 5. 44 9. 66 7. 82 6. 31 6. 04 8. 51 7. 35
0 .20
0 .16 0 .13 0 .15 0 .18 0 .26 0 .21 0 .19 0 .19
0.20
0.09 0.13 0.19 0.21 0.11 0.14 0.14 0.19 0.14 0.26
0.13 0.08 0.07 0.10 0.11 0.00 0.07 0.10 0.11 0.14
0. 07 0. 05 0. 05 0. 08 0. 14 0. 11 0. 09 0. 08 0. 05 0. 04
0. 09 0. 08 0. 05 0. 07 0. 04 0. 00 0. 03 0. .07 0. 05 0. 06
0 .09 0 .07 0 .05 0 .06 0 .13 0 .11 0 .10 0 .09 0 .06 0 .12
0 .16 0 .12 0 .03 0 .04 0 .08 0 .00 0 .05 0 .11 0 .07 0 .10
NT NT NT MT NT NT MT NT NT NT
NT NT NT NT NT
0.00
MT NT NT NT
NT NT MT MT NT NT NT NT MT NT
NT NT NT NT NT
0.00
NT NT NT NT
1075 923
RNV KMV
1278 1238
989 1350
RNV
1010
1097 1024 1073
RNV RNV 993 RMV 963
1149
RNV
671
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL HEMATOLOGY VALUES FOR FEMALE RATS
Animal Number
AMPR
xl(^"3/p.L
ALYM
xlO^/fiL
AMON
XlO^/fiL
A EOS
3cl0"3 /AlL
A BAS
xl0"3 /HL
A LUC
3cl0"3 /P.L
ABLT sC10"3/HL
AMSC
T ElO^/nL
PLT 5clO"3/^L
Female, Group: VI - 2'50 mg/kg - I )ay 92
641244 641251 641269 641292 641302 641362 641363 641375 641379 641398
NT NT
0.00
NT NT NT NT NT NT NT
10.21 6.82 6.98 7.11 8.65 6.46 9.07
11.53
5.79 10.83
0.39 0.21 0.37 0.15 0.12 0.25 0.30 0.23 0.13 0.32
Female, Group: VIII -
641237 641275 641279 641299 641300 641314 641326 641327 641380 641390
0.00" NT NT NT NT NT NT NT NT
. NT
1000 ing/kg -
5.24 6.30 8.42 8.61 14.50 9.55 9.93 7.79 5.65 8.38
Day 92
0.25 0.12 0.21 0.17 0..19 0.31 0.35 0.22 0.08 0.24
0 .14 0 .10 0 .12 0 .18 0 .10 0 .13 0 .17 0 .12 0 .08 0 .20
0 .12 0 .15 0 .19 0 .12 0 .11 0 .17 0 .13 0 .07 0 .06 0 .16
0 .06 0 .25 0 .00 0 .08 0 .14 0 .05 0 .08 0 .19 0 .09 0 .06
0 .00 0 .09 0 .06 0 .14
'
0 .18 0 .09 0 .09 0 .06 0 .06 0 .07
0 .11 0 .23 0 .00 0 .07 0 .17 0 .10 0 .11 0 .31 0 .07 0 .12
0 .00 0 .09 0 .06 0 .39 0 .28 0 .10 0 .12 0 .05 0.11 0 .08
NT NT
0.00
NT NT NT NT NT NT NT
0.00
NT NT NT NT NT NT NT NT NT
NT NT
0.00
NT NT NT NT NT NT NT
0.00
NT NT NT NT NT NT NT NT NT
850 1118
RNV 1071 1005 1058
999 1177
937 1168
RNV
1194 866
1017 927
1054 1132 1286 1136
837
672
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL HEMATOLOGY VALUES FOR FEMALE RATS
Animal Number
COND
RBC
xlO"6/^iL
HGB
g/dL
Female, Group: 11-0 mg/kg - Day 124
641253 641266 641281 641294 641325 641331 641359 641364 641383 641400
OK
8.43
15.1
OK
8.16
14.8
OK
8.07
14.8
OK
7.93
15.0
OK
8.11
14.9
OK
8.50
15.5
OK
7.77
15.3
OK
8.79
15.4
OK
7.59
14.3
OK
7.85
15.2
Female, Group: VIII - 1000 nig/kg - Day 124
641234 641256 641282 641352 641356 641366
641377 641385 641387 641399
OK" OK OK OK NSR OK OK OK OK OK
7.83 7.67 7.96 8.66
MT
8.79-
8.54 7.50 8.18 7.86
14.4 14.8 15.8 16.0
NT
15.8 15.4 14.1 15.0 14.3
HCT %
46.5 45.6 44.2 46.8 45.1 46.9. 46.1 47.1 43.3 46.6
43.8 44.5 49.1 49.0
NT
48.3 47.4 42.7 45.5 44.1
MCV L
55.2 55.9 54.8 59.0 55.7 55.2 59.3 53.6 57.1 59.3
56.0 58.0 61.6 56.7
NT
55.0 55.5 57.0 55.6 56.1
MCH
pg
17.9 18.2 18.4 18.9 18.3 18.2 19.7 17.5 18.9 19.4
18.4 19.2 19.8 18.5
NT
18.0 18.0 18.8 18.4 18.2
MCHC
g/dL
RDW
ARET
% xlO"3/(lL xlO
32.5 32.5' 33.5 32.0 32.9 33.0 33.2 32.7 33.1 32.7
32.8 33.2 32.1 32.7
NT
32.7 32.4 32.9 33.0 32.4
12.2 12.6 11.5 11.5 12.2 12.6 11.9 11.4 12.2 11.4
11.8 11.4 12.2 11.7
NT
12.4 11.9 12.0 11.7 11.6
195. 202. 157. 185. 166. 157. 157. 180. 155. 202.
123. 156. 229. 164.
NT
186. 186. 151. 170. 140.
673
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL HEMATOLOGY VALUES FOR FEMALE RATS
Animal Number
ANPR
xlO "3/nL
ALYM
xlO"3/(lL
AMON
xl0^3/(L
AEOS
xl0^3/iL
ABAS
xl0^3/^L
ALUC
x!0"3/iuL
ABLT
xl0^3/(iL
AMSC
X.10"3/HL
PLT
xl0"3/(ri-.
Female, Group:
641253 641266 641281 641294 641325 641331 641359 641364 641383 641400
11-0
NT NT NT NT MT
0.00
NT NT NT NT
ing/kg - Day 124
13.25 8.08 8.33 8.24 5.27
13.66 9.66 9.40 9.32 8.28
0.40 0.23
0.27 0.41 0.32 0.32 0.20 0.40 0.31 0.21
Pemale, Group: VIII -
641234 641256 641282 641352 641356 641366 641377 641385 641387 641399
NTNT
0.00
NT NT NT NT NT NT . NT
1000 ing/kg -
6.61 6.98 11.48 9.13
NT
8.86 7.86 11.68 12.17 6.61
Day 124
0.20 0.24 0.52 0.22
NT
0.51 0.17 0.33 0.33 0.29
0.18 0.11 0.19 0.09 0.15 0.48 0.07 0.21 0.08 0.08
0.13 0.06 0.13 0.12
NT
0.13 0.14 0.09 0.13 0.16
0.17 0.05 0.12 0.15 0.09 0.00 0.05 0.06 0.07 0.15
0.21 0.12 0.00 0.10
NT
0.16 0.06 0.04 0.05 0.06
0.20 0.25 0.10 0.36 0.27 0.00 0.11 0.18 0.17 0.22
0.14 0.14 0.00 0.09
NT
0.18 0.12 0.19 0.38 0.19
NT NT NT NT NT
0.00
NT NT NT NT
NT NT
0.00
NT NT NT NT NT NT NT
NT NT NT NT NT
0.00
NT NT NT NT
NT NT
0.00
NT NT NT NT NT NT NT
787 RNV RNV 947 1007 757 1096 RNV 1112 971
957 1168 1089 1033
NT 1041
794 934 898 948
674
-'ttd
Wi
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL RED BLOOD CELL MORPHOLOGY VALUES FOR MALE RATS
Animal
MORM
ANIS
MIC
Number
Male, Group: I - 0 ing/kg - Day 44
641069 641070 641094 641147 641149 641155 641172 641206 641214 641222
Male, Group: III -
641055 641056 641073 641081 641144 641146 641178 641198 641218 641224
50 ing/kg -
Day 44
MAC
POLY
HYPO
ECHI
ACAM
TARG
3.
l
443423132112121-------3324211221-------4322----
675
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL RED BLOOD CELL MORPHOLOGY VALUES FOR MALE RATS
Animal
NORM
ANIS
MIC
Number
Male, Group: V - 250 ing/kg - Day 44
641061 641089 641102 641134 641137 641162 641190 641197 641200 641202
Male, Group: VII -
641067 641077 641086 641095 641097 641132 641157 641166 641201 641223
1000 ing/kg -
Day 44
MAC
POLY
HYPO
ECHI
ACAN
TARG
2
2
22243321231------ 21-- 2331 311323------ 24 123----
676
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL RED BLOOD CELL MORPHOLOGY VALUES FOR MALE RATS
Animal Number
SPEC
Male, Group: I - 0 ing/kg - Day 44
641069 641070 641094 641147 641149 641155 641172 641206 641214 641222
4-HEMOGLOBIN CRYSTAL
4-HEMOGLOBIN CRYSTAL 4-HEMOGLOBIN CRYSTAL 4-HEMOGLOBIN CRYSTAL;
1-SPHEROCYTE
Male, Group:
641055 641056 641073 641081 641144 641146 641178 641198 641218 641224
III - 50 mg/kg - Day 44
4-HEMOGLOBIN CRYSTAL 4-HEMOGLOBIN CRYSTAL
677
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL RED BLOOD CELL MORPHOLOGY VALUES FOR MALE RATS
Animal Number
SPEC
Male, Group; V - 250 ing/kg - Day 44
641061 641089 641102 641134 641137 641162 641190 641197 641200 641202
4-HEMOGLOBIN CRYSTAL 2-HEMOGLOBIN CRYSTAL
4-HEMOGLOBIN CRYSTAL
Male, Group: VII - 1000 ing/kg - Day 44
641067 641077 641086 641095 641097 641132 641157 641166 641201 641223
1-SPHEROCYTE 4-HEMOGLOBIN CRYSTAL 1-SPHEROCYTE
4-HEMOGLOBIN CRYSTAL 1-SPHEROCYTE
678
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL RED BLOOD CELL MORPHOLOGY VALUES FOR MALE RATS
Animal
NORM
AMIS
MIC
Number
Male, Group: I - 0 ing/kg - Day 91
641069 641070 641094 641147 641149 641155 641172 641206 641214 641222
Male, Group:
641055 641056 641073 641081 641144 641146 641178 641198 641218 641224
III - 50 mg/kg - Day 91
--- -11
MAC
POLY
HYPO
ECHI
ACAN
TARG
2 1 " 1
21 1211
1
1111
-- -- --
11--
1
1
2111
111
-- -- --
1
2121--
679
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL RED BLOOD CELL MORPHOLOGY VALUES FOR MALE RATS
Animal
NORM
AMIS
MIC
Number
Male, Group: V - 250 ing/kg - Day 91
641061 641089 641102 641134 641137 641162 641190 641197 641200 641202
Male, Group: VII -
641067 641077 641086 641095 641097 641132 641157 641166 641201 641223
1000 mg/kg -
Day 91
MAC
POLY
HYPO
ECHI
ACAN
1-
2
2
2
1
1
1
1
1
2
2
1
1
1
1
1
2
1
1
2
1
1
1
1
TARG
680
''yy
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL RED BLOOD CELL MORPHOLOGY VALUES FOR MALE RATS
Animal Number
SPEC
Male, Group: I - 0 nig/kg - Day 91
641069 641070 641034 641147 641149 641155 641172 641206 641214 641222
1-SPHEROCYTE 1-SPHEROCYTE
Male, Group:
641055 641056 641073 641081 641144 641146 641178 641198 641218 641224
III - 50 nig/kg -
1-SPHEROCYTE
1-SPHEROCYTE 2-SPHEROCYTE 1-SPHEROCYTE 1-SPHEROCYTE
Day 91
681
IIH
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL RED BLOOD CELL MORPHOLOGY VALUES FOR MALE RATS
Animal Number
SPEC
Male, Group: V - 250 mg/kg - Day 91
641061 641089 641102 641134 641137 641162 641190 641197 641200 641202
1-SPHEROCYTE 1-SPHEROCYTE
Male, Group: VII - 1000 ing/kg -
641067 641077 641086 641095 641097 641132 641157 641166 641201 641223
2-SPHEROCYTE
2-SPHEROCYTE 1-SPHEROCYTE 1-SPHEROCYTE
1-SPHEROCYTE 1-SPHEROCYTE
Day 91
682
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL RED BLOOD CELL MORPHOLOGY VALUES FOR MALE RATS
Animal
NORM
AMIS
MIC
Number
Male, Group: I - 0 nig/kg - Day 123
641083 641084 641085 641101 641105 641123 641154 641159 641165 641215
Male, Group: VII -
641064 641092 641143 641153 641167 641185 641189 641203 641213 641216
1000 nig/kg -
Day 123
MAC
POLY
HYPO
ECHI
ACAN
1
1
1
1
2
1
.1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
2
1
2
1
TARG
683
v"^vMs^y^ V''''y'v^,f
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL RED BLOOD CELL MORPHOLOGY VALUES FOR MALE RATS
Animal Number
SPEC
Male, Group: I - 0 nig/kg - Day 123
641083 641084 641085 641101 641105 641123 641154 641159 641165 641215
Male, Group: VII -
641064 641092 641143 641153 641167 641185 641189 641203 641213 641216
1000 ing/kg -
Day 123
684
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL RED BLOOD CELL MORPHOLOGY VALUES FOR FEMALE RATS
Animal
MORM
ANIS
MIC
Number
Female, Group: II -
641240 641245 641249 641257 641283 641290 641293 641335 641344 641384
0 mg/kg -
Day 44
Female, Group: IV - 50 mg/kg - Day 44
664411226908 ---
641311 641312 641313 641336 641355 641361 641369 641396
MAC
POLY
HYPO
ECHI
ACAM
TARG
685
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL RED BLOOD CELL MORPHOLOGY VALUES FOR FEMALE RATS
Animal
NORM
ANIS
MIC
Number
Female, Group: VI -
641244 641251 641269 641292 641302 641362 641363 641375 641379 641398
250 ing/kg -
Day 44
Female, Group: VIII -
641237 641275 641279 641299 641300 641314 641326 641327 641380 641390 . --
1000 mg/kg -
Day 44
MAC
POLY
HYPO
ECHI
ACAN
TARG
686
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL RED BLOOD CELL MORPHOLOGY VALUES FOR FEMALE RATS
Animal Number
SPEC
Female, Group: II - 0 mg/kg - Day 44
641240 641245 641249 641257 641283 641290 641293 641335 641344 641384
Female, Group: IV - 50 mg/kg - Day 44
SB
641260
4-HEMOGLOBIN CRYSTAL
641298
0
641311
Q
641312
4-HEMOGLOBIN CRYSTAL
S3,
641313
3"
641336
-4
641355
641361
0
641369
>
641396
G3
687
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL RED BLOOD CELL MORPHOLOGY VALUES FOR FEMALE RATS
Animal Number
SPEC
Female, Group: VI - 250 ing/kg - Day 44
641244 641251 641269 641292 641302 641362 641363 641375 641379 641398
4-HEMOGLOBIM CRYSTAL
Female, Group: VIII - 1000 mg/kg - Day 44
641237 641275 641279 641299 641300 641314 641326 641327 641380 641390
4-HEMOGLOBIM CRYSTAL 4-HEMOGLOBIN CRYSTAL
4-HEMOGLOBIN CRYSTAL 4-HEMOGLOBIN CRYSTAL
688
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL RED BLOOD CELL MORPHOLOGY VALUES FOR FEMALE RATS
Animal
NORM
ANIS
MIC
Number
Female, Group: II -
641240 641245 641249 641257 641283 641290 641293 641335 641344 641384
0 ing/kg -
Day 92
Female, Group: IV - 50 mg/kg - Day 92
641260 641298 641311 641312 641313 641336 641355 641361 641369 641396
MAC
POLY
HYPO
ECHI
ACAN
TARG
121-- 31
2
1
1
2111----
1
1 1 -- 1
1
--
---
'1
11
11
1
21 1--
689
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL RED BLOOD CELL MORPHOLOGY VALUES FOR FEMALE RATS
Animal
NORM
ANIS
MIC
Number
Female, Group: VI - 250 mg/kg - Day 92
641244 641251 641269 641292 641302 641362 641363 641375 641373 641398
Female, Group: VIII -
641237 641275 641279 641299 641300 641314 641326 641327 641380 641390
1000 mg/kg -
Day 92
MAC
POLY
HYPO
ECHI
ACAN
3
1
2
1
2
1
1
1
1
2
1
2
1
1
2
1
2
1
2
1
2
1
1
TARG
690
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL RED BLOOD CELL MORPHOLOGY VALUES FOR FEMALE RATS
Animal Number
SPEC
Female, Group: II -
641240 641245 641249 641257 641283 641290 641293 641335 641344 641384
0 mg/kg -
Day 92
Female, Group: IV - 50 mg/kg - Day 92
641260 641298 641311 641312
641313 641336 641355 641361 641369 641396
1-SPHEROCYTE
691
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL RED BLOOD CELL MORPHOLOGY VALUES FOR FEMALE RATS
Animal Number
SPEC
Female, Group: VI - 250 mg/kg - Day 92
641244 641251 641269 641292 641302 641362 641363 641375 641379 641398
1-SPHEROCYTE
Female, Group: VIII - 1000 mg/kg -
641237 641275 641279 641299 641300 641314 641326 641327 641380 641390
1-SPHEROCYTE
Day 92
692
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL RED BLOOD CELL MORPHOLOGY VALUES FOR FEMALE RATS
Animal
NORM
AMIS
MIC
Number
Female, Group: II -
641253 641266 641281 641294 641325 641331 641359 641364 641383 641400
0 nig/kg -
Day 124
Female, Group: VIII -
641234
641256
641282
641352
641356
641366
--
641377
641385
641387
641399
1000 ing/kg -
--
Day 124
MAC
POLY
HYPO
ECHI
ACAN
2
2
1
1
1
1
1
1
2
1
2
1
1
3
1
1
1
3
1
1
1
3
1
2
1
3
2
1
TARG
693
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL RED BLOOD CELL MORPHOLOGY VALUES FOR FEMALE RATS
Animal Number
SPEC
Female, Group: II -
641253 641266 641281 641294 641325 641331 641359 641364 641383 641400
0 mg/kg -
Day 124
Female, Group: VIII -
641234 641256 641282 641352 641256 641366 641377 641385 641387 641399
1000 mg/kg -
Day 124
694
@
P
s
1 5
0
0
8
3
?
S S
o>
8
? j
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVII3UAL WHITE BLOOD CELL / PLATELET MORPHOLOGY{ VALUES FOR MALE RATS
Animal
NORM
SM
DB
PC
GP
BP
TOX
VC
SPEC
Number
Male, Group: 1-0 nig/kg - Day 44
664411006790 NORMAL -- ------ -- -- -- -- --
-- 641094
-
641147
-
-.-
1
'
1
ADEQ PLATEL ADEQ PLATEL
641149
NORMAL
-
,,
641155
NORMAL
--
,,
--
--
641172
--
-
1
---
--
--
DECR PLATEL
641206 NORMA--L -- -*-.
....
--
--
641214
-~
1
DECR PLATEL
641222
NORMAL
Male, Group: III - 50 mg/hg - Day 44
641055 641056 641073 641081 641144 641146 641178 641198 641218 641224
--
NORMAL
NORMAL NORMAL NORMAL NORMAL
-
--
--
. --
-.-
--
--
::
1 1 1
1
ADEQ PLATEL DECR PLATEL
ADEQ PLATEL
-
--
--
--
--
1
ADEQ PLATEL
695
0
$ n
s *s s51 s &
|H
3 0
3
S 3" S~i
2
9> 0
s.
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDXH\L WHITE BLOOD CELL / PLATELET MORPHOLOGYf VALUES FOR MALE RAT S
Animal
NORM
SM
DB
PC
GP
BP
TOX
VC
SPEC
Number
Male, Group: V - 250 ing/kg - Day 44
641061
NORMAL
,,.
641089
--
--
--
1
--
--
--
--
ADEQ PLATEL
1
DECR PLATEL
641102 641134
NORMA--L
--
--
641137
NORMAL
--
-
--
--
--
--
--
641162
NORMAL
--
--
--
--
--
--
--
641190
NORMAL
--
--
--
--
--
--
--
641197
NORMAL
--
-
,,
--
--
--
-
641200
--
--
--
,,
1
--
--
--
641202
NORMA--L
--
-,,
--
--
--
--
--
--
--
--
--
--
Male, Group: VIX - 1000 mg/kg - Day 44
641067
NORMAL
,,
641077 641086
NORMA--L
--
-
1
--
--
--
641095
NORMAL
..,,
-
--
--
641097
NORMAL
--
--
,,
--
--
--
641132
NORMAL
--
--
--
--
--
--
--
641157 641166
--
NORMAL
--
--
1
DECR PLATEL
641201
NORMAL
--
--
--
--
--
--
--
641223
NORMAL
--
--
--
--
--
--
--
,,
,,
^
696
'^S^^fS
x '
'w
H-24616: Subchironic Toxicity
90-Day Gavage S tudy in Rats with One-Generation Reproductive Evalinations
INDIVIDI.JAL WHITE BLOOD CELL / PLATELET VTORPHOLOG'1i VALUES FOR MALE RAT s
Animal
NORM
SM
DB
PC
GP
BP
TOX
VC
SPEC
Number
Male, Group: I - 0 ing/kg - Day 91
III 8Q
641069
NORMAL
641070
NORMAL
-
-
--
--
--
ii
641094
NORMAL
---
---
---
---
---
--
--
---
3 8
641147
NORMAL
--
--
--
--
--
--
--
641149
NORMAL
--
--
--
--
--
--
--
641155 641172
--
--
--
1 1
ADEQ PLATEL ADEQ PLATEL
641206
NORMA--L
--
-
--
-
--
--
--
--
---
p,
641214 641222
--
--
--
--
1
--
--
--
1
--
--
--
--
--
--
--
^
(6
Male, Group:
- 50 nig/kg - Day 91
a
3
641055
NORMAL-
a
641056
NORMAL
-
--.
-
641073
NORMAL
-^
-~
,,-
,,
-
--
3 a
641081 641144
--
--
--
1 1
-- -- -- AADDEEQQ PPLLAATTEELL
--' 3
641146
NORM-A-L
--
--
641178
--
,,
--
--.
1
a 0
>
641198 641218
NORMAL
--
1
--
--
ADEQ PLATEL
0
641224
NORMA--L
--
-
sa
-
--
,,,,.
-
--
697
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL WHITE BLOOD CELL / PLATELET MORPHOLOGY VALUES FOR MALE RATS
Animal
NORM
SM
DB
PC
GP
BP
TOX
VC
SPEC
Number
Male, Group: V - 250 ing/kg - Day 91
641061 641089 641102 641134 641137 641162 641190 641197 641200 641202
,,
NORMAL NORMAL
NORM-A-L
NORMA- -L
NORMAL NORMAL NORMAL
Male, Group: VII - 1(000 ing/kg -
641067 641077 641086 641095 641097 641132 641157 641166 641201 641223
NORMALNORMAL NORMAL
-
NORMA--L
NORMAL NORMAL NORMAL NORMAL
Day 91
DECR PLATEL
DECR PLATEL ADEQ PLATEL
698
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
;5BK
'
s
3 S S
(9
1p,
0 Q SB
w
I
0
SSOt
5,
^ Q
v
a
INDIV:IDUAL WHITE BLOOD CELL / PLATELET MORPHOLOG1C VALUES FOR MALE RATS
Animal
NORM
SM
DB
PC
GP
BP
TOX
VC
SPEC
Number
Male, Group: 1-0 ing/kg - Day 123
641083
NORMAL
,,
-,,
-
--
-
641084
NORMAL
--
--
--
--
--
--
--
641085
NORMAL
--
--
--
--
--
--
--
641101
NORMAL
--
--
--
--
--
--
--
641105
NORMAL
--
--
--
--
--
--
--
664411112534 NORMAL -- --
-
1
--
--
--
-- ADEQ PLATEL
--
--
--
641159
--
--
--
1
DECR PLATEL
641165
--
--
--
1
ADEQ PLATEL
641215
NORMAL
--
--
--
--
--
,-.-
--
Male, Group: VII - 1000 mg/kg - Day 123
641064
-
1
DECR PLATEL
641092
NORMAL
--
--
--
--
--
--
--
641143 641153
NORMAL NORMAL
--
--
--
--
--
--
--
641167
--
--
--
--
. --
---
--1
---
---
---
641185
NORMAL
--
--
--
--
--
--
--
641189
NORMAL
,,,,
-
-
-
--
--
--
641203
--
--
--
--
1
--
--
--
641213
NORMAL
--
--
--
--
--
--
--
641216
NORMAL
--
--
--
--
--
--
--
699
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL WHITE BLOOD CELL / PLATELET MORPHOLOGY VALUES FOR FEMALE RATS
Animal
NORM
SM
DB
PC
GP
BP
TOX
VC
SPEC
Number
Female, Group: 11-0 nig/kg - Day 44
jle
641240
NORMAL
.
--
-
S
641245
--
--
--
1
641249
NORMAL
DECR PLATEL
99
641257
-
-
1
--
--
-
--
ADEQ PLATEL
sii
641283
--
NORMAL
---
---
--
--
--
--
--
sss
641290
--
--
--
1
ADEQ PLATEL
3;
641293
NORMAL
--
--
--
--
--
--
--
641335
1
ADEQ PLATEL
641344
NORMA--L
---
---
--
--
--
--
--
641384
--
--
--
1
DECR PLATEL
0
Female, Group: IV - 50 mg/kg - Day 44
1 3
641260
--'
--
--
1
ADEQ PLATEL
s.
641298
NORMAL
--
--
--
--
--
--
--
S
0
641311
--
--
--
1
ADEQ PLATEL
641312
NORMAL
--
--
--
--
--
--
--
641313
NORMAL
--
. --
--
--
--
--
--
5"
641336
NORMAL
--
--
--
--
--
--
--
-j
641355
NORMAL
--
--
--
--
--
--
--
641361
NORMAL
9
641369
NORMAL
~
.-
--
~-~
> 0
641396
NORMAL
---
---
---
---
---
---
---
IS
700
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUA:L WHITE BLOOD CELL / PLATELET MORPHOLOGY VALUES FOR FEMALE RATS
Animal
NORM
SM
DB
PC
GP
BP
TOX
VC
SPEC
Number
Female, Group: VI - 250 mg/kg - Day 44
641244
NORMAL
1 641251 641269
NORMAL NORMAL
--
--
,,
--
--
--
s?
641292
--
AL
-
--
1
,,,,
,,.-
--
--
DECK PLATEL
a
o
641302 641362
NORM
--
--
--1
--
--
--
--
DECR PLATEL
641363
--
--
1
DECR PLATEL
641375
--
--
--
1
ADEQ PLATEL
o
641379
NORMA--L
--
--
641398
-- --- -- 1 -': " --
Female, Group: VIII - 1000 mg/kg - Day 44
a.
0
641237
NORMAL-
--
--
--
--
--
--
--
641275
NORMAL
.--
--
--
--
--
--
--
!
641279
NORMAL
-
641299
NORMAL
--
--
--
--
--
--
664411331040 NORMAL -- 1
DECR PLATEL
641326
8
641327
-- 11
DECR PLATEL DECR PLATEL
a ^
641380
NORMAL
--
--
--
--
--
-
--
641390
NORMAL
"
"
"
$
0 ra
701
[-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDXVIDUA.L WHITE BLOOD CELL / PLATELET MORPHOLOGY VALUES FOR FEMALE RATS
Animal
NORM
SM
DB
PC
GP
BP
TOX
VC
SPEC
Number
Female, Group; II-O mg/kg - Day 92
641240 641245
NORMAL
--
1
.
0
641249
--
-
-
,,-
1
-
1
--
--
ADEQ PLATEL
S
641257
--
--
--
1
ADEQ PLATEL
S
641283
NORM-A-L
--
--
S 5
641290
NORMAL
---
--
--
-
--
--
--
--
-
--
641293
NORMAL
,,
w
641335
NORMAL
--
-
-
5
641344
--
--
--1
--
,,
--
--
--
--
--
ADEQ PLATEL
sM 6413S4 NORMAL -- -- -- -- -- -- --
<s
a.
Female, Group: IV - 50 ing/kg - Day 92
1 0
641260
NORMAL"
.
,,,,
,,,,.
.
ffi
641298
NORMAL
--
--
--
--
--
--
--
3
a
641311
NORMAL
-
641312
--
--1
--
--
--
-- DECR PLATEL
a
641313
---
---
---
1
DECR PLATEL
0
641336
NORMAL
--
--
--
--
--
--
--
641355
--
--
--
1
ADEQ PLATEL
3"
641361
NORMAL
--
--
--
--
--
--
--
3
641369 641396
NORMAL
--
--
--1
--
--
--
--
ADEQ PLATEL
8
-
-~
>
0 GO
702
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
i'''S?
s
& 3
to
EB
I"
a
0 0 0 (0 3
<2,?
0 3
. 5'
-1 t 0 >
0 (S
INDIVIDUAL WHITE BLOOD CELL / PLATELET M(3RPHOLOBY VALUES FOR FEMALE RATS
Animal
NORM
SM
DB
PC
GP
BP
TOX
VC
SPEC
Number
Female/ Group! VI - 250 ing/kg - Day 92
641244
NORMAL
,,,,
--
,,
--
641251
NORMAL
--
--
-
-
--
--,
--
641269 641292
--
--
--
1
1
DECR PLATEL
641302
NORMA--L
--
-.
--
--
-,-
641362
NORMAL
--
--
-
-
-
--
--
-
~
641363 641375
NORMAL
--
--
--
,,
1
--
--
641379
--
NORMAL
--
--
,,
--
,,
641398
NORMAL
--
--
--
-
,,-.
-
--
--
--
--
--
,,-
--
Female/ Group: VIII - 1000 mg/kg - Day 92
641237
--.
--
--
1
DECR PLATEL
641275 641279
NORMAL
--
--
--
--1
--
--
--
641299
NORMA--L
--
--
--
--
--
--
641300
NORMAL
--
--
--
,,,,
-
-
,,-
641314
NORMAL
--
--
--
....
-
,,
641326
NORMAL
---
---
---
---
---
---
---
641327
NORMAL
--
--
--
--
--
--
--
641380 641390
NORMAL NORMAL
--
--
--
--
--
--
--
--
--
--
--
--
--
--
703
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUA:L WHITE BLOOD CELL / PLATELET :MORPHOLOGY VALUES FOR FEMALE RATS
Animal
MORM
SM
DB
PC
GP
BP
TOX
VC
SPEC
Number
Female, Group: XI - 0 mg/kg - Oay 124
641253
NORMAL
-
-..
,,
,,
-
J' 641266
--
--
--
1
1
ADEQ PLATEL
641281 641294
--
--
--
1
1
ADEQ PLATEL
641325
NORMA- -L
--
--
--
--
--
--
641331
NORMAL
--
--
--
--
--
--
641359
NORMAL
--
--
--
,-
--
--
--
641364 -- ' -- -- --1 .1- -- -- - ADEQ PLATEL 1
S3?
641383 641400
NORMA--L
--
--
--
--
--
--
IS"
^
,,.
,,
,,
--.
VIII a
P-
Female, Group:
- 1000 mg/kg - Day 124
.. 641234 a
0
-
,,
,,
,,
1
,,
.
(9 (B
641256 641282
--
--
--
--
1
--
--
--
3 0
641352
NORMA--L
--
-
1
--
,-
tBSa
0
641356
--
--
-
,,
641366
NORMAL
--
--
--
--
--
--
--
5'
3"
641377 641385
NORMAL NORMAL
--
--
--
--
--
--
--
3
641387
NORMAL
--
--
--
--
--
--
--
--
-
--
--
,,
--
,,
8
641399
--
--
--
--
1
--
--
--
>
0 ra
704
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL COAGULATION VALUES FOR MALE RATS
Animal Number
PHEM
FLIP
PICT
Male, Group: I - 0 mg,/kg - Day 91
641069 641070 641094 641147 641149 641155 641172 641206 641214 641222
NONE NONE NONE NONE NONE NONE NONE NONE NONE NONE
NONE NONE NONE NONE NONE NONE NONE NONE NONE NOME
NONE NONE NONE NONE NONE NONE NONE NONE NOME NOME
Male, Group:
641055 641056 641073 641081 641144 641146 641178 641198 641218 641224
III - 50 ing/kg - Day 91
NOMENONE NONE NONE NONE NONE NONE NONE NONE NONE
NONE NOME NOME NONE NOME NOME NOME MOME NONE NOME
NONE NONE NOME NOME NOME NOME NONE NOME NOME NONE
P T
se c
15. 1 15. 2 14. 5 15. 3 16. 0 15. 4 14. 9 15. 3 14. 6 15. 0
15. 1 14. 8 14.4 15. 6 15. 6 15. 0 15. 3 15. 7 14. 8 14. 5
AP'TT S-ec
19 .7 20 .6 20 .0 16 .7 30 .1 20 .1 16 .7 18 .8 18 .5 19 .4
22 .0 21 .2 18 .2 17 .1 20 .0 27 .2 19 .3 18 .1 17 .2 18 .3
705
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL COAGULATION VALUES FOR MALE RATS
Animal Number
PHEM
FLIP
PICT
Male, Group: V - 250 mg/'kg - Day 91
641061 641089 641102 641134 641137 641162 641190 641197 641200 641202
NOME NONE NONE NONE NONE NONE CLOT NONE NONE NONE
NONE NONE NONE NONE NONE NONE
NT NOME NONE NONE
NONE NONE NONE NONE NONE NONE
NT NOME NONE NONE
Male, Group: VII - 1000 nig/kg - Day 91
641067 641077 641086 641095 641097 641132 641157 641166 641201 641223
NONE NONE NONE NONE NONE NONE NONE NONE NONE NONE
NONE NONE NONE NONE NONE NONE NONE NONE NONE NONE
NOME NONE NONE NONE NONE NONE NONE NONE NONE NONE
PT s ec
16 .2 15 .9 15 .3 14 .9 16 .9 15 .5
NT
16 .6 15 .4 15 .0
15 .7 15 .5 16 .0 14 .8 15 .0 15.7 15 .9 16 .9 16 .1 15 .2
APTT s ec
21 .0 17.4 19 .5 20 .5 17 .9 19 .3
NT
22 .9 21 .0 19 .1
15 .3 18 .2 20 .7 22 .6 16 .8 16 .5 20 .4 20 .2 21 .7 22 .3
706
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL COAGULATION VALUES FOR FEMALE RATS
Animal Number
PHEM
FLIP
PICT
Female, Group:
641240 641245 641249 641257 641283 641290 641293 641335 641344 641384
II - 0
NONE NONE
NSR NONE NONE NONE NONE NOME NONE NONE
I ng/kg - Day S)2
NOME MOME
MT NONE MOME MOME NONE MOME MOME NONE
MOME NONE
NT NOME MOME NONE NONE NOME MOME NONE
Female, Group: IV - 50 mg/kg - Day 92
641260 641298 641311 641312 641313 641336 641355 641361 641369 641396
NONE NONE NOME NOME NONE NONE MOME MOME NONE MOME
NONE NONE NONE NONE NONE MOME MOME NONE MOME MOME
MONE NONE MONE MONE NONE NONE MONE NONE NONE MOME
PT s ec
15 .1 15 .2
NT
15 ,5 15 .2 14 .9 15 .8 15 .1 15 .9 15 .2
14 .8 15 .3 14 .7 15 .6 16 .3 15 .6 14 .9 13 .9 15 .9 15 .0
AFTT s ec
18 .6 19 .2
MT
18 .4 19 .0 19 .6 20 .7 22 .0 20 .3 20 .7
17.4 18 .2 23 .1 21 .8 19 .2 17 .7 20 .7 18 .9 20 .4 18 .2
707
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL COAGULATION VALUES FOR FEMALE RATS
Animal Number
PHEM
FLIP
PICT
Female, Group: VI - 250 nig/kg - Day 92
641244 641251 641269 641292 641302 641362 641363 641375 641379 641398
NOME NONE NONE NONE NONE NOME NONE NONE NONE NONE
NONE NONE NONE NONE NONE NONE NONE NONE NONE NONE
NONE NONE NONE NONE NONE NONE NONE NONE NONE NONE
Female, Group: VIII -
641237 641275 641279 641299 641300 641314 641326 641327 641380 641390
NONE NONE NONE NONE NONE NONE NOME NONE NONE NONE
1000 ing/kg -
NONE NONE NONE NONE NONE NONE NONE NONE NONE NONE
Day 92
NONE NONE NONE NONE NONE NONE NONE NONE NONE NONE
PT sec
15 .4 16 .0 15 .3 15 .3 16 .3 15 .2 13 .9 14 .5 14 .3 15 .6
15.4 15 .3 14 .8 15 .8 15 .6 15 .1 15.1 14 .3 15 .9 14 .6
APTT sec
17.3 16.9 18.2 19.5 17.4 19.5 20.3 17.4 17.9 18.4
20.2 16.4 16.7 19.2 17.8 16.8 20.2 17.6 18.3 20.0
708
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AND PLASMA CHEMISTRY VALUES FOR MALE RATS
Animal Number
SHEM
SLIP
SICT
Male, Group:
641069 641070 641094 641147 641149 641155 641172 641206 641214 641222
1-0 ing/kg -
TRACE TRACE SMALL
NONE NONE TRACE TRACE SMALL SMALL NONE
Day 44
NONE NONE NOME NOME NOME NOME NOME NOME NONE NOME
NONE NONE NOME NONE NONE NOME MOME MONE NONE MOME
Male, Group:
641055 641056 641073 641081 641144 641146 641178 641198 641218 641224
III - 50 nig/kg - Day 44
NONESMALL SMALL
NONE SMALL SMALL
NONE NONE SMALL NONE
NOME NOME MOME NOME NOME NONE MOME MOME MOME NONE
MONE NOME MONE MOME MONE NONE MOME MOME MONE MOME
AST
IU/L
105 81 91 67 87
114 85 75
119 81
72 88 88 65 86 71 79 99 132 83
ALT
IU/L
33 48 40 24 37 39 39 35 43 39
36 51 34 30 41 29 37 .44 47 36
SDH
IU/L
18.6 19.9 16.2 17.8 20.0 23.3 19.4 20.2 19.9 29.0
23.6 26.5 21.3 16.9 25.7 22.0 20.1 28.1 18.5 39.4
ALKP
IU/L
BILI
mg/dL
BUM
mg/dL
112
0.16
17
103
<0.10
14
152
<0.10
15
122
<0.10
12
125
0.11
15
138
<0.10
17
156
0.11
15
127
0.11
18
115
<0.10
14
121
0.14
14
99
0.11
12
121
<0.10
15
168
<0.10
19
111
<0.10
15
141
<0.10
16
143
<0.10
13
116
0.11
14
159
<0.10
14
102
0.12
15
136
<0.10
14
709
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AMD PLASMA CHEMISTRY VALUES FOR MALE RATS
Animal Number
SHEM
SLIP
SICT
Male, Group: V - 250 ing/kg - Day 44
641061 641089 641102 641134 641137 641162 641190 641197 641200 641202
NONE SMALL TRACE TRACE
NONE TRACE SMALL TRACE
MODE TRACE
NONE NONE NONE NONE NONE NONE NONE NONE NONE NONE
NONE NONE NONE NONE NONE NONE NONE NONE NONE NONE
Male, Group: VII - 1000 nig/kg - Day 44
641067 641077 641086 641095 641097 641132 641157 641166 641201 641223
SMALL. TRACE SMALL SMALL TRACE SMALL
SMALL NOME
SMALL NONE
NONE NONE NONE NONE NONE NONE NONE NONE NONE NONE
NONE NONE . NONE NONE NONE NONE NONE NONE NONE NONE
AST
IU/L
72 77 65 81 87 81 89 108 106 84
104 91 88 78 77 80 84
110 90 81
ALT
IU/L
32 33 35 39 55 34 33 36 38 30
53 42 42 41 35 35 37 68 37 45
SDH
IU/L
24.6 23.4 14.1 24.8 25.2 24.0 26.4 29.4 29.3 16.1
19.8 19.1 20.4 22.3 21.0 23.1 13.6 28.0 18.6 19.4
ALKP
IU/L
BILI
mg/dL
BUN
mg/dL
94
<0.10
19
119
<0.10
15
119
<0.10
11
142
0.10
17
106
<0.10
19
92
<0.10
17
153
<0.10
14
112
<0.10
14
102
0.11
13
110
<0.10
15
156
0.10
19
115
0.11
14
146
<0.10
14
138
<0.10
16
131
<0.10
15
206
<0.10
17
142
<0.10
18
209
<0.10
15
160
<0.10
18
180
<0.10
14
710
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AND PLASMA CHEMISTRY VALUES FOR MALE RATS
Animal Number
TRIG ing/dL
GLUC
mg/dL
TP
g/dL
Male, Group: 1-0 ing/kg - Day 44
641069
105
105
6.8
641070
116
105
7.0
641094
67
113
6.5
641147
38
97
6.5
641149
72
101
6.4
641155
51
101
6.7
641172
94
114
7.0
641206
41
108
6.8
641214
59
93
6.5
641222
105
101
7.1
Male, Group: III - 50 ing/kg - Day 44
641055
85"
107
6.8
641056
81
109
6.7
641073
101
99
6.6
641081
34
103
6.6
641144
140
114
6.9
641146
36
ioi
6.8
641178
84
94
6.7
641198
99
102
7.1
641218
42
101
6.8
641224
184
106
6.6
ALB
g/dL
4.3 4.3 4.4 4.1 4.1 4.1 4.2 4.2 4.2 4.4
4.2 4.1 4.4 4.1 4.4 4.2 4.1 4.4 4.4 4.3
GLOB
g/dL
CALC
mg/dL
IPHS mg/dL
NA
mnol/L
K
mrnol/L
2.5
10.6
2.7
11.2
2.1
10.3
2.4
10.3
2.3
10.8
2.6
10.8
2.8
10.9
2.6
10.4
2.3
10.7
2.7
11.1
2.6
10.7
2.6
10.3
2.2
11.0
2.5
11.0
2.5
10.7
2.6
10.8
2.6
10.8
2.7
11.3
2.4
10.4
2.3
11.1
8.7
144.3
8.8
149.1
8.1
147.9
8.1
147.7
9.1
149.9
8.6
147.7
7.9
147.1
7.9
149.8
9.2
148.4
9.6
147.9
9.3
147.6
9.0
148.1
9.1
148.8
7.8
148.1
8.4
148.0
8.7
149.0
8.7
147.8
9.5
149.6
8.6
146.4
8.1
147.2
6.71 7.10 6.31 6.14 6.14 6.21 6.01 6.55 6.86 6.50
6.39 6.13 6.57 6.29 6.41 6.06 6.16 6.48 6.08 6.31
711
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AMD PLASMA CHEMISTRY VALUES FOR MALE RATS
Animal Number
TRIG mg/dL
GLUC
mg/dL
TP
g/dL
Male, Group; V - 250 nig/kg - Day 44
641061
72
98
6.9
641089
38
103
5.8
641102
40
109
6.7
641134
29
99
6.3
641137
61
104
6.3
641162
46
97
6.3
641190
43
94
6.3
641197
27
88
6.1
641200
168
107
6.8
641202
49
96
6.3
Male, Group: VII - 1000 mg/kg - Day 44
641067 641077 641086 641095 641097 641132 641157 641166 641201 641223
29-
104
6.6
14
101
7.1
40
106
6.7
55
103
7.1
96
127
6.6
43
122
7.1
25
107
6.3
39
96
7.0
30
105
6.4
44
116
6.6
ALB
g/dL
4.3 3.8 4.4 4.4 4.2 4.4 3.9 4.2 4.4 4.3
4.4 4.7 4.5 4.9 4.5 4.8 4.3 4.8 4.2 4.6
GLOB
g/dL
CALC
mg/dL
IPHS mg/dL
NA
inmol/L
K
inmol/L
2.6
11.4
9.1
148.9
6.63
2.0
10.4
9.3
147.8
6.48
2.3
10.5
7.9
148.2
6.14
1.9
10.8
9.0
148.4
6.44
2.1
10.4
7.8
147.3
5.86
1.9
11.1
10.0
149.6
6.37
2.4
10.9
9.3
148.7
6.16
1.9
10.2
9.0
149.3
6.35
2.4
11.1
8.7
148.3
6.55
2.0
10.5
9.0
148.6
6.16
2.2
10.6
2.4
10.8
2.2
10.5
9.7
147.6
8.6
147.3
9.1
148.1
6.91 6.10 6.42
2.2
10.7
8.9
146.8
6.17
2.1
10.8
9.8
148.9
7.24
2.3
11.2
10.0
147.8
6.86
2.0
10.6
9.0
147.2
5.99
2.2
11.0
8.6
148.6
6.63
2.2
10.5
8.9
147.2
6.14
2.0
10.6
8.7
148.2
6.93
712
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AND PLASMA CHEMISTRY VALUES FOR MALE RATS
Animal Number
PLIP
PICT
PFLU
Male, Group: 1-0 mg/kg - - Day 44
641069
NT
NT
MT
641070
NT
NT
NT
641094
NT
NT
NT
641147
NT
NT
NT
641149
NT
NT
NT
641155
NT
NT
NT
641172
NT
NT
NT
641206
NT
NT
NT
641214
NT
NT
NT
641222
NT
NT
NT
Male, Group: III - 50 g/kg - Day 44
641055
NT-
NT
NT
641056
NT
NT
NT
641073
NT
NT
NT
641081
NT
NT
NT
641144
NT
NT
NT
641146
NT
NT
NT
641178
NT
NT
NT
641198
NT
NT
NT
641218
NT
NT
NT
641224
NT
NT
NT
713
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AND PLASMA CHEMISTRY VALUES FOR MALE RATS
Animal Number
PLIP
PICT
PFLU
Male, Group: V - 250 ing/kg - Day 44
641061
NT
NT
NT
641089
NT
NT
NT
641102
NT
NT
NT
641134
NT
NT
NT
641137
NT
NT
NT
641162
NT
NT
NT
641190
NT
NT
NT
641197
NT
NT
NT
641200
NT
NT
NT
641202
NT
NT
NT
Male, Group: VII - 1000 ing/kg - Day 44
641067
NT
NT
NT
641077
MT
NT
NT
641086
NT
NT
NT
641095
NT
NT
NT
641097
NT
NT
NT
641132
NT
NT
NT
641157
NT
NT
NT
641166
NT
NT
NT
641201
NT
NT
NT
641223
NT
NT
NT
714
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AND PLASMA CHEMISTRY VALUES FOR MALE RATS
Animal Number
SHEM
SLIP
SICT
Male, Group:
641069 641070 641094 641147 641149 641155 641172 641206 641214 641222
1-0 ing/kg -
NONE TRACE
NONE NONE NONE NONE TRACE TRACE NONE NONE
Day 91
NONE NONE NONE NONE NONE NONE NONE NONE NOME NONE
NONE NONE NONE NONE NONE NONE NONE NONE NOME NONE
Male, Group:
641055 641056 641073 641081 641144 641146 641178 641198 641218 641224
III - 50 ing/kg - Day 91
NONE TRACE TRACE
NONE TRACE
NONE NONE NONE NONE NONE
NONE NONE NONE NONE NONE NONE NONE NONE NONE NONE
NONE NONE . NONE NONE NONE NONE NONE NONE NONE NONE
AST
IU/L
94 74 81 66 96 96 83 84 86 84
78 129
84 83 72 78 79 134 93 90
ALT
IU/L
37 36 44 23 36 37 37 33 31 38
34 63 30 40 47 30 35 83 52 42
SDH
IU/L
31.2 20.0 20.8 20.1 21.8 21.9 22.7 17.6 22.0 35.8
21.6 27.2 26.9 22.2 26.0 20.3 20.7 44.6 21.9 39.9
ALKP
IU/L
BILI
mg/dL
BUN mg/dL
70
0.14
15
60
0.12
16
109
0.15
14
73
0.14
16
79
0.16
13
87
0.15
17
83
0.12
16
89
0.15
15
72
0.14
13
78
0.15
16
77
<0.10
14
82
0.15
17
123
0.11
16
149
0.14
18
90
0.12
17
109
0.12
14
101
0.15
19
106
0.20
14
69
0.20
16
94
0.13
15
715
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AND PLASMA CHEMISTRY VALUES FOR MALE RATS
Animal Number
SHEM
SLIP
SICT
Male, Group: V - 250 ing/kg - Day 91
641061 641089 641102 641134 641137 641162 641190 641197 641200 641202
NONE NONE NOME NONE NONE NONE TRACE NONE NONE NONE
NONE NONE NONE NONE NONE NONE NOME NONE NONE NONE
NONE NONE NONE NONE NOME NOME MONE NONE NOME NOME
Male, Group: VII - 1000 mg/kg - Day 91
641067 641077 641086 641095 641097 641132 641157 641166 641201 641223
NONE NONE TRACE TRACE TRACE TRACE TRACE TRACE TRACE NONE
NOME NONE NONE NOME NOME NONE NONE NONE NOME NOME
NOME MONE NONE NOME MONE MONE NOME NOME NOME MONE
AST
IU/L
91 77 66 150 74 65 112 108 98 73
113 92 88
100 82 84 90
128 91 67
ALT
IU/L
32 35 39 115 37 36 73 54 47 35
51 40 55 58 39 47 55 56 37 37
SDH
IU/L
23.5 18.0 15.7 41.8 21.3 20.2 24.7 25.1 27.3 22.8
18.6 19.0 20.9 31.8 18.5 24.8 22.1 27.1 21.4 19.3
ALKP
IU/L
BILI
mg/dL
BUM
mg/dL
93
<0.10
20
98
<0.10
19
108
0.13
15
146
0.17
20
100
0.14
22
77
0.16
18
162
0.12
20
114
0.14
16
115
0.10
18
91
0.13
17
177
0.11
22
130
0.14
14
180
0.10
18
202
0.11
21
157
0.12
19
223
0.14
17
192
0.15
22
179
0.10
18
168
0.10
19
217
0.13
19
716
w
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AND PLASMA CHEMISTRY VALUES FOR MALE RATS
Animal Number
TRIG mg/dL
GLUC
mg/dL
TP
g/dL
Male, Group: 1-0 mg/kg - Day 91
641069
109
117
7.0
641070
93
109
7.0
641094
139
120
7.3
641147
53
105
7.1
641149
52
105
7.0
641155
53
109
7.2
641172
85
117
7.4
641206
95
118
7.2
641214
54
118
7.3
641222
80
110
7.7
Male, Group; III - 50 ing/kg - Day 91
641055
77.
109
7.3
641056
92
110
6.8
641073
84
111
7.2
641081
164
153
7.2
641144
174
119
7.3
641146
82
113
6.9
641178
67
122
7.5
641198
71
119
7.4
641218
64
108
7.0
641224
150
115
7.2
ALB
g/dL
4.2 4.0 4.7 4.2 4.2 4.1 4.1 4.2 4.4 4.6
4.2 4.1 4.6 4.0 4.2 4.1 4.4 4.3 4.3 4.6
GLOB
g/dL
CALC mg/dL
IPHS
NA
K
mg/dL
mmol/L
inmol/L
m
2.8
10.5
3.0
10.6
2.6
10.9
2.9
10.8
2.8
10.5
3.1
10.8
3.3
10.9
3.0
10.4
2.9
11.0
3.1
10.9
3.1
10.4
2.7
10.4
2.6
10.7
3.2
11.2
3.1
10.4
2.8
10.3
3.1
10.9
3.1
10.9
2.7
10.4
2.6
10.9
7.4
145.4
7.3
147.2
7.4
146.1
7.2
146.9
7.6
145.9
7.3
145.9
7.1
146.6
7.3
148.3
7.7
147.5
7.8
145.6
7.8
148.7
7.7
145.7
6.8
146.9
6.6
146.1
6.7
145.9
7.1
146.1
7.7
146.0
7.8
146.9
7.2
146.1
6.8
147.3
6.19 6.50 6.66 5.99 6.23 5.96 5.90 5.90 6.24 6.90
6.28 5.76 5.96 6.36 5.72 5.46 6.24 5.91 5.72 6.32
717
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AMD PLASMA CHEMISTRY VALUES FOR MALE RATS
Animal Number
TRIG ing/dL
GLUC
mg/dL
TP
g/dL
Male, Group: V - 250 nig/kg - Day 91
641061
98
121
7.8
641089
82
127
6.8
641102
87
116
7.5
641134
36
104
7.0
641137
63
113
7.5
641162
79
123
7.3
641190
44
114
7.1
641197
47
113
6.5
641200
110
117
7.6
641202
59
120
7.0
Male, Group: VII - 1000 mg/kg - Day 91
641067 641077 641086 641095 641097 641132 641157 641166 641201 641223
37"
126
6.8
37
114
7.4
35
115
7.0
36
130
6.8
61
117
7.1
61
137
7.4
32
122
6.6
41
114
7.6
45
115
6.8
57
122
7.2
ALB
g/dL
4.6 4.3 4.7 4.6 4.5 4.7 4.4 4.3 4.8 4.6
4.4 4.7 4.6 4.7 5.0 4.9 4.4 5.1 4.5 4.9
GLOB
g/dL
CALC
mg/dL
IPHS mg/dL
NA
nrool/L
K
mmol/L
3.2
11.4
2.5
10.6
2.8
10.8
2.4
10.7
3.0
11.0
2.6
11.1
2.7
11.0
2.2
10.2
2.8
10.9
2.4
10.5
8.9
148.9
7.2
146.3
7.3
146.9
7.8
147.8
7.3
146.7
7.4
147.6
8.2
145.7
7.8
147.0
7.2
148.7
7.7
147.3
6.39 5.63 6.21 6.02 6.27 6.15 6.23
6.39 5.85 5.54
2.4
10.1
7.5
145.2
5.64
2.7
10.5
7.2
144.9
5.78
2.4
10.0
7.7
147.7
5.88
2.1
10.5
10.1
142.4
7.26
2.1
10.4
7.2
145.3
6.20
2.5
10.5
2.2
10.1
7.8
145.8
7.6
145.5
6.16 5.95
2.5
10.6
7.0
146.7
6.27
2.3
10.1
2.3
10.5
6.9
146.8
7.5
144.0
6.00
6'. 3 6
718
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SEROM AND PLASMA CHEMISTRY VALUES FOR MALE RATS
Animal Number
FLIP
PICT
PF:LU
(ig/inL
Male, Group: I - 0 ing/kg - - Day 91
641069
NONE
NONE
0 .1
641070
NONE
NONE
0 .1
641094
NONE
NONE
0 .1
641147
NONE
NONE
0 .1
641149
NONE
NONE
0 .1
641155
NONE
NONE
0 .1
641172
NONE
NONE
0 .1
641206
NONE
NONE
0 .1
641214
NOME
NONE
0 .1
641222
NONE
NONE
0 .1
Male, Group: III - 50 ing/kg - Day 91
641055
NONE-
NONE
0 .1
641056
NONE
NONE
0 .1
641073
NONE
NONE
0 .1
641081
NONE
NONE
0 .1
641144
NONE
NONE
0 .1
641146
NONE
NONE
0 .1
641178
NONE
NONE
QNS
641198
NONE
NONE
0 .1
641218
NONE
NONE
0 .1
641224
NONE
NOME
0 .1
719
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AMD PLASMA CHEMISTRY VALUES FOR MALE RATS
Animal Number
PLIP
PICT
PPLU lig/vS-i
Male, Group: V - 250 ing/kg - Day 91
641061
NOME
NONE
0.1
641089
NONE
NOME
0.1
641102
NONE
NONE
0.1
641134
NONE
NONE
QNS
641137
NONE
NONE
0.1
641162
NONE
NONE
0.1
641190
NONE
NONE
0.1
641197
NONE
NONE
0.1
641200
NONE
NONE
QNS
641202
NOME
NONE
0.1
Male, Group: VII - 1000 ing/kg - Day 91
641067
NONE"
NONE
0.1
641077
NONE
NONE
0.1
641086
NONE
NOME
0.1
641095
NONE
NOME
0.1
641097
NONE
NONE
0.1
641132
NONE
NOME
0.1
641157
NONE
NONE
0.1
641166
NONE
NONE
0.1
641201
NONE
NONE
0.1
641223
NONE
NONE
0.1
720
A A ^::^:: ::<s$3
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AND PLASMA CHEMISTRY VALUES FOR MALE RATS
Animal Number
SHEM
SLIP
SICT
Male/ Group:
641083 641084 641085 641101 641105 641123 641154 641159 641165 641215
1-0 nig/kg --
NONE NONE NONE NONE NONE NONE NONE NONE NONE NONE
Day 123
NONE NONE NONE NONE NONE NONE NONE NONE NONE NONE
NONE NONE NONE NONE NONE NOME NONE NONE NONE NONE
Male, Group: VII - 1000 ing/kg - Day 123
641064 641092 641143 641153 641167 641185 641189 641203 641213 641216
NONENOME NONE TRACE NONE TRACE NONE NONE NONE NONE
NONE NONE NONE NONE NONE NONE NONE NONE NONE NONE
NONE NONE NOME NONE NOME NONE NONE NONE NONE NONE
AST
IU/L
82 69 84 80 75 74 106 73 75 74
117 67 71 90
155 85 95
453 93 79
ALT
IU/L
SDH
IU/L
34
20.6
27
15.2
32
18.8
34
21.8
33
18.7
32
14.7
40
23.1
30
22.6
29
14.0
53
24.9
48
18.6
36
15.5
40
18.9
54
19.7
RNV
45.0
45
21.5
65
18.1
520
133.0
41
20.4
37
16.4
ALKP
IU/L
BILI
mg/dL
BUN mg/dL
66
0.12
16
66.
<0.10
16
84
0.10
15
73
0.12
12
83
<0.10
14
85
<0.10
13
61
0.10
14
78
<0.10
14
103
<0.10
12
103
0.12
13
114
<0.10
18
115
<0.10
15
83
<0.10
16
160
<0.10
18
161
<0.10
13
144
<0.10
17
136
<0.10
14
215
0.11
12
105
<0.10
12
116
<0.10
15
721
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
TNDIVIDUAL SERUM AND PLASMA CHEMISTRY VALUES FOR MALE RATS
Animal Number
TRIG mg/dL
GLUC
mg/dL
TP
g/dL
Male, Group: 1-0 ing/kg - Day 123
641083
180
118
7.2
641084
245
126
7.0
641085
120
112
7.1
641101
283
137
7.0
641105
157
110
7.0
641123
213
131
6.7
641154
169
112
6.4
641159
269
131
6.9
641165
157
111
6.8
641215
302
133
7.2
Male, Group: VII - 1000 ing/kg - Day 123
641064
110
113
7.0
641092
180
122
7.0
641143
92
114
7.0
641153
42
130
6.3
641167
153
135
7.3
641185
78
111
7.1
641189
71
124
6.9
641203
79
123
7.3
641213
209
131
7.4
641216
.137
116
6.8
ALB
g/dL
4.3 4.3 4.2 4.3 4.1 4.0 4.2 4.2 4.0 4.4
4.6 4.5 4.5 4.2 4.6 4.7 4.4 4.6 4.9 4.3
GLOB
g/dL
CALC mg/dL
IPHS mg/dL
NA mmol/L
K
mmol/L
2.9
11.3
2.7
10.7
2.9
11.3
2.7
11.3
2.9
10.8
2.7
11.1
2.2
10.8
2.7
11.0
2.8
10.8
2.8
11.5
2.4
10.8
2.5
11.3
2.5
10.8
2.1
10.4
2.7
11.1
2.4
10.9
2.5
10.6
2.7
11.1
2.5
11.3
2.5
11.3
7.3
145.6
6.8
145.0
7.0
146.7
7.2
147.2
7.3
146.1
7.0
147.3
6.5
145.4
7.4
146.1
6.6
147.6
6.9
147.7
8.2
146.2
7.3
146.9
7.0
148.9
7.8
147.5
7.2
146.6
7.9
146.7
7.2
146.7
7.6
146.3
7.2
146.1
8.0
147.9
5.93 5.83 5.85 6.54 6.23 6.17 5.92 6.29 5.81 5.96
6.47 6.64 5.93 6.31 6.07 6.51 5.91 6.12 6.10 5.79
722
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AND PLASMA CHEMISTRY VALUES FOR MALE RATS
Animal Number
PLIP
PICT
PFLU
Male, Group: 1-0 mg/kg - Day 123
641083
MT
NT
MT
641084
MT
NT
NT
641085
NT
NT
NT
641101
NT
NT
NT
641105
NT
NT
NT
641123
MT
NT
MT
641154
NT
NT
NT
641159
NT
NT
NT
641165
NT
MT
MT
641215
NT
NT
NT
Male, Group: VII - 1000 mg/kg - Day 123
641064
NT
NT
NT
641092
NT
NT
MT
641143
NT
NT
NT
641153
NT
NT
MT
641167
NT
NT
MT
641185
NT
NT
NT
641189
NT
MT
MT
641203
NT
NT
NT
641213
NT
NT
NT
641216
NT
NT
NT
723
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AMD PLASMA CHEMISTRY VALUES FOR FEMALE RATS
Animal Number
SHEM
SLIP
SICT
AST
IU/L
ALT
IU/L
Female, Group:
641240 641245 641249 641257 641283 641290 641293 641335 641344 641384
II - 0
SMALL SMALL TRACE
NONE SMALL TRACE
NONE NONE SMALL SMALL
ing/kg - Day 44
NONE NONE NONE NONE NONE NONE NONE NOME NONE NONE
NONE NONE NONE NONE NONE NONE NONE NOME NONE NONE
Female, Group: IV - 50 mg/kg - Day 44
641260 641298 641311 641312 641313 641336 641355 641361 641369 641396
SMALL SMALL
NONE MODERATE
NONE SMALL
NOME TRACE TRACE SMALL
NONE NONE NONE NONE NONE NONE NONE NONE NONE NONE
NONE NONE NONE NONE NONE NONE NONE NONE NONE NONE
83 95 74 90 79 89 79 80 78 73
106 79 82
MT-HEMOL 77
214 94 80
152 82
38 37 33 35 33 36 40 35 36 30
35 30 35 NT-HEMOL 28 104 44 36 95 35
SDH
IU/L
ALKP
IU/L
BILI
mg/dL
BUN
ing/dL
20.5
60
0.13
13
15.1
125
0.14
13
23.2
82
<0.10
14
37.1
118
0.15
17
21.0
66
0.11
15
17.9
58
0.12
15
25.8
93
0.12
17
20.8
92
0.10
17
19.8
56
0.15
21
23.1
64
0.10
14
12.7
90
0.11
13
22.2
91
0.10
16
21.1
112
0.11
16
14.6 NT-HEMOL NT-HEMOL
15
18.8
71
0.12
14
57.4
105
0.10
15
17.3
81
0.15
16
21.2
107
<0.10
15
32.4
77
<0.10
18
23.6
85
<0.10
17
724
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AND PLASMA CHEMISTRY VALUES FOR FEMALE RATS
Animal Number
SHEM
SLIP
SICT
Female, Group: VI - 250 mg/kg - Day 44
641244 641251 641269 641292 641302 641362 641363 641375 641379 641398
NONE TRACE
NONE SMALL
NOME SMALL
NONE SMALL SMALL SMALL
NONE NONE NONE NONE NONE NONE NONE NONE NOME NONE
MONE NONE NONE NONE NONE NOME NOME MOME MONE NONE
Female, Group: VIII -
641237 641275 641279 641299 641300 641314 641326 641327 641380 641390
MONETRACE SMALL SMALL TRACE TRACE TRACE SMALL SMALL SMALL
1000 mg/kg -
NONE NOME NONE NONE NONE NOME NOME MOME NOME NOME
Day 44
NONE NOME MOME MONE NONE NOME NOME NOME NOME MOME
AST
IU/L
68 76 85 82 86 80 87 83 87 83
100 92 75 94
135 82 74 62
100 99
ALT
IU/L
27 39 38 32 34 32 34 35 43 41
40 36 24 40 41 40 35 31 47 59
SDH
IU/L
19.1 20.2 23.1
9.7 24.7 19.2 14.0 12.2 21.5 22.5
22.8 25.3 20.5 20.4 12.4 16.8 18.3 15.2 17.4 34.2
ALKP
IU/L
BILI
mg/dL
BUM
mg/dL
72
<0.10
15
113'
<0.10
14
95
0.11
18
70
<0.10
16
98
0.13
17
81
0.15
17
68
<0.10
12
56
0.10
13
90
<0.10
20
68
0.10
16
66
<0.10
18
82
0.12
18
58
0.11
15
81
<0.10
15
103
<0.10
13
112
<0.10
16
78
<0.10
18
80
<0.10
19
104
<0.10
21
54
<0.10
16
725
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AMD PLASMA CHEMISTRY VALUES FOR FEMALE RATS
Animal Number
TRIG mg/dL
GLUC
mg/dL
TP
g/dL
ALB
g/dL
GLOB
g/dL
Female, Group: II - 0 mg/kg - Day 44
641240 641245 641249 641257 641283 641290 641293 641335 641344 641384
53
104
7.6
61
79
7.3
25
113
7.2
52
89
7.5
50
102
7.0
54
111
7.9
55
98
7.5
39
83
7.5
33
104
7.3
39
88
7.2
Female, Group: IV - 50 nig/kg - Day 44
641260 641298 641311 641312 641313 641336 641355 641361 641369 641396
31. 30 27
NT-HEMOL 18 58 69 31 43 40
96
6.8
95
7.4
95
7.9
113 NT-HEMOL
95
6.3
103
7.7
87
7.4
101
7.1
85
7.2
115
7.2
5.0 4.8 4.9 5.0 4.7 5.4 4.9 5.0 4.9 5.0
4.8 4.9 5.1
NT-HEMOL
4.3 5.4 5.1 4.8 5.1 4.9
2.6 2.5 2.3 2.5 2.3 2.5 2.6 2.5 2.4 2.2
2.0 2.5 2.8
NT-HEMOL
2.0 2.3 2.3 2.3 2.1 2.3
CALC
mg/dL
IPHS mg/dL
NA mmol/L
K
nrool/L
11.1 10.5 11.2 11.4 10.6 11.2 11.2
11.0 10.9 10.9
7.9
144.9
7.2
144.7
8.4
145.9
9.3
149.0
7.6
147.3
7.8
144.3
8.4
147.9
8.0
147.1
7.3
144.8
8.1
145.6
6.64 5.64 5.97 6.75 5.97 6.03 6.77 6.30 6.10 6.37
10.5
7.2
146.7
5.69
10.9
8.6
146.5
6.46
11.2
8.9
144.6
5.90
10.5 MT-HEMOL NT-HEMOL MT-HEMOL MT
10.2
8.1
146.9
5.51
10.8
6.5
144.0
6.01
10.9
7.8
145.4
5.81
10.6
7.8
147.9
6.23
11.2
8.1
146.2
6.51
10.6
7.0
147.9
5.93
726
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AND PLASMA CHEMISTRY VALUES FOR FEMALE RATS
Animal Number
TRIG mg/dL
GLUC
mg/dL
TP
g/dL
Female, Group: VI - 250 ing/kg - Day 44
641244 641251 641269 641292 641302 641362 641363 641375 641379 641398
16
98
6.8
26
109
7.0
43
84
7.1
56
103
6.7
28
105
6.8
29
102
6.5
46
117
7.7
41
101
6.8
31
116
7.0
24
101
7.2
Female, Group: VIII -
641237
17
641275
39
641279
34
641299
33
641300
35
641314
21
641326
16
641327
40
641380
26
641390
31
1000 mg/kg -
110 96
120 95 99 98 85
103 100 124
Day 44
7.5 7.4 7.9 7.5 7.0 7.0 7.2 7.7 7.5 8.3
ALB
g/dL
4.4 4.9 5.0 4.7 4.8 4.7 5.5 4.8 4.5 5.0
5.5 5.4 5.7 5.4 4.9 4.7 5.1 5.3 4.9 5.8
GLOB
g/dL
CALC mg/dL
IPHS mg/dL
NA mmol/L
K
mmol/L
2.4
10.5
2.1
10.6
2.1
11.2
2.0
10.6
2.0
10.2
1.8
10.0
2.2
10.8
2.0
10.1
2.5
10.5
2.2
10.9
2.0
10.3
2.0
10.9
2.2
11.1
2.1
11.0
2.1
10.3
2.3
10.5
2.1
11.0
2.4
11.0
2.6
10.3
2.5
RNV
8.0
145.8
6.8
145.5
8.4
146.6
9.7
143.1
6.2
146.9
6.5
147.7
6.6
146.1
7.3
144.5
7.6
147.2
8.3
145.9
7.1
147.5
6.9
147.2
7.9
147.9
8.3
146.1
7.7
144.6
8.5
144.4
8.2
147.4
7.8
146.2
8.4
144.2
8.2
146.1
5.88 6.02 6.20 6.05 5.54 6.11 5.46 6.27 6.11 6.44
5.89 5.70 6.46 6.04 6.08 6.36 6.05 6.39 5.69 6.68
727
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AMD PLASMA CHEMISTRY VALUES FOR FEMALE RATS
Animal Number
PLIP
PICT
PFLU
Female/ Group: 11-0 mg/kg - Day 44
641240
NT
NT
NT
641245
NT
NT
NT
641249
NT
NT
NT
641257
NT
NT
NT
641283
NT
NT
NT
641290
NT
NT
NT
641293
NT
NT
NT
641335
NT
NT
NT
641344
NT
NT
NT
641384
NT
NT
MT
Female, Group: IV - 50 mg/kg - Day 44
641260
NT"
NT
NT
641298
NT
NT
MT
641311
NT
NT
NT
641312
NT
NT
NT
641313
NT
NT
NT
641336
NT
NT
NT
641355
NT
NT
NT
641361
NT
MT
MT
641369
NT
NT
NT
641396
MT
NT
NT
728
'v^W'
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AMD PLASMA CHEMISTRY VALUES FOR FEMALE RATS
Animal Number
PLIP
PICT
PFLU
Female, Group: VI - 250 ing/kg - Day 44
641244
NT
NT
NT
641251
NT
NT
NT
641263
NT
NT
NT
641292
NT
NT
NT
641302
NT
NT
NT
641362
NT
NT
NT
641363
NT
NT
NT
641375
NT
NT
NT
641379
NT
NT
NT
641398
NT
NT
NT
Female, Group:
641237 641275 641279 641299 641300 641314 641326 641327 641380 641390
VIII -
MTNT NT MT NT NT NT NT NT NT
1000 ing/kg -
NT NT NT NT NT NT NT NT NT NT
Day 44
NT NT NT NT NT NT NT NT NT NT
729
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AND PLASMA CHEMISTRY VALUES FOR FEMALE RATS
Animal Number
SHEM
SLIP
SICT
Female, Group:
641240 641245 641249 641257 641283 641290 641293 641335 641344 641384
11-0
NONE TRACE
NSR NONE TRACE NONE NONE NONE TRACE NONE
mg/kg - Day 92
NONE NOME
NT
NONE NONE NONE NONE NONE NONE NONE
NONE NONE
MT NONE NONE NONE NONE NONE NONE NONE
Female, Group: IV - 50 mg/kg - Day 92
641260 641298 641311 641312 641313 641336 641355 641361 641369 641396
TRACENONE NONE
TRACE TRACE
NONE NONE NONE NONE NONE
NONE NONE NONE NONE NONE NONE NONE NONE NONE NONE
NONE NONE NONE NONE NONE NONE NONE NOME NOME NONE
AST
IU/L
87 109
NT 93 82 66 103 115 70 63
114 77 84
101 82 85
151 106 126 207
ALT
IU/L
28 58 NT 38 32 26 43 58 20 23
67 31 35 35 31 31 79 80 84 150
SDH
IU/L
16.2 23.5
NT
20.1 20.6 22.0 20.8 33.0 17.8 22.1
27.8 20.4 19.6 18.1 17.1 27.5 26.2 26.1 25.5 55.8
ALKP
IU/L
BILI
ing/dL
BUN
mg/dL
39
0.18
13
81
0.17
15
NT
NT
NT
47
0.18
15
48
0.18
16
31
0.24
14
88
0.12
15
53
0.19
17
27
0.21
16
41
0.18
11
54
0.17
17
46
0.17
16
66
0.16
16
54
0.21
15
50
0.20
18
114
0.11
16
66
0.10
23
55
0.14
12
37
0.15
19
36
0.19
15
730
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AND PLASMA CHEMISTRY VALUES FOR FEMALE RATS
Animal Number
SHEM
SLIP
SICT
Female, Group: VI - 250 mg/kg - Day 92
641244 641251 641269 641292 641302 641362 641363 641375 641379 641398
TRACE NOME NONE
TRACE TRACE TRACE
NONE TRACE
NONE TRACE
NONE NONE NONE NONE NONE NOME NONE NONE NOME NONE
MOME NOME NOME NONE NONE NONE NOME MOME NOME MOME
Female, Group:
641237 641275 641273 641299 641300 641314 641326 641327 641380 641390
VIII -
NONE TRACE TRACE
NONE NOME NONE NONE NONE HONE NONE
1000 mg/kg -
NONE NONE NOME NOME NONE MOME NONE NOME NONE NONE
Day 92
NONE MOME NONE NOME NONE NONE NONE NOME MOME MOME
AST
IU/L
89 66 117 91 77 82 68 72 137 70
160 87 80 99 71 83 77 68
120 61
ALT
IU/L
35 37 41 58 30 37 34 38 106 34
66 35 27 41 35 40 36 28 55 31
SDH
IU/L
19.4 19.6 28.7 25.5 19.0 19.9 17.8 20.1 30.6 19.7
15.2 21.0 20.6 20.0 16.3 19.1 21.2 20.6 27.7 19.1
ALKP
IU/L
BILI
mg/dL
BUM
mg/dL
44
0.14
17
59.
0.17
19
70
0.15
15
50
0.17
18
66
0.18
16
56
0.16
15
35
0.19
14
35
0.16
14
42
0.12
16
45
0.11
16
40
0.13
20
62
0.11
17
48
<0.10
13
71
0.14
18
61
0.11
15
90
0.13
19
61
0.10
21
56
<0.10
18
61
0.11
20
28
0.11
17
731
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AND PLASMA CHEMISTRY VALUES FOR FEMALE RATS
Animal Number
TRIG mg/dL
GLUC
mg/dL
TP
g/dL
Female, Group: II - 0 nig/kg - Day 92
641240
39
113
7.9
641245 641249
48
101
7.5
NT
NT
NT
641257
57
102
8.0
641283
51
125
8.0
641290
127
129
8.5
641293
59
107
8.0
641335
41
157
7.9
641344
40
107
8.0
641384
52
115
7.9
Female, Group: IV - 50 mg/kg - Day 92
641260 641298 641311 641312 641313 641336 641355 641361 641369 641396
3L
107
7.4
60
114
7.9
38
106
8.3
40
108
8.3
26
95
7.0
75
142
8.1
72
114
8.1
35
109
8.0
78
101
7.6
72
118
9.0
ALB
g/dL
5.2 4.7
NT
5.3 5.3 5.7 5.0 5.1 5.1 5.4
5.1 5.2 5.3 5.5 4.6 5.5 5.5 5.3 5.2 6.2
GLOB
g/dL
CALC
mg/dL
IPHS ing/dL
NA mrnol/L
K
mmol/L
2.7
10.8
2.8
10.7
NT
NT
2.7
11.1
2.7
11.1
2.8
12.0
3.0
11.1
2.8
10.9
2.9
11.2
2.5
11.2
2.3
2.7 3.0 2.8 2.4 2.6 2.6 2.7 2.4
2.8
11.1 11.1 11.3 11.0 10.6 11.2 11.4 11.0 11.3 11.8
RNV
146.7
5.5
148.3
NT
NT
5.8
146.7
5.2
148.6
6.0
147.2
5.7
150.3
3.1
147.2
5.1
147.3
4.5
147.3
5.5
148.5
6.0
148.1
6.1
145.8
4.4
146.6
6.1
147.3
5.0
147.9
5.0
148.5
6.0
149.1
5.3
146.9
4.9
147.2
5.75 5.77
NT
5.29 5.30 5.80 5.84 5.44 6.01 5.86
5.58 6.12 5.58 5.57 5.22 5.72 5.97 5.76 5.81 5.32
732
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AND PLASMA CHEMISTRY VALUES FOR FEMALE RATS
Animal Number
TRIG mg/dL
GLUC mg/dL
TP
g/dL
Female, Group; VI - 250 ing/kg - Day 92
641244 641251
27
96
7.6
55
106
7.9
641269 641292
54
102
7.9
77
122
7.9
641302
29
100
7.2
641362
26
105
6.9
641363
185
121
9.0
641375
50
112
7.4
641379 641398
36
120
8.1
44
105
7.5
Female, Group: VIII -
641237
41
641275
32
641279
44
641299
48
641300
55
641314
26
641326
41
641327
80
641380
47
641390
52
1000 ing/kg -
168 107 122 143 100 118 159 112 171 125
Day 92
8.0 8.0 8.4 8.1 6.8 7.8 8.0 8.8 7.9 8.9
ALB
g/dL
4.9 5.4 5.2 5.3 4.8 4.9 6.0 5.1 5.3 5.1
5.5 5.5 5.8 5.6 4.7 5.0 5.4 5.7 5.3 6.0
GLOB
g/dL
CALC mg/dL
IPHS
NA
K
mg/dL
inmol/L
mmol/L
m
2.7
10.8
2.5
11.5
2.7
12.0
2.6
11.1
2.4
10.7
2.0
11.0
3.0
12.1
2.3
10.5
2.8
11.2
2.4
11.3
2.5
10.6
2.5
11.2
2.6
11.3
2.5
11.0
2.1
10.9
2.8
10.9
2.6
11.4
3.1
11.5
2.6
11.0
2.9
11.9
5.4
147.7
5.1.
147.1
7.1
151.6
6.0
148.2
5.6
148.5
5.9
147.2
5.2
145.6
5.8
148.2
4.7
149.8
5.9
146.8
6.1
147.4
4.9
148.9
5.2
148.6
4.9
147.3
6.2
145.1
6.4
147.2
5.4
147.4
5.9
147.5
5.2
148.5
5.6
148.5
5.22 5.82 6.71 5.28 5.69 5.90 5.13 5.93 5.50 5.56
6.75 5.35 6.12 5.75 5.99 5.88 5.69 5.53 5.70 5.41
733
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AMD PLASMA CHEMISTRY VALUES FOR FEMALE RATS
Animal Number
PLIP
PICT
PFLU ^g/mL
Female, Group: 11-0 mg/kg - Day 92
641240
NOME
NOME
0.2
641245
NONE
NONE
0.2
641249
NT
NT
MSR
641257
NONE
MOME
0.2
641283
NONE
NONE
0.3
641290
NONE
NONE
0.2
641293
NONE
NONE
QNS
641335
NONE
NONE
0.1
641344
NONE
NONE
0.2
641384
NONE
NONE
0.2
Female, Group: IV - 50 ing/kg - Day 92
641260
NONE-
NONE
0.3
641298
NONE
NONE
0.2
641311
NOME
NOME
0.2
641312
NOME
NONE
0.2
641313
NOME
NONE
0.2
641336
NONE
NONE
0.2
641355
NONE
NOME
0.2
641361
NONE
MOME
0.2
641369
NONE
MOME
0.2
641396
NONE
MOME
0.2
734
H-24616; Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AMD PLASMA CHEMISTRY VALUES FOR FEMALE RATS
Animal Number
PLIP
PICT
PFLU Aig/mL
Female, Group: VI - 250 ing/kg - Day 92
641244
NONE
NOME
0.2
641251
NONE
NOME
0.2
641269
NONE
HOME
0.1
641292
NONE
NOME
0.2
641302
NONE
NOME
0.2
641362
NONE
NONE
0.1
641363
NONE
NONE
0.2
641375
NONE
HONE
0.2
641379
NONE
NONE
0.3
641398
NONE
NONE
0.2
Female, Group: VIII -
641237 641275 641279 641299 641300 641314 641326 641327 641380 641390
NONE NOME NONE NONE NONE NONE NONE MONE NOME NONE
1000 ing/kg -
NONE NOME NOME NONE NOME NONE NONE NONE NONE NONE
Day 92
0.2 0.3 0.2 0.2 0.2 0.2 0.3 0.2 0.3 0.2
735
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AMD PLASMA CHEMISTRY VALUES FOR FEMALE RATS
Animal Number
SHEM
SLIP
SICT
Female, Group:
641253 641266 641281 641294 641325 641331 641359 641364 641383 641400
11-0
TRACE NONE NONE NONE NONE NOME
TRACE NOME NOME NONE
ing/kg - Day 124
NONE NONE NONE NONE NONE NONE NONE NONE NONE NONE
NONE NONE NONE NONE NONE NOME NOME NONE NONE NONE
Female, Group: VIII -
641234 641256 641282 641352 641356 641366 641377 641385 641387 641399
NONENONE NOME NONE
NSR NONE NONE NONE NONE NONE
1000 mg/kg -
NONE NONE NONE NONE
NT
NOME NONE NONE NONE NONE
Day 124
NONE NONE NONE NONE
NT NONE NOME NONE NONE NONE
AST
IU/L
69 107 120
90 98 102 99 88 142 99
76 69 74 65 NT 598 76 89 81 243
ALT
IU/L
SDH
IU/L
26
20.6
48
26.1
89
28.9
96
24.9
93
28.4
58
18.9
37
23.6
40
24.8
108
38.8
44
26.0
39
15.1
36
16.7
31
19.0
32
13.1
NT
NT
590
226.0
35
22.7
50
23.4
27
20.0
277
52.9
ALKP
IU/L
BILI
mg/dL
BUN
mg/dL
40
0.12
15
37
0.18
15
38
0.16
16
41
0.18
14
33
0.21
14
72
0.17
10
51
0.12
13
32
0.10
16
27
0.15
15
32
0.10
17
60
0.11
14
29
<0.10
17
41
<0.10
15
36
0.13
14
NT
NT
NT
45
0.14
14
33
0.12
14
37
<0.10
17
76
0.12
14
35
<0.10
20
736
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AMD PLASMA CHEMISTRY VALUES FOR FEMALE RATS
Animal Number
TRIG mg/dL
GLUC
mg/dL
TP
g/dL
Female/ Group; II - 0 mg/kg - Day 124
641253
83
90
7.3
641266
64
106
8.4
641281
62
123
9.0
641294
108
118
8.6
641325
52
112
9.3
641331
35
109
7.9
641359
53
96
7.7
641364
60
103
8.1
641383
54
110
8.7
641400
47
99
8.1
Female, Group: VIII - 1000 mg/kg - Day 124
641234
50-
115
7.7
641256
57
116
8.4
641282
105
100
8.1
641352
62
109
8.5
641356
NT
NT
NT
641366
54
102
8.5
641377
20
96
7.6
641385
58
85
8.5
641387
41
99
8.1
641399
. 53
118
8.3
ALB
g/dL
4.7 5.5 6.2 5.7 6.5 5.6 5.2 5.3 6.0 5.5
5.4 6.1 5.0 5.8
NT
5.5 5.4 5.8 5.3 5.6
GLOB
g/dL
CALC mg/dL
IPHS mg/dL
NA inmol/L
K
inmol/L
2.6
11.1
2.9
11.8
2.8
12.3
2.9
12.0
2.8
12.4
2.3
11.2
2.5
11.0
2.8
11.5
2.7
11.9
2.6
11.4
2.3
11.1
2.3
11.8
3.1
11.8
2.7
11.9
NT
NT
3.0
12.0
2.2
11.2
2.7
11.8
2.8
11.5
2.7
11.6
6.7
145.1
6.8'
146.2
7.5
145.5
6.3
144.9
5.6
146.1
5.7
146.8
6.5
146.8
6.0
145.1
6.1
145.2
5.8
145.3
6.6
145.9
6.4
147.1
7.4
149.2
6.1
145.9
NT
NT
6.0
146.1
6.3
147.9
6.8
146.5
6.9
147.0
6.2
146.7
6.10 6.41 6.47 5.28 4.89 5.08 5.94 5.44 5.27 5.79
5.47 5.22 5.36 5.52
NT
5.18 5.95 5.30 5.43 5.22
737
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL SERUM AND PLASMA CHEMISTRY VALUES FOR FEMALE RATS
Animal Number
PLIP
PICT
PFLU
Female, Group: 11-0 mg/kg - Day 124
641253
NT
NT
NT
641266
NT
NT
NT
641281
NT
NT
NT
641294
NT
NT
NT
641325
NT
NT
NT
641331
NT
NT
NT
641359
NT
NT
NT
641364
NT
NT
NT
641383
NT
NT
NT
641400
NT
NT
NT
Female, Group: VIII -
641234
NT-
641256
NT
641282
NT
641352
NT
641356
NT
641366
NT
641377
NT
641385
NT
641387
NT
641399
NT
1000 ing/kg -
NT NT NT NT MT MT NT NT NT NT
Day 124
NT NT NT MT . NT NT NT NT NT NT
738
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URINALYSIS VALUES FOR MALE RATS
Animal Number
QUAL
COL
CLAR
Male, Group:
641069 641070 641094 641147 641149 641155 641172 641206 641214 641222
1-0 nig/kg
MEDIUM LIGHT LIGHT
MEDIUM MEDIUM
DARK MEDIUM
LIGHT MEDIUM
LIGHT
- Day 44
YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW
CLEAR CLEAR CLEAR CLEAR CLEAR CLOUDY CLEAR CLEAR
HAZY CLEAR
Male, Group:
641055 641056 641073 641081 641144 641146 641178 641198 641218 641224
III - 50 ing/kg - Day 44
MEDIUM LIGHT
MEDIUM LIGHT
MEDIUM MEDIUM MEDIUM
LIGHT MEDIUM MEDIUM
YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW
CLEAR CLEAR CLOUDY CLEAR
HAZY CLEAR
HAZY HAZY CLEAR CLOUDY
VOL
UOSM
SG
mL
mOsm/kg
9.4 11.0 16.0
7.0 4.8 8.4 13.4 1.0 4.8 18.0
13.4 12.8
7.0 12.0 12.0 10.2 11.0 22.0
4.6 14.0
1111 967 862
1017 1796 1200 1002
QNS
1705 628
779 627 1300 753 771 813 1121 .677 1692 921
1.037 1.029 1.026 1.033 1.055 1.038 1.030 1.025 1.055 1.021
1.024 1.020 1.041 1.024 1.024 1.025 1.036 1.022 1.053 1.029
PH
UGLU
KET
ing/dL
mg/dL
6.5 NEGATIVE
5 N
6.5 NEGATIVE
5 N
7.0 NEGATIVE
5 N
7.0 NEGATIVE
5 N
6.0 NEGATIVE
5 N
7.0 NEGATIVE
15
7.0 NEGATIVE NEGATIVE N
5.0 NEGATIVE
5 N
6.5 NEGATIVE
15 N
7.0 NEGATIVE
15 N
7.0 NEGATIVE NEGATIVE N
7.0 NEGATIVE
5 N
6.5 NEGATIVE
5
N
7.0 NEGATIVE
15 N
6.5 NEGATIVE
5
N
7.0 NEGATIVE
15 N
7.0 NEGATIVE
5 N
7.0 NEGATIVE
5 N
6.5 NEGATIVE
15 N
7.0 NEGATIVE
5 N
739
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URINALYSIS VALUES FOR MALE RATS
Animal number
QUAL
COL
CLAR
Male, Group: V - 250 ing/kg - Day 44
641061 641089 641102 641134 641137 641162 641190 641197 641200 641202
MEDIUM MEDIUM MEDIUM MEDIUM
NT MEDIUM
LIGHT MEDIUM MEDIUM MEDIUM
YELLOW YELLOW YELLOW YELLOW
NT YELLOW YELLOW YELLOW YELLOW YELLOW
CLEAR CLEAR CLEAR CLOUDY
NT CLOUDY
CLEAR CLEAR CLEAR CLEAR
Male, Group: VII - 1000 nig/kg - Day 44
641067 641077 641086 641095 641097 641132 641157 641166 641201 641223
LIGHT LIGHT MEDIUM MEDIUM LIGHT
DARK MEDIUM MEDIUM
LIGHT MEDIUM
YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW
CLEAR CLEAR CLEAR CLEAR CLEAR CLOUDY
HAZY CLEAR CLEAR CLEAR
VOL
UOSM
SG
mL
mOsm/kg
3.4 13.0 11.8
8.8
QNS
2.3 18.6 10.0
4.2 4.8
28.0 22.0
7.4 3.6 24.2 2.0 3.4 9.8 10.6 10.0
2771 629 924 959
QNS
2662 539 719
1854 1855
447 486 1347 2363 491 2306 2776 874 695 989
1.077 1.020 1.028 1.029
NT
1.076 1.018 1.024 1.056 1.058
1.014 1.016 1.044 1.069 1.016 1.070 1.076 1.027 1.023 1.030
pH
UGLU
KET
mg/dL
mg/dL
6.0 NEGATIVE 7.0 NEGATIVE 7.0 NEGATIVE 7.0 NEGATIVE
NT
NT
6.5 NEGATIVE 7.0 NEGATIVE 7.0 NEGATIVE
6.5 NEGATIVE 6.0 NEGATIVE
5
5 N 5 N 5 N NT 15 5 N 5 N 5 N 15 N
7.0 NEGATIVE
5 N
7.0 NEGATIVE NEGATIVE N
6.5 NEGATIVE
5 N
6.5 NEGATIVE
5 N
7.0 NEGATIVE NEGATIVE N
7.5 NEGATIVE
15
6.5 NEGATIVE
15 N
7.0 NEGATIVE
15 N
7.0 NEGATIVE
15 N
7.0 NEGATIVE
5 N
740
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URINALYSIS VALUES FOR MALE RATS
Animal Number
URO
EU/dL
UPLU
UMTP ing/dL
Male, Group: 1-0 nig/kg - Day 44
641069
0.2
641070
0.2
641094
0.2
641147
0.2
641149
0.2
641155
0.2
641172
0.2
641206
0.2
641214
0.2
641222
0.2
MT
111
NT
66
NT
53
NT
89
NT
151
NT
82
NT
60
NT
49
NT
186
NT
41
Male, Group: III - 50 ing/kg - Day 44
641055
0.2-
641056
0.2
641073
0.2
641081
0.2
641144
0.2
641146
0.2
641178
0.2
641198
0.2
641218
0.2
641224
0.2
NT
47
MT
23
NT
89
NT
42
NT . 46
NT
40
NT
62
NT
38
NT
157
NT
56
SPEC
FEECCJAL CONTAMINATION OBSERVED
SSaammi ple status: URINALYSIS TO BE RUN MANUALLY -
FECiAL CONTAMINATION OBSERVED
LOW VOLUME
PFECGAL CONTAMINATION OBSERVED PFEECC;AL CONTAMINATION OBSERVED
FEECQAL CONTAMINATION OBSERVED
741
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URINALYSIS VALUES FOR MALE RATS
Animal Number
UR 0 EU/d L
UFLU
TJMTP
meT/dL
Male, Group: V - 25 0 mg/'kg - Day 44
641061
1. 0
MT
220
641089
0. 2
NT
27
641102
0. 2
NT
51
641134
0. 2
NT
55
641137
MT
QNS
QMS
641162
1. 0
641190
0. 2
641197
0. 2
641200
0. 2
641202
0. 2
MT
85
MT
18
NT
32
MT
164
MT
94
Male, Group: VII - 1000 mg/kg - Day 44
641067 641077 641086 641095 641097 641132 641157 641166 641201 641223
0. 22". 0. 0. 2 0. 2 0. 2 1. 0 1. 0 0. 2 0. 2 0. 2
NT
18
MT
16
MT
96
NT
174
NT
14
NT
190
NT
160
NT
49
NT
27
NT
44
SPEC PFEECC.AL CONTAMINATION OBSERVED FEECC.AL CONTAMINATION OBSERVED
FECC.AL COMTAMINATIOM OBSERVED
742
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URIMALYSIS VALUES FOR MALE RATS
Animal Number
QUAL
COL
CLAR
Male, Group:
641069 641070 641094 641147 641149 641155 641172 641206 641214 641222
1-0 ing/kg
MEDIUM MEDIUM
LIGHT MEDIUM MEDIUM MEDIUM MEDIUM
LIGHT MEDIUM MEDIUM
- Day 91
YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW
CLEAR HAZY
CLEAR CLOUDY
HAZY HAZY CLEAR HAZY HAZY HAZY
Male, Group:
641055 641056 641073 641081 641144 641146 641178 641198 641218 641224
III - 50 mg/kg - Day 91
LIGHTLIGHT MEDIUM LIGHT LIGHT MEDIUM MEDIUM LIGHT LIGHT MEPIUM
YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW
HAZY HAZY CLEAR CLEAR CLEAR HAZY CLEAR CLEAR CLEAR HAZY
VOL
UOSM
SG
ItiL
mOsm/kg
6.4 4.4 7.4 2.4 5.5 5.4 6.8 30.0 10.0 7.1
17.4 4.0 5.4 9.7
14.0 4.3
11.6 17.6 18.8 11.0
1279 1540 1344 1818 1252 1585 1376
465 837 1256
493 1192 1530 1016
746 1861
817 543 482 1220
1.042 1.049 1.041 1.056 1.040 1.049 1.044 1.017 1.027 1.039
1.016 1.038 1.047 1.030 1.025 1.055 1.027 1.018 1.017 1.039
PH
UGLU
KET
mg/dL
mg/dL
6.5 NEGATIVE 6.5 NEGATIVE 7.0 NEGATIVE 6.5 NEGATIVE 6.5 NEGATIVE 6.5 NEGATIVE 7.0 NEGATIVE 6.0 NEGATIVE
7.0 NEGATIVE 7.0 NEGATIVE
5 NE 5 NE 5 NE 5 NE 5 NE
5
5 NE 5 NE 5 NE 5 NE
6.5 NEGATIVE NEGATIVE NE
6.5 NEGATIVE
15 NE
7.0 NEGATIVE
5 NE
6.0 NEGATIVE
5 NE
6.0 NEGATIVE 7.0 NEGATIVE 6.0 NEGATIVE
7.0 NEGATIVE 5.5 NEGATIVE 6.5 NEGATIVE
5 NE 15
5 NE 5 NE 5 NE 5 NE
743
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URINALYSIS VALUES FOR MALE RATS
Animal Number
QUAL
COL
CLAR
Male, Group: V - 250 mg/kg - Day 91
641061 641089 641102 641134 641137 641162 641190 641197 641200 641202
LIGHT MEDIUM MEDIUM
LIGHT MEDIUM MEDIUM MEDIUM MEDIUM MEDIUM MEDIUM
YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW
CLEAR HAZY HAZY HAZY HAZY HAZY HAZY HAZY HAZY
CLEAR
Male, Group: VII - 1000 mg/kg - Day 91
641067 641077 641086 641095 641097 641132 641157 641166 641201 641223
LIGHTLIGHT LIGHT MEDIUM LIGHT MEDIUM MEDIUM MEDIUM MEDIUM MEDIUM
YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW
HAZY CLEAR CLEAR CLEAR CLEAR CLOUDY CLEAR
HAZY CLOUDY
CLEAR
VOL
UOSM
SG
mL
BiOsm/kg
9.8 6.8 4.3 5.7 6.4 3.3 11.0 3.6 1.7 4.4
17.2 20.2
7.8 7.8 12.0 8.5 4.0 7.4 3.4 5.8
852 1175 1541 1507 1599 2855 1680 2066 3308 1897
509 587 1031 1046 715 1257 2145 1151 910 1401
1.027 1.037 1.048 1.045 1.049 1.077 1.028 1.061 1.083 1.058
1.017 1.019 1.033 1.034 1.023 1.040 1.063 1.035 1.053 1.044
PH
UGLU
KET
mg/dL
mg/dL
6.0 NEGATIVE 6.5' NEGATIVE
7.5 NEGATIVE 7.0 NEGATIVE 6.5 NEGATIVE 6.5 NEGATIVE 6.0 NEGATIVE 7.0 NEGATIVE 6.5 NEGATIVE 6.0 NEGATIVE
5 NE 5 NE 5 NE 5 NE
5
15 NE 5 NE 5 NE 5 NE
15 NE
6.0 NEGATIVE 6.0 NEGATIVE 7.0 NEGATIVE 6.5 NEGATIVE
5 NE 5 NE 5 NE 5 NE
6.5 NEGATIVE NEGATIVE NE
7.5 NEGATIVE 6.0 NEGATIVE 7.5 NEGATIVE
6.5 NEGATIVE 6.5 NEGATIVE
15 5 NE
15 NE 15
5 NE
744
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL UKINALYSIS VALUES FOR MALE RATS
Animal Number
URO
EIJ/dL
UF:LU
'v-g
UMTP i ng/dL
Male, Group: I - 0 ing/kg - Day 91
641069
0.2
8 .9
147
641070
0.2
9 .9
142
641094
0.2
10 .5
99
641147
1.0
QNS
40
641149
0.2
8 .9
108
641155
1.0
12 .3
92
641172
0.2
10 .4
77
641206
0.2
19 .4
40
641214
0.2
13 .6
79
641222
0.2
15 .6
101
Male, Group: III - 50 ing/kg - Day 91
641055
0.2-
18 .4
22
641056
0.2
8 .7
82
641073
0.2
11 .2
98
641081
0.2
11 .7
35
641144
0.2
12 .6
54
641146
1.0
12 .0
128
641178
0.2
19 .2
29
641198
0.2
16 .5
22
641218
0.2
15 .3
22
641224
0.2
15 .4
77
SPEC
745
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URIMALYSIS VALUES FOR MALE RATS
Animal Number
U RO
EU/.3L
UFLU 4g
1IMTP m<?/dL
Male, Group: V - 2 50 mg/'kg - Day 91
641061
0 .2
27.6
38
641089
0 .2
21.8
60
641102
0 .2
21.1
119
641134
0 .2
21.8
78
641137
0 .2
30.5
83
641162
1 .0
32.5
MV
641190
0 .2
22.4
101
641197
1 .0
21.9
148
641200
1 .0
QNS
55
641202
0 .2
24.7
92
Male, Group: VII - 1000 mg/kg - Day 91
641067
0 .2"
45.2
41
641077
0.2
42.2
18
641086
0 .2
40.7
50
641095
0 .2
50.3
30
641097
0 .2
43.6
21
641132
0 .2
63.1
77
641157
1 .0
42.0
75
641166
0 .2
37.9
42
641201
1 .0
8.7
29
641223
0 .2
53.3
65
SPEC
746
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URINALYSIS VALUES FOR MALE RATS
Animal Number
QUAL
COL
CLAR
Male, Group:
641083 641084 641085 641101 64110S 641123 641154 641159 641165 641215
1-0 ing/kg
MEDIUM MEDIUM MEDIUM MEDIUM MEDIUM MEDIUM MEDIUM
LIGHT LIGHT MEDIUM
- Day 123
YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW
HAZY HAZY CLEAR CLEAR CLEAR HAZY CLEAR CLEAR CLEAR CLEAR
Male, Group: VII - 1000 nig/kg - Day 123
641064 641092 641143 641153 641167 641185 641189 641203 641213 641216
MEDIUM. MEDIUM
MEDIUM DARK
LIGHT MEDIUM
LIGHT LIGHT MEDIUM MEDIUM
YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW
HAZY HAZY HAZY CLOUDY HAZY CLEAR HAZY HAZY HAZY CLEAR
VOL
UOSM
SG
mL
mOsm/kg
3.4
3095
1.083
4.1
1630
1.051
2.3
1757
1.055
4.5
2628
1.071
4.5
1390
1.046
3.6
1982
1.059
4.2
1766
1.055
9.8
539
1.017
3.2
1214
1.037
4.3
2225
1.066
3.0
3215
1.083
4.1
2464
1.069
3.1
2380
1.071
3.2
2545 '
1.069
8.2
1199
1.037
3.3
2155
1.065
9.0
900
1.027
9.8
928
1.028
7.9
1200
1.040
2.8
1924
1.061
PH
UGLU
KET
mg/dL
mg/dL
6.0 NEGATIVE 6.5 NEGATIVE 6.0 NEGATIVE
6.5 NEGATIVE 6.0 NEGATIVE 7.5 NEGATIVE 6.0 NEGATIVE 8.5 NEGATIVE 5.5 NEGATIVE 6.5 NEGATIVE
15 5 NE
15 NE 15 NE 15 NE 15 NE 15 NE
5 NE 15 NE
5 NE
6.5 NEGATIVE 7.0 NEGATIVE 6.0 NEGATIVE 8.5 NEGATIVE
7.5 NEGATIVE
15 NE 15 NE 15 NE 15
5 NE
6.5 NEGATIVE
5 NE
8.0 NEGATIVE NEGATIVE NE
7.5 NEGATIVE
5 NE
7.5 NEGATIVE 6.0 NEGATIVE
5 NE 15 NE
747
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URINALYSIS VALUES FOR MALE RATS
Animal Number
U RO
ETJ/ dL
UP L U ^g
UMTP
mg/dL
Male, Group: T -- 0 ing/kg - Day 123
641083
1 .0
16 .5
185
641084
0 .2
6 .0
174
641085
0 .2
6 .6
140
641101
0 .2
19 .7
186
641105
0 .2
8 .0
109
641123
0 .2
11 .4
168
641154
0 .2
7 .2
123
641159
0 .2
8 .8
26
641165
0 .2
5 .0
61
641215
0 .2
13 .5
240
Male, Group: VII - 1000 ing/kg - Day 123
641064 641092 641143 641153 641167 641185 641189 641203 641213 641216
1 .0" 0 .2 0 .2 1 .0 0 .2
0 .2 0 .2 0 .2 0 .2 0 .2
15.7
19 .3 5 .2
12 .3 17 .1 12 .9 16 .5 18 .7 18 .8 11 .6
192 175 159 197
.55
162 34 39 97
184
SPEC
PFEECGAL CONTAMINATION OBSERVED FFEECCJAL CONTAMINATION OBSERVED
748
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URINALYSIS VALUES FOR FEMALE RATS
Animal Number
QUAL
COL
CLAR
Female, Group: 11-0 mg/kg - Day 44
641240 641245 641249 641257
641283 641290 641293 641335 641344 641384
MEDIUM LIGHT
MEDIUM MEDIUM
LIGHT MEDIUM
LIGHT MEDIUM MEDIUM
MT
YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW
NT
CLEAR CLEAR
HAZY CLEAR CLEAR CLEAR CLEAR CLEAR CLEAR
NT
Female, Group: IV - 50 Big/kg - Day 44
641260 641298 641311 641312 641313 641336 641355 641361 641369 641396
LIGHTLIGHT MEDIUM
NT MEDIUM MEDIUM
LIGHT MEDIUM MEDIUM
LIGHT
YELLOW YELLOW YELLOW
NT YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW
CLEAR CLEAR CLEAR
NT CLEAR
HAZY CLEAR CLEAR CLEAR CLEAR
VOL
UOSM
SG
mL
mOsm/kg
10.8 21.6 13.2
4.0 22.0
9.0 17.0
9.0 7.2
QNS
13.4 12.6
7.6
QNS
5.0 5.2 17.8 11.0 1.5 13.2
959 348 591 970 413 803 464 810 1057
QKS
1.028
1.011 1.019 1.030 1.013 1.025 1.014 1.024 1.030
NT
456 578 987
QNS
1300 1124
342 716 QNS 604
1.014 1.018 1.029
NT
1.041 1.036 1.011 1.022 1.056 1.019
pH
UGLU
KET
mg/dL
mg/dL
6.5 NEGATIVE NEGATIVE NE 6.0' NEGATIVE NEGATIVE NE
7.0 NEGATIVE NEGATIVE NE 6.0 NEGATIVE NEGATIVE NE 6.5 NEGATIVE NEGATIVE NE
6.0 NEGATIVE NEGATIVE NE
7.0 NEGATIVE NEGATIVE NE
6.5 NEGATIVE NEGATIVE NE
6.5 NEGATIVE NEGATIVE NE
MT
NT
NT
6.5 NEGATIVE NEGATIVE NE 6.5 NEGATIVE NEGATIVE NE 6.0 NEGATIVE NEGATIVE NE
NT
NT
NT
6.5 NEGATIVE NEGATIVE NE 6.5 NEGATIVE NEGATIVE NE 6.5 NEGATIVE NEGATIVE NE 6.5 NEGATIVE NEGATIVE NE
6.0 NEGATIVE
5
6.5 NEGATIVE NEGATIVE NE
749
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URINALYSIS VALUES FOR FEMALE RATS
Animal Number
QUAL
COL
CLAR
Female, Group: VI - 250 ing/kg - Day 44
641244 641251 641269 641292 641302 641362 641363 641375 641379 641398
MEDIUM MEDIUM MEDIUM MEDIUM MEDIUM MEDIUM
NT LIGHT MEDIUM MEDIUM
YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW
NT YELLOW YELLOW YELLOW
CLEAR CLEAR CLEAR CLEAR CLEAR CLEAR
NT CLEAR CLEAR CLEAR
Female, Group: VIII -
641237 641275 641279 641299 641300 641314 641326 641327 641380 641390
MEDIUM MEDIUM MEDIUM MEDIUM MEDIUM MEDIUM
LIGHT MEDIUM MEDIUM
LIGHT
1000 ing/kg -
YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW
Day 44
CLEAR HAZY
CLEAR CLEAR CLEAR CLEAR CLEAR CLEAR CLOUDY CLEAR
VOL
UOSM
SG
BiL
mOsm/kg
4.3 5.2 3.4 11.6 1.0 2.0
QNS
15.0 8.0
11.4
5.2 7.4 5.0 5.0 8.8 3.4 7.8 6.0 4.4 15.0
1178 907
1659 669
QNS 1937
QNS 526 803 623
984 807 1158 956 684 2003 689 1282 1576 525
1.036 1.027 1.050 1.021 1.064 1.057
NT
1.016 1.024 1.019
1.028 1.024 1.036 1.029 1.022 1.059 1.021 1.039 1.048 1.017
pH
UBLU
KET
mg/dL
mg/dL
6.0 NEGATIVE NEGATIVE NE
6.5 NEGATIVE NEGATIVE NE
6.0 NEGATIVE NEGATIVE
6.0 NEGATIVE NEGATIVE NE
7.0 NEGATIVE NEGATIVE NE
6.0 NEGATIVE NEGATIVE NE
NT
NT
NT
6.5 NEGATIVE NEGATIVE NE 6.5 NEGATIVE NEGATIVE NE 6.5 NEGATIVE NEGATIVE NE
6.0 NEGATIVE NEGATIVE NE 6.0 NEGATIVE NEGATIVE NE 6.5 NEGATIVE NEGATIVE NE 6.0 NEGATIVE NEGATIVE NE
6.0 NEGATIVE NEGATIVE NE 6.0 NEGATIVE NEGATIVE 6.0 NEGATIVE NEGATIVE NE 6.5 NEGATIVE NEGATIVE NE 6.5 NEGATIVE NEGATIVE NE 7.0 NEGATIVE NEGATIVE NE
750
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URINALYSIS VALUES FOR FEMALE RATS
Animal Number
URO
EU/dL
UPLU
UMTP rtig/dL
Female, Group; II - 0 nig/kg - Day 44
641240
0.2
641245
0.2
641249
0.2
641257
0.2
641283
0.2
641290
0.2
641293
0.2
641335
0.2
641344
0.2
641384
NT
16
NT
<6
NT
14
NT
25
MT
8
NT
15
NT
<6
NT
15
NT
9
NT
QNS
ale. Group: IV - 50 g/kg - Day 44
641260 641298 641311 641312 641313 641336 641355 641361 641369 641396
0.20.2
0.2
NT
0.2 0.2 0.2 0.2 0.2
.0.2
NT
6
NT
8
NT
19
NT
QNS
NT
16
NT
28
NT
7
NT
11
MT
56
NT
8
SPEC FECAL CONTAMINATION OBSERVED
FECAL CONTAMINATION OBSERVED
Sample status: URINALYSIS TO BE RUN MANUALLY - LOW VOLUME
751
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URIMALYSIS VALUES FOR FEMALE RATS
Animal Number
URO
EU/dL
UPLU
UMTP ing/dL
Female, Group: VI - 250 ing/kg - Day 44
641244
0.2
641251
0.2
641269
0.2
641292
0.2
641302
0.2
641362
0.2
641363
NT
641375
0.2
641379
0.2
641398
0.2
NT
17
NT
19
MT
23
NT
12
NT
54
MT
33
NT
QMS
NT
9
MT
18
MT
9
Female, Group: VIII -
641237
0.2
641275
0.2
641279
0.2
641299
0.2
641300
0.2
641314
0.2
641326
0.2
641327
0.2
641380
0.2
641390
.0.2
1000 rng/kg -
NT NT MT MT NT NT NT NT MT MT
Day 44
16 15 18 21 . 15 41
8
21 45
9
SPEC
SSaammi ple ststus: URIMALYSIS TO BE RUN MAMUALLY - LOW VOLUME
FECiAL CONTAMINATION OBSERVED
752
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URIMALYSIS VALUES FOR FEMALE RATS
Animal Number
QUAL
COL
CLAR
Female, Group: 11-0 ing/kg - Day 92
641240 641245 641249 641257 641283 641290 641293 641335 641344 641384
LIGHT LIGHT MEDIUM LIGHT MEDIUM MEDIUM LIGHT MEDIUM LIGHT MEDIUM
YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW
CLEAR CLEAR CLEAR CLEAR CLEAR CLEAR CLEAR
HAZY CLEAR CLEAR
Feinal e, Group; IV - 50 mg/kg - Day 92
641260 641298 641311 641312 641313 641336 641355 641361 641369 641396
MEDIUM. MEDIUM MEDIUM MEDIUM MEDIUM MEDIUM
LIGHT MEDIUM MEDIUM MEDIUM
YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW
CLEAR CLEAR
HAZY HAZY CLEAR CLEAR CLEAR CLEAR CLEAR CLEAR
VOL
UOSM
SG
inL
mOsin/kg
13.0 8.7 8.0
16.2 4.4 8.1 9.4 6.1 5.9 6.4
3.8 7.1 4.9 2.7 3.2 4.5 4.4 4.0 3.0 5.2
544 646 1170 447 1401 1098 692 1018 829 754
1215 933
1057 1987 1893 1262
608 1278 1322
992
1.018 1.020 1.034 1.015 1.043 1.034 1.020 1.030 1.025 1.024
1.038 1.028 1.031 1.058 1.054 1.040 1.020 1.038 1.041 1.030
PH
UGLU
KET
mg/dL
mg/dL
6.0 NEGATIVE NEGATIVE NE 6.0 NEGATIVE NEGATIVE NE 7.5 NEGATIVE NEGATIVE NE 5.5 NEGATIVE NEGATIVE NE 6.0 NEGATIVE NEGATIVE NE 6.0 NEGATIVE NEGATIVE NE 6.0 NEGATIVE NEGATIVE NE 6.5 NEGATIVE NEGATIVE NE 5.5 NEGATIVE NEGATIVE NE 6.0 NEGATIVE NEGATIVE NE
5.5 NEGATIVE NEGATIVE NE 6.0 NEGATIVE NEGATIVE NE 6.0 NEGATIVE NEGATIVE NE 6.0 NEGATIVE NEGATIVE NE 6.0 NEGATIVE NEGATIVE NE 6.0 NEGATIVE NEGATIVE NE 5.5 NEGATIVE NEGATIVE NE 6.0 NEGATIVE NEGATIVE NE 5.5 NEGATIVE NEGATIVE NE 6.0 NEGATIVE NEGATIVE NE
753
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URINALYSIS VALUES FOR FEMALE RATS
Animal Number
QUAL
COL
CLAR
Female, Group: VI - 250 mg/kg - Day 92
641244 641251 641269 641292 641302 641362 641363 641375 641379 641398
MEDIUM MEDIUM MEDIUM
LIGHT LIGHT MEDIUM MEDIUM LIGHT MEDIUM LIGHT
YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW
HAZY CLEAR
HAZY CLEAR
HAZY HAZY CLEAR HAZY CLEAR HAZY
Female, Group: VIII -
641237 641275 641279 641299 641300 641314 641326 641327 641380 641390
MEDIUMMEDIUM
NT MEDIUM
LIGHT MEDIUM MEDIUM
LIGHT MEDIUM
LIGHT
1000 mg/kg -
YELLOW YELLOW
NT YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW
Day 92
CLEAR HAZY NT
CLOUDY CLEAR CLEAR
CLOUDY CLEAR CLEAR HAZY
VOL
UOSM
SG
mL
mOsm/kg
4.4 5.1 3.7 5.6 11.6 6.2 1.5 10.0 6.5 3.0
2.1 2.7
NSR
1.8 15.6
2.7 2.5 8.6 3.0 13.6
1598 1016 1320 1188
447 1070 2508
785 1053
695
1810 1686
NT 2036
438 2280 1163
705 1461
606
1.047 1.030 1.041 1.037 1.015 1.031 1.073 1.024 1.031 1.022
1.053 1.051
MT
1.061 1.015 1.065 1.036 1.022 1.046 1.020
pH
UGLU
KET
mg/dL
mg/dL
6.5 NEGATIVE NEGATIVE NE 5.5' NEGATIVE NEGATIVE NE 6.0 NEGATIVE NEGATIVE NE 6.0 NEGATIVE NEGATIVE NE 5.S NEGATIVE NEGATIVE NE 6.5 NEGATIVE NEGATIVE NE 5.5 NEGATIVE NEGATIVE 6.5 NEGATIVE NEGATIVE NE 6.0 NEGATIVE NEGATIVE NE 6.0 NEGATIVE NEGATIVE NE
6.0 NEGATIVE NEGATIVE NE
6.0 NEGATIVE NEGATIVE NE
NT
NT
NT
6.0 NEGATIVE
5
6.0 NEGATIVE NEGATIVE NE 5.5 NEGATIVE NEGATIVE 6.0 NEGATIVE NEGATIVE NE 6.0 NEGATIVE NEGATIVE NE 6.5 NEGATIVE NEGATIVE NE 5.5 NEGATIVE NEGATIVE NE
754
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URINALYSIS VALUES FOR FEMALE RATS
Animal Mmnber
URO
EU/dL
UPLU US
UMTP mg/dL
Female, Group: II - 0 mg/kg - Day 92
641240
0.2
11 .1
12
641245
0.2
9 .1
17
641249
0.2
13 .4
21
641257
0.2
9 .0
9
641283
0.2
6 .8
30
641290
0.2
10 .7
39
641293
0.2
7 .8
7
641335
0.2
10 .8
18
641344
0.2
6 .3
14
641384
0.2
10 .0
22
lale. Group: IV - 50 mg/kg - 1Day 92
641260
0.2-
7 .7
27
641298
0.2
12 .9
15
641311
0.2
6 .5
25
641312
1.0
10 .0
42
641313
0.2
9 .0
25
641336
0.2
10 .5
33
641355
0.2
5 .2
16
641361
0.2
7 .7
25
641369
0.2
6 .2
21
641396
.0.2
6 .5
23
SPEC
755
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URINALYSIS VALUES FOR FEMALE RATS
Animal Number
URO
EU/dL
UFLU fig
UMTP mg/dL
Female, Group: VI - 250 ing/kg - Day 92
641244
0.2
14.6
26
641251
0.2
12.9
17
641269
0.2
12.6
25
641292
0.2
10.7
21
641302
0.2
15.2
7
641362
0.2
16.1
15
641363
1.0
QNS
408
641375
0.2
21.7
12
641379
0.2
16.2
24
641398
0.2
5.7
10
Female, Group: VIII -
641237
0.2-
641275
0.2
641279
NT
641299
1.0
641300
0.2
641314
1.0
641326
0.2
641327
0.2
641380
0.2
641390
0.2
1000 mg/kg -
QNS
18.0
NSR QNS
33.6 26.5 10.1 27.7 20.1 30.1
Day 92
37 35 NSR 92 6 . 53 11 15 37 10
SPEC
756
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URINALYSIS VALUES FOR FEMALE RATS
Animal Number
QUAL
COL
CLAR
Female, Group: 11-0
641253 641266 641281 641294 641325 641331 641359 641364 641383 641400
MEDIUM LIGHT
MEDIUM MEDIUM MEDIUM
LIGHT MEDIUM MEDIUM
LIGHT LIGHT
ing/kg - Day
YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW YELLOW
124
CLOUDY CLEAR CLEAR HAZY CLEAR CLEAR CLEAR HAZY HAZY CLEAR
Female, Group: VIII -
641234 641256 641282 641352 641356 641366 641377 641385 641387 641399
LIGHT MEDIUM MEDIUM MEDIUM
NT MEDIUM MEDIUM
LIGHT MEDIUM
LIGHT
1000 ing/kg -
YELLOW YELLOW YELLOW YELLOW
NT YELLOW YELLOW YELLOW YELLOW YELLOW
Day 124
CLEAR CLEAR
HAZY CLEAR
NT HAZY CLEAR CLEAR HAZY HAZY
VOL
UOSM
SG
mL
mOsm/kg
8.6 6.8 1.9 4.0 2.7 10.4 3.0 4.5 13.4 10.0
7.7 5.8 4.1 4.6
MSR
3.8 3.0 7.8 4.2 5.7
1116 1253 2781 1555 1592
471 1639 1446
538 515
1.035 1.039 1.078 1.050 1.048 1.018 1.051 1.046 1.018 1.017
705 1122 1883 1150 .
NT 1122 1579
840 1550 1088
1.023 1.036 1.056 1.037
NT
1.037 1.048 1.026 1.049 1.036
PH
UGLU
KET
TOg/dL
mg/dL
7.5 NEGATIVE NEGATIVE NE
6.0 NEGATIVE NEGATIVE NE
5.0 NEGATIVE NEGATIVE NE
5.5 NEGATIVE NEGATIVE N
5.5 NEGATIVE NEGATIVE N
5.0 NEGATIVE NEGATIVE NE
5.5 NEGATIVE NEGATIVE N
6.0 NEGATIVE
5 N
5.5 NEGATIVE NEGATIVE N 5.5 NEGATIVE NEGATIVE N
6.0 NEGATIVE NEGATIVE N
5.5 NEGATIVE NEGATIVE N
6.0 NEGATIVE NEGATIVE N
5.5 NEGATIVE NEGATIVE N
NT
NT
NT
5.5 NEGATIVE NEGATIVE NE
6.0 NEGATIVE
5 N
5.5 NEGATIVE NEGATIVE N
6.0 NEGATIVE NEGATIVE N
6.0 NEGATIVE NEGATIVE N
757
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL ORINALYSIS VALUES FOR FEMALE RATS
Animal Number
URO
EU/dL
UFLU
M
UMTP
mg/dL
Female, Group: 11-0 mg/kg - Day 124
641253
0.2
5.7
43
641266
0.2
11.4
24
641281
0.2
NT
73
641294
0.2
9.9
42
641325
0.2
5.8
58
641331
0.2
16.3
9
641359
0.2
4.5
46
641364
0.2
9.2
36
641383
0.2
9.8
15
641400
0.2
10.1
8
Female, Group:
641234 641256 641282 641352 641356 641366 641377 641385 641387 641399
VIII -
0.20.2 0.2 0.2
MT
0.2 0.2 0.2 0.2 0.2
1000 mg/kg -
12.0 11.1 14.3 11.0
NSR
6.9 7.5 11.1 10.0 12.0
Day 124
18 15 47 24 NSR 48 24 18 38 39
SPEC FECGAL CONTAMINATION OBSERVED
PFEECC.AL CONTAMINATION OBSERVED
758
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URINE MICROSCOPIC VALUES FOR MALE RATS
Animal Number
EPIT
UWBC
URBC
Male, Group: 1-0 ing/kg - Day 44
641069
MOME
1-10
0
641070
FEW
1-10
0
641094
FEW
0
0
641147
FEW
0
0
641149
PEW
1-10
0
641155
FEW
1-10
0
641172
NONE
0
0
641206
FEW
1-10
0
641214
FEW
1-10
0
641222
FEW
1-10
0
Male, Group; III - 50 mg/kg - Day 44
641055
FEW
0
0
641056
FEW
1-10
0
641073
FEW
1-10
0
641081
NONE
0
0
641144
PEW
0
0
641146
PEW
1-10
0
641178
FEW
1-10
0
641198
NONE
0
0
641218
MOME
1-10
0
641224
FEW
0
0
MCRY
MICR
NOME FEW FEW
NONE NOME
PEW NONE
FEW FEW FEW
FEW MODERATE MODERATE MODERATE
FEW MODERATE
FEW FEW FEW PEW
FEW NONE
FEW FEW NONE PEW FEW FEW NONE FEW
PEW FEW PEW FEW MODERATE FEW FEW FEW PEW MODERATE
SPER
SPEC
0
1
2
2
2
3
FEW GGRRJANULAR CASTS
0
3
Ssample status: BELOW RECOMMENDED
2
1
1 1 2 1 2 0 3 1 2 1
759
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URINE MICROSCOPIC VALUES FOR MALE RATS
Animal Number
EPIT
UWBC
ORBC
NCRY
MICR
Male, Group: V - 250 ing/kg - Day 44
641061
NOME
0
0
641089
FEW
0
0
641102
NONE
0
0
641134
FEW
1-10
0
641137
NT
NT
NT
641162
FEW
0
0
641190
FEW
0
0
641197
FEW
1-10
0
641200
FEW
1-10
0
641202
FEW
1-10
0
Male, Group: VII - 1000 ing/kg - Day 44
641067
NONE
0
0
641077
NONE
0
0
641086
FEW
1-10
0
641095
FEW
1-10
0
641097
FEW
0
0
641132
PEW
0
0
641157
PEW
1-10
0
641166
FEW
0
0
641201
FEW
1-10
0
641223
NONE
0
0
NONE NONE
FEW PEW
NT FEW NONE NONE NONE NONE
NONE NONE NONE NONE NONE MODERATE
FEW NONE NONE NONE
MODERATE FEW PEW PEW NT
MODERATE FEW FEW FEW FEW
MODERATE FEW FEW FEW
MODERATE MANY PEW FEW PEW FEW
SPER
2 1 1 3
NT
1 0 0 2 2
2 2 0 1 0 0 3 1 0 0
SPEC
760
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URINE MICROSCOPIC VALUES FOR MALE RATS
Animal Number
EPIT
UWBC
URBC
Male/ Group: 1-0 ing/kg -
641069 641070 641094 641147 641149 641155 641172 641206 641214 641222
FEW FEW FEW MODERATE FEW NOME FEW NONE FEW FEW
Day 91
0 0 0
1-10
0 0 0 0 0 0
Male, Group:
641055 641056 641073 641081 641144 641146 641178 641198 641218 641224
III - 50 nig/kg -
NOMEFEW FEW FEW
MONE NOME
FEW FEW NOME FEW
Day 91
0 0 0 0 0 0 0 0 0 0
0 0 0
1-10 1-10
0 0 0 0 0
0 0 0
1-10
0 0 0
1-10
0 0
NCRY
MICR
NOME PEW FEW
NONE NONE
FEW NOME NONE
FEW PEW
MODERATE MODERATE
MANY MANY MODERATE MODERATE MODERATE MODERATE
FEW MODERATE
NONE NONE
FEW NONE NOME
FEW NONE NONE NONE NOME
MODERATE MODERATE MODERATE
FEW MANY MODERATE MODERATE
FEW FEW MAMY
SPER
SPEC
3
3
1-MUCUS
3
3
3
3
1
3
3
3
1-MUCUS
2
3
1-MUCUS
1
1-MUCUS
1
1-MUCUS
2
1-MUCUS
2
1-MUCUS
3
0
2
1
1-MUCUS
761
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URIME MICROSCOPIC VALUES FOR MALE RATS
Animal Mumber
EPIT
UWBC
URBC
MCRY
MICR
Male, Group: V - 250 ing/kg - Day 91
641061 641089 641102 641134 641137 641162 641190 641197 641200 641202
NOME NOME
FEW NONE NOME
FEW NONE
FEW FEW FEW
0 0 0 0
1-10
0 0 0 0 0
0 0 0 0
1-10 1-10
0 0 0 0
Male, Group: VII - 1000 ing/kg - Day 91
641067 641077 641086 641095 641097 641132 641157 641166 641201 641223
FEW PEW PEW NONE FEW FEW NONE FEW FEW MOME
0
0
0
0
0
1-10
0
0
0
0
0
0
0
0
0
0
0
0
0
0
MONE MONE
FEW PEW NONE FEW NOME FEW MODERATE NONE
NONE NONE NOME NOME NOME
FEW MONE MODERATE
FEW FEW
FEW MODERATE
FEW MODERATE MODERATE
MANY FEW FEW
MANY MODERATE
FEW FEW MODERATE MANY . FEW MANY FEW FEW MANY FEW
SPER
2 3 2 3 3 1 3 2 2 1
3 3 1 2 3 2 3 3 3 1
SPEC
2-MUCUS
2-MUCUS
Sample status:
1-MUCUS
BELOW RECOMMEMDED
1-MUCUS 1-MUCUS
1-MUCUS
762
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URIME MICROSCOPIC VALUES FOR MALE RATS
Animal
Number
EPIT
UWBC
URBC
NCRY
MICR
Male, Group: 1-0 ing/kg - Day 123
641083
FEW
0
0
641084
FEW
1-10
0
641085
FEW
1-10
0
641101
NONE
0
0
641105
FEW
0
0
641123
NONE
0
0
641154
NOME
1-10
0
641159
NOME
0
0
641165
NONE
0
0
641215
FEW
0
0
Male, Group: VII - 1000 mg/kg - Day 123
641064
FEW
1-10
0
641092
NOME
0
0
641143
NONE
0
0
641153
NONE
0
0
641167
NOME
0
0
641185
PEW
1-10
0
641189
MONE
0
0
641203
NONE
0
0
641213
NOME
0
0
641216
FEW
1-10
0
FEW FEW NOME FEW NONE MODERATE NONE FEW FEW FEW
FEW MODERATE
FEW PEW MODERATE NONE PEW FEW PEW MODERATE
FEW FEW FEW PEW FEW FEW PEW MODERATE FEW FEW
PEW PEW FEW FEW MODERATE FEW FEW FEW FEW FEW
SPER
SPEC
3
3
3
2
3
3
1-MUCUS
1
1-MUCUS
2
1
1
1-MUCUS
2
1-MUCUS
1
1-MUCUS
3
3
2
3
2
1
1
1-MUCUS
3
763
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URINE MICROSCOPIC VALUES FOR FEMALE RATS
Animal Number
EPIT
UWBC
URBC
Female, Group: 11-0 nig/kg - Day 44
641240
FEW
0
0
641245
NONE
1-10
0
641249
FEW
1-10
0
641257
FEW
0
0
641283
NONE
0
0
641290
NONE
0
0
641293
NONE
0
0
641335
NONE
0
0
641344
NONE
0
0
641384
NT
NT
NT
Female, Group: IV - 50 ing/kg - Day 44
641260 641298 641311 641312 641313 641336 641355 641361 641369 641396
PEW NOME
PEW
NT
FEW NONE
PEW NONE
FEW NONE
0
0
1-10
NT
1-10
0
0
0
1-10
0
0 0 0
NT
0 . 0 0 0 0 0
MCRY
NONE FEW
NONE NONE NONE NONE NONE NONE NONE
NT
NONE NONE NOME
MT NOME NOME MOME NOME
FEW NOME
MICR
FEW FEW PEW FEW FEW PEW PEW FEW FEW
NT
NOME FEW FEW
NT FEW FEW FEW FEW FEW FEW
SPER
SPEC
0 0 0 0 0 0 0 0 0
NT
0
0
0
NT
0
0
0
0
0
Sample
0
BELOW RECOMMENDED
764
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URINE MICROSCOPIC VALUES FOR FEMALE RATS
Animal Number
EPIT
UWBC
URBC
NCRY
MICR
Female, Group: VI - 250 nig/kg - Day 44
641244
FEW
1-10
0
641251
NONE
0
0
641269
NONE
0
0
641292
NONE
0
0
641302
FEW
1-10
0
641362
NONE
0
0
641375
FEW
1-10
0
641379
NONE
0
0
641398
NONE
0
0
Female, Group: VIII -
641237 641275 641279 641299 641300 641314 641326 641327 641380 641390
FEW NONE
FEW NONE NONE NONE NONE NOME NONE NONE
1000 ing/kg -
0 0 0
1-10 1-10
0 0
1-10
0
1-10
Day 44
0 0 0 0 0 0 0 0 0 0
NONE NONE NONE NONE NONE
FEW NONE NONE NONE
NONE NONE
FEW NONE NONE NONE NONE NONE MODERATE NONE
FEW FEW MODERATE FEW FEW
FEW FEW FEW FEW
FEW FEW FEW FEW FEW MODERATE MODERATE FEW MANY FEW
SPER
SPEC
0
0
0
0
0
Sample status: BELOW RECOMMENDED
FEW GRUANULAR CASTS
0
0
0
0
0 0 0 0 0 0 0 0 0 0
765
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URINE MICROSCOPIC VALUES FOR FEMALE RATS
Animal Number
EPIT
UWBC
URBC
MCRY
MICR
Female, Group:
641240 641245 641249 641257 641283 641290 641293 641335 641344 641384
11-0 nig/kg - Day 92
FEW NONE
FEW FEW FEW FEW FEW PEW FEW FEW
0 0 0 0 0 0 0
1-10
0 0
Female, Group: IV - 50 mg/kg - Day 92
641260 641298 641311 641312 641313 641336 641355 641361 641369 641396
FEWFEW PEW FEW FEW FEW PEW NOME FEW FEW
0
1-10 1-10 1-10 1-10
0
0
0
1-10
0
0
FEW
FEW
0
FEW
FEW
0
PEW
PEW
0
FEW
FEW
0
FEW
PEW
0
FEW
FEW
0 MODERATE MODERATE
0 MODERATE MODERATE
0 MODERATE
FEW
0 MODERATE MODERATE
0 MODERATE
FEW
0 MODERATE MODERATE
0 MODERATE MODERATE
0 MODERATE MODERATE
0
FEW MODERATE
0 MODERATE
FEW
0
FEW
PEW
0
FEW
FEW
0 MODERATE MODERATE
0
FEW
FEW
SPER
SPEC
0 0 0 0 0 0 0 0 0 0
0
0
0
1-MUCU!S
0
Sample status: BELOW RECOMMENDED
0
0
0
1-MUCUI
0
1-MUCUI
0
Sample
0
766
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URINE MICROSCOPIC VALUES FOR FEMALE RATS
Animal Number
EPIT
UWBC
URBC
NCRY
MICR
Female, Grcsup: VI - 2E?0 mg/kg - E3ay 92
641244
FEW
1-10
0
641251
NOME
0
0
641269
FEW
0
0
641292
FEW
1-10
0
641302
FEW
0
0
641362 MODERATE
1-10
0
641363
FEW
0
0
641375
NOME
0
0
641379
NONE
0
0
641398
PEW
0
0
Female, Group: VIII -
641237 641275 641279 641299 641300 641314 641326 641327 641380 641390
FEWFEW
NT MODERATE
FEW FEW MODERATE FEW FEW NONE
1000 mg/kg -
1-10
0
NT
1-10
0
1-10 1-10
0
1-10 1-10
Day 92
0 0
NT 0
0 0 0 0 0 0
FEW MODERATE MODERATE
FEW MODERATE MODERATE MODERATE
FEW FEW MANY
MODERATE MODERATE
NT MANY
FEW MODERATE
MANY PEW
MODERATE FEW
FEW MODERATE
FEW FEW MODERATE FEW FEW FEW FEW MANY
MODERATE MANY NT MANY FEW
MODERATE MODERATE
FEW MODERATE
FEW
SPER
SPEC
0
0
0
0
1-MUCUS3
0
0
1-MUCUS
0
Sample status: BELOW RECOMMENDED
0
0
0
Sample status: BELOW RECOMMENDED
0
Sample status BELOW RECOMMENDED
0
Sample status BELOW RECOMMENDED
NT
0
Sample status BELOW RECOMMENDED
0
0
Sample status BELOW RECOMMENDED
0
Sample status BELOW RECOMMENDED
0
0
Sample status BELOW RECOMMENDED
0
767
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL URIME MICROSCOPIC VALUES FOR FEMALE RATS
Animal Number
EPIT
UWBC
URBC
Female, Group: 11-0 mg/kg - Day 124
641253
MOME
0
0
641266
FEW
1-10
0
641281
NOME
0
0
641294
FEW
0
0
641325
FEW
0
0
641331
NOME
1-10
0
641359
NONE
0
0
641364
FEW
1-10
0
641383
FEW
0
0
641400
FEW
0
0
Female, Group: VIII -
641234 641256 641282 641352 641356 641366 641377 641385 641387 641399
NONE. FEW
NONE PEW MT FEW FEW
NONE NONE
PEW
1000 mg/kg -
0 0
1-10 1-10
NT
11-50
0 0 0
1-10
Day 124
0 0 0 0 MT 0 0 0 0 0
NCRY
MICR
FEW NONE NOME
PEW FEW NONE FEW FEW FEW NONE
MODERATE FEW FEW
MODERATE FEW PEW FEW FEW PEW FEW
NONE FEW FEW
NONE NT
NOME NONE
FEW FEW NOME
FEW FEW MODERATE PEW
NT FEW PEW FEW MODERATE MODERATE
SPER
SPEC
0
0
0
Sample i
0
0
0
0
0
0
0
0
0
0
0
MT
0
1-MUCUS
0
1-MUCUS
0
0
0
BELOW RECOMMENDED
768
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
APPENDIX K INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS
769
?Cft'"--"~ ---n ,,;qf
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL AMIMAL FINAL BODY AND ORGAN WEIGHTS FOR MALE RATS DESIGNATED FOR 90-DAY EXPOSURE EVALUATION
Group
0 mg/kg/day Sex :MALES
ANIMAL
FBW (Gms)
BRAIN
(Gms)
%FBW
ADRENAL GLANDS
(Gms)
%FBW %BRAIN
EPIDIDYMIDES
(Gms)
%PBW %BRAIN
(Gms)
HEART %FBW %BRAIN
641069 641070 641094 641147 641149 641155 641172 641206 641214 641222
629.0 587.7 608.4 491.3 509.1 500.4
580.9 636.8 612.4 556.0
2.016 2.040 2.051 2.001 2.059
2.187 2.085 2.365 2.109 2.250
0.3205 0.3471 0.3371 0.4073
0.4044 0.4371 0.3589 0.3714 0.3444 0.4047
0.054 0.058 0.064 0.055 0.057 0.035 0.048
0.051 0.060 0.060
0.0086 0.0099 0.0105
0.0112 0.0112 0.0070 0.0083 0.0080 0.0098 0.0108
2.6786 2.8431 3.1204 2.7486 2.7683
1.6004 2.3022 2.1564 2.8450 2.6667
1.551 1.512 1.623 1.301 1.440
1.359 1.551 1.671 1.724 1.497
0.2466 0.2573
0.2668 0.2648
0.2829
0.2716 0.2670 0.2624 0.2815 0.2692
76.935 74.118 79.132 65.017 69.937
62.140 74.388 70.655 81.745 66.533
1.944 1.588 1.710
1.556 1.527
1.512 1.921 1.901 1.914 1.642
0.3091 0.2702 0.2811 0.3167 0.2999 0.3022 0-.3307
0.2985 0.3125 0.2953
96.429 77.843 83.374 77.761 74.162 69.136
92.134 80.381 90.754 72.978
Mean S.D.
571.2 54.3
2.116 0.3733 0.117 0.0380
0.054 0.0095 2.5730 0.008 0.0015 0.4382
1.523 0.2670 72.060 0.132 0.0107 6.3444
1.722 0.3016 81.495 0.180 0.0174 9.0249
(Gms)
KIDNE
%FBW
4.325 4.003 4.102 3.755 3.893 3.558 3.969 4.951 4.856 3.767
0.687 0.681 0.674 0.764
0.764 0.711 0.683 0.777 0.792 0.677
4.118 0.721 0.464 0.047
Group : III - 50 mg/kg/day Sex
ANIMAL
PBW (Gms)
BRAIN
(Gms-)
%FBW
:MALES
ADRENAL GLANDS
(Gms)
%FBW %BRAIN
641055 641056 641073 641081 641144 641146 641178 641198 641218 641224
507.3 560.0 580.9 498.9 582.2 482.4
540.6 653.4 481.0 652.1
2.121 2.095 2.053
1.976 2.124 2.102 2.052 2.164 2.090 2.165
0.4181 0.3741 0.3534 0.3961 0.3648 0.4357 0.3796 0.3312 0.4345 0.3320
0.047 0.046 0.058 0.046 0.065 0.051 0.043 0.060 0.043 0.048
0.0093 0.0082 0.0100 0.0092 0.0112 0.0106 0.0080 0.0092 0.0089 0.0074
2.2159 2.1957 2.8251 2.3279 3.0603 2.4263 2.0955 2.7726 2.0574 2.2171
Mean S.D.
553.9 64.0
2.094 0.3820 0.057 0.0386
0.051 0.0092 2.4194 0.008 0.0012 0.3459
EPIDIDYMIDES
(Gms)
%FBW %BRAIN
1.575 1.551 1.408 1.612 1.538 1.361 1.481 1.440 1.370 1.323
0.3105 0.2770 0.2424 0.3231
0.2642 0.2821 0.2740 0.2204 0.2848 0.2029
74.257 74.033 68.583 81.579 72.411 64.748 72.173 66.543 65.550 61.109
1.466 0.2681 70.099 0.1.00 0.0374 5.9564
(Gms)
HEART %FBW %BRAIN
1.649 1.519 1.648 1.585 1.727 1.681 1.602 1.704 1.475 1.803
0.3251
0.2713 0.2837 0.3177 0.2966 0.3485 0.2963 0.2608 0.3067 0.2765
77.746 72.506 80.273 80.213 81.309 79.971 78.070 78.743 70.574 83.279
1.639 0.2983 78.268 0.098 0.0269 3.9157
(Gms)
KIDNE %FBW
4.089 3.977 4.267 3.339 4.041 3.755 4.120 5.068 3.824 4.234
0.806 0.710 0.734 0.669 0.694 0.778 0.762 0.775 0.795 0.649
4.071 0.737 0.443 0.054
FBW - Final Body Weight
770
I l l'"'sty
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Group : V - 250 nig/kg/day
INDIVIDUAL ANIMAL FINAL BODY AMD ORGAN WEIGHTS FOK MALE RATS DESIGNATED FOR 90-DAY EXPOSURE EVALUATION
Sex :MALES
ANIMAL
FBW (Gins)
BRAIN
(Gms)
%FBW
ADRENAL GLANDS
(Gms)
%PBW %BRAIN
EPIDIDYMIDES
(Gms)
%FBW %BRAIN
(Gins)
HEART %FBW %BRAIN
641061 641089 641102 641134 641137 641162 641190 641197 641200 641202
557.6 500.7 524.6 463.7
547.7 507.3 532.7 511.0 526.8 580.3
2.205 2.071 2.255 2.109 2.099 2.077 2.102
1.997 2.119 2.037
0.3954 0.4136 0.4299 0.4548 0.3832 0.4094 0.3946 0.3908 0.4022 0.3510
0.053 0.058 0.057 0.053 0.055 0.049 0.053 0.062 0.051 0.068
0.0095 0.0116 0.0109 0.0114 0.0100 0.0097 0.0099 0.0121 0.0097 0.0117
2.4036 2.8006 2.5277 2.5130 2.6203 2.3592 2.5214 3.1047 2.4068 3.3382
1.546 1.334 1.468 1.371 1.520 1.538
1.473 1.342 1.416 1.453
0.2773 0.2664 0.2798 0.2957 0.2775 0.3032
0.2765 0.2626 0.2688 0.2504
70.113 64.413 65.100 65.007 72.415 74.049 70.076 67.201 66.824 71.330
1.668 1.507
1.807 1.338 1.789 1.583 1.444 1.558 1.566 1.756
0.2991 0.3010 0.3445 0.2885 0.3266 0.3120 0.2711 0'.3049
0.2973 0.3026
75.646 72.767 80.133 63.442 85.231 76.216 68.696 78.017 73.903 86.205
Mean S.D.
525.2 32.6
2.107 0.4025 0.075 0.0277
0.056 0.0107 2.6596 0.006 0.0010 0.3262
1.446 0.2758 68.653 0.078 0.0154 3.3985
1.602 0.3048 76.026 0.154 0.0200 6.9647
(Gins)
KIDNEY
%PBW
4.594 3.803 4.608 3.829 4.549 4.370 4.488 4.020 4.274 4.432
0.8239 0.7595
0.8784 0.8257 0.8306 0.8614 0.8425
0.7867 0.8113 0.7637
4.297 0.8184 0.307 0.0391
Group : VII - 1000 mg/kg/day Sex :MALES
ANIMAL
FBW (Gms)
[
BRAIN
| (Gms")
%FBW
ADRENAL GLANDS
(Gms)
%PBW %BRAIN
641067 641077 641086 641095 641097 641132 641157 641166 641201 641223
426.5 499.5 464.6 422.6 462.1 490.9 420.2
456.2 446.9 445.9
1.882 2.110 2.093 2.070 2.010 2.161 2.055 2.290
2.062 2.144
0.4413 0.4224 0.4505 0.4898 0.4350 0.4402 0.4891 0.5020 0.4614 0.4808
0.037
0.053 0.046 0.045 0.034 0.057 0.048 0.053 0.038 0.043
0.0087 0.0106
0.0099 0.0106 0.0074 0.0116 0.0114 0.0116 0.0085 0.0096
1.9660 2.5118 2.1978 2.1739 1.6915 2.6377 2.3358 2.3144 1.8429 2.0056
Mean
S.D.
453.5 27.1
2.088 0.4612 0.106 0.0275
0.045 0.0100 2.1677 0.008 0.0015 0.2961
EPIDIDYMIDES
(Gms)
%FBW %BRAIN
1.287 1.529 1.450 1.344 1.336 1.479 1.427 1.612 1.656 1.310
0.3018 0.3061 0.3121 0.3180 0.2891 0.3013 0.3396 0.3534 0.3706 0.2938
68.385 72.464 69.279 64.928 66.468 68.441 69.440 70.393 80.310 61.101
1.443 0.3186 69.121 0.127 0.0271 5.0341
(Gms)
HEART %FSW %BRAIN
1.272 1.531 1.430 1.330 1.375 1.652
1.281 1.427 1.765 1.456
0.2982 0.3065 0.3078 0.3147 0.2976 0.3365 0.3049 0.3128 0.3949 0.3265
67.588 72.559 68.323 64.251 68.408 76.446 62.336 62.314 85.597 67.910
1.452 0.3200 69.573 0.159 0.0290 7.1174
(Gms)
KIDNEY %FBW
4.462 4.484 4.061 4.034 3.474 5.198 3.829 4.277 3.559 4.082
1.0462 0.8977 0.8741 0.9546 0.7518 1.0589 0.9112 0.9375 0.7964 0.9155
4.146 0.9144 0.501 0.0958
FBW - Final Body Weight
771
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS FOR MALE RATS DESIGNATED FOR 90-DAY EXPOSURE EVALUATION
Group ; I - 0 mg/kg/day Sex :MALES
ANIMAL (Gms)
LIVER
%FBW %BRAIN
(Gms)
SPLEEN %FBW %BRAIN
(Grns)
TESTES %FBW %BRAIN
(Gms)
THYMUS %FBW %BRAIN
641069 641070 641094 641147 641149
641155 641172 641206 641214 641222
19.077 15.934 16.957 12.243 14.739
13.483 16.341 19.998 17.749 16.478
3.0329 2.7112 2.7871 2.4920 2.8951
2.6944 2.8130 3.1404 2.8983 2.9637
946.28 781.08 826.77 611.84 715.83 616.51 783.74 845.58 841.58 732.36
0.869 0.927 0.771 0.603 0.641 0.672 0.916 0.834 0.992 0.881
0.1382 0.1577 0.1267 0.1227 0.1259
0.1343 0.1577 0.1310 0.1620 0.1585
43.105 45.441 37.591 30.135 31.132
30.727 43.933 35.264 47.037 39.156
4.047 3.502 3.441 3.243 3.603
3.116 3.491 3.828 3.629 3.624
0.6434 0.5959 0.5656 0.6601 0.7077 0.6227 0.6010 0.6011 0.5926 0.6518
200.74 171.67 167.77 162.07 174.99 142.48 167.43 161.86 172.07 161.07
0.506 0.240 0.473 0.328 0.379
0.256 0.405 0.366 0.570 0.432
0.0804 0.0408 0.0777 0.0668 0.0744 0.0512 0.0697 0'.0575
0.0931 0.0777
25.099 11.765 23.062 16.392
18.407 11.706 19.424 15.476 27.027 19.200
Mean S.D.
16.300 2.8428 770.16 2.379 0.1860 104.55
0.811 0.1415 38.352 0.133 0.0157 6.3942
3.552 0.6242 168.22 0.266 0.0418 14.618
0.396 0.0689 18.756 0.105 0.0154 5.1950
Group : III - 50 mg/kg/day Sex :MALES
ANIMAL (Gins)
LIVER
%FBW %BRAIN
(Gins)
SPLEEN %FBW %BRAIN
641055 641056 641073 641081 641144 641146 641178 641198 641218 641224
13.800 16.068 17.354 16.514 19.408 14.842 16.575 20.381 13.152 20.628
2.7203 2.8693 2.9874 3.3101 3.3336 3.0767 3.0660 3.1192 2.7343 3.1633
650.64 766.97 845.30 835.73 913.75 706.09 807.75 941.82 629.28 952.79
0.735 0.801 0.872 0.640 0.860 0.793 0.691 1.059 0.733 1.012
0.1449 0.1430 0.1501 0.1283 0.1477 0.1644 0.1278
0.1621
0.1524 0.1552
34.653 38.234 42.474 32.389 40.490 37.726 33.674 48.937 35.072 46.744
Mean S.D.
16.872 3.0380 805.01 2.611 0.2135 115.90
0.820 0.1476 39.039 0.135 0.0123 5.5936
(Gms)
TESTES %FBW %BRAIN
3.708 3.430 3.595 3.153
3.667 3.327 3.383
3.914 3.291 2.957
0.7309 0.6125 0.6189 0.6320 0.6299 0.6897 0.6258 0.5990 0.6842 0.4535
174.82 163.72 175.11 159.56 172.65 158.28 164.86 180.87 157.46 136.58
3.443 0.6276 164.39 0.284 0.0739 12.676
(Gms)
THYMUS %FBW %BRAIN
0.350 0.250 0.486 0.449 0.281 0.409 0.347 0.469 0.147 0.334
0.0690 0.0446 0.0837 0.0900 0.0483 0.0848 0.0642 0.0718 0.0306 0.0512
16.502 11.933 23.673 22.723 13.230 19.458 16.910
21.673
7.0335 15.427
0.352 0.0638 16.856 0.107 0.0197 5.2376
FBW - Final Body Weight
772
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL ANIMAL FINAL BODY AMD ORGAN WEIGHTS FOR MALE RATS DESIGNATED FOR 90-DAY EXPOSURE EVALUATION
Group : V - 250 mg/kg/day Sex :MALES
ANIMAL (Gas)
LIVER %FBW %BRAIN
(Gms)
SPLEEN %FBW %BRAIN
641061 641089 641102 641134 641137 641162 641190 641197 641200 641202
18.631 16.441 17.634 14.968 19.214 16.548 16.051 16.081 17.127 19.062
3.3413 3.2836 3.3614 3.2279 3.5081 3.2620 3.0131 3.1470 3.2511 3.2849
844.94 793.87 782.00 709.72
915.39 796.73
763.61 805.26 808.26 935.79
0.741 0.723 0.803 0.790
0.712 0.708 0.778 0.752 0.701 0.806
0.1329 0.1444 0.1531 0.1704 0.1300 0.1396
0.1460 0.1472 0.1331 0.1389
33.605 34.911 35.610 37.459
33.921 34.088 37.012 37.656 33.082 39.568
Mean S.D.
17.176 3.2680 815.56 1.427 0.1307 67.738
0.751 0.1435 35.691 0.040 0.0119 2.1407
(Gms)
TESTES %FBW %BRAIN
3.171 3.490 3.749 3.118 3.766 3.490 3.465 3.405 3.625 3.463
0.5687 0.6970 0.7146 0.6724
0.6876 0.6880 0.6505 0.6663 0.6881 0.5968
143.81 168.52 166.25 147.84
179.42 168.03 164.84 170.51 171.07 170.00
3.474 0.6630 165.03 0.213 0.0462 10.887
(Gms)
THYMUS %FBW %BRAIN
0.409 0.282 0.418 0.399
0.238 0.264 0.324 0.381 0.452 0.423
0.0734 0.0563 0.0797 0.0860
0.0435 0.0520 0.0608 0.0746 0.0858 0.0729
18.549 13.617 18.537 18.919
11.339 12.711 15.414 19.079 21.331 20.766
0.359 0.0685 17.026 0.076 0.0146 3.4977
Group : VII - 1000 mg/kg/day Sex :MALES
ANIMAL (Gms)
LIVER
%FBW %BRAIN
(Gms)
SPLEEN %FBW %BRAIN
641067 641077 641086 641095 641097 641132 641157 641166 641201 641223
14.947 3.5046 794.21 0.548 0.1285 29.118
19.083 3.8204 904.41 0.636 0.1273 30.142
17.103 3.6812 817.15 0.786 0.1692 37.554
17.741 4.1981 857.05 0.632 0.1496 30.531
17.631 3.8154 877.16 0.589 0.1275 29.303
21.326 4.3443 986.86 0.640 0.1304 29.616
16.209 3..8574 788.76 0.564 0.1342 27.445
18.115 3.9708 791.05
0.639 0.1401 27.904
17.184 3.8452 833.37
0.600 0.1343 29.098
18.047 4.0473 841.74 0.596 0.1337 27.799
Mean S.D.
17.739 3.9085 849.18 1.692 0.2438 61.674
0.623 0.1375 29.851 0.066 0.0130 2.8893
(Gms)
TESTES %FBW %BRAIN
3.089 3.981 3.236 3.448 3.366 3.808 3.609 3.801 3.351 4.686
0.7243 0.7970 0.6965 0.8159 0.7284 0.7757 0.8589 0.8332 0.7498 1.0509
164.13 188.67 154.61 166.57 167.46 176.21 175.62 165.98 162.51 218.56
3.638 0.8031 174.03 0.463 0.1013 18.185
(Gms)
THYMUS %FBW %BRAIN
0.265 0.420 0.330 0.355 0.188 0.386 0.185 0.263 0.320 0.195
0.0621 0.0841 0.0710 0.0840 0.0407 0.0786
0.0440 0.0577 0.0716 0.0437
14.081 19.905 15.767 17.150 9.3532 17.862
9.0024 11.485 15.519 9.0951
0.291 0.0638 13.922 0.085 0.0167 3.9726
FBW - Final Body Weight
773
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL ANIMAL FINAL BODY AMD ORGAN WEIGHTS FOR MALE RATS DESIGNATED FOR ONE-MONTH RECOVERY EVALUATION
Group ANIMAL
0 mg/kg/day Sex :MALES
PBW (Gms)
BRAIN
(Gms)
%PBW
ADRENAL GLANDS
(Gms)
%PBW %BRAIN
EPIDIDYMIDES
(Gms)
%FBW %BRAIN
(Gms)
HEART %PBW %BRAIN
641083 641084 641085 641101 641105 641123 641154 641159 641165 641215
Mean S.D.
644.7 558.2 603.3 623.2 653.2 593.8 660.0 618.6 590.9 596.4
614.2 31.9
2.088 2.131 2.233
2.273 2.195 2.298
2.157
2.360 2.256 2.178
0.3239 0.3818 0.3701
0.3647 0.3360 0.3870 0.3268
0.3815 0.3818 0.3652
2.217 0.3619 0.083 0.0241
0.052 0.041 0.060 0.053 0.059 0.065 0.054 0.058 0.064 0.044
0.0081 0.0073 0.0099 0.0085 0.0090 0.0109
0.0082 0.0094 0.0108 0.0074
2.4904 1.9240 2.6870 2.3317 2.6879
2.8285
2.5035 2.4576 2.8369 2.0202
0.055 0.0090 2.4768 0.008 0.0013 0.3124
1.631 1.514 1.424 1.429 1.681 1.433 1.737 1.669 1.563
1.531
0.2530 0.2712 0.2360 0.2293 0.2573 0.2413
0.2632 0.2698 0.2645 0.2567
78.113 71.046 63.771 62.868 76.583 62.359 80.529 70.720 69.282 70.294
1.561 0.2542 70.557 0.114 0.0144 6.3873
2.018 1.506 1.585 1.721 1.879 1.903 1.983
1.871 1.777 1.743
0.3130 0.2698 0.2627 0.2762 0.2877 0.3205 0.3005 0'.3025
0.3007 0.2923
96.647 70.671 70.981 75.715 85.604
82.811 91.933 79.280 78.768 80.028
1.799 0.2926 81.244 0.165 0.0186 8.3809
(Gms)
KIDMEY %FBW
4.533 3.453 4.097 4.394 5.067 4.400 4.823 4.748 4.918 4.112
0.7031 0.6186 0.6791 0.7051 0.7757 0.7410 0.7308
0.7675 0.8323
0.6895
4.455 0.7243 0.480 0.0594
Sroup : VI[I - 100C3 ing/kg/day Sext ; MALES
ANIMAL
FBW (Gins)
BRAIN
(Gms)
%PBW
ADRENAL GLANDS
(Gms)
%FBW %BRAIN
641064 641092 641143 641153 641167 641185 641189 641203 641213 641216
550.0 686.9 614.1 459.1 591.5 564.2
509.5 518.5 699.0 567.1
2.333 2.195 2.235 1.875 1.979 2.215 2.088 2.123 2.214 1.994
0.4242 0.3196 0.3639 0.4084 0.3346 0.3926 0.4098 0.4095 0.3167 0.3516
0.051 0.066 0.063 0.049 0.069 0.037 0.058 0.049 0.052 0.063
0.0093 0.0096 0.0103 0.0107 0.0117 0.0066 0.0114
0.0095 0.0074 0.0111
2.1860 3.0068 2.8188 2.6133 3.4866 1.6704 2.7778 2.3081 2.3487 3.1595
Mean S.D.
576.0 75.6
2.125 0.3731 0.141 0.0408
0.056 0.0097 2.6376 0.010 0.0017 0.5285
EPIDIDYMIDES
(Gms)
%PBW %BRAIN
1.578 1.573 1.662 1.263 1.559 1.601 1.447 1.355 1.624 1.690
0.2869 0.2290 0.2706 0.2751 0.2636 0.2838 0.2840 0.2613 0.2323 0.2980
67.638 71.663 74.362 67.360 78.777 72.280 69.301 63.825 73.351 84.754
1.535 0.2685 72.331 0.138 0.0228 6.0533
(Gms)
HEART %FBW %BRAIN
1.930 1.844 1.911 1.354 1.756 1.720 1.522 1.661
1.770 1.703
0.3509 0.2685 0.3112 0.2949 0.2969 0.3049
0.2987 0.3203 0.2532 0.3003
82.726 84.009 85.503 72.213 88.732 77.652 72.893
78.238 79.946 85.406
1.717 0.3000 80.732 0.175 0.0266 5.5143
(Gms)
KIDNEY
%FBW
4.607 4.821 4.630 3.257 4.731 4.320
3.548 4.538 5.027 4.203
0.8376 0.7018 0.7539 0.7094 0.7998 0.7657 0.6964 0.8752 0.7192 0.7411
4.368 0.7600 0.564 0.0605
FBW - Final Body Weight 774
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS FOR MALE RATS DESIGNATED FOR ONE-MONTH RECOVERY EVALUATION
Group ANIMAL
0 ing/kg/day Sex :MALES
(Gins)
LIVER %FBW %BRAIN
(Gms)
SPLEEN %FBW %BRAIN
(Gms)
TESTES %PBW %BRAIN
(Gins)
THYMUS %FBW %BRAIN
641083 641084 641085 641101 641105 641123 641154 641159 641165 641215
Mean S.D.
19.948 15.928 16.759 20.194 17.134 18.244 19.196 18.122 16.473 18.829
3.0942 2.8535 2.7779 3.2404 2.6231 3.0724 2.9085 2.9295 2.7878 3.1571
955.36 747.44 750.52 888.43
780.59 793.91 889.94 767.88 730.19 864.51
18.083 2.9444 816.88 1.477 0.1935 76.660
0.828 0.804 0.926 0.762 0.836 0.838 0.922 1.066 0.750 0.785
0.1284 0.1440 0.1535 0.1223 0.1280
0.1411 0.1397 0.1723 0.1269
0.1316
39.655 37.729 41.469 33.524 38.087
36.466 42.745 45.169 33.245 36.042
0.852 0.1388 38.413 0.096 0.0151 3.8858
3.351 3.560 3.430 3.269 3.659 3.315 3.670 3.646 3.659 3.472
0.5198 0.6378 0.5685 0.5246 0.5602
0.5583 0.5561 0.5894 0.6192 0.5822
160.49 167.06 153.61 143.82 166.70 144.26 170.14 154.49 162.19 159.41
3.503 0.5716 158.22 0.156 0.0373 9.1412
0.331 0.313 0.483
0.318 0.533
0.327 0.494 0.407 0.483 0.385
0.0513 0.0561 0.0801
0.0510 0.0816
0.0551
0..0748 0.0658 0.0817 0.0646
15.852 14.688 21.630
13.990 24.282
14.230 22.902 17.246 21.410 17.677
0.407 0.0662 18.391 0.085 0.0126 3.8489
Group : VII - 1000 mg/kg/day Sex :MALES
ANIMAL (GTOS)
LIVER %FBW. %BRAIN
(Gas)
SPLEEN %FBW %BRAIN
641064 641092 641143 641153 641167 641185 641189 641203 641213 641216
20.890 25.042 22.698 16.643
21.267 21.082 18.525 18.644 29.117 22.186
3.7982 3.6457 3.6961 3.6251 3.5954 3.7366 3.6359 3.5958 4.1655 3.9122
895.41 1140.9 1015.6 887.63 1074.6 951.78 887.21 878.19 1315.1 1112.6
0.684 0.880 0.754 0.714 0.905 0.716 0.824 0.724 0.730 0.785
0.1244 0.1281 0.1228 0.1555 0.1530 0.1269 0.1617 0.1396 0.1044 0.1384
29.318 40.091 33.736 38.080 45.730 32.325
39.464 34.103 32.972 39.368
Mean
S.D.
21.609 3.7407 1015.9 3.552 0.1797 144.75
0.772 0.1355 36.519 0.075 0.0176 4.8583
(Gms)
TESTES %FBW %BRAIN
3.799 3.725 4.179 3.085 3.809 3.953 3.294 3.424 3.255 3.718
0.6907 0.5423 0.6805 0.6720 0.6440 0.7006 0.6465 0.6604 0.4657 0.6556
162.84 169.70 186.98
164.53 192.47 178.47 157.76 161.28 147.02 186.46
3.624 0.6358 170.75 0.346 0.0741 14.778
(Gms)
THYMUS %PBW %BRAIN
0.298 0.440 0.407 0.248 0.352 0.379 0.262 0.330 0.323 0.327
0.0542 0.0641 0.0663
0.0540 0.0595 0.0672 0.0514 0.0636 0.0462 0.0577
12.773 20.046 18.210 13.227 17.787 17.111 12.548 15.544 14.589 16.399
0.337 0.0584 15.823 0.060 0.0069 2.5330
FBW - Final Body Weight
775
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL ANIMAL FINAL BODY AMD ORGAN WEIGHTS FOR MALE RATS DESIGNATED FOR 3-MONTH RECOVERY EVALUATION
Group : I - 0 ing/kg/day Sex :MALES
| ANIMAL
FBW
LIVER
|
(Gms) (Gms)
%PBW
|
641066 641098 641104 641115 641220
470.9 517.0 586.9
764.5 515.4
13.329 15.218 15.426
22.263 13.908
2.8305 2.9435 2.6284
2.9121 2.6985
Mean S.D.
570.9 115.9
16.029 2.8026 3.594 0.1358
Group : III - 50
| ANIMAL
FBW
(Gins)
ing/kg/day Sex
(Gms)
LIVER
%FBW
:MALES
641059 641113 641160 641194 641225
521.8 747.9
565.5 571.6 660.5
13.529 27.573 14.528 15.399 18.422
2.5928 3.6867 2.5691 2.6940 2.7891
Mean
S.D.
613.5 90.5
17.890 2.8663 5.713 0.4669
FBW - Final Body Weight
776
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL AMIMAL FINAL BODY AMD ORGAN WEIGHTS FOR MALE RATS DESIGNATED FOR 3-MONTH RECOVERY EVALUATION
Group : V - 250 nig/kg/day Sex :MALES
ANIMAL
FBW (Gins)
(Gms)
LIVER
%FBW
641076 641141 641148 641187
517.5 643.2 633.3 665.2
14.117 19.383 17.474 20.263
2.7279 3.0135 2.7592 3.0462
Mean
S.D.
614.8 66.2
17.809 2.8867 2.723 0.1663
3roup : VII - 1000 mg/kg /day Sex :MALES
AMIMAL
FBW |
LIVER
1
(Gms) |(Gms) %FBW
641057 641130 641169 641196 641205
524.7 514.4 640.5 645.3 816.8
14.650 17.965 21.224 17.996
27.635
2.7921 3.4924 3.3137 2.7888 3.3833
Mean S.D.
628.3 122.1
19.894 3.1541 4.912 0.3380
FBW - Final Body Weight
777
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS FOR FEMALE RATS DESIGNATED FOR 90-DAY EXPOSURE EVALUATION
Group : II
ANIMAL
0 nig/kg/day
Sex : FEMALES
FBW (Gms)
BRAIN
(Gins)
%PBW
ADRENAL GLANDS
(Gms)
%PBW %BRAIN
(Gins)
HEART %FBW' %BRAIN
(Gins)
KIDNEYS %FBW %BRAIN
641240 641245 641257 641283 641290 641293 641335 641344 641384
349.9 290.4 289.2 318.6 367.6 303.7 290.7 280.8 286.9
1.986 1.981 1.944 1.958 1.893 2.027
1.902 1.940 1.967
0.5676 0.6822 0.6722 0.6146 0.5150 0.6674 0.6543 0.6909 0.6856
0.090 0.084 0.073 0.076 0.059 0.044 0.057 0.066 0.059
0.0257 0.0289 0.0252 0.0239
0.0161 0.0145 0.0196 0.0235 0.0206
4.5317 4.2403 3.7551 3.8815 3.1167 2.1707 2.9968 3.4021 2.9995
1.279 1.043 0.985 1.255 1.285 1.178 1.060 1.071 1.056
0.3655 0.3592 0.3406 0.3939 0.3496 0.3879 0.3646 0.3814 0.3681
64.401 52.650 50.669 64.096 67.882 58.115 55.731 55.206 53.686
2.382 2.446 2.303
2.461 2.504
2.104
2.211 2.276 2.207
0.6808 0.8423 0.7963 0.7724 0.6812 0.6928 0.7606 0'.8105
0.7693
119.94 123.47 118.47
125.69 132.28 103.80
116.25 117.32 112.20
Mean S.D.
308.6 30.8
1.955 0.6389 0.042 0.0612
0.068 0.0220 3.4549 0.015 0.0047 0.7273
1.135 0.3679 58.048 0.115 0.0174 6.0177
2.322 0.7562 118.82 0.136 0.0589 8.1365
(Gms)
LIVER
%FBW
8.865 8.603 8.166 9.501 10.766 8.493 8.708 8.890 7.647
2.533 2.9625 2.8237 2.9821 2.928 2.7965 2.9955 3.1660 2.6654
8.849 2.8727 0.882 0.190
Group IV 50 mg/kg/day
Sex :FEMALES
ANIMAL
FBW (Gms)
BRAIN
(Gms)
%PBW
ADRENAL GLANDS
(Gms)
%PBW %BRAIN
641260 641298 641311 641312 641313 641336 641355 641361 641369 641396
Mean S.D.
306.0 320.3 311.6 281.1 300.5 289.8 276.0 309.7 266.8 283.3
294.5 17.6
1.952 0.6379 1.964 0.6132 1.813 0.5818 2.022 0.7193 1.922 0.6396
'
1.949 0.6725 1.921 0.6960 1.899 0.6132 1.924 0.7211 2.006 0.7081
1.937 0.6603 0.058 0.0499
0.087 0.066 0.066 0.082 0.061 0.063 0.055 0.080 0.066 0.077
0.0284 0.0206 0.0212 0.0292 0.0203 0.0217 0.0199 0.0258 0.0247 0.0272
4.4570 3.3605 3.6404 4.0554 3.1738 3.2324 2.8631 4.2127 3.4304 3.8385
0.070 0.0239 3.6264 0.010 0.0036 0.5071
(Gms)
HEART %FBW %BRAIN
0.958 1.151 1.015 1.223 1.073 0.975 0.962 1.022 0.934 1.028
0.3131 0.3594 0.3257 0.4372 0.3571 0.3364 0.3486 0.3300 0.3501 0.3629
49.078 58.605 55.985 60.781 55.827 50.026 50.078 53.818 48.545 51.246
1.035 0.3520 53.399 0.093 0.0340 4.2640
(Gins)
KIDNEYS %FBW %BRAIN
2.207 2.579 2.349 2.512
2.226 2.503 2.376 2.498 2.218 2.321
0.7212 0.8052 0.7539 0.8936 0.7408 0.8637 0.8609 0.8066 0.8313
0.8193
113.06
131.31 129.56 124.23 115.82 128.42 123.69
131.54 115.28 115.70
2.379 0.8096 122.86 0.138 0.0566 7.2998
(Gms)
LIVER
%FBW
9.175 9.045 8.361 8.851
8.033 8.723 9.188 8.732 8.429 8.482
2.998 2.823 2.683 3.148 2.6732 3.010 3.329 2.819 3.1593 2.994
8.702 2.963 0.378 0.214
FBW - Final Body Weight
778
SBr
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL ANIMAL FINAL BODY AMD ORGAN WEIGHTS FOR FEMALE RATS DESIGNATED FOR 90-DAY EXPOSURE EVALUATION
Group : VI - 250 mg/kg/day
Sex :FEMALES
ANIMAL
FBW (Gms)
BRAIN
(Gins)
%FBW
ADRENAL GLANDS
(GffiS)
%FBW %BRAIN
641244 641251 641269 641292 641302 641362 641363 641375 641379 641398
295.5 265.9
265.9 331.1
300.4 284.6 387.9 355.6 320.1
306.3
1.945 1.875 1.923
1.977 1.991 1.974 2.042 1.951 1.895 1.915
0.6582 0.7052
0.7232 0.5971 0.6628 0.6936 0.5264 0.5487 0.5920 0.6252
0.059 0.063 0.084 0.059 0.099 0.082 0.121 0.069 0.086 0.057
0.0200 0.0237 0.0316 0.0178
0.0330 0.0288 0.0312 0.0194 0.0269 0.0186
3.0334 3.3600
4.3682 2.9843 4.9724 4.1540 5.9256 3.5366 4.5383 2.9765
Mean S.D.
311.3 38.8
1.949 0.6332 0.050 0.0667
0.078 0.0251 3.9849 0.021 0.0059 0.9853
(Gms)
HEART %FBW %BRAIN
1.117 0.938
0.912 1.137 1.035 0.957 1.272 1.222 1.098 1.147
0.3780 0.3528
0.3430 0.3434 0.3445 0.3363 0.3279 0.3436 0.3430 0.3745
57.429 50.027 47.426
57.511 51.984 48.480 62.292 62.635 57.942 59.896
1.084 0.3487 55.562 0.121 0.0159 5.6454
(Gms)
KIDNEYS %FBW %BRAIM
2.170 2.337 2.239 2.275
2.473 2.237 3.092 2.818 2.614 2.072
0.7343 0.8789
0.8420 0.6871 0.8232 0.7860 0.7971 0.7925 0-8166 0.6765
111.57 124.64 116.43
115.07 124.21 113.32 151.42 144.44 137.94 108.20
2.433 0.7834 124.72 0.321 0.0655 14.961
(Gms)
LIVER
%FBW
7.867 8.086
7.990 9.682 8.530 8.401 12.955 9.852 9.797 8.161
2.6623 3.0410 3.0049
2.9242 2.8395 2.9519 3.3398 2.7705 3.0606 2.6644
9.132 2.9259 1.553 0.2052
Sroup : VIII - 1000 mg/kg/day
ANIMAL | FBW
(Gms)
"
BRAIN
(Gms)
%FBW
641237 641275 641279 641299 641300 641314 641326 641327 641380 641390
235.7 253.3 348.5 244.2 297.9 313.7 253.0 371.2 300.7 318.0
1.802 1.949 1.870 1.853 2.222 1.945 1.928 1.919 1.974 1.949
0.7645 0.7694 0.5366 0.7588 0.7459 0.6200 0.7621 0.5170 0.6565 0.6129
Mean S.D.
293.6 46.2
1.941 0.6744 0.112 0.0988
Sex :FEMALES
ADRENAL GLANDS
(Gms)
%FBW %BRAIN
0.066 0.076 0.055 0.079 0.069 0.080 0.079 0.083 0.080 0.071
0.0280 0.0300 0.0158 0.0324 0.0232 0.0255 0.0312 0.0224 0.0266
0.0223
3.6626 3.8994 2.9412 4.2634 3.1053 4.1131 4.0975 4.3252 4.0527 3.6429
0.074 0.0257 3.8103 0.009 0.0050 0.4730
(Gms)
HEART
%FBW %BRAIN | (Gms)
KIDNEYS
%FBW %BRAIN | (Gms)
LIVER
%FBW
1.024 0.979 1.143 0.843 1.058 1.093 0.880 1.393 1.101 1.047
0.4345 0.3865
0.3280 0.3452 0.3552 0.3484 0.3478 0.3753 0.3661 0.3292
56.826 50.231 61.123 45.494 47.615 56.195 45.643
72.590 55.775 53.720
2.516 2.075 2.573 2.201 2.472 2.528 2.164 2.721 2.498 2.383
1.0675 0.8192 0.7383 0.9013 0.8298 0.8059 0.8553 0.7330 0.8307
0.7494
139.62 106.46 137.59 118.78 111.25 129.97 112.24 141.79 126.55 122.27
8.288 8.063 10.645 8.620 9.026 9.742 8.273 12.673 10.323 10.461
3.5163 3.1832 3.0545 3.5299 3.0299 3.1055
3.2700 3.4141 3.4330 3.2896
1.056 0.3616 54.521 0.152 0.0316 8.2112
2.413 0.8330 124.65 0.205 0.0983 12.569
9.611 3.2826 1.451 0.1865
FBW Final Body Weight
779
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL ANIMAL FINAL BODY AMD ORGAN WEIGHTS FOR FEMALE RATS DESIGNATED FOR 90-DAY EXPOSURE EVALUATION
Group : II - 0 nig/kg/day
Sex
ANIMAL
(Gins)
OVARIES %FBW %BRAIN
: FEMALES
(Gms)
SPLEEN %FBW %BRAIN
(Gms)
THYMUS %FBW %BRAIN
(Gms)
UTERUS %FBW %BRAIN
641240 641245 641257 641283 641290 641293 641335 641344 641384
Mean S.D.
0.123 0.136 0.135
0.197 0.158 0.105 0.107 0.147 0.102
0.0352 0.0468 0.0467 0.0618 0.0430 0.0346 0.0368
0.0524 0.0356
6.1934 6.8652 6.9444 10.061 8.3465 5.1801 5.6257 7.5773 5.1856
0.134 0.0436 6.8866 0.030 0.0093 1.6034
0.564 0.493 0.428 0.503 0.515 0.423
0.408 0.560 0.420
0.1612 0.1698 0.1480 0.1579 0.1401 0.1393 0.1404 0.1994 0.1464
28.399 24.886 22.016 25.689 27.205 20.868 21.451 28.866 21.352
0.479 0.1558 24.526 0.061 0.0195 3.1957
0.353 0.289 0.287 0.179 0.379 0.327 0.349 0.339 0.271
0.1009 0.0995 0.0992 0.0562 0.1031 0.1077
0.1201 0.1207 0.0945
17.774 14.589 14.763
9.1420 20.021 16.132 18.349 17.474 13.777
0.308 0.1002 15.780 0.060 0.0189 3.2033
0.622 0.435 0.502 0.622 0.479 0.397 0.463 0.416 0.461
0.1778 0.1498 0.1736 0.1952 0.1303 0.1307 0.1593 0.1481 0.1607
31.319 21.959 25.823
31.767 25.304 19.586 24.343 21.443 23.437
0.489 0.1584 24.998 0.082 0.0215 4.1921
Group : IV - 50 ing/kg/day
Sex : FEMALES
ANIMAL
(Gms)
OVARIES %FBW %BRAIN
(Gms)
SPLEEN %FBW %BRAIN
|
(Gms)
THYMUS %FBW %BRAIN
641260 641298 641311 641312 641313 641336 641355 641361 641369 641396
0.127 0.096
0.132 0.158 0.141 0.114 0.120 0.129 0.147 0.074
0.0415 0.0300 0.0424 0.0562 0.0469 0.0393 0.0435 0.0417 0.0551 0.0261
6.5061 4.8880 7.2808 7.8140 7.3361 5.8492 6.2467 6.7930
7.6403 3.6889
0.612 0.575 0.498 0.553 0.526 0.453 0.476 0.375 0.620 0.432
0.2000 0.1795 0.1598 0.1967 0.1750 0.1563 0.1725 0.1211 0.2324 0.1525
31.352 29.277 27.468 27.349 27.367 23.243 24.779 19.747 32.225 21.535
0.290
0.303 0.226 0.307 0.288 0.309 0.206 0.382
0.292 0.179
0.0948 0.0946 0.0725 0.1092 0.0958 0.1066 0.0746 0.1233
0.1094 0.0632
14.857 15.428 12.466 15.183 14.984 15.854 10.724 20.116 15.177 8.9232
Mean
S.D.
0.124 0.0423 6.4043 0.025 0.0094 1.3046
0.512 0.1746 26.434 0.080 0.0306 4.0854
0.278 0.0944 14.371 0.059 0.0191 3.0705
(Gms)
UTERUS %FBW %BRAIN
0.660 0.817 0.571 0.672 0.818 0.445 0.406 0.487 0.617 0.732
0.2157 0.2551 0.1832 0.2391 0.2722 0.1536 0.1471 0.1572 0.2313 0.2584
33.811 41.599 31.495 33.234 42.560 22.832 21.135 25.645 32.069 36.491
0.623 0.2113 32.087 0.146 0.0474 7.2364
FBW - Final Body Weight
780
^vsy
H-24616: Subchronic Toxicity 90-Day Gavage Study in Ratswith One-Generation Reproductive Evaluations
INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS FOR FEMALE RATS DESIGNATED FOR 90-DAY EXPOSURE EVALUATION
Group : VI - 250 ing/kg/day
Sex :FEMALES
ANIMAL
(Gms)
OVARIES %FBW %BRAIN
(Gms)
SPLEEN %FBW %BRAIN
641244 641251 641269 641292 641302 641362 641363 641375 641379 641398
0.099 0.097 0.090 0.133 0.147 0.130 0.101 0.114 0.123 0.121
0.0335 0.0365 0.0338 0.0402 0.0489 0.0457 0.0260 0.0321 0.0384 0.0395
5.0900 5.1733
4.6802 6.7274 7.3832 6.5856 4.9461 5.8432 6.4908 6.3185
0.529 0.445 0.529 0.581
0.548 0.506 0.651 0.682 0.428 0.580
0.1790 0.1674 0.1989
0.1755 0.1824 0.1778 0.1678 0.1918 0.1337
0.1894
27.198 23.733 27.509 29.388 27.524 25.633
31.881 34.956 22.586 30.287
Mean S.D.
0.116 0.0375 5.9238 0.018 0.0067 0.9103
0.548 0.1764 28.070 0.080 0.0181 3.7237
(Gms)
THYMUS %FBW %BRAIN
0.258 0.238 0.274 0.306 0.357 0.255 0.444 0.472 0.339 0.267
0.0873 0.0895 0.1030 0.0924 0.1188 0.0896 0.1145 0.1327 0.1059 0.0872
13.265 12.693
14.249 15.478 17.931 12.918 21.743 24.193 17.889 13.943
0.321 0.1021 16.430 0.082 0.0158 3.9587
(Gins)
UTERUS %PBW %BRAIN
0.583 0.816
0.604 0.462 0.754 0.597 0.727 0.641 0.706 0.602
0.1973 0.3069 0.2272 0.1395 0.2510
0..2098 0.1874
0.1803 0.2206 0.1965
29.974 43.520
31.409 23.369 37.870 30.243 35.602 32.855 37.256 31.436
0.649 0.2116 33.354 0.103 0.0449 5.5029
Group : VIII - 1000 nig/kg/day
ANIMAL
(Gms)
OVARIES %FBW %BRAIN
641237 641275 641279 641299 641300 641314 641326 641327 641380 641390
0.069 0.128 0.121 0.130 0.141 0.113 0.105 0.149 0.146 0.147
0.0293 0.0505 0.0347 0.0532 0.0473 0.0360
0..0415 0.0401 0.0486 0.0462
3.8291 6.5675 6.4706 7.0156 6.3456 5.8098 5.4461 7.7645 7.3961 7.5423
Mean S.D.
0.125 0.0428 6.4187 0.025 0.0077 1.1756
Sex : FEMALES
(Gms)
SPLEEN %FBW %BRAIN
|
(Gms)
THYMUS %FBW %BRAIN
0.494 0.379 0.569 0.450 0.761 0.651 0.465 0.615 0.470 0.581
0.2096 0.1496
0.1633 0.1843
0.2555 0.2075 0.1838 0.1657 0.1563 0.1827
27.414 19.446 30.428 24.285 34.248 33.470 24.118 32.048 23.810 29.810
0.264 0.286 0.477 0.334 0.396 0.305 0.233 0.395 0.260
0.250.
0.1120 0.1129 0.1369 0.1368 0.1329 0.0972 0.0921 0.1064 0.0865
0.0786
14.650 14.674 25.508 18.025 17.822 15.681 12.085 20.584 13.171 12.827
0.544 0.1858 27.908 0.113 0.0316 4.8806
0.320 0.1092 16.503 0.079 0.0211 4.1282
(Gins)
UTERUS %FBW %BRAIN
0.670
0.992 0.419 0.738
0.510 0.521 0.473 0.697 0.618 0.550
0.2843 0.3916
0.1202 0.3022 0.1712 0.1661 0.1870 0.1878 0.2055 0.1730
37.181 50.898
22.406 39.827 22.952 26.787 24.533 36.321 31.307 28.220
0.619 0.2189 32.043 0.167 0.0817 9.0400
FBW - Final Body Weight
781
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL ANIMAL FINAL BODY AMD ORGAN WEIGHTS FOR FEMALE RATS DESIGNATED FOR ONE-MONTH RECOVERY EVALUATION
Group : II
ANIMAL
0 nig/kg/day
Sex
FBW (Gms)
BRAIN
(Gms)
%PBW
: FEMALES
ADRENAL GLANDS
(Gms)
%FBW %BRAIN
(Gms)
HEART %FBW %BRAIN
(Gms)
KIDNEYS %FBW %BRAIN
641253 641266 641281 641294 641325 641331 641359 641364 641383 641400
Mean S.D.
389.7 336.6 293.3 336.0 314.2 311.1 309.5 322.6 295.5 290.4
319.9 29.5
1.977 1.842 1.906
2.037 1.918 1.850 1.864
1.942 2.019 1.915
0.5073 0.5472 0.6498 0.6062 0.6104 0.5947 0.6023 0.6020 0.6832 0.6594
1.927 0.6063 0.068 0.0518
0.065 0.058 0.077 0.086 0.067 0.058 0.058 0.072 0.070 0.061
0.0167 0.0172 0.0263
0.0256 0.0213 0.0186 0.0187 0.0223 0.0237 0.0210
3.2878 3.1488 4.0399 4.2219 3.4932 3.1351 3.1116 3.7075 3.4671 3.1854
0.067 0.0211 3.4798 0.009 0.0034 0.3950
1.251 1.169 1.096 1.277
1.309 1.329 0.987 1.123 1.260 1.012
0.3210 0.3473 0.3737 0.3801 0.4166 0.4272
0.3189 0.3481 0.4264 0.3485
63.278 63.464 57.503 62.690 68.248 71.838 52.951 57.827 62.407 52.846
1.181 0.3708 61.305 0.123 0.0411 6.1350
2.730 2.419 2.515 2.541 2.488 2.486 2.463 2.337 2.692 2.295
0.7005 0.7187 0.8575 0.7562 0.7919 0.7991 0.7958 0.7244 0.9110 0.7903
138.09 131.32 131.95 124.74 129.72 134.38 132.14 120.34 133.33 119.84
2.497 0.7845 129.59 0.137 0.0646 6.0397
(Gms)
LIVER
%FBW
9.714 10.148
9.356 10.798
9.967
7.274 8.587 9.869 9.307 7.817
2.4927 3.0149 3.1899 3.2137 3.1722 2.3382 2.7745 3.0592 3.1496 2.6918
9.284 2.9097 1.091 0.3157
3roup : VIII - 1000 ing/kg/day
ANIMAL | FBW | (Gms)
BRAIN
(Gms)
%PBW
641234 641256 641282 641352 641366 641377 641385 641387 641399
301.3 288.1 414.9 303.5 310.1 293.4 320.5 301.2 342.2
1.792
1.873 1.968 2.028 1.987 1.890 1.819 1.904 1.902
0.5948 0.6501 0.4743 0.6682 0.6408 0.6442 0.5676 0.6321 0.5558
Mean
S.D.
319.5 39.2
1.907 0.6031 0.077 0.0618
Sex :FEMALES
ADRENAL GLANDS
|
(Gms)
%FBW %BRAIN | (Gms)
HEART %FBW %BRAIN
0.088 0.062 0.092 0.068 0.076 0.077 0.064 0.060 0.082
0.0292 0.0215 0.0222 0.0224 0.0245 0.0262 0.0200 0.0199 0.0240
4.9107 3.3102 4.6748 3.3531 3.8249 4.0741 3.5184 3.1513 4.3113
0.074 0.0233 3.9032 0.012 0.0030 0.6305
1.110 1.101 1.317 1.151 1.205 1.109 1.142 1.148 1.212
0.3684 0.3822 0.3174 0.3792 0.3886 0.3780 0.3563 0.3811 0.3542
61.942 58.783 66.921 56.755 60.644 58.677 62.782 60.294 63.722
1.166 0.3673 61.169 0.069 0.0221 3.0664
(Gms)
KIDNEYS %FBW %BRAIM
2.375 2.369 2.863 2.194
2.885 2.447 2.387 2.227 2.702
0.7883 0.8223 0.6900 0.7229 0.9303 0.8340 0.7448 0.7394 0.7896
132.53 126.48 145.48 108.19 145.19 129.47 131.23 116.96 142.06
2.494 0.7846 130.84 0.259 0.0720 12.629
(Gms)
LIVER
%FBW
9.403 9.379 12.117
9.306 10.726
8.708 9.682 9.137 9.895
3.1208 3.2555 2.9205 3.0662 3.4589 2.9680 3.0209 3.0335 2.8916
9.817 3.0818 1.028 0.1786
FBW - Final Body Weight
782
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL ANIMAL FINAL BODY AMD ORGAN WEIGHTS FOR FEMALE RATS DESIGNATED FOR ONE-MONTH RECOVERY EVALUATION
Group : II - 0 mg/kg/day
Sex
ANIMAL
(Gins)
OVARIES %FBW %BRAIN
:FEMALES
(Gms)
SPLEEN %FBW %BRAIN
(Gins)
THYMUS %FBW %BRAIN
(Gms)
UTERUS %FBW %BRAIN
641253 641266 641281 641294 641325 641331 641359 641364 641383 641400
Mean
S.D.
0.141 0.133 0.110 0.127 0.100
0.085 0.097 0.126 0.093 0.126
0.0362 0.0395 0.0375 0.0378 0.0318 0.0273 0.0313 0.0391 0.0315 0.0434
7.1320 7.2204 5.7712 6.2347 5.2138 4.5946 5.2039 6.4882 4.6062 6.5796
0.114 0.0355 5.9045 0.019 0.0049 0.9736
0.570 0.540 0.503
0.555 0.557 0.489 0.404 0.613 0.602 0.516
0.1463 0.1604 0.1715 0.1652 0.1773 0.1572
0.1305 0.1900 0.2037 0.1777
28.832 29.316 26.390 27.246 29.041 26.432 21.674 31.565 29.817 26.945
0.535 0.1680 27.726 0.061 0.0211 2.6981
0.280 0.292 0.219 0.382 0.330 0.211 0.273 0.306 0.162 0.249
0.0719 0.0867 0.0747 0.1137 0.1050 0.0678 0.0882 0.0949 0.0548 0.0857
14.163 15.852 11.490 18.753 17.205
11.405 14.646 15.757 8.0238 13.003
0.270 0.0843 14.030 0.063 0.0177 3.1546
0.460 0.697 0.634 0.818 0.813 0.620 0.494 0.658 0.758 0.972
0.1180 0.2071 0.2162 0.2435 0.2588 0.1993 0.1596 0.2040 0.2565 0.3347
23.268 37.839 33.263
40.157 42.388 33.514 26.502 33.883 37.543 50.757
0.692 0.2198 35.911 0.155 0.0591 7.8317
Group : VIII - 1000 mg/kg/day
ANIMAL
(Gms)
OVARIES %FBW %BRAIN
Sex :FEMALES
(Gms)
SPLEEN %FBW %BRAIN
641234 641256 641282 641352 641366 641377 641385 641387 641399
0.142 0.0471 7.9241 0.497 0.1650 27.734
0.085 0.0295 4.5382
0.521 0.1808 27.816
0.177 0.0427 8.9939 0.641 0.1545 32.571
0.130 0.0428 6.4103 0.489 0.1611 24.112
0.113 0.0364 5.6870 0.530 0.1709 26.673
0.136 0.0464 7.1958 0.516 0.1759 27.302
0.087 0.0271 4.7828 0.427 0.1332 23.474
0.158 0.0525 8.2983
0.525 0.1743 27.574
0.146 0.0427 7.6761 0.636 0.1859 33.438
Mean
S.D.
0.130 0.0408 6.8341 0.031 0.0083 1.5737
0.531 0.1668 27.855 0.068 0.0159 3.3244
(Gms)
THYMUS %FBW %BRAIN
0.234 0.229
0.481 0.233 0.242 0.223 0.283 0.222 0.245
0.0777 0.0795 0.1159 0.0768 0.0780 0.0760 0.0883 0.0737 0.0716
13.058 12.226 24.441 11.489 12.179 11.799 15.558 11.660 12.881
0.266 0.0819 13.921 0.083 0.0136 4.1324
(Gms)
UTERUS %FBW %BRAIN
0.473 0.938 0.640 0.491 0.533 0.592 0.738 0.675 0.680
0.1570 0.3256 0.1543 0.1618 0.1719 0.2018 0.2303 0.2241 0.1987
26.395 50.080 32.520 24.211 26.824 31.323
40.572 35.452 35.752
0.640 0.2028 33.681 0.144 0.0541 8.0663
FBW - Final Body Weight
783
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS FOR FEMALE RATS DESIGNATED FOR 3-MONTH RECOVERY EVALUATION
Group : II
ANIMAL
- 0 ing/kg/day
PBW (Gms)
(Gms)
Sex : FEMALES
LIVER
%FBW
641241 641285 641288 641309 641394
300.8 326.9 317.5 318.5 342.3
10.718 8.303
10.830 9.555 9.523
3.5632 2.5399 3.4110 3.0000 2.7821
Mean S.D.
321.2 15.1
9.786 3.0592 1.034 0.4265
Group : IV - 50 nig/kg/day Sex : FEMALES
ANIMAL
FBW (Gms)
(Gms)
LIVER
%FBW
641247 641319 641321 641340 641391
334.9 314.9 350.6 318.4 326.9
9.668 7.923 10.479 8.266 9.135
2.8868
2.5160 2.9889 2.5961 2.7944
Mean S.D.
329.1 14.3
9.094 2.7565 1.038 0.1975
FBW - Final Body Weight
784
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS FOR FEMALE RATS DESIGNATED FOR 3-MONTH RECOVERY EVALUATION
Group : VI - 250 nig/kg/day Sex : FEMALES
ANIMAL
PBW
LIVER
|
(Gms) (Gms)
%FBW
641232 641262 641305 641372 641382
410.8 374.5 320.4 317.3 305.5
12.055 9.519
10.094 10.064
9.058
2.9345 2.5418 3.1504 3.1718 2.9650
Mean S.D.
345.7 45.1
10.158 2.9527 1.143 0.2532
Group : VIII - 1000 ing/kg/day Sex :FEMALES
ANIMAL
FBW (Gins)
(Gais)
LIVER
%FBW
641259 641264 641278 641301 641395
409.8 381.3 325.9 392.3 349.6
11.057 11.335
9.404 10.618 12.302
2.6981 2.9727 2.8855 2.7066 3.5189
Mean S.D.
371.8 33.7
10.943 2.9564 1.059 0.3357
FBW Final Body Weight
785
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
APPENDIX L INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
786
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
KEY TO APPENDIX
LESION GRADING:
Histopathological changes are described according to their morphologic character, distribution and severity. The distribution (extent of tissue involvement) is indicated, where appropriate, by modifiers such as focal,
multifocal, diffuse, unilateral, bilateral, etc. A severity score, if
appropriate, is also assigned as follows:
MINIMAL: MILD:
MODERATE: SEVERE:
The amount of change present barely exceeds that which is considered to be within normal limits.
In general, the lesion is easily identified but of limited severity. The lesion probably does not produce any functional
impairment.
The lesion is prominent but there is significant potential for increased severity. Limited tissue or organ dysfunction is possible.
The degree of change is either as complete as considered possible or great enough in intensity or extent to expect significant tissue or organ dysfunction.
COMMENT:
Grades minimal through severe represent progressive involvement/severity along a continuum with minimal lesions being the least severe and severe lesions being the most severe. While the grades refer to the morphological
characteristics of lesions, they also indicate their relative biological
significance.
Gross observations listing multiple masses for a tissue are distinguished
with letters (i.e., a, b, c, d, etc.).
787
SamBSaiA Does not cwta'n TSSA '"-f
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641066
Terminal Sacrifice Killed on Day : 182
Exposure Group - FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, mild.
minimal.
No Microscopic Abnormality Observed :
NOSE
788
. Does not confab "e^. -?
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_______
DuPont-4739
INDIVIDUAL AWIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641069
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MAMDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES. URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, LUNGS :
INFLAMMATION, SUBACUTE/CHRONIC, HEART :
CARDIOMYOPATHY, minimal.
PARATHYROID GLANDS : NOT PRESENT.
EYE(S) WITH OPTIC NERVE : OPTIC NERVE NOT PRESENT.
minimal. minimal.
641069 Continued on the next page ....
789
Simpeuy SanlfeeA 0@es no8 errtain TSCA <
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641069
Continued from previous page
Histopathology
No Microscopic Abnormality Observed :
KIDNEYS, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY
GLANDS. MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS,
SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE
641070
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
641070 Continued on the next page
790
SanHbeA Does not contain T8CA CB?
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 nig/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641070
Continued from previous page
Histopathology :
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
KIDNEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
LUNGS :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
PANCREAS :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
PROSTATE :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
No Microscopic Abnormality Observed :
HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH
NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE
791
'Qmpwy Sanitized,
not eontain TSCA CB!
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641083
Terminal Sacrifice Killed on Day : 122
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES. URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
No Microscopic Abnormality Observed :
LIVER. THYROID GLAND, NOSE
641084
Terminal Sacrifice Killed on Day : 122
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
641084
Wo Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
Continued on the next page ....
792
WBpany Santeed.
not ontain TSCA <
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641084
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
No Microscopic Abnormality Observed :
THYROID GLAND, NOSE
641085
Terminal Sacrifice Killed on Day : 122
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
641085 Continued on the next page ....
793 Company Sanitized. Does not contain TSCA CB8
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations______
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641085
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
INFLAMMATION, SUBACUTE/CHROWIC, THYROID GLAND :
ALTERATION, COLLOID, mild.
minimal.
No Microscopic Abnormality Observed :
NOSE
641094
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
641094
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
Continued on the next page ....
794
,
not eonSafs TSCA CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641094
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAMD, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE. SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
KIDNEYS : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
PARATHYROID GLANDS :
NOT PRESENT.
minimal.
BRAIN,
No Microscopic Abnormality Observed :
LIVER, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA,
SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE
795
iTSCACBl
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641098
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM. COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
INFLAMMATION, FATTY CHANGE, THYROID GLAND :
SUBACUTE/CHRONIC, minimal. MEDIAN CLEFT, mild.
ALTERATION, COLLOID, minimal.
No Microscopic Abnormality Observed :
NOSE
796
Smted. Does mi contain TSCA CBS
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_______
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641101
Terminal Sacrifice Killed on Day : 122
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
NOSE
797
OH8pany
Does not eonfq'n I-S^A CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
__
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641104
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
NOSE
^^^^.o------*^08'
798
3@e nrt? g--s<s~ .*< a f^QJ
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
_
_
_DuPont-4739
_
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641105
Terminal Sacrifice Killed on Day : 122
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIM, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopafchology :
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
NOSE
799
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations____
___
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref 641115
Microscopic & Macroscopic Findings
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology
LIVER :
INFLAMMATION, FATTY CHANGE, THYROID GLAND :
SUBACUTE/CHRONIC, minimal. PERIPORTAL, minimal.
ALTERATION, COLLOID, minimal.
No Microscopic Abnormality Observed :
NOSE
800
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref 641123
Microscopic & Macroscopic Findings
Terminal Sacrifice Killed on Day : 122
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
NOSE
801
Company Sanitized, Does not eontain TSCA CBI
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641147
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
KIDNEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
HEART :
CARDIOMYOPATHY, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
641147 Continued on the next page ....
802 Company Sanitized. Does not contain TSCA CBS
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 ing/kg/day Sex: Males
Animal Ref 641147
Microscopic & Macroscopic Findings Continued from previous page
Histopathology :
No Microscopic Abnormality Observed :
LUNGS, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS. MANDIBULAR
LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE
641149
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS. TRACHEA, ESOPHAGUS, PHARYNX/LARYNX. EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
641149 Continued on the next page ....
803 Does not eortain TSCA CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 ing/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641149
Continued from previous page
Histopathology :
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal. NECROSIS, FOCAL, minimal.
KIDNEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
HEART :
CARDIOMYOPATHY, minimal.
PANCREAS :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
PARATHYROID GLANDS :
NOT PRESENT.
No Microscopic Abnormality Observed :
LUNGS, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD,
STOMACH, DUODENUM, JEJUNUM, ILEUM, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH
NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY
GLAND, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX,
EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT,
STERNUM, BONE MARROW, NOSE
804
Company Sanffized. Does not contain TSCA CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641154
Terminal Sacrifice Killed on Day : 122
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON. RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
NOSE
805
Company Sanitized. Does not eontai'R TSCA CBJ
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641155
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
LUNGS :
INFLAMMATION, SUBACUTE/CHRONIC, THYROID GLAND :
ALTERATION, COLLOID, minimal.
PARATHYROID GLANDS : NOT PRESENT.
minimal. minimal.
641155 Continued on the next page
806
Company Sanitized Does not contain TSCA CBg
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641155
Continued from previous page
Histopathology :
No Microscopic Abnormality Observed :
KIDNEYS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY
GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS,
SCIATIC NERVE, PITUITARY GLAND, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, MOSE
641159
Terminal Sacrifice Killed on Day : 122
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN.
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
641159 Continued on the next page ....
807
1 Does not esinlam TSCA '
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations______ _
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641159
Continued from previous page
Histopathology :
LIVER :
INFLAMMATION, FATTY CHANGE, THYROID GLAND :
SUBACUTE/CHRONIC, minimal. MEDIAN CLEFT, minimal.
ALTERATION, COLLOID, minimal.
No Microscopic Abnormality Observed :
NOSE
641165
Terminal Sacrifice Killed on Day : 122
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MAMDIBULAR LYMPH NODE. THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
641165 Continued on the next page ....
808
Company Sanitized. Does not c^fafn TSCA COI
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref 641165
Microscopic & Macroscopic Findings Continued from previous page
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
No Microscopic Abnormality Observed :
THYROID GLAND, NOSE
641172
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON. RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
641172
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
NECROSIS, FOCAL, minimal.
Continued on the next page ....
minimal.
809
Company Sanitized. Does not contain TSCA CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641172
Continued from previous page
Histopathology :
LIVER : HYPERPLASIA,
LUNGS :
BILE DUCT,
minimal.
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
ESOPHAGUS :
FIBROSIS, minimal. EYE(S) WITH OPTIC NERVE :
FOLD/ROSETTE, RETINAL, minimal.
No Microscopic Abnormality Observed :
KIDNEYS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY
GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS,
SCIATIC NERVE, PITUITARY GLAND, PARATHYROID GLANDS, TRACHEA, PHARYNX/LARYNX, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT,
STERNUM, BONE MARROW, NOSE
810
-CesBpanySanitized. Does not <^..r>t-!)8 if?<"^ f^y
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641206
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN. AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS. TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
641206
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
KIDNEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
LUNGS :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
HEART :
CARDIOMYOPATHY, minimal.
PANCREAS :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
Continued on the next page ....
811
Sasipesy SanKteed, Doe not cmWn
CBl
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641206
Continued from previous page
Histopathology
No Microscopic Abnormality Observed :
SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH
NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE
641214
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM,
ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
641214 Continued on the next page
812 not eontain TSCA CSJ
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641214
Continued from previous page
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
HEART :
CARDIOMYOPATHY, minimal.
PANCREAS :
ATROPHY, minimal.
INFLAMMATION, SUBACUTE/CHRONIC, THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal. minimal.
No Microscopic Abnormality Observed :
KIDNEYS, LUNGS, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS,
MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE
813
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations______
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641215
Terminal Sacrifice Killed on Day : 122
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM,
ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
No Microscopic Abnormality Observed :
THYROID GLAND, NOSE
814
Ooffi^aaySaniteed.
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641220
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
MOSE
815
Company Sanitized. Does not contain TSCA CB(
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641222
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
GLANDS,
No Microscopic Abnormality Observed :
KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE,
SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, PARATHYROID
641222 Continued on the next page
816 i Does not contain'
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : I - 0 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641222
Continued from previous page
Histopathology :
No Microscopic Abnormality Observed :
TRACHEA, ESOPHAGUS, PHARYNX/LARYNX,
EYE(S) WITH OPTIC NERVE, SKIM, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES. FEMUR/KMEE JOINT,
STERNUM, BONE MARROW, NOSE
817 Company Sanitized. Does not contain
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : III
Animal Ref
50 mg/kg/day Sex: Males Microscopic & Macroscopic Findings
641055
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN. PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
NOSE :
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
minimal.
818
Company SanKizeA Does not contain TSCA CB!
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : Animal Ref
III -
50 mg/kg/day Sex: Males Microscopic & Macroscopic Findings
641056
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS. TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
THYROID GLAND :
ALTERATION, COLLOID, mild.
NOSE :
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
minimal.
819 Company SanESEzed. Doss not eontam TSCA CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : III -
Animal Ref
50 mg/kg/day Sex: Males Microscopic & Macroscopic Findings
641059
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
INFLAMMATION, PATTY CHANGE, THYROID GLAND :
SUBACUTE/CHRONIC, minimal. MEDIAN CLEFT, minimal.
ALTERATION, COLLOID, mild.
No Microscopic Abnormality Observed :
NOSE
820 Company SaniSfeed. Does not contain TSCA CB8
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations__________
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : III -
Animal Ref
50 mg/kg/day Sex: Males Microscopic & Macroscopic Findings
641073
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
NOSE :
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
minimal.
821
Company SanESIzed. Does wt en^aw f^CA CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : III
Animal Ref
641081
50 mg/kg/day Sex: Males
Microscopic & Macroscopic Findings
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Hisfcopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. NECROSIS, FOCAL, minimal. HYPERPLASIA, BILE DUCT, minimal. HYPERTROPHY, HEPATOCELLULAR, minimal.
THYROID GLAND :
ALTERATION, COLLOID, mild.
NOSE :
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
minimal.
822
ompan]f Sanitized. Does not cw?a'"n TSCA CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : Animal Ref
III -
50 mg/kg/day Sex: Males Microscopic & Macroscopic Findings
641113
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
LIVER : DISCOLORATION, TAN, MANY, < 2MM DIA.
No Macroscopic Abnormality Observed :
KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE,
SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL
GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND,
PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. NECROSIS, FOCAL, moderate. HYPERPLASIA, BILE DUCT, minimal. PATTY CHANGE, PERIPORTAL, minimal.
FATTY CHANGE, MEDIAN CLEFT, minimal.
THYROID GLAND :
ALTERATION, COLLOID, mild.
641113 Continued on the next page ....
823
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : III -
Animal Ref
50 nig/kg/day Sex: Males Microscopic & Macroscopic Findings
641113
Continued from previous page
Histopathology :
No Microscopic Abnormality Observed :
NOSE
641144
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM. COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS. MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Hisfcopathology :
641144
LIVER :
INFLAMMATION, FATTY CHANGE, THYROID GLAND :
SUBACUTE/CHRONIC, minimal. PERIPORTAL, minimal.
ALTERATION, COLLOID, minimal.
Continued on the next page ....
824
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : Animal Ref
III -
50 mg/kg/day Sex: Males Microscopic & Macroscopic Findings
641144
Continued from previous page
Histopathology :
NOSE :
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM, minimal.
641146
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
INFLAMMATION, THYROID GLAND :
SUBACUTE/CHRONIC,
minimal.
ALTERATION, COLLOID, minimal.
NOSE :
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
mild.
825
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : Animal Ref
III -
50 mg/kg/day Sex: Males Microscopic & Macroscopic Findings
641160
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS. CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Hisfcopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
NOSE
CSSSeue^yanKbecl
826
not contain TSCA CBS
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : Animal Ref
III -
50 mg/kg/day Sex: Males Microscopic & Macroscopic Findings
641178
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN. PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES,
FEMUR/KNEE JOINT. STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
NOSE
827 SanBtecfc Does not contain TSCA CB!
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : HI -
Animal Ref
50 mg/kg/day Sex: Males Microscopic & Macroscopic Findings
641194
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE. SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Hisfcopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
No Microscopic Abnormality Observed :
THYROID GLAND, NOSE
828
SwapanySanSlted. Does not contain TSCA CBJ
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : Animal Ref
III -
50 mg/kg/day Sex: Males Microscopic & Macroscopic Findings
641198
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAMD, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal. FATTY CHANGE, PERIPORTAL, minimal. NECROSIS, FOCAL, minimal.
THYROID GLAND :
ALTERATION, COLLOID, mild.
No Microscopic Abnormality Observed :
NOSE
829
Does not contain T8CA CBI
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
__
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : Animal Ref
III -
50 mg/kg/day Sex: Males Microscopic & Macroscopic Findings
641218
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
NOSE
INFLAMMATION, FATTY CHANGE,
:
SUBACUTE/CHRONIC, minimal. MEDIAN CLEFT, minimal.
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
minimal.
No Microscopic Abnormality Observed :
THYROID GLAND
Company
830
rot contain TSCA CB8
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : III
Animal Ref 641224
50 mg/kg/day Sex: Males
Microscopic & Macroscopic Findings
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology
Mo Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND. PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, MOSE
Histopathology :
LIVER :
INFLAMMATION, FATTY CHANGE, NOSE :
SUBACUTE/CHRONIC, minimal. PERIPORTAL, minimal.
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
minimal.
No Microscopic Abnormality Observed :
THYROID GLAND
Company
831
Does not contain TSCA CB(
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : III - 50 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641225
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER. TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
NOSE
832
Company Sanftlzed. Does not contain TSCA CB"?
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations__________
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : V - 250 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641061
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology ;
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERTROPHY, HEPATOCELLULAR, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
NOSE :
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
minimal.
833
CompanySanitized. Does not contain TSCA C3(
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : V - 250 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641076
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS. MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES. EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : HYPERTROPHY, HEPATOCELLULAR, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
No Microscopic Abnormality Observed :
NOSE
834
Company Sanitized. Does not contain Tcsra CBI
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : V - 250 nig/kg/day Sex: Males
Animal Ref 641089
Microscopic & Macroscopic Findings
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERTROPHY, HEPATOCELLULAR, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
NOSE :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
mild.
835
OffipanySanitized. Does not contain TSCA CBI
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : V - 250 mg/kg/day Sex: Males
Animal Ref 641102
Microscopic & Macroscopic Findings
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM,
ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
HYPERTROPHY, HEPATOCELLULAR, mild. INFLAMMATION. SUBACUTE/CHRONIC, minimal.
THYROID GLAND :
ALTERATION, COLLOID, mild. HYPERTROPHY, FOLLICULAR, minimal.
NOSE :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
mild.
836
^QWpanySanBbed. Does not confab f<ffi ^
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : V - 250 mg/kg/day Sex: Males
Animal Ref 641134
Microscopic & Macroscopic Findings
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM. JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES,
FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERTROPHY, HEPATOCELLULAR, mild.
THYROID GLAND :
ALTERATION, COLLOID, mild.
NOSE :
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
minimal.
837
Svauwiy SanMzed. Does not contain TSCA cgt
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : V - 250 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641137
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS. HEART, SKELETAL MUSCLE. SPLEEN.
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
HYPERTROPHY, HEPATOCELLULAR, mild. INFLAMMATION, SUBACUTE/CHRONIC, minimal.
THYROID GLAND :
ALTERATION, COLLOID, mild. HYPERTROPHY, FOLLICULAR, minimal.
NOSE :
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
minimal.
838
oinpuiiy Sanitized. Does not e*ww.i T-ecA CBI
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : V - 250 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641141
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERTROPHY, HEPATOCELLULAR, minimal.
THYROID GLAND :
ALTERATION, COLLOID, mild.
No Microscopic Abnormality Observed :
NOSE
839
OonnpanySanHIzed. Does not contain TSCA CB(
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : V - 250 nig/kg/day Sex: Males
Animal Ref 641148
Microscopic & Macroscopic Findings
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERTROPHY, HEPATOCELLULAR, minimal.
THYROID GLAND :
ALTERATION, COLLOID, moderate.
No Microscopic Abnormality Observed :
NOSE
840
CompanySanitoed. Does not conta?n TSCA CS(
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : V - 250 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641162
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON. RECTUM. MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
HYPERTROPHY, HEPATOCELLULAR, mild.
THYROID GLAND :
HYPERTROPHY, FOLLICULAR, minimal. ALTERATION, COLLOID, mild.
NOSE :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
DEGENERATION/NECROSIS. OLFACTORY, EPITHELIUM,
mild.
841
Company Sanitized. Does not contain TSCA CB
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : V - 250 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641187
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS. SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE,
SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND : ALTERATION, COLLOID, moderate.
minimal.
No Microscopic Abnormality Observed :
NOSE
842
Company Sanitized. Does not contain TSCA CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : V - 250 ing/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641190
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES. URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
HYPERTROPHY, HEPATOCELLULAR, mild.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
NOSE :
INFLAMMATION, SUBACUTE/CHRONIC, minimal. DEGENERATION/NECROSIS, OLFACTORY. EPITHELIUM,
mild.
843
Company SanBlzed. Does not contain TSCA CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
____
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : V - 250 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641197
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
HYPERTROPHY. HEPATOCELLULAR, mild-
THTK6TD_GLAMD
ALTERATlSH. 58iWlB, minimal,
HYPERTROPHY, FOLLICUIAR, m-lnimal.
NQ3E -
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
mild.
844
Company Sanitized. Does not conla?n TSCA CBft
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : V - 250 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641200
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERTROPHY, HEPATOCELLULAR, mild. FATTY CHANGE, MEDIAN CLEFT, mild. FATTY CHANGE, CENTRILOBULAR, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
NOSE :
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
mild.
845
Company Sanltfcc&d. Does not contain T5CA OBI
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : V - 250 mg/kg/day Sex: Males
Animal Ref 641202
Microscopic & Macroscopic Findings
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERTROPHY, HEPATOCELLULAR, mild.
THYROID GLAND :
ALTERATION, COLLOID, minimal. HYPERTROPHY, FOLLICULAR, minimal.
NOSE :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
mild.
846
Company Sanitized. Does not contain TSCA CBI
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641057
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON. RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
NOSE
847
Company Sanitized. Does not contain TSCA CBI
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 mg/kg/day Sex: Males
Animal Ret
Microscopic & Macroscopic Findings
641064
Terminal Sacrifice Killed on Day : 122
Exposure Group : RECOVERY
Animal is signed off from
necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM. MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS. TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERTROPHY. HEPATOCELLULAR, minimal.
THYROID GLAND :
ALTERATION, COLLOID, severe. HYPERTROPHY, FOLLICULAR, mild.
NOSE :
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
minimal.
848
Company Sanitized. Does not confs'n ^SCA CBI
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations______
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641067
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
641067
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERTROPHY, HEPATOCELLULAR, mild.
KIDNEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
LUNGS :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
HEART :
CARDIOMYOPATHY, minimal.
THYROID GLAND :
ALTERATION, COLLOID, mild. HYPERTROPHY, FOLLICULAR, mild.
Continued on the next page ....
849
Company Sanftlzed. Does nnt ^^ T<s^ ^g,
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641067
Continued from previous page
Histopathology :
NOSE
:
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
mild.
No Microscopic Abnormality Observed :
SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS. MANDIBULAR
LYMPH NODE, THYMUS. ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, BONE MARROW
641077
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
641077 Continued on the next page ....
850
CompanySanitized. Does not contain TSCA CBl
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641077
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERTROPHY, HEPATOCELLULAR, mild.
KIDNEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
HEART :
CARDIOMYOPATHY, minimal.
THYROID GLAND :
HYPERTROPHY, FOLLICULAR, mild. ALTERATION, COLLOID, mild.
NOSE :
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
minimal.
No Microscopic Abnormality Observed :
LUNGS, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN. SPINAL CORD,
STOMACH. DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
641077 Continued on the next page ....
851
Company Sanitized. Does not contain TSCA C8(
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641077
Continued from previous page
Histopathology :
No Microscopic Abnormality Observed :
PHARYNX/LARYNX. EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE,
SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES,
FEMUR/KNEE JOINT, STERNUM, BONE MARROW
641086
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER. KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
641086
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERTROPHY, HEPATOCELLULAR, mild.
Continued on the next page ....
852
Company Sanitized. Does not contain TSCA CB(
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641086
Continued from previous page
Histopathology :
PANCREAS :
ATROPHY, minimal.
PITUITARY GLAND :
CYST, minimal.
THYROID GLAND :
ALTERATION, COLLOID, moderate. HYPERTROPHY, FOLLICULAR, mild.
PARATHYROID GLANDS :
NOT PRESENT. NOSE :
INFLAMMATION, SUBACUTE/CHRONIC, minimal. DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
mild.
No Microscopic Abnormality Observed :
KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS,
SCIATIC NERVE, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT,
STERNUM, BONE MARROW
853
Company Sanitized. Does not contain TSCA CBt
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641092
Terminal Sacrifice Killed on Day : 122
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERTROPHY, HEPATOCELLULAR, minimal.
THYROID GLAND :
ALTERATION, COLLOID, mild. HYPERTROPHY, FOLLICULAR, minimal.
No Microscopic Abnormality Observed :
NOSE
854
oompanysaniteed- D^ ot con^n TSCA cm
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 ing/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641095
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE. SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
641095
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERTROPHY, HEPATOCELLULAR. mild.
KIDNEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
LUNGS :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
HEART :
CARDIOMYOPATHY, minimal.
THYROID GLAND :
HYPERTROPHY, FOLLICULAR, mild.
ALTERATION, COLLOID, moderate.
Continued on the next page ....
855
col*'PWySanitized. Does not contain TSCA CBf
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641095
Continued from previous page
Histopathology :
NOSE
:
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
moderate.
No Microscopic Abnormality Observed :
SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, BONE MARROW
641097
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER. KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
641097 Continued on the next page ....
856
^Pany Sanitized. Does not contain TSCA CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641097
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
HYPERTROPHY, HEPATOCELLULAR, mild.
KIDNEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
LUNGS :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
PANCREAS :
ATROPHY, minimal.
THYROID GLAND :
ALTERATION, COLLOID, mild. HYPERTROPHY, FOLLICULAR, mild.
PARATHYROID GLANDS :
NOT PRESENT.
NOSE :
DEGENERATION/NECROSIS. OLFACTORY, EPITHELIUM,
mild.
641097 Continued on the next page ....
857
CompanySanitized. Does not contain . SCA cdl
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 nig/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641097
Continued from previous page
Histopathology :
No Microscopic Abnormality Observed :
HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD,
STOMACH, DUODENUM, JEJUNUM, ILEUM, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY
GLAND, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, BONE MARROW
641130
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN. PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
641130 Continued on the next page ....
858
Company Sanitized. Does not contain TSCA CBt
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations____________ DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641130
Continued from previous page
Histopathology :
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERTROPHY, HEPATOCELLULAR, minimal.
THYROID GLAND :
ALTERATION, COLLOID, mild.
No Microscopic Abnormality Observed :
NOSE
641132
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LONGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM. PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
641132 Continued on the next page ....
859
CompanySanSteed. Does not eontain TSCA CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
___
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641143
Terminal Sacrifice Killed on Day : 122
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopafchology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERTROPHY, HEPATOCELLULAR, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
NOSE :
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
minimal.
861
Does not eontain TSCA CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : VII
Animal Ref
1000 ing/kg/day Sex: Males Microscopic & Macroscopic Findings
641153
Terminal Sacrifice Killed on Day : 122
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERTROPHY, HEPATOCELLULAR, minimal.
THYROID GLAND :
HYPERTROPHY, FOLLICULAR, minimal. ALTERATION, COLLOID, moderate.
No Microscopic Abnormality Observed :
NOSE
862
Company Sanitized. Does not confam TSCA CB8
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641157
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS. LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
. ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAMD, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
641157
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal. NECROSIS, FOCAL, minimal. HYPERTROPHY, HEPATOCELLULAR, mild.
KIDNEYS :
MEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
THYROID GLAND :
HYPERTROPHY, FOLLICULAR, minimal. ALTERATION, COLLOID, moderate.
PROSTATE :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
NOSE :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
Continued on the next page ....
863
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 mg/kg/day Sex: Males
Animal Ref 641157
Microscopic & Macroscopic Findings Continued from previous page
Histopathology :
SPINAL
NOSE : DEGENERATION/NECROSIS,
OLFACTORY,
EPITHELIUM,
No Microscopic Abnormality Observed :
LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA,
mild.
BRAIN,
CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH MODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, BONE MARROW
641166
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
641166 Continued on the next page
864
ta?" 'y^1'" " -ifrt
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
^s^ 'i"?'511?!!
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641166
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
HYPERTROPHY, HEPATOCELLULAR, mild.
THYROID GLAND :
ALTERATION, COLLOID, severe. HYPERTROPHY, FOLLICULAR, mild.
ESOPHAGUS :
FIBROSIS, minimal.
NOSE :
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
mild.
GLANDS,
No Microscopic Abnormality Observed :
KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, PARATHYROID
TRACHEA, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, BONE MARROW
865
SosStoA Does f@8etmgss's "yA ^af
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
____
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 ing/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641167
Terminal Sacrifice Killed on Day : 122
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERTROPHY, HEPATOCELLULAR, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal. HYPERTROPHY, FOLLICULAR, minimal.
NOSE :
DEGENERATION/NECROSIS, OLFACTORY. EPITHELIUM,
minimal.
866
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641169
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM,
ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH MODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS. SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
NECROSIS, FOCAL, mild.
HYPERTROPHY, HEPATOCELLULAR, minimal.
THYROID GLAND :
ALTERATION, COLLOID, moderate.
No Microscopic Abnormality Observed :
NOSE
867
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641185
Terminal Sacrifice Killed on Day : 122
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE. SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM,
ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERTROPHY, HEPATOCELLULAR, minimal.
THYROID GLAND :
HYPERTROPHY, POLLICULAR, minimal. ALTERATION, COLLOID, moderate.
No Microscopic Abnormality Observed :
NOSE
868 D@ noS contain TSCA r-iqi
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII
Animal Ref
1000 mg/kg/day Sex: Males Microscopic & Macroscopic Findings
641189
Terminal Sacrifice Killed on Day : 122
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIM, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM,
ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE. PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal. NECROSIS, FOCAL, minimal. HYPERTROPHY, HEPATOCELLULAR, minimal.
THYROID GLAND :
ALTERATION, COLLOID, severe. HYPERTROPHY, FOLLICULAR, mild.
No Microscopic Abnormality Observed :
NOSE
869
Does not contain TCCA CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 ing/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641196
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS. LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal. NECROSIS, FOCAL, mild. HYPERTROPHY, HEPATOCELLULAR, minimal.
THYROID GLAND :
ALTERATION, COLLOID, moderate.
No Microscopic Abnormality Observed :
NOSE
870 'in TSCA CBr
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641201
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM. PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS.
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
641201
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERTROPHY, HEPATOCELLULAR, mild. FATTY CHANGE, MEDIAN CLEFT, minimal.
LUNGS :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
THYROID GLAND :
HYPERTROPHY, FOLLICULAR, mild. ALTERATION, COLLOID, severe.
NOSE :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
Continued on the next page ....
moderate.
871
& Does rot eontatn T@e^ ^q,
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641201
Continued from previous page
Histopathology :
NOSE : HYPERPLASIA/HYPERTROPHY,
minimal.
TRANSITIONAL CELL,
EPITHELIUM,
No Microscopic Abnormality Observed :
KIDNEYS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY
GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, PARATHYROID GLANDS,
TRACHEA, ESOPHAGUS, PHARYNX/LARYNX,
EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES. URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT,
STERNUM, BONE MARROW
641203
Terminal Sacrifice Killed on Day : 122
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
641203
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
Continued on the next page ....
Swsapsas
872 Does noi eontate TSCA CBS
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII -
Animal Ref
1000 mg/kg/day Sex: Males Microscopic & Macroscopic Findings
641203
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal. NECROSIS, FOCAL, minimal. HYPERTROPHY, HEPATOCELLULAR, minimal.
THYROID GLAND :
ALTERATION, COLLOID, moderate. HYPERTROPHY, FOLLICULAR, minimal.
No Microscopic Abnormality Observed :
NOSE
641205
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
641205
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
Continued on the next page ....
873
Does not soMatn TSCA CBS
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII -
Animal Ref
1000 mg/kg/day Sex: Males Microscopic & Macroscopic Findings
641205
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopafchology :
LIVER :
HYPERTROPHY, HEPATOCELLULAR, minimal. FATTY CHANGE, CENTRILOBULAR, mild. FATTY CHANGE, PERIPORTAL, mild.
THYROID GLAND :
ALTERATION, COLLOID, severe.
NOSE :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
641213
Terminal Sacrifice Killed on Day : 122
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
641213
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
Continued on the next page ....
874
Does ro8 certain TSCA CBI
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations__________ __DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641213
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. NECROSIS, FOCAL, minimal. HYPERTROPHY, HEPATOCELLULAR, minimal -
THYROID GLAND :
ALTERATION, COLLOID, severe.
No Microscopic Abnormality Observed :
NOSE
641216
Terminal Sacrifice Killed on Day : 122
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
641216
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS.
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
Continued on the next page ....
875
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : VII -
Animal Ref
1000 mg/kg/day Sex: Males Microscopic & Macroscopic Findings
641216
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE. SEMINAL VESICLES, URINARY BLADDER, TESTES, EPIDIDYMIDES, FEMUR/KNEE JOINT, STERNUM, NOSE
Hisfcopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERTROPHY, HEPATOCELLULAR, minimal.
THYROID GLAND :
ALTERATION, COLLOID, severe. HYPERTROPHY, FOLLICULAR, mild.
No Microscopic Abnormality Observed :
NOSE
641223
Terminal Sacrifice Killed on Day : 91
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
TESTES : LARGE, RIGHT.
641223 Continued on the next page ....
876 Does not contain TSCA CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641223
Continued from previous page
Gross Pathology :
FEMUR/KNEE
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, EPIDIDYMIDES,
JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
HYPERTROPHY, HEPATOCELLULAR, mild.
THYROID GLAND :
ALTERATION, COLLOID, severe. HYPERTROPHY, FOLLICULAR, mild.
PARATHYROID GLANDS :
NOT PRESENT. TESTES :
DILATATION, SEMINIFEROUS TUBULES, UNILATERAL,
NOSE :
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
mild. mild.
641223 Continued on the next page ....
877
i?n T8CA ^q|
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : VII - 1000 mg/kg/day Sex: Males
Animal Ref
Microscopic & Macroscopic Findings
641223
Continued from previous page
Histopathology :
ESOPHAGUS, FEMUR/KNEE
No Microscopic Abnormality Observed :
KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, TRACHEA,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, PROSTATE, SEMINAL VESICLES, URINARY BLADDER, EPIDIDYMIDES,
JOINT, STERNUM, BONE MARROW
878
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
641240
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA. BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA. ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
HEART :
CARDIOMYOPATHY, minimal.
minimal.
No Microscopic Abnormality Observed :
KIDNEYS, LUNGS, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY
GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND,
641240 Continued on the next page ....
879 Does not contetn TSCA CBI
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
641240
Continued from previous page
Histopathology :
No Microscopic Abnormality Observed :
PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX,
EYE(S) WITH OPTIC NERVE, SKIN. MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT,
STERNUM, BONE MARROW, MOSE
641241
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLAMDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
641241
THYROID GLAND : ALTERATION, COLLOID,
Continued on the next page ....
minimal.
SaMpaay
880 Doe not contain TSCA f
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 ing/kg/day Sex: Females Microscopic & Macroscopic Findings
641241
Continued from previous page
Histopathology :
No Microscopic Abnormality Observed : LIVER, NOSE
641245
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
641245
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
HEART :
CARDIOMYOPATHY, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
Continued on the next page ....
minimal.
881
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref 641245
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings Continued from previous page
Histopafchology :
No Microscopic Abnormality Observed :
KIDNEYS, LUNGS, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH MODE, THYMUS, ADRENAL GLANDS,
SCIATIC NERVE, PITUITARY GLAND, PARATHYROID GLANDS,
TRACHEA, ESOPHAGUS, PHARYNX/LARYNX,
EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT,
STERNUM, BONE MARROW, NOSE
641249
Accidentally Killed
Duration of dosing-days: 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
LUNGS :
DISCOLORATION, DARK, DIFFUSE.
No Macroscopic Abnormality Observed :
LIVER. KIDNEYS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE,
SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL
GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND,
641249 Continued on the next page ....
^OBBpasy
882
Does nog contain 7SGA ^
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
_____
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
641249
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX,
EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT,
STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION,
SPLEEN :
SUBACUTE/CHRONIC,
PIGMENT INCREASED, mild.
STOMACH :
CYST, KERATIN, minimal.
PARATHYROID GLANDS :
NOT PRESENT.
minimal.
No Microscopic Abnormality Observed :
KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, AORTA, BRAIN, SPINAL CORD, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS,
MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIM, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE
883
i?nT8CA CBi
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations___________
DuPont-4739
IMDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
641253
Terminal Sacrifice Killed on Day : 123
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
. THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Hisfcopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
No Microscopic Abnormality Observed :
THYROID GLAND, NOSE
884
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 nig/kg/day Sex: Females Microscopic & Macroscopic Findings
641257
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA. BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, . THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYMX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
PANCREAS :
ATROPHY, minimal. PITUITARY GLAND :
MOT PRESENT. PARATHYROID GLANDS :
NOT PRESENT.
minimal.
641257 Continued on the next page
885
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
641257
Continued from previous page
Histopathology :
No Microscopic Abnormality Observed :
KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY
GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, THYROID GLAND, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE
641266
Terminal Sacrifice Killed on Day : 123
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM. PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
641266 Continued on the next page ....
886
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
641266
Continued from previous page
Histopathology :
LIVER :
INFLAMMATION, FATTY CHANGE, THYROID GLAND :
SUBACUTE/CHRONIC, minimal. MEDIAN CLEFT, mild.
ALTERATION, COLLOID, minimal.
No Microscopic Abnormality Observed :
NOSE
641281
. Terminal Sacrifice Killed on Day : 123
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER. KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM,
ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAMD, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
641281 Continued on the next page ....
887
, Boes no? contafrn rsca rw
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
641281
Continued from previous page
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
No Microscopic Abnormality Observed :
THYROID GLAND, NOSE
641283
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS. CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
641283
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal. FATTY CHANGE, MEDIAN CLEFT, minimal.
Continued on the next page ....
888
s'RTgCACat
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : II
Animal Ref
0 ing/kg/day Sex: Females Microscopic & Macroscopic Findings
641283
Continued from previous page
Hi s topathology
Wo Microscopic Abnormality Observed :
KIDNEYS, LUNGS. HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX,
EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT,
STERNUM. BONE MARROW, NOSE
641285
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
641285
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Continued on the next page ....
889
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
641285
Continued from previous page
Histopathology :
LIVER : INFLAMMATION,
NOSE :
INFLAMMATION,
SUBACUTE/CHROMIC, SUBACUTE/CHRONIC,
minimal. minimal.
No Microscopic Abnormality Observed :
THYROID GLAND
641288
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYMX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
641288 Continued on the next page ....
890 Does not eontaft, TSCACB?
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
641288
Continued from previous page
Histopathology :
LIVER :
INFLAMMATION, NOSE :
INFLAMMATION,
SUBACUTE/CHRONIC, SUBACUTE/CHRONIC,
minimal. minimal.
No Microscopic Abnormality Observed :
THYROID GLAND
641290
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
641290 Continued on the next page ....
891
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
641290
Continued from previous page
Histopathology :
LIVER :
INFLAMMATION, KIDNEYS :
SUBACUTE/CHRONIC,
minimal.
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
PANCREAS :
ATROPHY, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
EYE(S) WITH OPTIC NERVE :
FOLD/ROSETTE, RETINAL, minimal.
SPINAL
No Microscopic Abnormality Observed :
LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN,
CORD, STOMACH, DUODENUM. JEJUNUM, ILEUM, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE. THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE
MARROW, NOSE
892
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref 641293
0 mg/kg/day Sex: Females
Microscopic & Macroscopic Findings
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS. SCIATIC NERVE, PITUITARY GLAND,
. THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX. EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
No Microscopic Abnormality Observed :
KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE,
SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX,
EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT,
STERNUM, BONE MARROW, NOSE
893
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
641294
Terminal Sacrifice Killed on Day : 123
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
. THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopafchology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
No Microscopic Abnormality Observed :
THYROID GLAND, NOSE
894 Company Sanitized, Does not eontain TSCA CBI
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 ing/kg/day Sex: Females Microscopic & Macroscopic Findings
641309
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, PAT
Histopathology :
THYROID GLAND :
ALTERATION, COLLOID, minimal.
No Microscopic Abnormality Observed : LIVER, NOSE
895
Sanitized,
not contain TSCA CBS
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
641325
Terminal Sacrifice Killed on Day : 123
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLAMDS, MAMDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN. MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopafchology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
.minimal.
No Microscopic Abnormality Observed :
NOSE
896
Company Sanitized. Does not contain TSCA CBS
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
641331
Terminal Sacrifice Killed on Day : 123
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, . THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Hiptopafchology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
No Microscopic Abnormality Observed :
THYROID GLAND, NOSE
897
Company Sanitized. Does not eonSam TSCA CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
641335
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA. BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION,
KIDNEYS :
SUBACUTE/CHRONIC,
minimal.
HYDRONEPHROSIS, UNILATERAL, minimal.
PANCREAS :
ATROPHY, minima1. EYE(S) WITH OPTIC NERVE :
OPTIC NERVE NOT PRESENT.
641335 Continued on the next page
898
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II - - 0 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
641335
Continued from previous page
Histopathology
SPINAL
No Microscopic Abnormality Observed :
LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN,
CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), . OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT,
STERNUM, BONE MARROW, NOSE
641344
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
641344
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD. STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYMX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Continued on the next page ....
899
Company SanKIzed. Does not contain TSCA CB!
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
641344
Continued from previous page
Histopathology :
PANCREAS :
ATROPHY, minimal.
THYROID GLAND : ALTERATION, COLLOID,
ESOPHAGUS :
PIBROSIS, minimal.
minimal.
GLANDS,
No Microscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS. HEART, SKELETAL MUSCLE, SPLEEN, . AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM,
ILEUM, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, PARATHYROID
TRACHEA, PHARYNX/LARYNX. EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE
641359
Terminal Sacrifice Killed on Day : 123
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
LIVER : HERNIA.
641359 Continued on the next page ....
900
CQMpany SanStbed. Does no! ronfain T8CA CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
641359
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
NOSE
901
SanHteed. Does not contain
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
____ ___
DuPont-4739
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref 641364
0 mg/kg/day Sex: Females
Microscopic & Macroscopic Findings
Terminal Sacrifice Killed on Day : 123
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD. STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM. NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
NOSE
902 oot eortew T: !,
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
641383
Terminal Sacrifice Killed on Day : 123
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
INFLAMMATION, FATTY CHANGE, THYROID GLAND :
SUBACUTE/CHRONIC, minimal. MEDIAN CLEFT, minimal.
ALTERATION, COLLOID, minimal.
No Microscopic Abnormality Observed :
NOSE
903 i TSCA ^-f.
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref 641384
0 mg/kg/day Sex: Females
Microscopic & Macroscopic Findings
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM. PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
No Microscopic Abnormality Observed :
KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON. RECTUM, MESENTERIC LYMPH NODE,
SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX,
EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE
904
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
641394
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM. PANCREAS, CECUM, COLON, RECTUM, MESEMTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
THYROID GLAMD :
ALTERATION, COLLOID, minimal.
NOSE :
ATROPHY, UNILATERAL, NASAL GLANDS, severe.
905 .Company Sanitized. Does not contain TSCA CBS
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
641400
Terminal Sacrifice Killed on Day : 123
Exposure Group : RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
INFLAMMATION, FATTY CHANGE, THYROID GLAND :
SUBACUTE/CHRONIC, minimal. MEDIAN CLEFT, minimal.
ALTERATION, COLLOID, minimal.
No Microscopic Abnormality Observed :
NOSE
906
Company Sanitized. Does not contain TSCA CB1
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : IV - 50 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
641247
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN. MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
INFLAMMATION, FATTY CHANGE, THYROID GLAND :
SUBACUTE/CHRONIC, minimal. MEDIAN CLEFT, minimal.
ALTERATION, COLLOID, minimal.
No Microscopic Abnormality Observed :
NOSE
907 Company Sanitized. Does not contain TSCA CBI
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : IV - 50 ing/kg/day Sex: Females
Animal Ref 641260
Microscopic & Macroscopic Findings
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH. DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
No Microscopic Abnormality Observed :
THYROID GLAND, NOSE
908
Company SanIISzed.
not contain TSCA CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : IV - 50 mg/kg/day Sex: Females
Animal Ref 641298
Microscopic & Macroscopic Findings
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIM, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KMEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
NOSE
909
.Company SanEIEzed.
not contain TSCA CBI
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations________ ____DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : IV - 50 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
641311
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
Wo Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART. SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Hisfcopathology :
LIVER : INFLAMMATION, FATTY CHANGE,
SUBACUTE/CHRONIC, minimal. MEDIAN CLEFT, minimal.
No Microscopic Abnormality Observed :
THYROID GLAND, NOSE
910 .Company Sanitized. Does not contain TSCA CB!
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : IV - 50 nig/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
641312
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHROMIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAMD (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHROMIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
NOSE
Company
911
Does not eontain TSCA CBI
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : IV - 50 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
641313
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS. MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
NOSE :
DEGENERATION/NECROSIS. OLFACTORY, EPITHELIUM,
minimal.
912 i Does no? eonta'n TS^A
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : IV - 50 mg/kg/day Sex: Females
Animal Ref 641319
Microscopic & Macroscopic Findings
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Hisfcopafchology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
NOSE :
INFLAMMATION, SUBACUTE/CHRONIC,
minimal. minimal.
913
Company SanKfead. Does not contain'
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : IV - 50 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
641321
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
THYROID GLAND :
ALTERATION, COLLOID, minimal.
No Microscopic Abnormality Observed : LIVER, NOSE
914
Company Sanitized. Does not contain TSCA cri
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : IV - 50 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
641336
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH. DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Hisfcopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
No Microscopic Abnormality Observed :
THYROID GLAND, NOSE
915
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
__
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : IV - 50 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
641340
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM,
ILEUM, PANCREAS, CECUM, COLON, RECTUM. MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
NOSE
916
tin TSCA ^^t
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____
DuPont-4739
__
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : IV - 50 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
641355
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MAMDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS. SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
NOSE
917 Company SanSSteed. Does not contain TSCA CBS
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : IV - 50 mg/kg/day Sex: Females
Animal Ref 641361
Microscopic & Macroscopic Findings
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE. SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESEMTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
No Microscopic Abnormality Observed :
THYROID GLAND, NOSE
918
Conipan^ SanISIzed. Does not congaEn TSCA CBS
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : IV - 50 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
641369
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS. ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION,
THYROID GLAND :
SUBACUTE/CHRONIC,
minimal.
ALTERATION, COLLOID, minimal.
NOSE :
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
minimal.
Gempmy
919 Does not contain TSCA CB?
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
_________
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : IV - 50 ing/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
641391
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM. ILEUM. PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
NOSE
920 Company SaniSizsd. Does not contain TSCA CBi
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : IV - 50 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
641396
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
No Microscopic Abnormality Observed :
THYROID GLAND, NOSE
921
Company Sanitized. Doss not ewta'n TSCA fflt
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : VI - 250 mg/kg/day Sex: Females
Animal Ref 641232
Microscopic & Macroscopic Findings
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER. FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
NOSE
922
Company Sanitized. De not contain TSCA CBB
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VI - 250 mg/kg/day Sex: Females
Animal Ref 641244
Microscopic & Macroscopic Findings
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN. SPINAL CORD, STOMACH, DUODENUM, JEJUNUM,
ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND : ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
NOSE
Company
923 D@s not contain!
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VI - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
641251
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH MODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
NOSE :
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
minimal.
924
Cempwy Santeecj. Does not contain TSCA CT?
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : VI - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
641262
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH MODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
THYROID GLAND :
ALTERATION, COLLOID, minimal.
No Microscopic Abnormality Observed :
LIVER, NOSE
925
Company SanRfced. Does not contain T8CA CB8
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : VI - 250 mg/kg/day Sex: Females
Animal Ref 641269
Microscopic & Macroscopic Findings
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION,
NOSE :
SUBACUTE/CHRONIC,
minimal.
INFLAMMATION, SUBACUTE/CHRONIC, mild. DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM, mild.
HYPERPLASIA/HYPERTROPHY, TRANSITIONAL CELL, EPITHELIUM,
minimal.
No Microscopic Abnormality Observed :
THYROID GLAND
926
Santeed. Does rot contain TSCA ^
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
___ _______DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VI - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
641292
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH MODE, SALIVARY GLANDS, MAMDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM. NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
NOSE
927
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VI - 250 ing/kg/day Sex: Females
Animal Ref 641302
Microscopic & Macroscopic Findings
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MAMDIBULAR LYMPH MODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
INFLAMMATION, FATTY CHANGE, THYROID GLAND :
SUBACUTE/CHRONIC, minimal. MEDIAN CLEFT, minimal.
ALTERATION, COLLOID, minimal. HYPERTROPHY, FOLLICULAR, minimal.
No Microscopic Abnormality Observed :
NOSE
928
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VI - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
641305
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES. UTERUS, URINARY BLADDER, PEMUR/KMEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
No Microscopic Abnormality Observed :
THYROID GLAND, NOSE
929
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VI - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
641362
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART. SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE). OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
NOSE :
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
minimal.
930
H-24616: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations________
DuPont-4739
___
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VI - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
641363
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM,
ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
No Microscopic Abnormality Observed :
THYROID GLAND, NOSE
931
H-24616: Subchronic Toxicity
___ 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VI - 250 mg/kg/day Sex: Females
Animal Ref 641372
Microscopic & Macroscopic Findings
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM. MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE). OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
THYROID GLAND :
ALTERATION. COLLOID, minimal.
No Microscopic Abnormality Observed : LIVER, NOSE
932
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VI - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
641375
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MAMDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal. HYPERTROPHY, FOLLICULAR, minimal.
No Microscopic Abnormality Observed :
NOSE
933
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VI - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
641379
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
No Microscopic Abnormality Observed :
THYROID GLAND, NOSE
934
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : VI - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
641382
Terminal Sacrifice Killed on Day : 182
Exposure Group : FLUORINE ANALYSIS
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUMUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE
Higstopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
FATTY CHANGE, FOCAL, mild.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
NOSE
935
H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-4739
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : VI - 250 ing/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
641398
Terminal Sacrifice Killed on Day : 92
Exposure Group : SUBCHRONIC
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC,
NECROSIS, FOCAL, minimal.
NOSE :
minimal.
DEGENERATION/NECROSIS, OLFACTORY, EPITHELIUM,
minimal.
No Microscopic Abnormality Observed :
THYROID GLAND
936