TDMS No 20201 - 01

Test Type 26-WEEK

Route SKIN APPLICATION

SpeciesStrain MICETGAC HEMI

C Number

Lock Date

Cage Range

Date Range

Reasons For Removal

Removal Date Range

Treatment Groups

C20201A

07242004

ALL

ALL

ALL

ALL

Include 001 0 NGKG

P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

CAS Number 1746-01-6 First Dose MF NA 042103

Lab BAT

Include 002 121 NGKG Include 003 760 NGKG

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

SUMMARY OF STATISTICALLY SIGNIFICANT (Plt=05) RESULTS IN THE ANALYSIS OF TEF TRANSGENICS (TCDD)

FEMALE MICE

Organ Morphology Liver Fatty Change

Hematopoietic Cell Proliferation Myelodysplasia Necrosis Pigmentation

Liver Hepatocyte Degeneration Lung Bronchiole Inflammation Skin Hyperplasia Skin Control Dermis Inflammation Chronic Skin SOA No Mass Hyperplasia

Inflammation Chronic Skin Site of Application Hyperplasia

Inflammation Chronic Spleen Hematopoietic Cell Proliferation

Myelodysplasia Stomach Forestomach Hyperplasia

Page 2

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Liver Fatty Change

LESION RATES

OVERALL (a) 120 (5) 420 (20) 820 (40)

POLY-3 RATE (b) 11789 41659 81516

POLY-3 PERCENT (g) 56 241 528

TERMINAL (d) 117 (6) 212 (17) 711 (64)

FIRST INCIDENCE 183 (T) 110 155

STATISTICAL TESTS

LIFE TABLE P=0003 P=0117 Plt0001

POLY 3 P=0002 P=0143 P=0002

POLY 15 P=0004 P=0153 P=0003

POLY 6 Plt0001 P=0131 Plt0001

LOGISTIC REGRESSION P=0008 P=0191 Plt0001

COCH-ARM FISHERS P=0011 P=0171 P=0010

ORDER RESTRICTED Plt0001 (e) (e)

MAX-ISO-POLY-3 P=0002 (e) (e)

Page 3

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Liver Hematopoietic Cell Proliferation

LESION RATES

OVERALL (a) 120 (5) 420 (20) 720 (35)

POLY-3 RATE (b) 11789 41557 71624

POLY-3 PERCENT (g) 56 257 431

TERMINAL (d) 117 (6) 212 (17) 411 (36)

FIRST INCIDENCE 183 (T) 163 122

STATISTICAL TESTS

LIFE TABLE P=0010 P=0099 P=0008

POLY 3 P=0015 P=0125 P=0010

POLY 15 P=0019 P=0140 P=0013

POLY 6 P=0011 P=0113 P=0007

LOGISTIC REGRESSION P=0021 P=0124 P=0019

COCH-ARM FISHERS P=0029 P=0171 P=0022

ORDER RESTRICTED P=0004 (e) (e)

MAX-ISO-POLY-3 P=0008 (e) (e)

Page 4

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Liver Inflammation

LESION RATES

OVERALL (a) 1920 (95) 1920 (95) 1820 (90)

POLY-3 RATE (b) 192000 191955 181915

POLY-3 PERCENT (g) 95 972 94

TERMINAL (d) 1617 (94) 1212 (100) 1011 (91)

FIRST INCIDENCE 74 57 84

STATISTICAL TESTS

LIFE TABLE P=0185 P=0095 P=0110

POLY 3 P=0621N P=0689 P=0714N

POLY 15 P=0559N P=0726 P=0654N

POLY 6 P=0642N P=0622 P=0744N

LOGISTIC REGRESSION P=0427N P=0767N P=0535N

COCH-ARM FISHERS P=0410N P=0756N P=0500N

ORDER RESTRICTED P=0512N (e) (e)

MAX-ISO-POLY-3 P=0515N (e) (e)

Page 5

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Liver Hematopoietic Cell Proliferation

LESION RATES

OVERALL (a) 120 (5) 420 (20) 720 (35)

POLY-3 RATE (b) 11789 41557 71624

POLY-3 PERCENT (g) 56 257 431

TERMINAL (d) 117 (6) 212 (17) 411 (36)

FIRST INCIDENCE 183 (T) 163 122

STATISTICAL TESTS

LIFE TABLE P=0010 P=0099 P=0008

POLY 3 P=0015 P=0125 P=0010

POLY 15 P=0019 P=0140 P=0013

POLY 6 P=0011 P=0113 P=0007

LOGISTIC REGRESSION P=0021 P=0124 P=0019

COCH-ARM FISHERS P=0029 P=0171 P=0022

ORDER RESTRICTED P=0004 (e) (e)

MAX-ISO-POLY-3 P=0008 (e) (e)

Page 4

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Liver Inflammation

LESION RATES

OVERALL (a) 1920 (95) 1920 (95) 1820 (90)

POLY-3 RATE (b) 192000 191955 181915

POLY-3 PERCENT (g) 95 972 94

TERMINAL (d) 1617 (94) 1212 (100) 1011 (91)

FIRST INCIDENCE 74 57 84

STATISTICAL TESTS

LIFE TABLE P=0185 P=0095 P=0110

POLY 3 P=0621N P=0689 P=0714N

POLY 15 P=0559N P=0726 P=0654N

POLY 6 P=0642N P=0622 P=0744N

LOGISTIC REGRESSION P=0427N P=0767N P=0535N

COCH-ARM FISHERS P=0410N P=0756N P=0500N

ORDER RESTRICTED P=0512N (e) (e)

MAX-ISO-POLY-3 P=0515N (e) (e)

Page 5

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Liver Inflammation

LESION RATES

OVERALL (a) 1920 (95) 1920 (95) 1820 (90)

POLY-3 RATE (b) 192000 191955 181915

POLY-3 PERCENT (g) 95 972 94

TERMINAL (d) 1617 (94) 1212 (100) 1011 (91)

FIRST INCIDENCE 74 57 84

STATISTICAL TESTS

LIFE TABLE P=0185 P=0095 P=0110

POLY 3 P=0621N P=0689 P=0714N

POLY 15 P=0559N P=0726 P=0654N

POLY 6 P=0642N P=0622 P=0744N

LOGISTIC REGRESSION P=0427N P=0767N P=0535N

COCH-ARM FISHERS P=0410N P=0756N P=0500N

ORDER RESTRICTED P=0512N (e) (e)

MAX-ISO-POLY-3 P=0515N (e) (e)

Page 5

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Liver Myelodysplasia

LESION RATES

OVERALL (a) 020 (0) 020 (0) 220 (10)

POLY-3 RATE (b) 01789 01511 21555

POLY-3 PERCENT (g) 0 0 129

TERMINAL (d) 017 (0) 012 (0) 011 (0)

FIRST INCIDENCE --- --- 155

STATISTICAL TESTS

LIFE TABLE P=0074 (e) P=0183

POLY 3 P=0079 (e) P=0202

POLY 15 P=0084 (e) P=0216

POLY 6 P=0072 (e) P=0187

LOGISTIC REGRESSION P=0097 (e) P=0253

COCH-ARM FISHERS P=0093 (e) P=0244

ORDER RESTRICTED P=0035 (e) (e)

MAX-ISO-POLY-3 P=0054 (e) (e)

Page 6

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Liver Necrosis

LESION RATES

OVERALL (a) 720 (35) 920 (45) 1320 (65)

POLY-3 RATE (b) 71815 91705 131839

POLY-3 PERCENT (g) 386 528 707

TERMINAL (d) 617 (35) 512 (42) 611 (55)

FIRST INCIDENCE 165 110 97

STATISTICAL TESTS

LIFE TABLE P=0017 P=0163 P=0014

POLY 3 P=0048 P=0307 P=0047

POLY 15 P=0048 P=0333 P=0050

POLY 6 P=0047 P=0278 P=0044

LOGISTIC REGRESSION P=0042 P=0309 P=0048

COCH-ARM FISHERS P=0049 P=0374 P=0056

ORDER RESTRICTED P=0028 (e) (e)

MAX-ISO-POLY-3 P=0034 (e) (e)

Page 7

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Liver Necrosis

LESION RATES

OVERALL (a) 720 (35) 920 (45) 1320 (65)

POLY-3 RATE (b) 71815 91705 131839

POLY-3 PERCENT (g) 386 528 707

TERMINAL (d) 617 (35) 512 (42) 611 (55)

FIRST INCIDENCE 165 110 97

STATISTICAL TESTS

LIFE TABLE P=0017 P=0163 P=0014

POLY 3 P=0048 P=0307 P=0047

POLY 15 P=0048 P=0333 P=0050

POLY 6 P=0047 P=0278 P=0044

LOGISTIC REGRESSION P=0042 P=0309 P=0048

COCH-ARM FISHERS P=0049 P=0374 P=0056

ORDER RESTRICTED P=0028 (e) (e)

MAX-ISO-POLY-3 P=0034 (e) (e)

Page 7

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Liver Pigmentation

LESION RATES

OVERALL (a) 1020 (50) 920 (45) 1520 (75)

POLY-3 RATE (b) 101815 91557 151715

POLY-3 PERCENT (g) 551 578 875

TERMINAL (d) 917 (53) 712 (58) 1011 (91)

FIRST INCIDENCE 165 163 129

STATISTICAL TESTS

LIFE TABLE P=0003 P=0356 P=0005

POLY 3 P=0018 P=0575 P=0031

POLY 15 P=0025 P=0618N P=0049

POLY 6 P=0013 P=0498 P=0019

LOGISTIC REGRESSION P=0008 P=0497 P=0023

COCH-ARM FISHERS P=0044 P=0500N P=0095

ORDER RESTRICTED P=0017 (e) (e)

MAX-ISO-POLY-3 P=0024 (e) (e)

Page 8

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Liver Hepatocyte Degeneration

LESION RATES

OVERALL (a) 020 (0) 020 (0) 420 (20)

POLY-3 RATE (b) 01789 01511 41612

POLY-3 PERCENT (g) 0 0 248

TERMINAL (d) 017 (0) 012 (0) 211 (18)

FIRST INCIDENCE --- --- 122

STATISTICAL TESTS

LIFE TABLE P=0006 (e) P=0039

POLY 3 P=0005 (e) P=0037

POLY 15 P=0005 (e) P=0043

POLY 6 P=0004 (e) P=0030

LOGISTIC REGRESSION P=0009 (e) P=0067

COCH-ARM FISHERS P=0008 (e) P=0053

ORDER RESTRICTED P=0003 (e) (e)

MAX-ISO-POLY-3 P=0005 (e) (e)

Page 9

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lung Alveolus Infiltration Cellular Histiocyte

LESION RATES

OVERALL (a) 020 (0) 220 (10) 120 (5)

POLY-3 RATE (b) 01789 21540 11477

POLY-3 PERCENT (g) 0 13 68

TERMINAL (d) 017 (0) 112 (8) 111 (9)

FIRST INCIDENCE --- 163 183 (T)

STATISTICAL TESTS

LIFE TABLE P=0530 P=0177 P=0413

POLY 3 P=0556 P=0200 P=0462

POLY 15 P=0594 P=0212 P=0480

POLY 6 P=0508 P=0188 P=0440

LOGISTIC REGRESSION P=0598 P=0211 P=0413

COCH-ARM FISHERS P=0638 P=0244 P=0500

ORDER RESTRICTED P=0165 (e) (e)

MAX-ISO-POLY-3 P=0206 (e) (e)

Page 10

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lung Bronchiole Inflammation

LESION RATES

OVERALL (a) 020 (0) 020 (0) 220 (10)

POLY-3 RATE (b) 01789 01511 21477

POLY-3 PERCENT (g) 0 0 135

TERMINAL (d) 017 (0) 012 (0) 211 (18)

FIRST INCIDENCE --- --- 183 (T)

STATISTICAL TESTS

LIFE TABLE P=0057 (e) P=0146

POLY 3 P=0073 (e) P=0191

POLY 15 P=0081 (e) P=0210

POLY 6 P=0064 (e) P=0170

LOGISTIC REGRESSION (e) (e) P=0146

COCH-ARM FISHERS P=0093 (e) P=0244

ORDER RESTRICTED P=0032 (e) (e)

MAX-ISO-POLY-3 P=0053 (e) (e)

Page 11

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lung Interstitium Inflammation

LESION RATES

OVERALL (a) 120 (5) 120 (5) 320 (15)

POLY-3 RATE (b) 11815 11511 31568

POLY-3 PERCENT (g) 55 66 191

TERMINAL (d) 017 (0) 112 (8) 111 (9)

FIRST INCIDENCE 165 183 (T) 143

STATISTICAL TESTS

LIFE TABLE P=0133 P=0684 P=0203

POLY 3 P=0166 P=0719 P=0247

POLY 15 P=0181 P=0737 P=0271

POLY 6 P=0148 P=0697 P=0220

LOGISTIC REGRESSION P=0190 P=0747 P=0313

COCH-ARM FISHERS P=0195 P=0756N P=0302

ORDER RESTRICTED P=0127 (e) (e)

MAX-ISO-POLY-3 P=0160 (e) (e)

Page 12

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lung Perivascular Inflammation

LESION RATES

OVERALL (a) 220 (10) 220 (10) 220 (10)

POLY-3 RATE (b) 21789 21511 21516

POLY-3 PERCENT (g) 112 132 132

TERMINAL (d) 217 (12) 212 (17) 111 (9)

FIRST INCIDENCE 183 (T) 183 (T) 155

STATISTICAL TESTS

LIFE TABLE P=0527 P=0566 P=0548

POLY 3 P=0602 P=0635 P=0636

POLY 15 P=0630 P=0661 P=0665

POLY 6 P=0564 P=0605 P=0599

LOGISTIC REGRESSION P=0584 P=0566 P=0643

COCH-ARM FISHERS P=0660 P=0698N P=0698N

ORDER RESTRICTED P=0584 (e) (e)

MAX-ISO-POLY-3 P=0589 (e) (e)

Page 13

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lung Serosa Inflammation Chronic

LESION RATES

OVERALL (a) 720 (35) 420 (20) 420 (20)

POLY-3 RATE (b) 71789 41598 41594

POLY-3 PERCENT (g) 391 25 251

TERMINAL (d) 717 (41) 212 (17) 211 (18)

FIRST INCIDENCE 183 (T) 122 129

STATISTICAL TESTS

LIFE TABLE P=0509N P=0460N P=0502N

POLY 3 P=0347N P=0307N P=0309N

POLY 15 P=0322N P=0279N P=0273N

POLY 6 P=0386N P=0340N P=0360N

LOGISTIC REGRESSION P=0355N P=0320N P=0314N

COCH-ARM FISHERS P=0308N P=0240N P=0240N

ORDER RESTRICTED P=0256N (e) (e)

MAX-ISO-POLY-3 P=0284N (e) (e)

Page 14

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lymph Node Mandibular Hyperplasia Lymphoid

LESION RATES

OVERALL (a) 00 (0) 11 (100) 22 (100)

POLY-3 RATE (b) 0000 1100 2200

POLY-3 PERCENT (g) 0 100 100

TERMINAL (d) 00 (0) 11 (100) 00 (0)

FIRST INCIDENCE --- 183 (T) 155

STATISTICAL TESTS

LIFE TABLE (e) (e) (e)

POLY 3 (e) (e) (e)

POLY 15 (e) (e) (e)

POLY 6 (e) (e) (e)

LOGISTIC REGRESSION (e) (e) (e)

COCH-ARM FISHERS (e) (e) (e)

ORDER RESTRICTED (e) (e) (e)

MAX-ISO-POLY-3 (e) (e) (e)

Page 15

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Hyperplasia

LESION RATES

OVERALL (a) 44 (100) 02 (0) 06 (0)

POLY-3 RATE (b) 4400 0171 0469

POLY-3 PERCENT (g) 100 0 0

TERMINAL (d) 44 (100) 01 (0) 03 (0)

FIRST INCIDENCE 183 (T) --- --shy

STATISTICAL TESTS

LIFE TABLE P=0052N P=0227N P=0041N

POLY 3 Plt0001N Plt0001N Plt0001N

POLY 15 Plt0001N Plt0001N Plt0001N

POLY 6 Plt0001N Plt0001N Plt0001N

LOGISTIC REGRESSION P=0052N (e) (e)

COCH-ARM FISHERS P=0015N P=0067N P=0005N

ORDER RESTRICTED Plt0001N (e) (e)

MAX-ISO-POLY-3 Plt0001N (e) (e)

Page 16

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Inflammation Chronic

LESION RATES

OVERALL (a) 34 (75) 12 (50) 46 (67)

POLY-3 RATE (b) 3400 1171 4548

POLY-3 PERCENT (g) 75 586 73

TERMINAL (d) 34 (75) 11 (100) 23 (67)

FIRST INCIDENCE 183 (T) 183 (T) 155

STATISTICAL TESTS

LIFE TABLE P=0210 P=0773 P=0290

POLY 3 P=0679 P=0694N P=0738N

POLY 15 P=0689N P=0651N P=0700N

POLY 6 P=0662 P=0764N P=0750

LOGISTIC REGRESSION P=0584 P=0773 P=0803N

COCH-ARM FISHERS P=0681N P=0600N P=0667N

ORDER RESTRICTED P=0575N (e) (e)

MAX-ISO-POLY-3 P=0589N (e) (e)

Page 17

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Control Dermis Inflammation Chronic

LESION RATES

OVERALL (a) 020 (0) 020 (0) 420 (20)

POLY-3 RATE (b) 01789 01511 41586

POLY-3 PERCENT (g) 0 0 252

TERMINAL (d) 017 (0) 012 (0) 211 (18)

FIRST INCIDENCE --- --- 122

STATISTICAL TESTS

LIFE TABLE P=0005 (e) P=0035

POLY 3 P=0004 (e) P=0036

POLY 15 P=0005 (e) P=0042

POLY 6 P=0004 (e) P=0029

LOGISTIC REGRESSION P=0008 (e) P=0061

COCH-ARM FISHERS P=0008 (e) P=0053

ORDER RESTRICTED P=0002 (e) (e)

MAX-ISO-POLY-3 P=0005 (e) (e)

Page 18

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin SOA No Mass Hyperplasia

LESION RATES

OVERALL (a) 120 (5) 720 (35) 1017 (59)

POLY-3 RATE (b) 11789 71725 101463

POLY-3 PERCENT (g) 56 406 684

TERMINAL (d) 117 (6) 312 (25) 710 (70)

FIRST INCIDENCE 183 (T) 122 84

STATISTICAL TESTS

LIFE TABLE P=0002 P=0014 Plt0001

POLY 3 Plt0001 P=0014 Plt0001

POLY 15 Plt0001 P=0015 Plt0001

POLY 6 Plt0001 P=0013 Plt0001

LOGISTIC REGRESSION P=0002 P=0026 Plt0001

COCH-ARM FISHERS P=0002 P=0022 Plt0001

ORDER RESTRICTED Plt0001 (e) (e)

MAX-ISO-POLY-3 Plt0001 (e) (e)

Page 19

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lung Alveolus Infiltration Cellular Histiocyte

LESION RATES

OVERALL (a) 020 (0) 220 (10) 120 (5)

POLY-3 RATE (b) 01789 21540 11477

POLY-3 PERCENT (g) 0 13 68

TERMINAL (d) 017 (0) 112 (8) 111 (9)

FIRST INCIDENCE --- 163 183 (T)

STATISTICAL TESTS

LIFE TABLE P=0530 P=0177 P=0413

POLY 3 P=0556 P=0200 P=0462

POLY 15 P=0594 P=0212 P=0480

POLY 6 P=0508 P=0188 P=0440

LOGISTIC REGRESSION P=0598 P=0211 P=0413

COCH-ARM FISHERS P=0638 P=0244 P=0500

ORDER RESTRICTED P=0165 (e) (e)

MAX-ISO-POLY-3 P=0206 (e) (e)

Page 10

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lung Bronchiole Inflammation

LESION RATES

OVERALL (a) 020 (0) 020 (0) 220 (10)

POLY-3 RATE (b) 01789 01511 21477

POLY-3 PERCENT (g) 0 0 135

TERMINAL (d) 017 (0) 012 (0) 211 (18)

FIRST INCIDENCE --- --- 183 (T)

STATISTICAL TESTS

LIFE TABLE P=0057 (e) P=0146

POLY 3 P=0073 (e) P=0191

POLY 15 P=0081 (e) P=0210

POLY 6 P=0064 (e) P=0170

LOGISTIC REGRESSION (e) (e) P=0146

COCH-ARM FISHERS P=0093 (e) P=0244

ORDER RESTRICTED P=0032 (e) (e)

MAX-ISO-POLY-3 P=0053 (e) (e)

Page 11

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lung Interstitium Inflammation

LESION RATES

OVERALL (a) 120 (5) 120 (5) 320 (15)

POLY-3 RATE (b) 11815 11511 31568

POLY-3 PERCENT (g) 55 66 191

TERMINAL (d) 017 (0) 112 (8) 111 (9)

FIRST INCIDENCE 165 183 (T) 143

STATISTICAL TESTS

LIFE TABLE P=0133 P=0684 P=0203

POLY 3 P=0166 P=0719 P=0247

POLY 15 P=0181 P=0737 P=0271

POLY 6 P=0148 P=0697 P=0220

LOGISTIC REGRESSION P=0190 P=0747 P=0313

COCH-ARM FISHERS P=0195 P=0756N P=0302

ORDER RESTRICTED P=0127 (e) (e)

MAX-ISO-POLY-3 P=0160 (e) (e)

Page 12

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lung Perivascular Inflammation

LESION RATES

OVERALL (a) 220 (10) 220 (10) 220 (10)

POLY-3 RATE (b) 21789 21511 21516

POLY-3 PERCENT (g) 112 132 132

TERMINAL (d) 217 (12) 212 (17) 111 (9)

FIRST INCIDENCE 183 (T) 183 (T) 155

STATISTICAL TESTS

LIFE TABLE P=0527 P=0566 P=0548

POLY 3 P=0602 P=0635 P=0636

POLY 15 P=0630 P=0661 P=0665

POLY 6 P=0564 P=0605 P=0599

LOGISTIC REGRESSION P=0584 P=0566 P=0643

COCH-ARM FISHERS P=0660 P=0698N P=0698N

ORDER RESTRICTED P=0584 (e) (e)

MAX-ISO-POLY-3 P=0589 (e) (e)

Page 13

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lung Serosa Inflammation Chronic

LESION RATES

OVERALL (a) 720 (35) 420 (20) 420 (20)

POLY-3 RATE (b) 71789 41598 41594

POLY-3 PERCENT (g) 391 25 251

TERMINAL (d) 717 (41) 212 (17) 211 (18)

FIRST INCIDENCE 183 (T) 122 129

STATISTICAL TESTS

LIFE TABLE P=0509N P=0460N P=0502N

POLY 3 P=0347N P=0307N P=0309N

POLY 15 P=0322N P=0279N P=0273N

POLY 6 P=0386N P=0340N P=0360N

LOGISTIC REGRESSION P=0355N P=0320N P=0314N

COCH-ARM FISHERS P=0308N P=0240N P=0240N

ORDER RESTRICTED P=0256N (e) (e)

MAX-ISO-POLY-3 P=0284N (e) (e)

Page 14

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lymph Node Mandibular Hyperplasia Lymphoid

LESION RATES

OVERALL (a) 00 (0) 11 (100) 22 (100)

POLY-3 RATE (b) 0000 1100 2200

POLY-3 PERCENT (g) 0 100 100

TERMINAL (d) 00 (0) 11 (100) 00 (0)

FIRST INCIDENCE --- 183 (T) 155

STATISTICAL TESTS

LIFE TABLE (e) (e) (e)

POLY 3 (e) (e) (e)

POLY 15 (e) (e) (e)

POLY 6 (e) (e) (e)

LOGISTIC REGRESSION (e) (e) (e)

COCH-ARM FISHERS (e) (e) (e)

ORDER RESTRICTED (e) (e) (e)

MAX-ISO-POLY-3 (e) (e) (e)

Page 15

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Hyperplasia

LESION RATES

OVERALL (a) 44 (100) 02 (0) 06 (0)

POLY-3 RATE (b) 4400 0171 0469

POLY-3 PERCENT (g) 100 0 0

TERMINAL (d) 44 (100) 01 (0) 03 (0)

FIRST INCIDENCE 183 (T) --- --shy

STATISTICAL TESTS

LIFE TABLE P=0052N P=0227N P=0041N

POLY 3 Plt0001N Plt0001N Plt0001N

POLY 15 Plt0001N Plt0001N Plt0001N

POLY 6 Plt0001N Plt0001N Plt0001N

LOGISTIC REGRESSION P=0052N (e) (e)

COCH-ARM FISHERS P=0015N P=0067N P=0005N

ORDER RESTRICTED Plt0001N (e) (e)

MAX-ISO-POLY-3 Plt0001N (e) (e)

Page 16

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Inflammation Chronic

LESION RATES

OVERALL (a) 34 (75) 12 (50) 46 (67)

POLY-3 RATE (b) 3400 1171 4548

POLY-3 PERCENT (g) 75 586 73

TERMINAL (d) 34 (75) 11 (100) 23 (67)

FIRST INCIDENCE 183 (T) 183 (T) 155

STATISTICAL TESTS

LIFE TABLE P=0210 P=0773 P=0290

POLY 3 P=0679 P=0694N P=0738N

POLY 15 P=0689N P=0651N P=0700N

POLY 6 P=0662 P=0764N P=0750

LOGISTIC REGRESSION P=0584 P=0773 P=0803N

COCH-ARM FISHERS P=0681N P=0600N P=0667N

ORDER RESTRICTED P=0575N (e) (e)

MAX-ISO-POLY-3 P=0589N (e) (e)

Page 17

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Control Dermis Inflammation Chronic

LESION RATES

OVERALL (a) 020 (0) 020 (0) 420 (20)

POLY-3 RATE (b) 01789 01511 41586

POLY-3 PERCENT (g) 0 0 252

TERMINAL (d) 017 (0) 012 (0) 211 (18)

FIRST INCIDENCE --- --- 122

STATISTICAL TESTS

LIFE TABLE P=0005 (e) P=0035

POLY 3 P=0004 (e) P=0036

POLY 15 P=0005 (e) P=0042

POLY 6 P=0004 (e) P=0029

LOGISTIC REGRESSION P=0008 (e) P=0061

COCH-ARM FISHERS P=0008 (e) P=0053

ORDER RESTRICTED P=0002 (e) (e)

MAX-ISO-POLY-3 P=0005 (e) (e)

Page 18

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin SOA No Mass Hyperplasia

LESION RATES

OVERALL (a) 120 (5) 720 (35) 1017 (59)

POLY-3 RATE (b) 11789 71725 101463

POLY-3 PERCENT (g) 56 406 684

TERMINAL (d) 117 (6) 312 (25) 710 (70)

FIRST INCIDENCE 183 (T) 122 84

STATISTICAL TESTS

LIFE TABLE P=0002 P=0014 Plt0001

POLY 3 Plt0001 P=0014 Plt0001

POLY 15 Plt0001 P=0015 Plt0001

POLY 6 Plt0001 P=0013 Plt0001

LOGISTIC REGRESSION P=0002 P=0026 Plt0001

COCH-ARM FISHERS P=0002 P=0022 Plt0001

ORDER RESTRICTED Plt0001 (e) (e)

MAX-ISO-POLY-3 Plt0001 (e) (e)

Page 19

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lung Bronchiole Inflammation

LESION RATES

OVERALL (a) 020 (0) 020 (0) 220 (10)

POLY-3 RATE (b) 01789 01511 21477

POLY-3 PERCENT (g) 0 0 135

TERMINAL (d) 017 (0) 012 (0) 211 (18)

FIRST INCIDENCE --- --- 183 (T)

STATISTICAL TESTS

LIFE TABLE P=0057 (e) P=0146

POLY 3 P=0073 (e) P=0191

POLY 15 P=0081 (e) P=0210

POLY 6 P=0064 (e) P=0170

LOGISTIC REGRESSION (e) (e) P=0146

COCH-ARM FISHERS P=0093 (e) P=0244

ORDER RESTRICTED P=0032 (e) (e)

MAX-ISO-POLY-3 P=0053 (e) (e)

Page 11

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lung Interstitium Inflammation

LESION RATES

OVERALL (a) 120 (5) 120 (5) 320 (15)

POLY-3 RATE (b) 11815 11511 31568

POLY-3 PERCENT (g) 55 66 191

TERMINAL (d) 017 (0) 112 (8) 111 (9)

FIRST INCIDENCE 165 183 (T) 143

STATISTICAL TESTS

LIFE TABLE P=0133 P=0684 P=0203

POLY 3 P=0166 P=0719 P=0247

POLY 15 P=0181 P=0737 P=0271

POLY 6 P=0148 P=0697 P=0220

LOGISTIC REGRESSION P=0190 P=0747 P=0313

COCH-ARM FISHERS P=0195 P=0756N P=0302

ORDER RESTRICTED P=0127 (e) (e)

MAX-ISO-POLY-3 P=0160 (e) (e)

Page 12

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lung Perivascular Inflammation

LESION RATES

OVERALL (a) 220 (10) 220 (10) 220 (10)

POLY-3 RATE (b) 21789 21511 21516

POLY-3 PERCENT (g) 112 132 132

TERMINAL (d) 217 (12) 212 (17) 111 (9)

FIRST INCIDENCE 183 (T) 183 (T) 155

STATISTICAL TESTS

LIFE TABLE P=0527 P=0566 P=0548

POLY 3 P=0602 P=0635 P=0636

POLY 15 P=0630 P=0661 P=0665

POLY 6 P=0564 P=0605 P=0599

LOGISTIC REGRESSION P=0584 P=0566 P=0643

COCH-ARM FISHERS P=0660 P=0698N P=0698N

ORDER RESTRICTED P=0584 (e) (e)

MAX-ISO-POLY-3 P=0589 (e) (e)

Page 13

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lung Serosa Inflammation Chronic

LESION RATES

OVERALL (a) 720 (35) 420 (20) 420 (20)

POLY-3 RATE (b) 71789 41598 41594

POLY-3 PERCENT (g) 391 25 251

TERMINAL (d) 717 (41) 212 (17) 211 (18)

FIRST INCIDENCE 183 (T) 122 129

STATISTICAL TESTS

LIFE TABLE P=0509N P=0460N P=0502N

POLY 3 P=0347N P=0307N P=0309N

POLY 15 P=0322N P=0279N P=0273N

POLY 6 P=0386N P=0340N P=0360N

LOGISTIC REGRESSION P=0355N P=0320N P=0314N

COCH-ARM FISHERS P=0308N P=0240N P=0240N

ORDER RESTRICTED P=0256N (e) (e)

MAX-ISO-POLY-3 P=0284N (e) (e)

Page 14

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lymph Node Mandibular Hyperplasia Lymphoid

LESION RATES

OVERALL (a) 00 (0) 11 (100) 22 (100)

POLY-3 RATE (b) 0000 1100 2200

POLY-3 PERCENT (g) 0 100 100

TERMINAL (d) 00 (0) 11 (100) 00 (0)

FIRST INCIDENCE --- 183 (T) 155

STATISTICAL TESTS

LIFE TABLE (e) (e) (e)

POLY 3 (e) (e) (e)

POLY 15 (e) (e) (e)

POLY 6 (e) (e) (e)

LOGISTIC REGRESSION (e) (e) (e)

COCH-ARM FISHERS (e) (e) (e)

ORDER RESTRICTED (e) (e) (e)

MAX-ISO-POLY-3 (e) (e) (e)

Page 15

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Hyperplasia

LESION RATES

OVERALL (a) 44 (100) 02 (0) 06 (0)

POLY-3 RATE (b) 4400 0171 0469

POLY-3 PERCENT (g) 100 0 0

TERMINAL (d) 44 (100) 01 (0) 03 (0)

FIRST INCIDENCE 183 (T) --- --shy

STATISTICAL TESTS

LIFE TABLE P=0052N P=0227N P=0041N

POLY 3 Plt0001N Plt0001N Plt0001N

POLY 15 Plt0001N Plt0001N Plt0001N

POLY 6 Plt0001N Plt0001N Plt0001N

LOGISTIC REGRESSION P=0052N (e) (e)

COCH-ARM FISHERS P=0015N P=0067N P=0005N

ORDER RESTRICTED Plt0001N (e) (e)

MAX-ISO-POLY-3 Plt0001N (e) (e)

Page 16

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Inflammation Chronic

LESION RATES

OVERALL (a) 34 (75) 12 (50) 46 (67)

POLY-3 RATE (b) 3400 1171 4548

POLY-3 PERCENT (g) 75 586 73

TERMINAL (d) 34 (75) 11 (100) 23 (67)

FIRST INCIDENCE 183 (T) 183 (T) 155

STATISTICAL TESTS

LIFE TABLE P=0210 P=0773 P=0290

POLY 3 P=0679 P=0694N P=0738N

POLY 15 P=0689N P=0651N P=0700N

POLY 6 P=0662 P=0764N P=0750

LOGISTIC REGRESSION P=0584 P=0773 P=0803N

COCH-ARM FISHERS P=0681N P=0600N P=0667N

ORDER RESTRICTED P=0575N (e) (e)

MAX-ISO-POLY-3 P=0589N (e) (e)

Page 17

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Control Dermis Inflammation Chronic

LESION RATES

OVERALL (a) 020 (0) 020 (0) 420 (20)

POLY-3 RATE (b) 01789 01511 41586

POLY-3 PERCENT (g) 0 0 252

TERMINAL (d) 017 (0) 012 (0) 211 (18)

FIRST INCIDENCE --- --- 122

STATISTICAL TESTS

LIFE TABLE P=0005 (e) P=0035

POLY 3 P=0004 (e) P=0036

POLY 15 P=0005 (e) P=0042

POLY 6 P=0004 (e) P=0029

LOGISTIC REGRESSION P=0008 (e) P=0061

COCH-ARM FISHERS P=0008 (e) P=0053

ORDER RESTRICTED P=0002 (e) (e)

MAX-ISO-POLY-3 P=0005 (e) (e)

Page 18

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin SOA No Mass Hyperplasia

LESION RATES

OVERALL (a) 120 (5) 720 (35) 1017 (59)

POLY-3 RATE (b) 11789 71725 101463

POLY-3 PERCENT (g) 56 406 684

TERMINAL (d) 117 (6) 312 (25) 710 (70)

FIRST INCIDENCE 183 (T) 122 84

STATISTICAL TESTS

LIFE TABLE P=0002 P=0014 Plt0001

POLY 3 Plt0001 P=0014 Plt0001

POLY 15 Plt0001 P=0015 Plt0001

POLY 6 Plt0001 P=0013 Plt0001

LOGISTIC REGRESSION P=0002 P=0026 Plt0001

COCH-ARM FISHERS P=0002 P=0022 Plt0001

ORDER RESTRICTED Plt0001 (e) (e)

MAX-ISO-POLY-3 Plt0001 (e) (e)

Page 19

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lung Interstitium Inflammation

LESION RATES

OVERALL (a) 120 (5) 120 (5) 320 (15)

POLY-3 RATE (b) 11815 11511 31568

POLY-3 PERCENT (g) 55 66 191

TERMINAL (d) 017 (0) 112 (8) 111 (9)

FIRST INCIDENCE 165 183 (T) 143

STATISTICAL TESTS

LIFE TABLE P=0133 P=0684 P=0203

POLY 3 P=0166 P=0719 P=0247

POLY 15 P=0181 P=0737 P=0271

POLY 6 P=0148 P=0697 P=0220

LOGISTIC REGRESSION P=0190 P=0747 P=0313

COCH-ARM FISHERS P=0195 P=0756N P=0302

ORDER RESTRICTED P=0127 (e) (e)

MAX-ISO-POLY-3 P=0160 (e) (e)

Page 12

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lung Perivascular Inflammation

LESION RATES

OVERALL (a) 220 (10) 220 (10) 220 (10)

POLY-3 RATE (b) 21789 21511 21516

POLY-3 PERCENT (g) 112 132 132

TERMINAL (d) 217 (12) 212 (17) 111 (9)

FIRST INCIDENCE 183 (T) 183 (T) 155

STATISTICAL TESTS

LIFE TABLE P=0527 P=0566 P=0548

POLY 3 P=0602 P=0635 P=0636

POLY 15 P=0630 P=0661 P=0665

POLY 6 P=0564 P=0605 P=0599

LOGISTIC REGRESSION P=0584 P=0566 P=0643

COCH-ARM FISHERS P=0660 P=0698N P=0698N

ORDER RESTRICTED P=0584 (e) (e)

MAX-ISO-POLY-3 P=0589 (e) (e)

Page 13

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lung Serosa Inflammation Chronic

LESION RATES

OVERALL (a) 720 (35) 420 (20) 420 (20)

POLY-3 RATE (b) 71789 41598 41594

POLY-3 PERCENT (g) 391 25 251

TERMINAL (d) 717 (41) 212 (17) 211 (18)

FIRST INCIDENCE 183 (T) 122 129

STATISTICAL TESTS

LIFE TABLE P=0509N P=0460N P=0502N

POLY 3 P=0347N P=0307N P=0309N

POLY 15 P=0322N P=0279N P=0273N

POLY 6 P=0386N P=0340N P=0360N

LOGISTIC REGRESSION P=0355N P=0320N P=0314N

COCH-ARM FISHERS P=0308N P=0240N P=0240N

ORDER RESTRICTED P=0256N (e) (e)

MAX-ISO-POLY-3 P=0284N (e) (e)

Page 14

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lymph Node Mandibular Hyperplasia Lymphoid

LESION RATES

OVERALL (a) 00 (0) 11 (100) 22 (100)

POLY-3 RATE (b) 0000 1100 2200

POLY-3 PERCENT (g) 0 100 100

TERMINAL (d) 00 (0) 11 (100) 00 (0)

FIRST INCIDENCE --- 183 (T) 155

STATISTICAL TESTS

LIFE TABLE (e) (e) (e)

POLY 3 (e) (e) (e)

POLY 15 (e) (e) (e)

POLY 6 (e) (e) (e)

LOGISTIC REGRESSION (e) (e) (e)

COCH-ARM FISHERS (e) (e) (e)

ORDER RESTRICTED (e) (e) (e)

MAX-ISO-POLY-3 (e) (e) (e)

Page 15

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Hyperplasia

LESION RATES

OVERALL (a) 44 (100) 02 (0) 06 (0)

POLY-3 RATE (b) 4400 0171 0469

POLY-3 PERCENT (g) 100 0 0

TERMINAL (d) 44 (100) 01 (0) 03 (0)

FIRST INCIDENCE 183 (T) --- --shy

STATISTICAL TESTS

LIFE TABLE P=0052N P=0227N P=0041N

POLY 3 Plt0001N Plt0001N Plt0001N

POLY 15 Plt0001N Plt0001N Plt0001N

POLY 6 Plt0001N Plt0001N Plt0001N

LOGISTIC REGRESSION P=0052N (e) (e)

COCH-ARM FISHERS P=0015N P=0067N P=0005N

ORDER RESTRICTED Plt0001N (e) (e)

MAX-ISO-POLY-3 Plt0001N (e) (e)

Page 16

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Inflammation Chronic

LESION RATES

OVERALL (a) 34 (75) 12 (50) 46 (67)

POLY-3 RATE (b) 3400 1171 4548

POLY-3 PERCENT (g) 75 586 73

TERMINAL (d) 34 (75) 11 (100) 23 (67)

FIRST INCIDENCE 183 (T) 183 (T) 155

STATISTICAL TESTS

LIFE TABLE P=0210 P=0773 P=0290

POLY 3 P=0679 P=0694N P=0738N

POLY 15 P=0689N P=0651N P=0700N

POLY 6 P=0662 P=0764N P=0750

LOGISTIC REGRESSION P=0584 P=0773 P=0803N

COCH-ARM FISHERS P=0681N P=0600N P=0667N

ORDER RESTRICTED P=0575N (e) (e)

MAX-ISO-POLY-3 P=0589N (e) (e)

Page 17

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Control Dermis Inflammation Chronic

LESION RATES

OVERALL (a) 020 (0) 020 (0) 420 (20)

POLY-3 RATE (b) 01789 01511 41586

POLY-3 PERCENT (g) 0 0 252

TERMINAL (d) 017 (0) 012 (0) 211 (18)

FIRST INCIDENCE --- --- 122

STATISTICAL TESTS

LIFE TABLE P=0005 (e) P=0035

POLY 3 P=0004 (e) P=0036

POLY 15 P=0005 (e) P=0042

POLY 6 P=0004 (e) P=0029

LOGISTIC REGRESSION P=0008 (e) P=0061

COCH-ARM FISHERS P=0008 (e) P=0053

ORDER RESTRICTED P=0002 (e) (e)

MAX-ISO-POLY-3 P=0005 (e) (e)

Page 18

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin SOA No Mass Hyperplasia

LESION RATES

OVERALL (a) 120 (5) 720 (35) 1017 (59)

POLY-3 RATE (b) 11789 71725 101463

POLY-3 PERCENT (g) 56 406 684

TERMINAL (d) 117 (6) 312 (25) 710 (70)

FIRST INCIDENCE 183 (T) 122 84

STATISTICAL TESTS

LIFE TABLE P=0002 P=0014 Plt0001

POLY 3 Plt0001 P=0014 Plt0001

POLY 15 Plt0001 P=0015 Plt0001

POLY 6 Plt0001 P=0013 Plt0001

LOGISTIC REGRESSION P=0002 P=0026 Plt0001

COCH-ARM FISHERS P=0002 P=0022 Plt0001

ORDER RESTRICTED Plt0001 (e) (e)

MAX-ISO-POLY-3 Plt0001 (e) (e)

Page 19

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lung Perivascular Inflammation

LESION RATES

OVERALL (a) 220 (10) 220 (10) 220 (10)

POLY-3 RATE (b) 21789 21511 21516

POLY-3 PERCENT (g) 112 132 132

TERMINAL (d) 217 (12) 212 (17) 111 (9)

FIRST INCIDENCE 183 (T) 183 (T) 155

STATISTICAL TESTS

LIFE TABLE P=0527 P=0566 P=0548

POLY 3 P=0602 P=0635 P=0636

POLY 15 P=0630 P=0661 P=0665

POLY 6 P=0564 P=0605 P=0599

LOGISTIC REGRESSION P=0584 P=0566 P=0643

COCH-ARM FISHERS P=0660 P=0698N P=0698N

ORDER RESTRICTED P=0584 (e) (e)

MAX-ISO-POLY-3 P=0589 (e) (e)

Page 13

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lung Serosa Inflammation Chronic

LESION RATES

OVERALL (a) 720 (35) 420 (20) 420 (20)

POLY-3 RATE (b) 71789 41598 41594

POLY-3 PERCENT (g) 391 25 251

TERMINAL (d) 717 (41) 212 (17) 211 (18)

FIRST INCIDENCE 183 (T) 122 129

STATISTICAL TESTS

LIFE TABLE P=0509N P=0460N P=0502N

POLY 3 P=0347N P=0307N P=0309N

POLY 15 P=0322N P=0279N P=0273N

POLY 6 P=0386N P=0340N P=0360N

LOGISTIC REGRESSION P=0355N P=0320N P=0314N

COCH-ARM FISHERS P=0308N P=0240N P=0240N

ORDER RESTRICTED P=0256N (e) (e)

MAX-ISO-POLY-3 P=0284N (e) (e)

Page 14

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lymph Node Mandibular Hyperplasia Lymphoid

LESION RATES

OVERALL (a) 00 (0) 11 (100) 22 (100)

POLY-3 RATE (b) 0000 1100 2200

POLY-3 PERCENT (g) 0 100 100

TERMINAL (d) 00 (0) 11 (100) 00 (0)

FIRST INCIDENCE --- 183 (T) 155

STATISTICAL TESTS

LIFE TABLE (e) (e) (e)

POLY 3 (e) (e) (e)

POLY 15 (e) (e) (e)

POLY 6 (e) (e) (e)

LOGISTIC REGRESSION (e) (e) (e)

COCH-ARM FISHERS (e) (e) (e)

ORDER RESTRICTED (e) (e) (e)

MAX-ISO-POLY-3 (e) (e) (e)

Page 15

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Hyperplasia

LESION RATES

OVERALL (a) 44 (100) 02 (0) 06 (0)

POLY-3 RATE (b) 4400 0171 0469

POLY-3 PERCENT (g) 100 0 0

TERMINAL (d) 44 (100) 01 (0) 03 (0)

FIRST INCIDENCE 183 (T) --- --shy

STATISTICAL TESTS

LIFE TABLE P=0052N P=0227N P=0041N

POLY 3 Plt0001N Plt0001N Plt0001N

POLY 15 Plt0001N Plt0001N Plt0001N

POLY 6 Plt0001N Plt0001N Plt0001N

LOGISTIC REGRESSION P=0052N (e) (e)

COCH-ARM FISHERS P=0015N P=0067N P=0005N

ORDER RESTRICTED Plt0001N (e) (e)

MAX-ISO-POLY-3 Plt0001N (e) (e)

Page 16

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Inflammation Chronic

LESION RATES

OVERALL (a) 34 (75) 12 (50) 46 (67)

POLY-3 RATE (b) 3400 1171 4548

POLY-3 PERCENT (g) 75 586 73

TERMINAL (d) 34 (75) 11 (100) 23 (67)

FIRST INCIDENCE 183 (T) 183 (T) 155

STATISTICAL TESTS

LIFE TABLE P=0210 P=0773 P=0290

POLY 3 P=0679 P=0694N P=0738N

POLY 15 P=0689N P=0651N P=0700N

POLY 6 P=0662 P=0764N P=0750

LOGISTIC REGRESSION P=0584 P=0773 P=0803N

COCH-ARM FISHERS P=0681N P=0600N P=0667N

ORDER RESTRICTED P=0575N (e) (e)

MAX-ISO-POLY-3 P=0589N (e) (e)

Page 17

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Control Dermis Inflammation Chronic

LESION RATES

OVERALL (a) 020 (0) 020 (0) 420 (20)

POLY-3 RATE (b) 01789 01511 41586

POLY-3 PERCENT (g) 0 0 252

TERMINAL (d) 017 (0) 012 (0) 211 (18)

FIRST INCIDENCE --- --- 122

STATISTICAL TESTS

LIFE TABLE P=0005 (e) P=0035

POLY 3 P=0004 (e) P=0036

POLY 15 P=0005 (e) P=0042

POLY 6 P=0004 (e) P=0029

LOGISTIC REGRESSION P=0008 (e) P=0061

COCH-ARM FISHERS P=0008 (e) P=0053

ORDER RESTRICTED P=0002 (e) (e)

MAX-ISO-POLY-3 P=0005 (e) (e)

Page 18

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin SOA No Mass Hyperplasia

LESION RATES

OVERALL (a) 120 (5) 720 (35) 1017 (59)

POLY-3 RATE (b) 11789 71725 101463

POLY-3 PERCENT (g) 56 406 684

TERMINAL (d) 117 (6) 312 (25) 710 (70)

FIRST INCIDENCE 183 (T) 122 84

STATISTICAL TESTS

LIFE TABLE P=0002 P=0014 Plt0001

POLY 3 Plt0001 P=0014 Plt0001

POLY 15 Plt0001 P=0015 Plt0001

POLY 6 Plt0001 P=0013 Plt0001

LOGISTIC REGRESSION P=0002 P=0026 Plt0001

COCH-ARM FISHERS P=0002 P=0022 Plt0001

ORDER RESTRICTED Plt0001 (e) (e)

MAX-ISO-POLY-3 Plt0001 (e) (e)

Page 19

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lung Serosa Inflammation Chronic

LESION RATES

OVERALL (a) 720 (35) 420 (20) 420 (20)

POLY-3 RATE (b) 71789 41598 41594

POLY-3 PERCENT (g) 391 25 251

TERMINAL (d) 717 (41) 212 (17) 211 (18)

FIRST INCIDENCE 183 (T) 122 129

STATISTICAL TESTS

LIFE TABLE P=0509N P=0460N P=0502N

POLY 3 P=0347N P=0307N P=0309N

POLY 15 P=0322N P=0279N P=0273N

POLY 6 P=0386N P=0340N P=0360N

LOGISTIC REGRESSION P=0355N P=0320N P=0314N

COCH-ARM FISHERS P=0308N P=0240N P=0240N

ORDER RESTRICTED P=0256N (e) (e)

MAX-ISO-POLY-3 P=0284N (e) (e)

Page 14

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lymph Node Mandibular Hyperplasia Lymphoid

LESION RATES

OVERALL (a) 00 (0) 11 (100) 22 (100)

POLY-3 RATE (b) 0000 1100 2200

POLY-3 PERCENT (g) 0 100 100

TERMINAL (d) 00 (0) 11 (100) 00 (0)

FIRST INCIDENCE --- 183 (T) 155

STATISTICAL TESTS

LIFE TABLE (e) (e) (e)

POLY 3 (e) (e) (e)

POLY 15 (e) (e) (e)

POLY 6 (e) (e) (e)

LOGISTIC REGRESSION (e) (e) (e)

COCH-ARM FISHERS (e) (e) (e)

ORDER RESTRICTED (e) (e) (e)

MAX-ISO-POLY-3 (e) (e) (e)

Page 15

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Hyperplasia

LESION RATES

OVERALL (a) 44 (100) 02 (0) 06 (0)

POLY-3 RATE (b) 4400 0171 0469

POLY-3 PERCENT (g) 100 0 0

TERMINAL (d) 44 (100) 01 (0) 03 (0)

FIRST INCIDENCE 183 (T) --- --shy

STATISTICAL TESTS

LIFE TABLE P=0052N P=0227N P=0041N

POLY 3 Plt0001N Plt0001N Plt0001N

POLY 15 Plt0001N Plt0001N Plt0001N

POLY 6 Plt0001N Plt0001N Plt0001N

LOGISTIC REGRESSION P=0052N (e) (e)

COCH-ARM FISHERS P=0015N P=0067N P=0005N

ORDER RESTRICTED Plt0001N (e) (e)

MAX-ISO-POLY-3 Plt0001N (e) (e)

Page 16

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Inflammation Chronic

LESION RATES

OVERALL (a) 34 (75) 12 (50) 46 (67)

POLY-3 RATE (b) 3400 1171 4548

POLY-3 PERCENT (g) 75 586 73

TERMINAL (d) 34 (75) 11 (100) 23 (67)

FIRST INCIDENCE 183 (T) 183 (T) 155

STATISTICAL TESTS

LIFE TABLE P=0210 P=0773 P=0290

POLY 3 P=0679 P=0694N P=0738N

POLY 15 P=0689N P=0651N P=0700N

POLY 6 P=0662 P=0764N P=0750

LOGISTIC REGRESSION P=0584 P=0773 P=0803N

COCH-ARM FISHERS P=0681N P=0600N P=0667N

ORDER RESTRICTED P=0575N (e) (e)

MAX-ISO-POLY-3 P=0589N (e) (e)

Page 17

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Control Dermis Inflammation Chronic

LESION RATES

OVERALL (a) 020 (0) 020 (0) 420 (20)

POLY-3 RATE (b) 01789 01511 41586

POLY-3 PERCENT (g) 0 0 252

TERMINAL (d) 017 (0) 012 (0) 211 (18)

FIRST INCIDENCE --- --- 122

STATISTICAL TESTS

LIFE TABLE P=0005 (e) P=0035

POLY 3 P=0004 (e) P=0036

POLY 15 P=0005 (e) P=0042

POLY 6 P=0004 (e) P=0029

LOGISTIC REGRESSION P=0008 (e) P=0061

COCH-ARM FISHERS P=0008 (e) P=0053

ORDER RESTRICTED P=0002 (e) (e)

MAX-ISO-POLY-3 P=0005 (e) (e)

Page 18

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin SOA No Mass Hyperplasia

LESION RATES

OVERALL (a) 120 (5) 720 (35) 1017 (59)

POLY-3 RATE (b) 11789 71725 101463

POLY-3 PERCENT (g) 56 406 684

TERMINAL (d) 117 (6) 312 (25) 710 (70)

FIRST INCIDENCE 183 (T) 122 84

STATISTICAL TESTS

LIFE TABLE P=0002 P=0014 Plt0001

POLY 3 Plt0001 P=0014 Plt0001

POLY 15 Plt0001 P=0015 Plt0001

POLY 6 Plt0001 P=0013 Plt0001

LOGISTIC REGRESSION P=0002 P=0026 Plt0001

COCH-ARM FISHERS P=0002 P=0022 Plt0001

ORDER RESTRICTED Plt0001 (e) (e)

MAX-ISO-POLY-3 Plt0001 (e) (e)

Page 19

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Lymph Node Mandibular Hyperplasia Lymphoid

LESION RATES

OVERALL (a) 00 (0) 11 (100) 22 (100)

POLY-3 RATE (b) 0000 1100 2200

POLY-3 PERCENT (g) 0 100 100

TERMINAL (d) 00 (0) 11 (100) 00 (0)

FIRST INCIDENCE --- 183 (T) 155

STATISTICAL TESTS

LIFE TABLE (e) (e) (e)

POLY 3 (e) (e) (e)

POLY 15 (e) (e) (e)

POLY 6 (e) (e) (e)

LOGISTIC REGRESSION (e) (e) (e)

COCH-ARM FISHERS (e) (e) (e)

ORDER RESTRICTED (e) (e) (e)

MAX-ISO-POLY-3 (e) (e) (e)

Page 15

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Hyperplasia

LESION RATES

OVERALL (a) 44 (100) 02 (0) 06 (0)

POLY-3 RATE (b) 4400 0171 0469

POLY-3 PERCENT (g) 100 0 0

TERMINAL (d) 44 (100) 01 (0) 03 (0)

FIRST INCIDENCE 183 (T) --- --shy

STATISTICAL TESTS

LIFE TABLE P=0052N P=0227N P=0041N

POLY 3 Plt0001N Plt0001N Plt0001N

POLY 15 Plt0001N Plt0001N Plt0001N

POLY 6 Plt0001N Plt0001N Plt0001N

LOGISTIC REGRESSION P=0052N (e) (e)

COCH-ARM FISHERS P=0015N P=0067N P=0005N

ORDER RESTRICTED Plt0001N (e) (e)

MAX-ISO-POLY-3 Plt0001N (e) (e)

Page 16

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Inflammation Chronic

LESION RATES

OVERALL (a) 34 (75) 12 (50) 46 (67)

POLY-3 RATE (b) 3400 1171 4548

POLY-3 PERCENT (g) 75 586 73

TERMINAL (d) 34 (75) 11 (100) 23 (67)

FIRST INCIDENCE 183 (T) 183 (T) 155

STATISTICAL TESTS

LIFE TABLE P=0210 P=0773 P=0290

POLY 3 P=0679 P=0694N P=0738N

POLY 15 P=0689N P=0651N P=0700N

POLY 6 P=0662 P=0764N P=0750

LOGISTIC REGRESSION P=0584 P=0773 P=0803N

COCH-ARM FISHERS P=0681N P=0600N P=0667N

ORDER RESTRICTED P=0575N (e) (e)

MAX-ISO-POLY-3 P=0589N (e) (e)

Page 17

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Control Dermis Inflammation Chronic

LESION RATES

OVERALL (a) 020 (0) 020 (0) 420 (20)

POLY-3 RATE (b) 01789 01511 41586

POLY-3 PERCENT (g) 0 0 252

TERMINAL (d) 017 (0) 012 (0) 211 (18)

FIRST INCIDENCE --- --- 122

STATISTICAL TESTS

LIFE TABLE P=0005 (e) P=0035

POLY 3 P=0004 (e) P=0036

POLY 15 P=0005 (e) P=0042

POLY 6 P=0004 (e) P=0029

LOGISTIC REGRESSION P=0008 (e) P=0061

COCH-ARM FISHERS P=0008 (e) P=0053

ORDER RESTRICTED P=0002 (e) (e)

MAX-ISO-POLY-3 P=0005 (e) (e)

Page 18

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin SOA No Mass Hyperplasia

LESION RATES

OVERALL (a) 120 (5) 720 (35) 1017 (59)

POLY-3 RATE (b) 11789 71725 101463

POLY-3 PERCENT (g) 56 406 684

TERMINAL (d) 117 (6) 312 (25) 710 (70)

FIRST INCIDENCE 183 (T) 122 84

STATISTICAL TESTS

LIFE TABLE P=0002 P=0014 Plt0001

POLY 3 Plt0001 P=0014 Plt0001

POLY 15 Plt0001 P=0015 Plt0001

POLY 6 Plt0001 P=0013 Plt0001

LOGISTIC REGRESSION P=0002 P=0026 Plt0001

COCH-ARM FISHERS P=0002 P=0022 Plt0001

ORDER RESTRICTED Plt0001 (e) (e)

MAX-ISO-POLY-3 Plt0001 (e) (e)

Page 19

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Hyperplasia

LESION RATES

OVERALL (a) 44 (100) 02 (0) 06 (0)

POLY-3 RATE (b) 4400 0171 0469

POLY-3 PERCENT (g) 100 0 0

TERMINAL (d) 44 (100) 01 (0) 03 (0)

FIRST INCIDENCE 183 (T) --- --shy

STATISTICAL TESTS

LIFE TABLE P=0052N P=0227N P=0041N

POLY 3 Plt0001N Plt0001N Plt0001N

POLY 15 Plt0001N Plt0001N Plt0001N

POLY 6 Plt0001N Plt0001N Plt0001N

LOGISTIC REGRESSION P=0052N (e) (e)

COCH-ARM FISHERS P=0015N P=0067N P=0005N

ORDER RESTRICTED Plt0001N (e) (e)

MAX-ISO-POLY-3 Plt0001N (e) (e)

Page 16

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Inflammation Chronic

LESION RATES

OVERALL (a) 34 (75) 12 (50) 46 (67)

POLY-3 RATE (b) 3400 1171 4548

POLY-3 PERCENT (g) 75 586 73

TERMINAL (d) 34 (75) 11 (100) 23 (67)

FIRST INCIDENCE 183 (T) 183 (T) 155

STATISTICAL TESTS

LIFE TABLE P=0210 P=0773 P=0290

POLY 3 P=0679 P=0694N P=0738N

POLY 15 P=0689N P=0651N P=0700N

POLY 6 P=0662 P=0764N P=0750

LOGISTIC REGRESSION P=0584 P=0773 P=0803N

COCH-ARM FISHERS P=0681N P=0600N P=0667N

ORDER RESTRICTED P=0575N (e) (e)

MAX-ISO-POLY-3 P=0589N (e) (e)

Page 17

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Control Dermis Inflammation Chronic

LESION RATES

OVERALL (a) 020 (0) 020 (0) 420 (20)

POLY-3 RATE (b) 01789 01511 41586

POLY-3 PERCENT (g) 0 0 252

TERMINAL (d) 017 (0) 012 (0) 211 (18)

FIRST INCIDENCE --- --- 122

STATISTICAL TESTS

LIFE TABLE P=0005 (e) P=0035

POLY 3 P=0004 (e) P=0036

POLY 15 P=0005 (e) P=0042

POLY 6 P=0004 (e) P=0029

LOGISTIC REGRESSION P=0008 (e) P=0061

COCH-ARM FISHERS P=0008 (e) P=0053

ORDER RESTRICTED P=0002 (e) (e)

MAX-ISO-POLY-3 P=0005 (e) (e)

Page 18

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin SOA No Mass Hyperplasia

LESION RATES

OVERALL (a) 120 (5) 720 (35) 1017 (59)

POLY-3 RATE (b) 11789 71725 101463

POLY-3 PERCENT (g) 56 406 684

TERMINAL (d) 117 (6) 312 (25) 710 (70)

FIRST INCIDENCE 183 (T) 122 84

STATISTICAL TESTS

LIFE TABLE P=0002 P=0014 Plt0001

POLY 3 Plt0001 P=0014 Plt0001

POLY 15 Plt0001 P=0015 Plt0001

POLY 6 Plt0001 P=0013 Plt0001

LOGISTIC REGRESSION P=0002 P=0026 Plt0001

COCH-ARM FISHERS P=0002 P=0022 Plt0001

ORDER RESTRICTED Plt0001 (e) (e)

MAX-ISO-POLY-3 Plt0001 (e) (e)

Page 19

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Inflammation Chronic

LESION RATES

OVERALL (a) 34 (75) 12 (50) 46 (67)

POLY-3 RATE (b) 3400 1171 4548

POLY-3 PERCENT (g) 75 586 73

TERMINAL (d) 34 (75) 11 (100) 23 (67)

FIRST INCIDENCE 183 (T) 183 (T) 155

STATISTICAL TESTS

LIFE TABLE P=0210 P=0773 P=0290

POLY 3 P=0679 P=0694N P=0738N

POLY 15 P=0689N P=0651N P=0700N

POLY 6 P=0662 P=0764N P=0750

LOGISTIC REGRESSION P=0584 P=0773 P=0803N

COCH-ARM FISHERS P=0681N P=0600N P=0667N

ORDER RESTRICTED P=0575N (e) (e)

MAX-ISO-POLY-3 P=0589N (e) (e)

Page 17

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Control Dermis Inflammation Chronic

LESION RATES

OVERALL (a) 020 (0) 020 (0) 420 (20)

POLY-3 RATE (b) 01789 01511 41586

POLY-3 PERCENT (g) 0 0 252

TERMINAL (d) 017 (0) 012 (0) 211 (18)

FIRST INCIDENCE --- --- 122

STATISTICAL TESTS

LIFE TABLE P=0005 (e) P=0035

POLY 3 P=0004 (e) P=0036

POLY 15 P=0005 (e) P=0042

POLY 6 P=0004 (e) P=0029

LOGISTIC REGRESSION P=0008 (e) P=0061

COCH-ARM FISHERS P=0008 (e) P=0053

ORDER RESTRICTED P=0002 (e) (e)

MAX-ISO-POLY-3 P=0005 (e) (e)

Page 18

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin SOA No Mass Hyperplasia

LESION RATES

OVERALL (a) 120 (5) 720 (35) 1017 (59)

POLY-3 RATE (b) 11789 71725 101463

POLY-3 PERCENT (g) 56 406 684

TERMINAL (d) 117 (6) 312 (25) 710 (70)

FIRST INCIDENCE 183 (T) 122 84

STATISTICAL TESTS

LIFE TABLE P=0002 P=0014 Plt0001

POLY 3 Plt0001 P=0014 Plt0001

POLY 15 Plt0001 P=0015 Plt0001

POLY 6 Plt0001 P=0013 Plt0001

LOGISTIC REGRESSION P=0002 P=0026 Plt0001

COCH-ARM FISHERS P=0002 P=0022 Plt0001

ORDER RESTRICTED Plt0001 (e) (e)

MAX-ISO-POLY-3 Plt0001 (e) (e)

Page 19

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Control Dermis Inflammation Chronic

LESION RATES

OVERALL (a) 020 (0) 020 (0) 420 (20)

POLY-3 RATE (b) 01789 01511 41586

POLY-3 PERCENT (g) 0 0 252

TERMINAL (d) 017 (0) 012 (0) 211 (18)

FIRST INCIDENCE --- --- 122

STATISTICAL TESTS

LIFE TABLE P=0005 (e) P=0035

POLY 3 P=0004 (e) P=0036

POLY 15 P=0005 (e) P=0042

POLY 6 P=0004 (e) P=0029

LOGISTIC REGRESSION P=0008 (e) P=0061

COCH-ARM FISHERS P=0008 (e) P=0053

ORDER RESTRICTED P=0002 (e) (e)

MAX-ISO-POLY-3 P=0005 (e) (e)

Page 18

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin SOA No Mass Hyperplasia

LESION RATES

OVERALL (a) 120 (5) 720 (35) 1017 (59)

POLY-3 RATE (b) 11789 71725 101463

POLY-3 PERCENT (g) 56 406 684

TERMINAL (d) 117 (6) 312 (25) 710 (70)

FIRST INCIDENCE 183 (T) 122 84

STATISTICAL TESTS

LIFE TABLE P=0002 P=0014 Plt0001

POLY 3 Plt0001 P=0014 Plt0001

POLY 15 Plt0001 P=0015 Plt0001

POLY 6 Plt0001 P=0013 Plt0001

LOGISTIC REGRESSION P=0002 P=0026 Plt0001

COCH-ARM FISHERS P=0002 P=0022 Plt0001

ORDER RESTRICTED Plt0001 (e) (e)

MAX-ISO-POLY-3 Plt0001 (e) (e)

Page 19

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin SOA No Mass Hyperplasia

LESION RATES

OVERALL (a) 120 (5) 720 (35) 1017 (59)

POLY-3 RATE (b) 11789 71725 101463

POLY-3 PERCENT (g) 56 406 684

TERMINAL (d) 117 (6) 312 (25) 710 (70)

FIRST INCIDENCE 183 (T) 122 84

STATISTICAL TESTS

LIFE TABLE P=0002 P=0014 Plt0001

POLY 3 Plt0001 P=0014 Plt0001

POLY 15 Plt0001 P=0015 Plt0001

POLY 6 Plt0001 P=0013 Plt0001

LOGISTIC REGRESSION P=0002 P=0026 Plt0001

COCH-ARM FISHERS P=0002 P=0022 Plt0001

ORDER RESTRICTED Plt0001 (e) (e)

MAX-ISO-POLY-3 Plt0001 (e) (e)

Page 19

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin SOA No Mass Inflammation Chronic

LESION RATES

OVERALL (a) 320 (15) 820 (40) 1317 (76)

POLY-3 RATE (b) 31789 81556 131545

POLY-3 PERCENT (g) 168 514 842

TERMINAL (d) 317 (18) 712 (58) 810 (80)

FIRST INCIDENCE 183 (T) 150 84

STATISTICAL TESTS

LIFE TABLE Plt0001 P=0017 Plt0001

POLY 3 Plt0001 P=0033 Plt0001

POLY 15 Plt0001 P=0046 Plt0001

POLY 6 Plt0001 P=0024 Plt0001

LOGISTIC REGRESSION Plt0001 P=0027 Plt0001

COCH-ARM FISHERS Plt0001 P=0078 Plt0001

ORDER RESTRICTED Plt0001 (e) (e)

MAX-ISO-POLY-3 Plt0001 (e) (e)

Page 20

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Site of Application Hyperplasia

LESION RATES

OVERALL (a) 120 (5) 1320 (65) 1420 (70)

POLY-3 RATE (b) 11789 131750 141844

POLY-3 PERCENT (g) 56 743 759

TERMINAL (d) 117 (6) 812 (67) 811 (73)

FIRST INCIDENCE 183 (T) 110 84

STATISTICAL TESTS

LIFE TABLE Plt0001 Plt0001 Plt0001

POLY 3 Plt0001 Plt0001 Plt0001

POLY 15 Plt0001 Plt0001 Plt0001

POLY 6 Plt0001 Plt0001 Plt0001

LOGISTIC REGRESSION P=0002 Plt0001 Plt0001

COCH-ARM FISHERS P=0002 Plt0001 Plt0001

ORDER RESTRICTED Plt0001 (e) (e)

MAX-ISO-POLY-3 Plt0001 (e) (e)

Page 21

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Skin Site of Application Inflammation Chronic

LESION RATES

OVERALL (a) 220 (10) 1720 (85) 2020 (100)

POLY-3 RATE (b) 21789 171750 202000

POLY-3 PERCENT (g) 112 971 100

TERMINAL (d) 217 (12) 1212 (100) 1111 (100)

FIRST INCIDENCE 183 (T) 110 84

STATISTICAL TESTS

LIFE TABLE Plt0001 Plt0001 Plt0001

POLY 3 Plt0001 Plt0001 Plt0001

POLY 15 Plt0001 Plt0001 Plt0001

POLY 6 Plt0001 Plt0001 Plt0001

LOGISTIC REGRESSION Plt0001 Plt0001 Plt0001

COCH-ARM FISHERS Plt0001 Plt0001 Plt0001

ORDER RESTRICTED Plt0001 (e) (e)

MAX-ISO-POLY-3 Plt0001 (e) (e)

Page 22

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Spleen Hematopoietic Cell Proliferation

LESION RATES

OVERALL (a) 320 (15) 920 (45) 1120 (55)

POLY-3 RATE (b) 31789 91557 111694

POLY-3 PERCENT (g) 168 578 649

TERMINAL (d) 317 (18) 712 (58) 711 (64)

FIRST INCIDENCE 183 (T) 163 122

STATISTICAL TESTS

LIFE TABLE P=0005 P=0008 P=0002

POLY 3 P=0011 P=0012 P=0002

POLY 15 P=0015 P=0019 P=0003

POLY 6 P=0007 P=0008 Plt0001

LOGISTIC REGRESSION P=0012 P=0010 P=0006

COCH-ARM FISHERS P=0029 P=0041 P=0009

ORDER RESTRICTED Plt0001 (e) (e)

MAX-ISO-POLY-3 P=0002 (e) (e)

Page 23

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Spleen Myelodysplasia

LESION RATES

OVERALL (a) 020 (0) 020 (0) 220 (10)

POLY-3 RATE (b) 01789 01511 21555

POLY-3 PERCENT (g) 0 0 129

TERMINAL (d) 017 (0) 012 (0) 011 (0)

FIRST INCIDENCE --- --- 155

STATISTICAL TESTS

LIFE TABLE P=0074 (e) P=0183

POLY 3 P=0079 (e) P=0202

POLY 15 P=0084 (e) P=0216

POLY 6 P=0072 (e) P=0187

LOGISTIC REGRESSION P=0097 (e) P=0253

COCH-ARM FISHERS P=0093 (e) P=0244

ORDER RESTRICTED P=0035 (e) (e)

MAX-ISO-POLY-3 P=0054 (e) (e)

Page 24

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Stomach Forestomach Hyperplasia

LESION RATES

OVERALL (a) 06 (0) 04 (0) 25 (40)

POLY-3 RATE (b) 0600 0400 2396

POLY-3 PERCENT (g) 0 0 505

TERMINAL (d) 06 (0) 04 (0) 12 (50)

FIRST INCIDENCE --- --- 155

STATISTICAL TESTS

LIFE TABLE P=0037 (e) P=0107

POLY 3 P=0038 (e) P=0107

POLY 15 P=0048 (e) P=0129

POLY 6 P=0029 (e) P=0083

LOGISTIC REGRESSION P=0081 (e) P=0173

COCH-ARM FISHERS P=0079 (e) P=0182

ORDER RESTRICTED P=0010 (e) (e)

MAX-ISO-POLY-3 P=0027 (e) (e)

Page 25

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Thymus Atrophy

LESION RATES

OVERALL (a) 320 (15) 319 (16) 519 (26)

POLY-3 RATE (b) 31815 31555 51617

POLY-3 PERCENT (g) 165 193 309

TERMINAL (d) 217 (12) 112 (8) 110 (10)

FIRST INCIDENCE 165 122 97

STATISTICAL TESTS

LIFE TABLE P=0178 P=0534 P=0202

POLY 3 P=0230 P=0593 P=0279

POLY 15 P=0246 P=0613 P=0301

POLY 6 P=0205 P=0574 P=0248

LOGISTIC REGRESSION P=0280 P=0655 P=0377

COCH-ARM FISHERS P=0250 P=0644 P=0317

ORDER RESTRICTED P=0212 (e) (e)

MAX-ISO-POLY-3 P=0238 (e) (e)

Page 26

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

LEGEND

(a) Number of tumor-bearing animalsnumber of animals examined at site

(b) Number of tumor-bearing animalsPoly-3 number

(d) Observed incidence at terminal kill

(f) Beneath the control incidence are the P-values associated with the trend test Beneath the dosed group incidence are theP-values corresponding to pairwise comparisons between the controls and that dosed group The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death

(e) Value of Statistic cannot be computed

(g) Poly-3 adjusted lifetime tumor incidence

(I) Interim sacrifice

(T) Terminal sacrifice

Tumor rates based on numbers of animals necropsied

To the right of any statistical result indicates significance at (Plt=005)

To the right of any statistical result indicates significance at (Plt=001)

N Indicates a negative trend for all tests

Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors

The Cochran-Armitage and Fishers exact tests compare directly the overall incidence rates

END OF REPORT

Page 27

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Stomach Forestomach Hyperplasia

LESION RATES

OVERALL (a) 06 (0) 04 (0) 25 (40)

POLY-3 RATE (b) 0600 0400 2396

POLY-3 PERCENT (g) 0 0 505

TERMINAL (d) 06 (0) 04 (0) 12 (50)

FIRST INCIDENCE --- --- 155

STATISTICAL TESTS

LIFE TABLE P=0037 (e) P=0107

POLY 3 P=0038 (e) P=0107

POLY 15 P=0048 (e) P=0129

POLY 6 P=0029 (e) P=0083

LOGISTIC REGRESSION P=0081 (e) P=0173

COCH-ARM FISHERS P=0079 (e) P=0182

ORDER RESTRICTED P=0010 (e) (e)

MAX-ISO-POLY-3 P=0027 (e) (e)

Page 25

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Thymus Atrophy

LESION RATES

OVERALL (a) 320 (15) 319 (16) 519 (26)

POLY-3 RATE (b) 31815 31555 51617

POLY-3 PERCENT (g) 165 193 309

TERMINAL (d) 217 (12) 112 (8) 110 (10)

FIRST INCIDENCE 165 122 97

STATISTICAL TESTS

LIFE TABLE P=0178 P=0534 P=0202

POLY 3 P=0230 P=0593 P=0279

POLY 15 P=0246 P=0613 P=0301

POLY 6 P=0205 P=0574 P=0248

LOGISTIC REGRESSION P=0280 P=0655 P=0377

COCH-ARM FISHERS P=0250 P=0644 P=0317

ORDER RESTRICTED P=0212 (e) (e)

MAX-ISO-POLY-3 P=0238 (e) (e)

Page 26

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

LEGEND

(a) Number of tumor-bearing animalsnumber of animals examined at site

(b) Number of tumor-bearing animalsPoly-3 number

(d) Observed incidence at terminal kill

(f) Beneath the control incidence are the P-values associated with the trend test Beneath the dosed group incidence are theP-values corresponding to pairwise comparisons between the controls and that dosed group The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death

(e) Value of Statistic cannot be computed

(g) Poly-3 adjusted lifetime tumor incidence

(I) Interim sacrifice

(T) Terminal sacrifice

Tumor rates based on numbers of animals necropsied

To the right of any statistical result indicates significance at (Plt=005)

To the right of any statistical result indicates significance at (Plt=001)

N Indicates a negative trend for all tests

Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors

The Cochran-Armitage and Fishers exact tests compare directly the overall incidence rates

END OF REPORT

Page 27

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(TGAC HEMI)

TERMINAL SACRIFICE AT 27 WEEKS

Females

DOSE 0 NGKG 121 NGKG 760 NGKG

Thymus Atrophy

LESION RATES

OVERALL (a) 320 (15) 319 (16) 519 (26)

POLY-3 RATE (b) 31815 31555 51617

POLY-3 PERCENT (g) 165 193 309

TERMINAL (d) 217 (12) 112 (8) 110 (10)

FIRST INCIDENCE 165 122 97

STATISTICAL TESTS

LIFE TABLE P=0178 P=0534 P=0202

POLY 3 P=0230 P=0593 P=0279

POLY 15 P=0246 P=0613 P=0301

POLY 6 P=0205 P=0574 P=0248

LOGISTIC REGRESSION P=0280 P=0655 P=0377

COCH-ARM FISHERS P=0250 P=0644 P=0317

ORDER RESTRICTED P=0212 (e) (e)

MAX-ISO-POLY-3 P=0238 (e) (e)

Page 26

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

LEGEND

(a) Number of tumor-bearing animalsnumber of animals examined at site

(b) Number of tumor-bearing animalsPoly-3 number

(d) Observed incidence at terminal kill

(f) Beneath the control incidence are the P-values associated with the trend test Beneath the dosed group incidence are theP-values corresponding to pairwise comparisons between the controls and that dosed group The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death

(e) Value of Statistic cannot be computed

(g) Poly-3 adjusted lifetime tumor incidence

(I) Interim sacrifice

(T) Terminal sacrifice

Tumor rates based on numbers of animals necropsied

To the right of any statistical result indicates significance at (Plt=005)

To the right of any statistical result indicates significance at (Plt=001)

N Indicates a negative trend for all tests

Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors

The Cochran-Armitage and Fishers exact tests compare directly the overall incidence rates

END OF REPORT

Page 27

TDMS No 20201 - 01 P10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Reqsted 06152006

Test Type 26-WEEK TEF TRANSGENICS (TCDD) Time Report Reqsted 145813

Route SKIN APPLICATION CAS Number 1746-01-6 First Dose MF NA 042103

SpeciesStrain MICETGAC HEMI Lab BAT

LEGEND

(a) Number of tumor-bearing animalsnumber of animals examined at site

(b) Number of tumor-bearing animalsPoly-3 number

(d) Observed incidence at terminal kill

(f) Beneath the control incidence are the P-values associated with the trend test Beneath the dosed group incidence are theP-values corresponding to pairwise comparisons between the controls and that dosed group The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death

(e) Value of Statistic cannot be computed

(g) Poly-3 adjusted lifetime tumor incidence

(I) Interim sacrifice

(T) Terminal sacrifice

Tumor rates based on numbers of animals necropsied

To the right of any statistical result indicates significance at (Plt=005)

To the right of any statistical result indicates significance at (Plt=001)

N Indicates a negative trend for all tests

Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors

The Cochran-Armitage and Fishers exact tests compare directly the overall incidence rates

END OF REPORT

Page 27