Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF … · 2020-05-31 · Experiment Number:...
Transcript of Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF … · 2020-05-31 · Experiment Number:...
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F1_Rev.1_R2_vc_tgNTP Study Number: C20316
Lock Date: 03/06/2006
Cage Range: ALL
Date Range: ALL
Reasons For Removal: ALL
Removal Date Range: ALL
Treatment Groups: Include 003 0 % Include 004 0 % Include 005 6.25 %
Include 006 6.25 % Include 007 12.5 % Include 008 12.5 %
Include 009 25 % Include 010 25 % Include 011 50 %
Include 012 50 % Include 013 100 % Include 014 100 %
Study Gender: Both
TDMSE Version: 3.0.2.0_001
PWG Approval Date: 11/26/2007
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
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MALE RATS
Organ MorphologyAdrenal Cortex AngiectasisBone Marrow HyperplasiaKidney Accumulation, Hyaline Droplet
MineralizationKidney: Renal Tubule Casts Granular
DegenerationSkin: Hair Follicle, Site of Application HyperplasiaSkin: Sebaceous Gland, Site of Application HyperplasiaSkin: Site of Application - Dermis FibrosisSkin: Site of Application - Epidermis Hyperkeratosis
HyperplasiaUlcer
Skin: Site of Application Inflammation ChronicTestes: Right, Germinal Epithelium Atrophy
FEMALE RATS
Organ MorphologyBone Marrow HyperplasiaLiver Hepatodiaphragmatic Nodule
InflammationSalivary Glands: Submandibular Gland Vacuolization CytoplasmicSkin: Hair Follicle, Site of Application HyperplasiaSkin: Sebaceous Gland, Site of Application HyperplasiaSkin: Site of Application - Dermis FibrosisSkin: Site of Application - Epidermis Hyperkeratosis
HyperplasiaUlcer
Skin: Site of Application Inflammation ChronicThyroid Gland Infiltration Cellular Mononuclear Cell
Ultimobranchial Cyst
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF CEDARWOOD OIL
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Adrenal CortexAngiectasis
LESION RATES
OVERALL (a) 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%)
POLY-3 RATE (b) 2/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/9.23
POLY-3 PERCENT (g) 20% 0% 0% 0% 0% 0%
TERMINAL (d) 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%)
FIRST INCIDENCE 93 (T) --- --- --- --- ---
STATISTICAL TESTS
POLY 3 P=0.186N P=0.227N P=0.227N P=0.227N P=0.227N P=0.246N
POLY 1.5 P=0.189N P=0.227N P=0.227N P=0.227N P=0.227N P=0.237N
POLY 6 P=0.180N P=0.227N P=0.227N P=0.227N P=0.227N P=0.259N
COCH-ARM / FISHERS P=0.203N P=0.237N P=0.237N P=0.237N P=0.237N P=0.237N
MAX-ISO-POLY-3 P=0.014N* P=0.067N P=0.067N P=0.067N P=0.067N P=0.083N
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Adrenal CortexInfiltration Cellular Mononuclear Cell
LESION RATES
OVERALL (a) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%)
POLY-3 RATE (b) 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/9.23
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Adrenal CortexMineralization
LESION RATES
OVERALL (a) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%)
POLY-3 RATE (b) 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/9.23
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Bone MarrowHyperplasia
LESION RATES
OVERALL (a) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 7/10 (70%)
POLY-3 RATE (b) 0/10.00 0/10.00 0/10.00 0/10.00 1/10.00 7/10.00
POLY-3 PERCENT (g) 0% 0% 0% 0% 10% 70%
TERMINAL (d) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 5/8 (63%)
FIRST INCIDENCE --- --- --- --- 93 (T) 79
STATISTICAL TESTS
POLY 3 P<0.001** (e) (e) (e) P=0.500 P<0.001**
POLY 1.5 P<0.001** (e) (e) (e) P=0.500 P<0.001**
POLY 6 P<0.001** (e) (e) (e) P=0.500 P<0.001**
COCH-ARM / FISHERS P<0.001** (e) (e) (e) P=0.500 P=0.002**
MAX-ISO-POLY-3 P<0.001** (e) (e) (e) P=0.158 P<0.001**
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
EpididymisInfiltration Cellular Mononuclear Cell
LESION RATES
OVERALL (a) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 1/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/9.23
POLY-3 PERCENT (g) 10% 0% 0% 0% 0% 0%
TERMINAL (d) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/8 (0%)
FIRST INCIDENCE 93 (T) --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.516N
POLY 1.5 (e) (e) (e) (e) (e) P=0.509N
POLY 6 (e) (e) (e) (e) (e) P=0.526N
COCH-ARM / FISHERS P=0.304N (e) (e) (e) (e) P=0.500N
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.178N
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
EpididymisInflammation
LESION RATES
OVERALL (a) 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%)
POLY-3 RATE (b) 2/10.00 0/0.00 0/0.00 0/0.00 0/0.00 2/10.00
POLY-3 PERCENT (g) 20% 0% 0% 0% 0% 20%
TERMINAL (d) 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/8 (0%)
FIRST INCIDENCE 93 (T) --- --- --- --- 79
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.702
POLY 1.5 (e) (e) (e) (e) (e) P=0.702
POLY 6 (e) (e) (e) (e) (e) P=0.702
COCH-ARM / FISHERS P=0.610 (e) (e) (e) (e) P=0.709N
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=1.000
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Harderian GlandInfiltration Cellular
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/9.23
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/8 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
HeartCardiomyopathy
LESION RATES
OVERALL (a) 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%)
POLY-3 RATE (b) 10/10.00 0/0.00 0/0.00 0/0.00 0/0.00 10/10.00
POLY-3 PERCENT (g) 100% 0% 0% 0% 0% 100%
TERMINAL (d) 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 8/8 (100%)
FIRST INCIDENCE 93 (T) --- --- --- --- 79
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) (e)
POLY 1.5 (e) (e) (e) (e) (e) (e)
POLY 6 (e) (e) (e) (e) (e) (e)
COCH-ARM / FISHERS (e) (e) (e) (e) (e) (e)
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) (e)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Heart: EpicardiumHyperplasia
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 1/9.23
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 10.8%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/8 (13%)
FIRST INCIDENCE --- --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.484
POLY 1.5 (e) (e) (e) (e) (e) P=0.491
POLY 6 (e) (e) (e) (e) (e) P=0.473
COCH-ARM / FISHERS P=0.304 (e) (e) (e) (e) P=0.500
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.157
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Intestine Large, RectumParasite Metazoan
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 1/9.23
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 10.8%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/8 (13%)
FIRST INCIDENCE --- --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.484
POLY 1.5 (e) (e) (e) (e) (e) P=0.491
POLY 6 (e) (e) (e) (e) (e) P=0.473
COCH-ARM / FISHERS P=0.304 (e) (e) (e) (e) P=0.500
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.157
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Islets, PancreaticInfiltration Cellular Mononuclear Cell
LESION RATES
OVERALL (a) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 1/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/9.23
POLY-3 PERCENT (g) 10% 0% 0% 0% 0% 0%
TERMINAL (d) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/8 (0%)
FIRST INCIDENCE 93 (T) --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.516N
POLY 1.5 (e) (e) (e) (e) (e) P=0.509N
POLY 6 (e) (e) (e) (e) (e) P=0.526N
COCH-ARM / FISHERS P=0.304N (e) (e) (e) (e) P=0.500N
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.178N
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
KidneyAccumulation, Hyaline Droplet
LESION RATES
OVERALL (a) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%)
POLY-3 RATE (b) 0/10.00 0/10.00 0/10.00 10/10.00 10/10.00 10/10.00
POLY-3 PERCENT (g) 0% 0% 0% 100% 100% 100%
TERMINAL (d) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) 8/8 (100%)
FIRST INCIDENCE --- --- --- 93 (T) 93 (T) 79
STATISTICAL TESTS
POLY 3 P<0.001** (e) (e) P<0.001** P<0.001** P<0.001**
POLY 1.5 P<0.001** (e) (e) P<0.001** P<0.001** P<0.001**
POLY 6 P<0.001** (e) (e) P<0.001** P<0.001** P<0.001**
COCH-ARM / FISHERS P<0.001** (e) (e) P<0.001** P<0.001** P<0.001**
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) (e)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 14
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
KidneyInfiltration Cellular Mononuclear Cell
LESION RATES
OVERALL (a) 1/10 (10%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/10 (10%)
POLY-3 RATE (b) 1/10.00 0/10.00 0/10.00 1/10.00 0/10.00 1/9.23
POLY-3 PERCENT (g) 10% 0% 0% 10% 0% 10.8%
TERMINAL (d) 1/10 (10%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/8 (13%)
FIRST INCIDENCE 93 (T) --- --- 93 (T) --- 93 (T)
STATISTICAL TESTS
POLY 3 P=0.460 P=0.500N P=0.500N P=0.760 P=0.500N P=0.743
POLY 1.5 P=0.469 P=0.500N P=0.500N P=0.760 P=0.500N P=0.751
POLY 6 P=0.449 P=0.500N P=0.500N P=0.760 P=0.500N P=0.731
COCH-ARM / FISHERS P=0.478 P=0.500N P=0.500N P=0.763N P=0.500N P=0.763N
MAX-ISO-POLY-3 P=0.448 P=0.158N P=0.158N P=1.000 P=0.158N P=0.477
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 15
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
KidneyMineralization
LESION RATES
OVERALL (a) 4/10 (40%) 7/10 (70%) 9/10 (90%) 8/10 (80%) 8/10 (80%) 8/10 (80%)
POLY-3 RATE (b) 4/10.00 7/10.00 9/10.00 8/10.00 8/10.00 8/10.00
POLY-3 PERCENT (g) 40% 70% 90% 80% 80% 80%
TERMINAL (d) 4/10 (40%) 7/10 (70%) 9/10 (90%) 8/10 (80%) 8/10 (80%) 6/8 (75%)
FIRST INCIDENCE 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) 79
STATISTICAL TESTS
POLY 3 P=0.170 P=0.186 P=0.018* P=0.077 P=0.077 P=0.077
POLY 1.5 P=0.170 P=0.186 P=0.018* P=0.077 P=0.077 P=0.077
POLY 6 P=0.170 P=0.186 P=0.018* P=0.077 P=0.077 P=0.077
COCH-ARM / FISHERS P=0.174 P=0.185 P=0.029* P=0.085 P=0.085 P=0.085
MAX-ISO-POLY-3 P=0.026* P=0.090 P=0.005** P=0.029* P=0.029* P=0.029*
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 16
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
KidneyNephropathy
LESION RATES
OVERALL (a) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%)
POLY-3 RATE (b) 10/10.00 10/10.00 10/10.00 10/10.00 10/10.00 10/10.00
POLY-3 PERCENT (g) 100% 100% 100% 100% 100% 100%
TERMINAL (d) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 8/8 (100%)
FIRST INCIDENCE 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) 79
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) (e)
POLY 1.5 (e) (e) (e) (e) (e) (e)
POLY 6 (e) (e) (e) (e) (e) (e)
COCH-ARM / FISHERS (e) (e) (e) (e) (e) (e)
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) (e)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 17
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Kidney: Renal TubuleCasts Granular
LESION RATES
OVERALL (a) 0/10 (0%) 0/10 (0%) 0/10 (0%) 5/10 (50%) 10/10 (100%) 10/10 (100%)
POLY-3 RATE (b) 0/10.00 0/10.00 0/10.00 5/10.00 10/10.00 10/10.00
POLY-3 PERCENT (g) 0% 0% 0% 50% 100% 100%
TERMINAL (d) 0/10 (0%) 0/10 (0%) 0/10 (0%) 5/10 (50%) 10/10 (100%) 8/8 (100%)
FIRST INCIDENCE --- --- --- 93 (T) 93 (T) 79
STATISTICAL TESTS
POLY 3 P<0.001** (e) (e) P=0.008** P<0.001** P<0.001**
POLY 1.5 P<0.001** (e) (e) P=0.008** P<0.001** P<0.001**
POLY 6 P<0.001** (e) (e) P=0.008** P<0.001** P<0.001**
COCH-ARM / FISHERS P<0.001** (e) (e) P=0.016* P<0.001** P<0.001**
MAX-ISO-POLY-3 P<0.001** (e) (e) P=0.002** (e) (e)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 18
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Kidney: Renal TubuleDegeneration
LESION RATES
OVERALL (a) 4/10 (40%) 5/10 (50%) 6/10 (60%) 7/10 (70%) 10/10 (100%) 10/10 (100%)
POLY-3 RATE (b) 4/10.00 5/10.00 6/10.00 7/10.00 10/10.00 10/10.00
POLY-3 PERCENT (g) 40% 50% 60% 70% 100% 100%
TERMINAL (d) 4/10 (40%) 5/10 (50%) 6/10 (60%) 7/10 (70%) 10/10 (100%) 8/8 (100%)
FIRST INCIDENCE 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) 79
STATISTICAL TESTS
POLY 3 P<0.001** P=0.500 P=0.333 P=0.186 P<0.001** P<0.001**
POLY 1.5 P<0.001** P=0.500 P=0.333 P=0.186 P<0.001** P<0.001**
POLY 6 P<0.001** P=0.500 P=0.333 P=0.186 P<0.001** P<0.001**
COCH-ARM / FISHERS P<0.001** P=0.500 P=0.328 P=0.185 P=0.005** P=0.005**
MAX-ISO-POLY-3 P<0.001** P=0.334 P=0.192 P=0.090 P<0.001** P<0.001**
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 19
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
LiverHematopoietic Cell Proliferation
LESION RATES
OVERALL (a) 1/10 (10%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/10 (10%) 0/10 (0%)
POLY-3 RATE (b) 1/10.00 0/10.00 1/10.00 0/10.00 1/10.00 0/9.23
POLY-3 PERCENT (g) 10% 0% 10% 0% 10% 0%
TERMINAL (d) 1/10 (10%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/10 (10%) 0/8 (0%)
FIRST INCIDENCE 93 (T) --- 93 (T) --- 93 (T) ---
STATISTICAL TESTS
POLY 3 P=0.451N P=0.500N P=0.760 P=0.500N P=0.760 P=0.516N
POLY 1.5 P=0.445N P=0.500N P=0.760 P=0.500N P=0.760 P=0.509N
POLY 6 P=0.460N P=0.500N P=0.760 P=0.500N P=0.760 P=0.526N
COCH-ARM / FISHERS P=0.436N P=0.500N P=0.763N P=0.500N P=0.763N P=0.500N
MAX-ISO-POLY-3 P=0.328N P=0.158N P=1.000 P=0.158N P=1.000 P=0.178N
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 20
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
LiverHepatodiaphragmatic Nodule
LESION RATES
OVERALL (a) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%)
POLY-3 RATE (b) 1/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/9.23
POLY-3 PERCENT (g) 10% 0% 0% 0% 0% 0%
TERMINAL (d) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%)
FIRST INCIDENCE 93 (T) --- --- --- --- ---
STATISTICAL TESTS
POLY 3 P=0.400N P=0.500N P=0.500N P=0.500N P=0.500N P=0.516N
POLY 1.5 P=0.407N P=0.500N P=0.500N P=0.500N P=0.500N P=0.509N
POLY 6 P=0.388N P=0.500N P=0.500N P=0.500N P=0.500N P=0.526N
COCH-ARM / FISHERS P=0.415N P=0.500N P=0.500N P=0.500N P=0.500N P=0.500N
MAX-ISO-POLY-3 P=0.099N P=0.158N P=0.158N P=0.158N P=0.158N P=0.178N
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 21
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
LiverInflammation
LESION RATES
OVERALL (a) 8/10 (80%) 10/10 (100%) 10/10 (100%) 7/10 (70%) 7/10 (70%) 9/10 (90%)
POLY-3 RATE (b) 8/10.00 10/10.00 10/10.00 7/10.00 7/10.00 9/10.00
POLY-3 PERCENT (g) 80% 100% 100% 70% 70% 90%
TERMINAL (d) 8/10 (80%) 10/10 (100%) 10/10 (100%) 7/10 (70%) 7/10 (70%) 7/8 (88%)
FIRST INCIDENCE 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) 79
STATISTICAL TESTS
POLY 3 P=0.460N P=0.227 P=0.227 P=0.500N P=0.500N P=0.500
POLY 1.5 P=0.460N P=0.227 P=0.227 P=0.500N P=0.500N P=0.500
POLY 6 P=0.460N P=0.227 P=0.227 P=0.500N P=0.500N P=0.500
COCH-ARM / FISHERS P=0.461N P=0.237 P=0.237 P=0.500N P=0.500N P=0.500
MAX-ISO-POLY-3 P=0.266N P=0.067 P=0.067 P=0.310N P=0.310N P=0.274
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 22
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
LiverNecrosis Focal
LESION RATES
OVERALL (a) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%)
POLY-3 RATE (b) 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 1/9.23
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 10.8%
TERMINAL (d) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/8 (13%)
FIRST INCIDENCE --- --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 P=0.100 (e) (e) (e) (e) P=0.484
POLY 1.5 P=0.103 (e) (e) (e) (e) P=0.491
POLY 6 P=0.096 (e) (e) (e) (e) P=0.473
COCH-ARM / FISHERS P=0.105 (e) (e) (e) (e) P=0.500
MAX-ISO-POLY-3 P=0.073 (e) (e) (e) (e) P=0.157
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 23
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
LungHemorrhage
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 1/9.23
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 10.8%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/8 (13%)
FIRST INCIDENCE --- --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.484
POLY 1.5 (e) (e) (e) (e) (e) P=0.491
POLY 6 (e) (e) (e) (e) (e) P=0.473
COCH-ARM / FISHERS P=0.304 (e) (e) (e) (e) P=0.500
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.157
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 24
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
LungInfiltration Cellular Histiocyte
LESION RATES
OVERALL (a) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%)
POLY-3 RATE (b) 1/10.00 0/0.00 0/0.00 0/0.00 0/0.00 2/9.61
POLY-3 PERCENT (g) 10% 0% 0% 0% 0% 20.8%
TERMINAL (d) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/8 (13%)
FIRST INCIDENCE 93 (T) --- --- --- --- 79
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.486
POLY 1.5 (e) (e) (e) (e) (e) P=0.492
POLY 6 (e) (e) (e) (e) (e) P=0.477
COCH-ARM / FISHERS P=0.377 (e) (e) (e) (e) P=0.500
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.265
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 25
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
LungInflammation
LESION RATES
OVERALL (a) 5/10 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/10 (40%)
POLY-3 RATE (b) 5/10.00 0/0.00 0/0.00 0/0.00 0/0.00 4/9.23
POLY-3 PERCENT (g) 50% 0% 0% 0% 0% 43.4%
TERMINAL (d) 5/10 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/8 (50%)
FIRST INCIDENCE 93 (T) --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.563N
POLY 1.5 (e) (e) (e) (e) (e) P=0.535N
POLY 6 (e) (e) (e) (e) (e) P=0.605N
COCH-ARM / FISHERS P=0.411N (e) (e) (e) (e) P=0.500N
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.394N
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 26
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
LungMetaplasia Osseous
LESION RATES
OVERALL (a) 5/10 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/10 (40%)
POLY-3 RATE (b) 5/10.00 0/0.00 0/0.00 0/0.00 0/0.00 4/9.23
POLY-3 PERCENT (g) 50% 0% 0% 0% 0% 43.4%
TERMINAL (d) 5/10 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/8 (50%)
FIRST INCIDENCE 93 (T) --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.563N
POLY 1.5 (e) (e) (e) (e) (e) P=0.535N
POLY 6 (e) (e) (e) (e) (e) P=0.605N
COCH-ARM / FISHERS P=0.411N (e) (e) (e) (e) P=0.500N
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.394N
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 27
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
LungPigmentation Hemosiderin
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 1/9.23
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 10.8%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/8 (13%)
FIRST INCIDENCE --- --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.484
POLY 1.5 (e) (e) (e) (e) (e) P=0.491
POLY 6 (e) (e) (e) (e) (e) P=0.473
COCH-ARM / FISHERS P=0.304 (e) (e) (e) (e) P=0.500
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.157
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 28
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Lung: SerosaInflammation Granulomatous
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 1/9.23
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 10.8%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/8 (13%)
FIRST INCIDENCE --- --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.484
POLY 1.5 (e) (e) (e) (e) (e) P=0.491
POLY 6 (e) (e) (e) (e) (e) P=0.473
COCH-ARM / FISHERS P=0.304 (e) (e) (e) (e) P=0.500
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.157
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 29
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
MesenteryMineralization
LESION RATES
OVERALL (a) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%)
POLY-3 RATE (b) 0/0.00 0/0.00 0/0.00 0/0.00 0/0.00 0/0.00
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 30
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
MesenteryNecrosis
LESION RATES
OVERALL (a) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%)
POLY-3 RATE (b) 0/0.00 0/0.00 0/0.00 0/0.00 0/0.00 0/0.00
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 31
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Mesentery: FatInflammation Chronic Granulomatous
LESION RATES
OVERALL (a) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%)
POLY-3 RATE (b) 0/0.00 0/0.00 0/0.00 0/0.00 0/0.00 0/0.00
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 32
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
NoseInflammation Chronic
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 2/9.61
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 20.8%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/8 (13%)
FIRST INCIDENCE --- --- --- --- --- 79
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.217
POLY 1.5 (e) (e) (e) (e) (e) P=0.221
POLY 6 (e) (e) (e) (e) (e) P=0.211
COCH-ARM / FISHERS P=0.132 (e) (e) (e) (e) P=0.237
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.066
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 33
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
NoseVacuolization Cytoplasmic
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/9.23
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/8 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 34
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
PancreasAtrophy
LESION RATES
OVERALL (a) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%)
POLY-3 RATE (b) 1/10.00 0/0.00 0/0.00 0/0.00 0/0.00 1/9.23
POLY-3 PERCENT (g) 10% 0% 0% 0% 0% 10.8%
TERMINAL (d) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/8 (13%)
FIRST INCIDENCE 93 (T) --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.743
POLY 1.5 (e) (e) (e) (e) (e) P=0.751
POLY 6 (e) (e) (e) (e) (e) P=0.731
COCH-ARM / FISHERS P=0.645 (e) (e) (e) (e) P=0.763N
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.477
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 35
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
PancreasInfiltration Cellular Mononuclear Cell
LESION RATES
OVERALL (a) 5/10 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%)
POLY-3 RATE (b) 5/10.00 0/0.00 0/0.00 0/0.00 0/0.00 3/9.61
POLY-3 PERCENT (g) 50% 0% 0% 0% 0% 31.2%
TERMINAL (d) 5/10 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/8 (25%)
FIRST INCIDENCE 93 (T) --- --- --- --- 79
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.354N
POLY 1.5 (e) (e) (e) (e) (e) P=0.343N
POLY 6 (e) (e) (e) (e) (e) P=0.370N
COCH-ARM / FISHERS P=0.247N (e) (e) (e) (e) P=0.325N
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.209N
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 36
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Pituitary GlandCyst
LESION RATES
OVERALL (a) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 1/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/9.23
POLY-3 PERCENT (g) 10% 0% 0% 0% 0% 0%
TERMINAL (d) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/8 (0%)
FIRST INCIDENCE 93 (T) --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.516N
POLY 1.5 (e) (e) (e) (e) (e) P=0.509N
POLY 6 (e) (e) (e) (e) (e) P=0.526N
COCH-ARM / FISHERS P=0.304N (e) (e) (e) (e) P=0.500N
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.178N
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 37
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Preputial GlandInflammation Chronic Focal
LESION RATES
OVERALL (a) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%)
POLY-3 RATE (b) 1/10.00 0/0.00 0/0.00 0/0.00 0/0.00 3/9.23
POLY-3 PERCENT (g) 10% 0% 0% 0% 0% 32.5%
TERMINAL (d) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/8 (38%)
FIRST INCIDENCE 93 (T) --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.260
POLY 1.5 (e) (e) (e) (e) (e) P=0.274
POLY 6 (e) (e) (e) (e) (e) P=0.240
COCH-ARM / FISHERS P=0.201 (e) (e) (e) (e) P=0.291
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.124
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 38
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Salivary Glands: Sublingual GlandEctopic Tissue
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/9.23
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/8 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 39
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Salivary Glands: Submandibular GlandEctopic Tissue
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/9.23
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/8 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 40
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Salivary Glands: Submandibular GlandVacuolization Cytoplasmic
LESION RATES
OVERALL (a) 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/10 (40%)
POLY-3 RATE (b) 2/10.00 0/0.00 0/0.00 0/0.00 0/0.00 4/9.23
POLY-3 PERCENT (g) 20% 0% 0% 0% 0% 43.4%
TERMINAL (d) 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/8 (50%)
FIRST INCIDENCE 93 (T) --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.274
POLY 1.5 (e) (e) (e) (e) (e) P=0.293
POLY 6 (e) (e) (e) (e) (e) P=0.247
COCH-ARM / FISHERS P=0.232 (e) (e) (e) (e) P=0.314
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.147
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 41
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Skin: Hair Follicle, Site of ApplicationHyperplasia
LESION RATES
OVERALL (a) 0/10 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) 10/10 (100%) 9/10 (90%)
POLY-3 RATE (b) 0/10.00 0/10.00 0/10.00 9/10.00 10/10.00 9/10.00
POLY-3 PERCENT (g) 0% 0% 0% 90% 100% 90%
TERMINAL (d) 0/10 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) 10/10 (100%) 7/8 (88%)
FIRST INCIDENCE --- --- --- 93 (T) 93 (T) 79
STATISTICAL TESTS
POLY 3 P<0.001** (e) (e) P<0.001** P<0.001** P<0.001**
POLY 1.5 P<0.001** (e) (e) P<0.001** P<0.001** P<0.001**
POLY 6 P<0.001** (e) (e) P<0.001** P<0.001** P<0.001**
COCH-ARM / FISHERS P<0.001** (e) (e) P<0.001** P<0.001** P<0.001**
MAX-ISO-POLY-3 P<0.001** (e) (e) P<0.001** (e) P<0.001**
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 42
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Skin: Sebaceous Gland, Site of ApplicationHyperplasia
LESION RATES
OVERALL (a) 0/10 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) 10/10 (100%) 10/10 (100%)
POLY-3 RATE (b) 0/10.00 0/10.00 0/10.00 9/10.00 10/10.00 10/10.00
POLY-3 PERCENT (g) 0% 0% 0% 90% 100% 100%
TERMINAL (d) 0/10 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) 10/10 (100%) 8/8 (100%)
FIRST INCIDENCE --- --- --- 93 (T) 93 (T) 79
STATISTICAL TESTS
POLY 3 P<0.001** (e) (e) P<0.001** P<0.001** P<0.001**
POLY 1.5 P<0.001** (e) (e) P<0.001** P<0.001** P<0.001**
POLY 6 P<0.001** (e) (e) P<0.001** P<0.001** P<0.001**
COCH-ARM / FISHERS P<0.001** (e) (e) P<0.001** P<0.001** P<0.001**
MAX-ISO-POLY-3 P<0.001** (e) (e) P<0.001** (e) (e)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 43
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Skin: Site of Application - DermisFibrosis
LESION RATES
OVERALL (a) 0/10 (0%) 0/10 (0%) 0/10 (0%) 7/10 (70%) 10/10 (100%) 10/10 (100%)
POLY-3 RATE (b) 0/10.00 0/10.00 0/10.00 7/10.00 10/10.00 10/10.00
POLY-3 PERCENT (g) 0% 0% 0% 70% 100% 100%
TERMINAL (d) 0/10 (0%) 0/10 (0%) 0/10 (0%) 7/10 (70%) 10/10 (100%) 8/8 (100%)
FIRST INCIDENCE --- --- --- 93 (T) 93 (T) 79
STATISTICAL TESTS
POLY 3 P<0.001** (e) (e) P<0.001** P<0.001** P<0.001**
POLY 1.5 P<0.001** (e) (e) P<0.001** P<0.001** P<0.001**
POLY 6 P<0.001** (e) (e) P<0.001** P<0.001** P<0.001**
COCH-ARM / FISHERS P<0.001** (e) (e) P=0.002** P<0.001** P<0.001**
MAX-ISO-POLY-3 P<0.001** (e) (e) P<0.001** (e) (e)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 44
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Skin: Site of Application - EpidermisHyperkeratosis
LESION RATES
OVERALL (a) 0/10 (0%) 0/10 (0%) 1/10 (10%) 7/10 (70%) 10/10 (100%) 10/10 (100%)
POLY-3 RATE (b) 0/10.00 0/10.00 1/10.00 7/10.00 10/10.00 10/10.00
POLY-3 PERCENT (g) 0% 0% 10% 70% 100% 100%
TERMINAL (d) 0/10 (0%) 0/10 (0%) 1/10 (10%) 7/10 (70%) 10/10 (100%) 8/8 (100%)
FIRST INCIDENCE --- --- 93 (T) 93 (T) 93 (T) 79
STATISTICAL TESTS
POLY 3 P<0.001** (e) P=0.500 P<0.001** P<0.001** P<0.001**
POLY 1.5 P<0.001** (e) P=0.500 P<0.001** P<0.001** P<0.001**
POLY 6 P<0.001** (e) P=0.500 P<0.001** P<0.001** P<0.001**
COCH-ARM / FISHERS P<0.001** (e) P=0.500 P=0.002** P<0.001** P<0.001**
MAX-ISO-POLY-3 P<0.001** (e) P=0.158 P<0.001** (e) (e)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 45
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Skin: Site of Application - EpidermisHyperplasia
LESION RATES
OVERALL (a) 0/10 (0%) 2/10 (20%) 4/10 (40%) 10/10 (100%) 10/10 (100%) 9/10 (90%)
POLY-3 RATE (b) 0/10.00 2/10.00 4/10.00 10/10.00 10/10.00 9/10.00
POLY-3 PERCENT (g) 0% 20% 40% 100% 100% 90%
TERMINAL (d) 0/10 (0%) 2/10 (20%) 4/10 (40%) 10/10 (100%) 10/10 (100%) 7/8 (88%)
FIRST INCIDENCE --- 93 (T) 93 (T) 93 (T) 93 (T) 79
STATISTICAL TESTS
POLY 3 P<0.001** P=0.227 P=0.033* P<0.001** P<0.001** P<0.001**
POLY 1.5 P<0.001** P=0.227 P=0.033* P<0.001** P<0.001** P<0.001**
POLY 6 P<0.001** P=0.227 P=0.033* P<0.001** P<0.001** P<0.001**
COCH-ARM / FISHERS P<0.001** P=0.237 P=0.043* P<0.001** P<0.001** P<0.001**
MAX-ISO-POLY-3 P<0.001** P=0.067 P=0.007** (e) (e) P<0.001**
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 46
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Skin: Site of Application - EpidermisUlcer
LESION RATES
OVERALL (a) 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) 7/10 (70%) 8/10 (80%)
POLY-3 RATE (b) 0/10.00 0/10.00 1/10.00 1/10.00 7/10.00 8/10.00
POLY-3 PERCENT (g) 0% 0% 10% 10% 70% 80%
TERMINAL (d) 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) 7/10 (70%) 6/8 (75%)
FIRST INCIDENCE --- --- 93 (T) 93 (T) 93 (T) 79
STATISTICAL TESTS
POLY 3 P<0.001** (e) P=0.500 P=0.500 P<0.001** P<0.001**
POLY 1.5 P<0.001** (e) P=0.500 P=0.500 P<0.001** P<0.001**
POLY 6 P<0.001** (e) P=0.500 P=0.500 P<0.001** P<0.001**
COCH-ARM / FISHERS P<0.001** (e) P=0.500 P=0.500 P=0.002** P<0.001**
MAX-ISO-POLY-3 P<0.001** (e) P=0.158 P=0.158 P<0.001** P<0.001**
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 47
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Skin: Site of ApplicationInflammation Chronic
LESION RATES
OVERALL (a) 0/10 (0%) 1/10 (10%) 4/10 (40%) 9/10 (90%) 10/10 (100%) 10/10 (100%)
POLY-3 RATE (b) 0/10.00 1/10.00 4/10.00 9/10.00 10/10.00 10/10.00
POLY-3 PERCENT (g) 0% 10% 40% 90% 100% 100%
TERMINAL (d) 0/10 (0%) 1/10 (10%) 4/10 (40%) 9/10 (90%) 10/10 (100%) 8/8 (100%)
FIRST INCIDENCE --- 93 (T) 93 (T) 93 (T) 93 (T) 79
STATISTICAL TESTS
POLY 3 P<0.001** P=0.500 P=0.033* P<0.001** P<0.001** P<0.001**
POLY 1.5 P<0.001** P=0.500 P=0.033* P<0.001** P<0.001** P<0.001**
POLY 6 P<0.001** P=0.500 P=0.033* P<0.001** P<0.001** P<0.001**
COCH-ARM / FISHERS P<0.001** P=0.500 P=0.043* P<0.001** P<0.001** P<0.001**
MAX-ISO-POLY-3 P<0.001** P=0.158 P=0.007** P<0.001** (e) (e)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 48
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
SpleenHematopoietic Cell Proliferation
LESION RATES
OVERALL (a) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 1/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/9.23
POLY-3 PERCENT (g) 10% 0% 0% 0% 0% 0%
TERMINAL (d) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/8 (0%)
FIRST INCIDENCE 93 (T) --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.516N
POLY 1.5 (e) (e) (e) (e) (e) P=0.509N
POLY 6 (e) (e) (e) (e) (e) P=0.526N
COCH-ARM / FISHERS P=0.304N (e) (e) (e) (e) P=0.500N
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.178N
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 49
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Stomach, Glandular: GlandsEctasia
LESION RATES
OVERALL (a) 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 2/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/9.23
POLY-3 PERCENT (g) 20% 0% 0% 0% 0% 0%
TERMINAL (d) 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/8 (0%)
FIRST INCIDENCE 93 (T) --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.246N
POLY 1.5 (e) (e) (e) (e) (e) P=0.237N
POLY 6 (e) (e) (e) (e) (e) P=0.259N
COCH-ARM / FISHERS P=0.132N (e) (e) (e) (e) P=0.237N
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.083N
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 50
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Testes: Right, Germinal EpitheliumAtrophy
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 0/10.00 0/0.00 1/1.00 0/0.00 0/0.00 0/9.23
POLY-3 PERCENT (g) 0% 0% 100% 0% 0% 0%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/8 (0%)
FIRST INCIDENCE --- --- 93 (T) --- --- ---
STATISTICAL TESTS
POLY 3 (e) (e) P=0.091 (e) (e) (e)
POLY 1.5 (e) (e) P=0.091 (e) (e) (e)
POLY 6 (e) (e) P=0.091 (e) (e) (e)
COCH-ARM / FISHERS P=0.412N (e) P=0.091 (e) (e) (e)
MAX-ISO-POLY-3 (e) (e) P<0.001** (e) (e) (e)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 51
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Thyroid GlandInfiltration Cellular Mononuclear Cell
LESION RATES
OVERALL (a) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%)
POLY-3 RATE (b) 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/9.23
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 52
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Thyroid GlandUltimobranchial Cyst
LESION RATES
OVERALL (a) 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%)
POLY-3 RATE (b) 0/10.00 2/10.00 0/10.00 0/10.00 0/10.00 0/9.23
POLY-3 PERCENT (g) 0% 20% 0% 0% 0% 0%
TERMINAL (d) 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%)
FIRST INCIDENCE --- 93 (T) --- --- --- ---
STATISTICAL TESTS
POLY 3 P=0.272N P=0.227 (e) (e) (e) (e)
POLY 1.5 P=0.275N P=0.227 (e) (e) (e) (e)
POLY 6 P=0.268N P=0.227 (e) (e) (e) (e)
COCH-ARM / FISHERS P=0.285N P=0.237 (e) (e) (e) (e)
MAX-ISO-POLY-3 P=0.210N P=0.067 (e) (e) (e) (e)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 53
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Urinary BladderInfiltration Cellular Mononuclear Cell
LESION RATES
OVERALL (a) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%)
POLY-3 RATE (b) 1/10.00 0/0.00 0/0.00 0/0.00 0/0.00 1/9.23
POLY-3 PERCENT (g) 10% 0% 0% 0% 0% 10.8%
TERMINAL (d) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/8 (13%)
FIRST INCIDENCE 93 (T) --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.743
POLY 1.5 (e) (e) (e) (e) (e) P=0.751
POLY 6 (e) (e) (e) (e) (e) P=0.731
COCH-ARM / FISHERS P=0.645 (e) (e) (e) (e) P=0.763N
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.477
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 54
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Urinary Bladder: SerosaMineralization Focal
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 1/9.23
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 10.8%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/8 (13%)
FIRST INCIDENCE --- --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.484
POLY 1.5 (e) (e) (e) (e) (e) P=0.491
POLY 6 (e) (e) (e) (e) (e) P=0.473
COCH-ARM / FISHERS P=0.304 (e) (e) (e) (e) P=0.500
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.157
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Males
Page 55
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Adrenal CortexAngiectasis
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 56
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Adrenal CortexInfiltration Cellular Mononuclear Cell
LESION RATES
OVERALL (a) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 1/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00
POLY-3 PERCENT (g) 10% 0% 0% 0% 0% 0%
TERMINAL (d) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
FIRST INCIDENCE 93 (T) --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.500N
POLY 1.5 (e) (e) (e) (e) (e) P=0.500N
POLY 6 (e) (e) (e) (e) (e) P=0.500N
COCH-ARM / FISHERS P=0.304N (e) (e) (e) (e) P=0.500N
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.158N
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 57
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Adrenal CortexMineralization
LESION RATES
OVERALL (a) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 1/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00
POLY-3 PERCENT (g) 10% 0% 0% 0% 0% 0%
TERMINAL (d) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
FIRST INCIDENCE 93 (T) --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.500N
POLY 1.5 (e) (e) (e) (e) (e) P=0.500N
POLY 6 (e) (e) (e) (e) (e) P=0.500N
COCH-ARM / FISHERS P=0.304N (e) (e) (e) (e) P=0.500N
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.158N
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 58
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Bone MarrowHyperplasia
LESION RATES
OVERALL (a) 0/10 (0%) 0/9 (0%) 0/10 (0%) 2/10 (20%) 2/10 (20%) 7/10 (70%)
POLY-3 RATE (b) 0/10.00 0/9.00 0/10.00 2/10.00 2/10.00 7/10.00
POLY-3 PERCENT (g) 0% 0% 0% 20% 20% 70%
TERMINAL (d) 0/10 (0%) 0/9 (0%) 0/10 (0%) 2/10 (20%) 2/10 (20%) 7/10 (70%)
FIRST INCIDENCE --- --- --- 93 (T) 93 (T) 93 (T)
STATISTICAL TESTS
POLY 3 P<0.001** (e) (e) P=0.227 P=0.227 P<0.001**
POLY 1.5 P<0.001** (e) (e) P=0.227 P=0.227 P<0.001**
POLY 6 P<0.001** (e) (e) P=0.227 P=0.227 P<0.001**
COCH-ARM / FISHERS P<0.001** (e) (e) P=0.237 P=0.237 P=0.002**
MAX-ISO-POLY-3 P<0.001** (e) (e) P=0.066 P=0.066 P<0.001**
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 59
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Harderian GlandInfiltration Cellular
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 1/10.00
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 10%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%)
FIRST INCIDENCE --- --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.500
POLY 1.5 (e) (e) (e) (e) (e) P=0.500
POLY 6 (e) (e) (e) (e) (e) P=0.500
COCH-ARM / FISHERS P=0.304 (e) (e) (e) (e) P=0.500
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.158
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 60
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
HeartCardiomyopathy
LESION RATES
OVERALL (a) 9/10 (90%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%)
POLY-3 RATE (b) 9/10.00 0/0.00 0/0.00 0/0.00 0/0.00 10/10.00
POLY-3 PERCENT (g) 90% 0% 0% 0% 0% 100%
TERMINAL (d) 9/10 (90%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%)
FIRST INCIDENCE 93 (T) --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.500
POLY 1.5 (e) (e) (e) (e) (e) P=0.500
POLY 6 (e) (e) (e) (e) (e) P=0.500
COCH-ARM / FISHERS P=0.304 (e) (e) (e) (e) P=0.500
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.158
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 61
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Heart: EpicardiumHyperplasia
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 62
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Intestine Large, RectumParasite Metazoan
LESION RATES
OVERALL (a) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 1/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00
POLY-3 PERCENT (g) 10% 0% 0% 0% 0% 0%
TERMINAL (d) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
FIRST INCIDENCE 93 (T) --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.500N
POLY 1.5 (e) (e) (e) (e) (e) P=0.500N
POLY 6 (e) (e) (e) (e) (e) P=0.500N
COCH-ARM / FISHERS P=0.304N (e) (e) (e) (e) P=0.500N
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.158N
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 63
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Islets, PancreaticInfiltration Cellular Mononuclear Cell
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 64
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
KidneyAccumulation, Hyaline Droplet
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 65
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
KidneyInfiltration Cellular Mononuclear Cell
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 66
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
KidneyMineralization
LESION RATES
OVERALL (a) 5/10 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 6/10 (60%)
POLY-3 RATE (b) 5/10.00 0/0.00 0/0.00 0/0.00 0/0.00 6/10.00
POLY-3 PERCENT (g) 50% 0% 0% 0% 0% 60%
TERMINAL (d) 5/10 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 6/10 (60%)
FIRST INCIDENCE 93 (T) --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.500
POLY 1.5 (e) (e) (e) (e) (e) P=0.500
POLY 6 (e) (e) (e) (e) (e) P=0.500
COCH-ARM / FISHERS P=0.411 (e) (e) (e) (e) P=0.500
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.332
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 67
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
KidneyNephropathy
LESION RATES
OVERALL (a) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%)
POLY-3 RATE (b) 1/10.00 0/0.00 0/0.00 0/0.00 0/0.00 1/10.00
POLY-3 PERCENT (g) 10% 0% 0% 0% 0% 10%
TERMINAL (d) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%)
FIRST INCIDENCE 93 (T) --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.760
POLY 1.5 (e) (e) (e) (e) (e) P=0.760
POLY 6 (e) (e) (e) (e) (e) P=0.760
COCH-ARM / FISHERS P=0.645 (e) (e) (e) (e) P=0.763N
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=1.000
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 68
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Kidney: Renal TubuleCasts Granular
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 69
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Kidney: Renal TubuleDegeneration
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 70
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
LiverHematopoietic Cell Proliferation
LESION RATES
OVERALL (a) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%)
POLY-3 RATE (b) 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 71
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
LiverHepatodiaphragmatic Nodule
LESION RATES
OVERALL (a) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%)
POLY-3 RATE (b) 1/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00
POLY-3 PERCENT (g) 10% 0% 0% 0% 0% 0%
TERMINAL (d) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%)
FIRST INCIDENCE 93 (T) --- --- --- --- ---
STATISTICAL TESTS
POLY 3 P=0.416N P=0.500N P=0.500N P=0.500N P=0.500N P=0.500N
POLY 1.5 P=0.416N P=0.500N P=0.500N P=0.500N P=0.500N P=0.500N
POLY 6 P=0.416N P=0.500N P=0.500N P=0.500N P=0.500N P=0.500N
COCH-ARM / FISHERS P=0.415N P=0.500N P=0.500N P=0.500N P=0.500N P=0.500N
MAX-ISO-POLY-3 P=0.041N* P=0.158N P=0.158N P=0.158N P=0.158N P=0.158N
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 72
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
LiverInflammation
LESION RATES
OVERALL (a) 9/10 (90%) 10/10 (100%) 9/10 (90%) 8/10 (80%) 5/10 (50%) 7/10 (70%)
POLY-3 RATE (b) 9/10.00 10/10.00 9/10.00 8/10.00 5/10.00 7/10.00
POLY-3 PERCENT (g) 90% 100% 90% 80% 50% 70%
TERMINAL (d) 9/10 (90%) 10/10 (100%) 9/10 (90%) 8/10 (80%) 5/10 (50%) 7/10 (70%)
FIRST INCIDENCE 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) 93 (T)
STATISTICAL TESTS
POLY 3 P=0.025N* P=0.500 P=0.760 P=0.500N P=0.061N P=0.292N
POLY 1.5 P=0.025N* P=0.500 P=0.760 P=0.500N P=0.061N P=0.292N
POLY 6 P=0.025N* P=0.500 P=0.760 P=0.500N P=0.061N P=0.292N
COCH-ARM / FISHERS P=0.030N* P=0.500 P=0.763N P=0.500N P=0.070N P=0.291N
MAX-ISO-POLY-3 P=0.021N* P=0.158 P=1.000 P=0.274N P=0.020N* P=0.136N
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 73
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
LiverNecrosis Focal
LESION RATES
OVERALL (a) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%)
POLY-3 RATE (b) 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 74
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
LungHemorrhage
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 75
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
LungInfiltration Cellular Histiocyte
LESION RATES
OVERALL (a) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%)
POLY-3 RATE (b) 1/10.00 0/0.00 0/0.00 0/0.00 0/0.00 1/10.00
POLY-3 PERCENT (g) 10% 0% 0% 0% 0% 10%
TERMINAL (d) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%)
FIRST INCIDENCE 93 (T) --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.760
POLY 1.5 (e) (e) (e) (e) (e) P=0.760
POLY 6 (e) (e) (e) (e) (e) P=0.760
COCH-ARM / FISHERS P=0.645 (e) (e) (e) (e) P=0.763N
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=1.000
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 76
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
LungInflammation
LESION RATES
OVERALL (a) 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%)
POLY-3 RATE (b) 2/10.00 0/0.00 0/0.00 0/0.00 0/0.00 2/10.00
POLY-3 PERCENT (g) 20% 0% 0% 0% 0% 20%
TERMINAL (d) 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%)
FIRST INCIDENCE 93 (T) --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.702
POLY 1.5 (e) (e) (e) (e) (e) P=0.702
POLY 6 (e) (e) (e) (e) (e) P=0.702
COCH-ARM / FISHERS P=0.610 (e) (e) (e) (e) P=0.709N
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=1.000
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 77
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
LungMetaplasia Osseous
LESION RATES
OVERALL (a) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 1/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00
POLY-3 PERCENT (g) 10% 0% 0% 0% 0% 0%
TERMINAL (d) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
FIRST INCIDENCE 93 (T) --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.500N
POLY 1.5 (e) (e) (e) (e) (e) P=0.500N
POLY 6 (e) (e) (e) (e) (e) P=0.500N
COCH-ARM / FISHERS P=0.304N (e) (e) (e) (e) P=0.500N
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.158N
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 78
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
LungPigmentation Hemosiderin
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 79
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Lung: SerosaInflammation Granulomatous
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 80
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
MesenteryMineralization
LESION RATES
OVERALL (a) 0/0 (0%) 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%)
POLY-3 RATE (b) 0/0.00 1/1.00 0/0.00 0/0.00 0/0.00 0/0.00
POLY-3 PERCENT (g) 0% 100% 0% 0% 0% 0%
TERMINAL (d) 0/0 (0%) 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%)
FIRST INCIDENCE --- 93 (T) --- --- --- ---
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) (e)
POLY 1.5 (e) (e) (e) (e) (e) (e)
POLY 6 (e) (e) (e) (e) (e) (e)
COCH-ARM / FISHERS (e) (e) (e) (e) (e) (e)
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) (e)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 81
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
MesenteryNecrosis
LESION RATES
OVERALL (a) 0/0 (0%) 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%)
POLY-3 RATE (b) 0/0.00 1/1.00 0/0.00 0/0.00 0/0.00 0/0.00
POLY-3 PERCENT (g) 0% 100% 0% 0% 0% 0%
TERMINAL (d) 0/0 (0%) 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%)
FIRST INCIDENCE --- 93 (T) --- --- --- ---
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) (e)
POLY 1.5 (e) (e) (e) (e) (e) (e)
POLY 6 (e) (e) (e) (e) (e) (e)
COCH-ARM / FISHERS (e) (e) (e) (e) (e) (e)
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) (e)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 82
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Mesentery: FatInflammation Chronic Granulomatous
LESION RATES
OVERALL (a) 0/0 (0%) 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%)
POLY-3 RATE (b) 0/0.00 1/1.00 0/0.00 0/0.00 0/0.00 0/0.00
POLY-3 PERCENT (g) 0% 100% 0% 0% 0% 0%
TERMINAL (d) 0/0 (0%) 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%)
FIRST INCIDENCE --- 93 (T) --- --- --- ---
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) (e)
POLY 1.5 (e) (e) (e) (e) (e) (e)
POLY 6 (e) (e) (e) (e) (e) (e)
COCH-ARM / FISHERS (e) (e) (e) (e) (e) (e)
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) (e)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 83
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
NoseInflammation Chronic
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 1/10.00
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 10%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%)
FIRST INCIDENCE --- --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.500
POLY 1.5 (e) (e) (e) (e) (e) P=0.500
POLY 6 (e) (e) (e) (e) (e) P=0.500
COCH-ARM / FISHERS P=0.304 (e) (e) (e) (e) P=0.500
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.158
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 84
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
NoseVacuolization Cytoplasmic
LESION RATES
OVERALL (a) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 1/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00
POLY-3 PERCENT (g) 10% 0% 0% 0% 0% 0%
TERMINAL (d) 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
FIRST INCIDENCE 93 (T) --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.500N
POLY 1.5 (e) (e) (e) (e) (e) P=0.500N
POLY 6 (e) (e) (e) (e) (e) P=0.500N
COCH-ARM / FISHERS P=0.304N (e) (e) (e) (e) P=0.500N
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.158N
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 85
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
PancreasAtrophy
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 1/10.00
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 10%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%)
FIRST INCIDENCE --- --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.500
POLY 1.5 (e) (e) (e) (e) (e) P=0.500
POLY 6 (e) (e) (e) (e) (e) P=0.500
COCH-ARM / FISHERS P=0.304 (e) (e) (e) (e) P=0.500
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.158
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 86
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
PancreasInfiltration Cellular Mononuclear Cell
LESION RATES
OVERALL (a) 4/10 (40%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%)
POLY-3 RATE (b) 4/10.00 0/0.00 0/0.00 0/0.00 0/0.00 3/10.00
POLY-3 PERCENT (g) 40% 0% 0% 0% 0% 30%
TERMINAL (d) 4/10 (40%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%)
FIRST INCIDENCE 93 (T) --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.500N
POLY 1.5 (e) (e) (e) (e) (e) P=0.500N
POLY 6 (e) (e) (e) (e) (e) P=0.500N
COCH-ARM / FISHERS P=0.407N (e) (e) (e) (e) P=0.500N
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.325N
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 87
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Pituitary GlandCyst
LESION RATES
OVERALL (a) 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%)
POLY-3 RATE (b) 2/10.00 0/0.00 0/0.00 0/0.00 0/0.00 1/10.00
POLY-3 PERCENT (g) 20% 0% 0% 0% 0% 10%
TERMINAL (d) 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%)
FIRST INCIDENCE 93 (T) --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.500N
POLY 1.5 (e) (e) (e) (e) (e) P=0.500N
POLY 6 (e) (e) (e) (e) (e) P=0.500N
COCH-ARM / FISHERS P=0.377N (e) (e) (e) (e) P=0.500N
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.274N
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 88
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Salivary Glands: Sublingual GlandEctopic Tissue
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/10.00 0/10.00 1/10.00
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 10%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%)
FIRST INCIDENCE --- --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.500
POLY 1.5 (e) (e) (e) (e) (e) P=0.500
POLY 6 (e) (e) (e) (e) (e) P=0.500
COCH-ARM / FISHERS P=0.196 (e) (e) (e) (e) P=0.500
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.158
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 89
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Salivary Glands: Submandibular GlandEctopic Tissue
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/10.00 0/10.00 1/10.00
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 10%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%)
FIRST INCIDENCE --- --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.500
POLY 1.5 (e) (e) (e) (e) (e) P=0.500
POLY 6 (e) (e) (e) (e) (e) P=0.500
COCH-ARM / FISHERS P=0.196 (e) (e) (e) (e) P=0.500
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.158
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 90
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Salivary Glands: Submandibular GlandVacuolization Cytoplasmic
LESION RATES
OVERALL (a) 4/10 (40%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%)
POLY-3 RATE (b) 4/10.00 0/0.00 0/0.00 0/10.00 0/10.00 1/10.00
POLY-3 PERCENT (g) 40% 0% 0% 0% 0% 10%
TERMINAL (d) 4/10 (40%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%)
FIRST INCIDENCE 93 (T) --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 (e) (e) (e) P=0.033N* P=0.033N* P=0.148N
POLY 1.5 (e) (e) (e) P=0.033N* P=0.033N* P=0.148N
POLY 6 (e) (e) (e) P=0.033N* P=0.033N* P=0.148N
COCH-ARM / FISHERS P=0.113N (e) (e) P=0.043N* P=0.043N* P=0.152N
MAX-ISO-POLY-3 (e) (e) (e) P=0.007N** P=0.007N** P=0.058N
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 91
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Skin: Hair Follicle, Site of ApplicationHyperplasia
LESION RATES
OVERALL (a) 0/10 (0%) 0/10 (0%) 1/10 (10%) 9/10 (90%) 10/10 (100%) 10/10 (100%)
POLY-3 RATE (b) 0/10.00 0/10.00 1/10.00 9/10.00 10/10.00 10/10.00
POLY-3 PERCENT (g) 0% 0% 10% 90% 100% 100%
TERMINAL (d) 0/10 (0%) 0/10 (0%) 1/10 (10%) 9/10 (90%) 10/10 (100%) 10/10 (100%)
FIRST INCIDENCE --- --- 93 (T) 93 (T) 93 (T) 93 (T)
STATISTICAL TESTS
POLY 3 P<0.001** (e) P=0.500 P<0.001** P<0.001** P<0.001**
POLY 1.5 P<0.001** (e) P=0.500 P<0.001** P<0.001** P<0.001**
POLY 6 P<0.001** (e) P=0.500 P<0.001** P<0.001** P<0.001**
COCH-ARM / FISHERS P<0.001** (e) P=0.500 P<0.001** P<0.001** P<0.001**
MAX-ISO-POLY-3 P<0.001** (e) P=0.158 P<0.001** (e) (e)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 92
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Skin: Sebaceous Gland, Site of ApplicationHyperplasia
LESION RATES
OVERALL (a) 0/10 (0%) 0/10 (0%) 4/10 (40%) 9/10 (90%) 10/10 (100%) 10/10 (100%)
POLY-3 RATE (b) 0/10.00 0/10.00 4/10.00 9/10.00 10/10.00 10/10.00
POLY-3 PERCENT (g) 0% 0% 40% 90% 100% 100%
TERMINAL (d) 0/10 (0%) 0/10 (0%) 4/10 (40%) 9/10 (90%) 10/10 (100%) 10/10 (100%)
FIRST INCIDENCE --- --- 93 (T) 93 (T) 93 (T) 93 (T)
STATISTICAL TESTS
POLY 3 P<0.001** (e) P=0.033* P<0.001** P<0.001** P<0.001**
POLY 1.5 P<0.001** (e) P=0.033* P<0.001** P<0.001** P<0.001**
POLY 6 P<0.001** (e) P=0.033* P<0.001** P<0.001** P<0.001**
COCH-ARM / FISHERS P<0.001** (e) P=0.043* P<0.001** P<0.001** P<0.001**
MAX-ISO-POLY-3 P<0.001** (e) P=0.007** P<0.001** (e) (e)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 93
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Skin: Site of Application - DermisFibrosis
LESION RATES
OVERALL (a) 0/10 (0%) 0/10 (0%) 1/10 (10%) 7/10 (70%) 8/10 (80%) 10/10 (100%)
POLY-3 RATE (b) 0/10.00 0/10.00 1/10.00 7/10.00 8/10.00 10/10.00
POLY-3 PERCENT (g) 0% 0% 10% 70% 80% 100%
TERMINAL (d) 0/10 (0%) 0/10 (0%) 1/10 (10%) 7/10 (70%) 8/10 (80%) 10/10 (100%)
FIRST INCIDENCE --- --- 93 (T) 93 (T) 93 (T) 93 (T)
STATISTICAL TESTS
POLY 3 P<0.001** (e) P=0.500 P<0.001** P<0.001** P<0.001**
POLY 1.5 P<0.001** (e) P=0.500 P<0.001** P<0.001** P<0.001**
POLY 6 P<0.001** (e) P=0.500 P<0.001** P<0.001** P<0.001**
COCH-ARM / FISHERS P<0.001** (e) P=0.500 P=0.002** P<0.001** P<0.001**
MAX-ISO-POLY-3 P<0.001** (e) P=0.158 P<0.001** P<0.001** (e)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 94
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Skin: Site of Application - EpidermisHyperkeratosis
LESION RATES
OVERALL (a) 0/10 (0%) 1/10 (10%) 5/10 (50%) 10/10 (100%) 10/10 (100%) 10/10 (100%)
POLY-3 RATE (b) 0/10.00 1/10.00 5/10.00 10/10.00 10/10.00 10/10.00
POLY-3 PERCENT (g) 0% 10% 50% 100% 100% 100%
TERMINAL (d) 0/10 (0%) 1/10 (10%) 5/10 (50%) 10/10 (100%) 10/10 (100%) 10/10 (100%)
FIRST INCIDENCE --- 93 (T) 93 (T) 93 (T) 93 (T) 93 (T)
STATISTICAL TESTS
POLY 3 P<0.001** P=0.500 P=0.008** P<0.001** P<0.001** P<0.001**
POLY 1.5 P<0.001** P=0.500 P=0.008** P<0.001** P<0.001** P<0.001**
POLY 6 P<0.001** P=0.500 P=0.008** P<0.001** P<0.001** P<0.001**
COCH-ARM / FISHERS P<0.001** P=0.500 P=0.016* P<0.001** P<0.001** P<0.001**
MAX-ISO-POLY-3 P<0.001** P=0.158 P<0.001** (e) (e) (e)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 95
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Skin: Site of Application - EpidermisHyperplasia
LESION RATES
OVERALL (a) 0/10 (0%) 4/10 (40%) 7/10 (70%) 10/10 (100%) 10/10 (100%) 10/10 (100%)
POLY-3 RATE (b) 0/10.00 4/10.00 7/10.00 10/10.00 10/10.00 10/10.00
POLY-3 PERCENT (g) 0% 40% 70% 100% 100% 100%
TERMINAL (d) 0/10 (0%) 4/10 (40%) 7/10 (70%) 10/10 (100%) 10/10 (100%) 10/10 (100%)
FIRST INCIDENCE --- 93 (T) 93 (T) 93 (T) 93 (T) 93 (T)
STATISTICAL TESTS
POLY 3 P<0.001** P=0.033* P<0.001** P<0.001** P<0.001** P<0.001**
POLY 1.5 P<0.001** P=0.033* P<0.001** P<0.001** P<0.001** P<0.001**
POLY 6 P<0.001** P=0.033* P<0.001** P<0.001** P<0.001** P<0.001**
COCH-ARM / FISHERS P<0.001** P=0.043* P=0.002** P<0.001** P<0.001** P<0.001**
MAX-ISO-POLY-3 P<0.001** P=0.007** P<0.001** (e) (e) (e)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 96
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Skin: Site of Application - EpidermisUlcer
LESION RATES
OVERALL (a) 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) 4/10 (40%) 10/10 (100%)
POLY-3 RATE (b) 0/10.00 0/10.00 1/10.00 1/10.00 4/10.00 10/10.00
POLY-3 PERCENT (g) 0% 0% 10% 10% 40% 100%
TERMINAL (d) 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) 4/10 (40%) 10/10 (100%)
FIRST INCIDENCE --- --- 93 (T) 93 (T) 93 (T) 93 (T)
STATISTICAL TESTS
POLY 3 P<0.001** (e) P=0.500 P=0.500 P=0.033* P<0.001**
POLY 1.5 P<0.001** (e) P=0.500 P=0.500 P=0.033* P<0.001**
POLY 6 P<0.001** (e) P=0.500 P=0.500 P=0.033* P<0.001**
COCH-ARM / FISHERS P<0.001** (e) P=0.500 P=0.500 P=0.043* P<0.001**
MAX-ISO-POLY-3 P<0.001** (e) P=0.158 P=0.158 P=0.007** (e)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 97
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Skin: Site of ApplicationInflammation Chronic
LESION RATES
OVERALL (a) 0/10 (0%) 0/10 (0%) 7/10 (70%) 10/10 (100%) 10/10 (100%) 10/10 (100%)
POLY-3 RATE (b) 0/10.00 0/10.00 7/10.00 10/10.00 10/10.00 10/10.00
POLY-3 PERCENT (g) 0% 0% 70% 100% 100% 100%
TERMINAL (d) 0/10 (0%) 0/10 (0%) 7/10 (70%) 10/10 (100%) 10/10 (100%) 10/10 (100%)
FIRST INCIDENCE --- --- 93 (T) 93 (T) 93 (T) 93 (T)
STATISTICAL TESTS
POLY 3 P<0.001** (e) P<0.001** P<0.001** P<0.001** P<0.001**
POLY 1.5 P<0.001** (e) P<0.001** P<0.001** P<0.001** P<0.001**
POLY 6 P<0.001** (e) P<0.001** P<0.001** P<0.001** P<0.001**
COCH-ARM / FISHERS P<0.001** (e) P=0.002** P<0.001** P<0.001** P<0.001**
MAX-ISO-POLY-3 P<0.001** (e) P<0.001** (e) (e) (e)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 98
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
SpleenHematopoietic Cell Proliferation
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 99
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Stomach, Glandular: GlandsEctasia
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 100
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Thyroid GlandInfiltration Cellular Mononuclear Cell
LESION RATES
OVERALL (a) 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%)
POLY-3 RATE (b) 2/10.00 0/10.00 0/10.00 0/10.00 0/10.00 1/10.00
POLY-3 PERCENT (g) 20% 0% 0% 0% 0% 10%
TERMINAL (d) 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%)
FIRST INCIDENCE 93 (T) --- --- --- --- 93 (T)
STATISTICAL TESTS
POLY 3 P=0.649 P=0.227N P=0.227N P=0.227N P=0.227N P=0.500N
POLY 1.5 P=0.649 P=0.227N P=0.227N P=0.227N P=0.227N P=0.500N
POLY 6 P=0.649 P=0.227N P=0.227N P=0.227N P=0.227N P=0.500N
COCH-ARM / FISHERS P=0.647 P=0.237N P=0.237N P=0.237N P=0.237N P=0.500N
MAX-ISO-POLY-3 P=0.030N* P=0.066N P=0.066N P=0.066N P=0.066N P=0.274N
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 101
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Thyroid GlandUltimobranchial Cyst
LESION RATES
OVERALL (a) 3/10 (30%) 2/10 (20%) 0/10 (0%) 3/10 (30%) 3/10 (30%) 2/10 (20%)
POLY-3 RATE (b) 3/10.00 2/10.00 0/10.00 3/10.00 3/10.00 2/10.00
POLY-3 PERCENT (g) 30% 20% 0% 30% 30% 20%
TERMINAL (d) 3/10 (30%) 2/10 (20%) 0/10 (0%) 3/10 (30%) 3/10 (30%) 2/10 (20%)
FIRST INCIDENCE 93 (T) 93 (T) --- 93 (T) 93 (T) 93 (T)
STATISTICAL TESTS
POLY 3 P=0.526 P=0.500N P=0.095N P=0.678 P=0.678 P=0.500N
POLY 1.5 P=0.526 P=0.500N P=0.095N P=0.678 P=0.678 P=0.500N
POLY 6 P=0.526 P=0.500N P=0.095N P=0.678 P=0.678 P=0.500N
COCH-ARM / FISHERS P=0.527 P=0.500N P=0.105N P=0.686N P=0.686N P=0.500N
MAX-ISO-POLY-3 P=0.296N P=0.310N P=0.025N* P=1.000 P=1.000 P=0.310N
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
Page 102
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Urinary BladderInfiltration Cellular Mononuclear Cell
LESION RATES
OVERALL (a) 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 2/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00
POLY-3 PERCENT (g) 20% 0% 0% 0% 0% 0%
TERMINAL (d) 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
FIRST INCIDENCE 93 (T) --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (e) (e) (e) (e) (e) P=0.227N
POLY 1.5 (e) (e) (e) (e) (e) P=0.227N
POLY 6 (e) (e) (e) (e) (e) P=0.227N
COCH-ARM / FISHERS P=0.132N (e) (e) (e) (e) P=0.237N
MAX-ISO-POLY-3 (e) (e) (e) (e) (e) P=0.066N
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
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DOSE 0 % 6.25 % 12.5 % 25 % 50 % 100 %
Urinary Bladder: SerosaMineralization Focal
LESION RATES
OVERALL (a) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
POLY-3 RATE (b) 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00
POLY-3 PERCENT (g) 0% 0% 0% 0% 0% 0%
TERMINAL (d) 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%)
FIRST INCIDENCE --- --- --- --- --- ---
STATISTICAL TESTS
POLY 3 (n) (n) (n) (n) (n) (n)
POLY 1.5 (n) (n) (n) (n) (n) (n)
POLY 6 (n) (n) (n) (n) (n) (n)
COCH-ARM / FISHERS (n) (n) (n) (n) (n) (n)
MAX-ISO-POLY-3 (n) (n) (n) (n) (n) (n)
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(F 344/N)TERMINAL SACRIFICE AT 14 WEEKS
Females
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LEGEND
(a) Number of tumor-bearing animals/number of animals examined at site.(b) Number of tumor-bearing animals/Poly-3 number(d) Observed incidence at terminal kill.(e) Value of statistic cannot be computed.(f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group.(g) Poly-3 adjusted lifetime tumor incidence.(n) No statistics are calculated if all dose groups have fewer than two tumors.(I) Interim sacrifice(T) Terminal sacrifice# Tumor rates based on numbers of animals necropsied.* To the right of any statistical result, indicates significance at (P<=0.05).** To the right of any statistical result, indicates significance at (P<=0.01).N Indicates a negative trend for all tests
The Cochran-Armitage and Fishers exact tests compare directly the overall incidence rates.
*** END OF REPORT ***
Experiment Number: 20316 - 01 P10: STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS Date Report Requested: 02/03/2014Test Type: 90-DAY Cedarwood oil Time Report Requested: 10:16:53
Route: SKIN APPLICATION CAS Number: 8000-27-9 First Dose M/F: 06/15/05 / 06/16/05Species/Strain: RATS/F 344/N Lab: BAT
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