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AR226-3200 TRADE SECRET Study Title H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations Volume 4 of 5 Laboratory Project ID: DuPont-5386 TEST GUIDELINES: U.S. EPA Health Effects Test Guidelines OPPTS 870.3100 (1998) AUTHOR; Gregorys. Ladies, Ph.D., D.A.B.T. STUDY COMPLETED ON: December 3,2001 PERFORMING LABORATORY: E.I. du Font de Nemours and Company Haskell Laboratory for Toxicology and Industrial Medicine Elkton Road, P.O. Box 50 Newark, Delaware 19714-0050 WORK REQUEST NUMBER:|^Bfl SERVICE CODE NUMBERa^JJV SPONSOR STUDY NUMBER:!----------^IHF Page 970 of 1500 Company Sanitized. Does not contain TSCA CB) 41. H H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations____ INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS Dose Group : II - Animal Ref 0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings 643330 Terminal Sacrifice Killed on Day : 125 Exposure Group : ONE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, . PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. KIDNEYS : NEPHROPATHY, CHRONIC PROGRESSIVE, minimal. : THYROID GLAND : ALTERATION, COLLOID, minimal. No Microscopic Abnormality Observed : NOSE, MANDIBLE 971 .Company Sanitized. Does not contain H H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Geqeration Reproduction Evaluations___ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : II - Animal Ref 0 nig/kg/day Sex: Females Microscopic & Macroscopic Findings 643336 Unscheduled Sacrifice Duration of dosing-days: 105. Exposure Group : ONE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : KIDNEYS : CALCULUS\CALCULI, URINARY BLADDER : CALCULUS\CALCULI, BILATERAL, severe. severe. No Macroscopic Abnormality Observed : LIVER, LUNGS, HEART, SKELETAL MUSCLE. SPLEEN, AORTA, BRAIN, " SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC MERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, FEMUR/KNEE JOINT, STERNUM, NOSE Histopathology : 643336 LIVER : INFLAMMATION, SUBACUTE/CHRONIC, KIDNEYS : MINERALIZATION, mild. NECROSIS, TUBULAR, mild. HYPERPLASIA, TRANSITIONAL CELL, INFLAMMATION, ACUTE, mild. THYMUS : ATROPHY, mild. Continued on the next page .... minimal. moderate, 972 Company Sanitized. Does not contain TS H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : II - Animal Ref 0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings 643336 Continued from previous page Histopathology : URINARY BLADDER : HYPERPLASIA, SIMPLE, TRANSITIONAL CELL, INFLAMMATION, SUBACUTE/CHRONIC, HEMORRHAGE, mild. BONE MARROW : mild. HYPERPLASIA, GRANULOCYTIC, mild. moderate. No Microscopic Abnormality Observed : LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, - "COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) .WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE 643354 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology ; 643354 No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA. BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, Continued on the next page .... 973 CompanySanitized. Does not conta H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS Dose Group : II - 0 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643354 . Continued from previous page Gross Pathology : No Macroscopic Abnormality Observed : THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIM, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : No Microscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE. SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH ' NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE, MANDIBLE 643361 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : 643361 No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, Continued on the next page .... 974 Company Sanitized. Does not contain 0 H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : II - Animal Ref 0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings 643361 Continued from previous page Gross Pathology : No Macroscopic Abnormality Observed : THYROID GLAND, PARATHYROID GLANDS, TRACHBA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, PARATHYROID GLANDS NOT PRESENT. SUBACUTE/CHRONIC, : minimal. No Microscopic Abnormality Observed : KIDNEYS,'LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLAMDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE, MANDIBLE 975 . . 1 H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations____ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : II - 0 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643362 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, .PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : NECROSIS, FOCAL, minimal. INFLAMMATION, SUBACUTE/CHRONIC, KIDNEYS : minimal. NEPHROPATHY, CHRONIC PROGRESSIVE, minimal. HEART : CARDIOMYOPATHY, minimal. 643362 Continued on the next page .... 976 Company Sanitized. Does not con H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS Dose Group : II - Animal Ref 0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings 643362 , Continued from previous page Histopathology : No Microscopic Abnormality Observed : LUNGS, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE, MANDIBLE 643374 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : 643374 No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE. SALIVARY GLANDS. MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Continued on the next page .... 977 H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Gengration Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS Dose Group : II - 0 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643374 . Continued from previous page Histopathology : LIVER : FATTY CHANGE, INFLAMMATION, MEDIAN CLEFT, mild. SUBACUTE/CHRONIC. minimal. No Microscopic Abnormality Observed : KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, "PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE, MANDIBLE 643377 Terminal Sacrifice Killed on Day : 125 Exposure Group : ONE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : PITUITARY GLAND : LARGE. 643377 Continued on the next page 978 eompany Sanitized. Does not contain T ^ ^ H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : II - 0 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643377 Continued from previous page Gross Pathology : Mo Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. KIDNEYS : NEPHROPATHY. CHRONIC PROGRESSIVE, minimal. THYROID GLAND : ALTERATION. COLLOID, minimal. No Microscopic Abnormality Observed : NOSE, MANDIBLE 979 Company Sanitized. Does not contain TS ^ 1 H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations____ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : II - 0 ing/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643383 Terminal Sacrifice Killed on Day : 181 Exposure Group : THREE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, .THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE Histopathology : THYROID GLAND : ALTERATION. COLLOID, mild. NOSE : INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERPLASIA/SQUAMOUS METAPLASIA, TRANSITIONAL CELL, mild. 980 Company Sanitized. Does not contain 1 H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations____ INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS Dose Group : II - Animal Ref 0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings 643384 Terminal Sacrifice Killed on Day : 181 Exposure Group : THREE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, "PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE Histopathology : THYROID GLAND : ALTERATION, COLLOID, minimal. No Microscopic Abnormality Observed : NOSE 981 Company Sanitized. Does not con ' ^ H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : II - 0 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643387 . Terminal Sacrifice Killed on Day : 125 Exposure Group : ONE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND. PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, -PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. No Microscopic Abnormality Observed : KIDNEYS, THYROID GLAND, NOSE, MANDIBLE 982 Company Sanitized. Does not con H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : II - Animal Ref 0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings 643398 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, ' PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE. MANDIBLE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. PATTY CHANGE, MEDIAN CLEFT, mild. KIDNEYS : NEPHROPATHY, CHRONIC PROGRESSIVE, minimal. HEART : CARDIOMYOPATHY, minimal. PARATHYROID GLANDS : NOT PRESENT. 643398 Continued on the next page 983 Company Sanitized. Does not co ^ n H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : II - Animal Ref 0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings 643398 . Continued from previous page Histopathology : No Microscopic Abnormality Observed : LUNGS, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAMD, THYROID GLAND, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE, MANDIBLE 643402 . Terminal Sacrifice Killed on Day : 181 Exposure Group : THREE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS. SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE 643402 Continued on the next page .... 984 Company Sanitized. Dees not conta ^ n H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___ INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS Dose Group : II - Animal Ref 0 nig/kg/day Sex: Females Microscopic & Macroscopic Findings 643402 Continued from previous page Histopathology : THYROID GLAND : ALTERATION, COLLOID, minimal. No Microscopic Abnormality Observed : NOSE 643405 Terminal Sacrifice Killed on Day : 125 Exposure Group : ONE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM. COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS. ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : 643405 LIVER : INFLAMMATION, SUBACUTE/CHRONIC, NECROSIS, FOCAL, minimal. Continued on the next page .... minimal. 985 company Sanitized. Does not conta e . H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : II - 0 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643405 . Continued from previous page Histopathology : THYROID GLAND : ALTERATION, COLLOID, minimal. No Microscopic Abnormality Observed : KIDNEYS, NOSE, MANDIBLE 643406 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : 643406 LIVER : INFLAMMATION, SUBACUTE/CHRONIC, Continued on the next page .... minimal. 986 Gwapmy Sanitized. Does no H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : II - 0 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643406 Continued from previous page Histopathology : No Microscopic Abnormality Observed : KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAMD, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE, MANDIBLE 643415 Terminal Sacrifice Killed on Day : 125 Exposure Group : ONE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : PITUITARY GLAND : LARGE. No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM. PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, THYROID GLAND, 643415 Continued on the next page .... 987 fiompanySanRbed. Does not c H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : II - Animal Ref 0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings 643415 Continued from previous page Gross Pathology : No Macroscopic Abnormality Observed : PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE. MANDIBLE Histopathology : KIDNEYS : NEPHROPATHY, CHRONIC PROGRESSIVE, minimal. PITUITARY GLAND : HYPERPLASIA, DIFFUSE, mild. NOSE : SQUAMOUS HYPERPLASIA, NASOLACRIMAL DUCT, mild. No Microscopic Abnormality Observed : LIVER, THYROID GLAND, MANDIBLE 643425 Terminal Sacrifice Killed on Day : 125 Exposure Group : ONE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : 643425 No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA. BRAIN. SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, Continued on the next page .... 988 Company Sanitized, Does not cont ' H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : II - Animal Ref 0 nig/kg/day Sex: Females Microscopic & Macroscopic Findings 643425 Continued from previous page Gross Pathology : No Macroscopic Abnormality Observed : THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : FATTY CHANGE, MEDIAN CLEFT, minimal. KIDNEYS : HYDRONEPHROSIS, BILATERAL, minimal. THYROID GLAND : ALTERATION, COLLOID, minimal. No Microscopic Abnormality Observed : NOSE, MANDIBLE 643426 . Terminal Sacrifice Killed on Day : 125 Exposure Group : ONE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : 643426 No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, Continued on the next page .... 989 '"^'^."o.^ 1 H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : II - 0 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643426 Continued from previous page Gross Pathology : No Macroscopic Abnormality Observed : THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS. URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. KIDNEYS : NEPHROPATHY, CHRONIC PROGRESSIVE, minimal. THYROID GLAND : ALTERATION, COLLOID, minimal. No Microscopic Abnormality Observed ; NOSE, MANDIBLE 643436 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : 643436 No Macroscopic Abnormality Observed : LIVER. KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, Continued on the next page .... 555" Does not contai H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : II - Animal Ref 643436 0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings Continued from previous page Gross Pathology : No Macroscopic Abnormality Observed ; THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES. UTERUS, URINARY BLADDER. FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, KIDNEYS : CYST, minimal. HEART ; CARDIOMYOPATHY, minimal. minimal. No Microscopic Abnormality Observed : LUNGS, SKELETAL MUSCLE. SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MAMDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAMD, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE, MANDIBLE 991 Company Sanitized. Does not contain ^ _ ^ H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : II - Animal Ref 0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings 643448 Terminal Sacrifice Killed on Day : 125 Exposure Group : ONE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, "PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. No Microscopic Abnormality Observed : KIDNEYS, THYROID GLAND, NOSE, MANDIBLE 992 Company Sanitized. Does not con T-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : II - 0 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643453 Terminal Sacrifice Killed on Day : 125 Exposure Group : ONE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, -PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. KIDNEYS : NEPHROPATHY, CHRONIC PROGRESSIVE, minimal. CYST, minimal. No Microscopic Abnormality Observed : THYROID GLAND, NOSE, MANDIBLE 993 tBampwy SenRbed. Does H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : II - Animal Ref 0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings 643463 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, -PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology LIVER ; INFLAMMATION, SUBACUTE/CHRONIC, LUNGS : THROMBUS, minimal. EYE(S) WITH OPTIC NERVE : OPTIC NERVE NOT PRESENT. minimal. 643463 No Microscopic Abnormality Observed : KIDNEYS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, Continued on the next page 994 H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : II - 0 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643463 Continued from previous page Histopathology : No Microscopic Abnormality Observed : PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE, MANDIBLE 643465 Terminal Sacrifice Killed on Day : 181 Exposure Group : THREE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUMGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM. MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE Histopathology : 643465 THYROID GLAND : ALTERATION, COLLOID, Continued on the next page .... minimal. 995 Company Sanitized. Does not conta /-H-N i-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : II - Animal Ref 0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings 643465 Continued from previous page Histopathology : NOSE : INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERPLASIA/SQUAMOUS METAPLASIA, TRANSITIONAL CELL, mild. 643477 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, ^BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : 643477 LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. KIDNEYS : .... NEPHROPATHY, CHRONIC PROGRESSIVE, minimal. Continued on the next page 996 Company SanKlzed. Does not contain H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : II - Animal Ref 0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings 643477 Continued from previous page Histopathology : PARATHYROID GLANDS : NOT PRESENT. EYE(S) WITH OPTIC NERVE : OPTIC NERVE NOT PRESENT. No Microscopic Abnormality Observed : LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC . NERVE, PITUITARY GLAND, THYROID GLAND, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT. STERNUM, BONE MARROW, NOSE, MANDIBLE 643484 Terminal Sacrifice Killed on Day : 181 Exposure Group : THREE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : 643484 No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, Continued on the next page .... 997 Company Sanitized. Does not contain H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : II - Animal Ref 0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings 643484 Continued from previous page Gross Pathology : No Macroscopic Abnormality Observed : THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE Histopathology : THYROID GLAND : ALTERATION, COLLOID, minimal. NOSE. ": INFLAMMATION, SUBACUTE/CHRONIC, mild. HYPERPIASIA/SQUAMOUS METAPLASIA, TRANSITIONAL CELL, mild. 643486 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM. JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, 643486 Continued on the next page .... 998 Company Sanitized. Does not con H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : II - Animal Ref 643486 0 nig/kg/day Sex: Females Microscopic & Macroscopic Findings Continued from previous page Gross Pathology : No Macroscopic Abnormality Observed : THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, MESENTERIC LYMPH NODE : NOT PRESENT. PARATHYROID GLANDS : NOT PRESENT. minimal. No Microscopic Abnormality Observed : KIDNEYS, LUNGS, HEART, SKELETAL.MUSCLE, SPLEEN, AORTA. BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, TRACHEA, ESOPHAGUS, PHARYMX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE, MANDIBLE 999 Company Sanitized. Does not cont Bh. H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : IV - 25 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643321 Unscheduled Sacrifice Duration of dosing-days: 29 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : KIDNEYS : DILATATION, BILATERAL, PELVIS, DISCOLORATION, TAN, BILATERAL, URINARY BLADDER : DILATATION, severe. CALCULUS \ CALCULI, 7MM DIA. moderate. GRANULAR . No.Macroscopic Abnormality Observed : LIVER, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, FEMUR/KNEE JOINT, STERNUM, NOSE Histopathology : 643321 KIDNEYS : HYDRONEPHROSIS, BILATERAL, mild. INFLAMMATION, ACUTE, moderate. HYPERPLASIA, TRANSITIONAL CELL, mild. NECROSIS, TUBULAR, moderate. HEART : CARDIOMYOPATHY, minimal. Continued on the next page .... 1000 Company Sanitized. Dom not contain ^ ^ H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS Dose Group : IV - 25 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643321 Continued from previous page Histopathology : SPLEEN : DEPLETION, LYMPHOID, THYMUS : ATROPHY, moderate. URINARY BLADDER : HYPERPLASIA, SIMPLE, BONE MARROW : ATROPHY, mild. MANDIBLE : .NOT PRESENT. moderate. TRANSITIONAL CELL, moderate. No Microscopic Abnormality Observed : LIVER, LUNGS, SKELETAL MUSCLE, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS. TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, FEMUR/KNEE JOINT, STERNUM, NOSE 1001 Company Sanitized. Ooe not conta ^ 1 H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS Dose Group : IV - 25 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643324 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, - -THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, THYROID GLAND : ALTERATION, COLLOID, minimal. minimal. No Microscopic Abnormality Observed : KIDNEYS, NOSE, MANDIBLE 1002 Company Sanitized. Does not contain H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : IV - 25 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643364 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, .THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. KIDNEYS : NEPHROPATHY, CHRONIC PROGRESSIVE, minimal. No Microscopic Abnormality Observed : THYROID GLAND, NOSE, MANDIBLE 1003 Company Sanitized. Does not co H-24516: Subchronic Toxicnty 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : IV - 25 ing/kg/day Sex: Females Animal Ref 643379 Microscopic & Macroscopic Findings Terminal Sacrifice Killed on Day : 181 Exposure Group : THREE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY - -GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KMEE JOINT, STERNUM, NOSE Histopathology : THYROID GLAND : ALTERATION, COLLOID, minimal. 643380 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : 643380 No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, Continued on the next page .... 1004 Company Sanitized. Does not con H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : IV - 25 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643380 Continued from previous page Gross Pathology : No Macroscopic Abnormality Observed : THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : -INFLAMMATION, SUBACUTE/CHRONIC, THYROID GLAND : ALTERATION, COLLOID, minimal. minimal. No Microscopic Abnormality Observed : KIDNEYS, NOSE, MANDIBLE 643389 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : 643389 No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, Continued on the next page .... ^ "Ml contai H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : IV - 25 mg/kg/day Sex; Females Animal Ref Microscopic & Macroscopic Findings 643389 . Continued from previous page Gross Pathology No Macroscopic Abnormality Observed : THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN. MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. . THYROID GLAMD : .ALTERATION, COLLOID, minimal. NOSE : INFLAMMATION, SUBACUTE/CHRONIC, mild. FRACTURE/CALLUS, TOOTH. No Microscopic Abnormality Observed : KIDNEYS, MANDIBLE 643390 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : 643390 No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAMD, Continued on the next page .... 1006 t not contai ^ A H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations____ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : IV - 25 mg/kg/day Sex: Females Animal Ref 643390 Microscopic & Macroscopic Findings Continued from previous page Gross Pathology : No Macroscopic Abnormality Observed : THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopatholo9y : LIVER : . -INFLAMMATION, SUBACUTE/CHRONIC, minimal. No Microscopic Abnormality Observed : KIDNEYS, THYROID GLAND, NOSE, MANDIBLE 643391 Terminal Sacrifice Killed on Day : 181 Exposure Group : THREE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART. SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, 643391 Continued on the next page .... 1007 '"otcon H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations____ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : IV - 25 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643391 Continued from previous page Gross Pathology : No Macroscopic Abnormality Observed : THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES,.UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE Histopathology : THYROID GLAND : -ALTERATION, COLLOID, minimal. 643396 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : 643396 No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE). OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Continued on the next page .... 1008 euvwswwwi'^"^<M,r H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : IV - 25 nig/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643396 . . Continued from previous page Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. KIDNEYS : NEPHROPATHY, CHRONIC PROGRESSIVE, minimal. No Microscopic Abnormality Observed : THYROID GLAND, NOSE, MANDIBLE 643410 Terminal Sacrifice Killed on Day : 93 - "Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, . THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX. EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE 643410 Continued on the next page 1009 "ot con H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS Dose Group : IV - 25 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643410 Continued from previous page Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, THYROID GLAND : ALTERATION, COLLOID, minimal. minimal. No Microscopic Abnormality Observed : KIDNEYS, NOSE, MANDIBLE 643433 Terminal Sacrifice Killed on Day : 93 "Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE 643433 Continued on the next page .... 1010 Company SanRfzed. Does not 1 H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : IV - 25 nig/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643433 Continued from previous page Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, THYROID GLAND : ALTERATION, COLLOID, minimal. minimal. No Microscopic Abnormality Observed : KIDNEYS, NOSE, MANDIBLE 643437 Terminal Sacrifice -Killed on Day : 181 " Exposure Group : THREE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE 643437 Continued on the next page .... 1011 Company SanRlzed. Does not co H-24516: Subchronic Toxicity ' 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___ INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS Dose Group : IV - 25 mg/kg/day Sex: Females Animal Ref 643437 Microscopic & Macroscopic Findings Continued from previous page Histopathology : THYROID GLAND : ALTERATION, COLLOID, minimal. 643458 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is si9ned off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS. HEART, SKELETAL MUSCLE, SPLEEN, AORTA. BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAMD, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAMD (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : 643458 LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. FATTY CHANGE, MEDIAN CLEFT, minimal. THYROID GLAMD : ALTERATION, COLLOID, minimal. Continued on the next page .... 1012 Company Sanitized. Does not co H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS Dose Group : IV - 25 nig/kg/day Sex: Females Animal Ref 643458 Microscopic & Macroscopic Findings Continued from previous page Histopathology : No Microscopic Abnormality Observed : KIDNEYS, NOSE, MANDIBLE 643483 Terminal Sacrifice Killed on Day : 181 Exposure Group : THREE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN. SPINAL CORD, STOMACH, DUODENUM. JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAMD, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS. URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE Histopathology : THYROID GLAND : ALTERATION, COLLOID, moderate. 1013 Company Sanitized. Does no ^ n H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VI - Animal Ref 643322 100 mg/kg/day Sex: Females Microscopic & Macroscopic Findings Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, -.THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS. URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : NOSE : DEGENERATION, AMELOBLASTS, minimal. No Microscopic Abnormality Observed : LIVER, KIDNEYS, THYROID GLAND, MANDIBLE 1014 Company Sanitized. Does no e H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VI - 100 mg/kg/day Sex; Females Animal Ref Microscopic & Macroscopic Findings 643323 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAMD, -THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYMX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. KIDNEYS : NEPHROPATHY, CHRONIC PROGRESSIVE, minimal. No Microscopic Abnormality Observed : THYROID GLAND, NOSE, MANDIBLE 1015 Company Sanitized. Doe not co H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VI - 100 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643360 Terminal Sacrifice Killed on Day : 181 Exposure Group : THREE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, .THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE Histopathology : THYROID GLAND : ALTERATION, COLLOID, minimal. NOSE : INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERPLASIA/SQUAMOUS METAPLASIA, TRANSITIONAL CELL, mild. 1016 company sanlHzed- 0<x "ot con 0 H H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VI - 100 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643366 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS. SCIATIC NERVE, PITUITARY GLAND, - .THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. THYROID GLAND : ALTERATION, COLLOID, moderate. NOSE : DEGENERATION, AMELOBLASTS, minimal. No Microscopic Abnormality Observed : KIDNEYS, MANDIBLE 1017 Company Sanitized. Does not conta I H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VI - 100 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643367 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, .THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, " PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, NOSE : DEGENERATION, SUBACUTE/CHRONIC, minimal. AMELOBLASTS, minimal. No Microscopic Abnormality Observed : KIDNEYS, THYROID GLAND, MANDIBLE 1018 Company Sanitized. Does not con H H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VI - 100 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643373 Terminal Sacrifice Killed on Day : 181 Exposure Group : THREE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART. SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON. RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, "PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE Histopathology : THYROID GLAND : ALTERATION, COLLOID, mild. No Microscopic Abnormality Observed : NOSE 1019 Company Sanitized. Does not co H-24516: Subchronic Toxicity ^^ 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VI - 100 mg/kg/day Sex: Females Animal Ref 643381 Microscopic & Macroscopic Findings Terminal Sacrifice Killed on Day : 181 Exposure Group : THREE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, " "PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE Histopathology : THYROID GLAND : ALTERATION, COLLOID, minimal. NOSE : INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERPLASIA/SQUAMOUS METAPLASIA, TRANSITIONAL minimal. CELL, 1020 Company Sanitized. Does not contain T ^ ^ H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations ^^ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VI - 100 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643382 Terminal Sacrifice Killed on Day : 181 Exposure Group : THREE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology ; No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, .THYROID GLAMD, PARATHYROID GLANDS. TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE Histopathology : No Microscopic Abnormality Observed : THYROID GLAND, NOSE 643392 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : 643392 LUNGS : DISCOLORATION, Continued on the next page DARK. .... 1021 Company SanMzed. Does not contai 1 H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VI - 100 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643392 Continued from previous page Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, . .STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC. minimal. KIDNEYS : NEPHROPATHY, CHRONIC PROGRESSIVE, minimal. No Microscopic Abnormality Observed : LUNGS, THYROID GLAND, NOSE, MANDIBLE 1022 Company SanHteed. Does not conta ^ H-24516: Subchronic 90-Day Gavage Study Toxicity in Rats with One-Generation Reproduction Evaluations ^^ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VI - 100 mg/kg/day Sex: Females Animal Ref 643409 Microscopic & Macroscopic Findings Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, .THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, - PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, NOSE : DEGENERATION, SUBACUTE/CHRONIC, minimal. AMELOBLASTS, minimal. No Microscopic Abnormality Observed : KIDNEYS, THYROID GLAND, MANDIBLE 1023 Company Sanitized. Does not conta H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VI - 100 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643412 Terminal Sacrifice Killed on Day : 181 Exposure Group : THREE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE. SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, . THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, "PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE Histopathology : THYROID GLAND : ALTERATION, COLLOID, minimal. No Microscopic Abnormality Observed : NOSE 1024 Company Sanitized. Does not conta ^ ^, H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations____ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VI - 100 nig/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643461 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, .THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. THYROID GLAND : ALTERATION, COLLOID, minimal. NOSE : DEGENERATION, AMELOBLASTS, minimal. No Microscopic Abnormality Observed : KIDNEYS, MANDIBLE 1025 Company Sanitized. Does not conte!n T ' H-24516: Subchronic ToKicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VI - 100 ing/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643462 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA. BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY " "GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC,.minimal. THYROID GLAND : ALTERATION, COLLOID, minimal. No Microscopic Abnormality Observed : KIDNEYS, NOSE, MANDIBLE 1026 Company Sanitized. Does not contain H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VI - 100 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643472 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC MERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, " PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER. FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, NOSE : DEGENERATION, SUBACUTE/CHRONIC, minimal. AMELOBLASTS, minimal. No Microscopic Abnormality Observed : KIDNEYS, THYROID GLAND, MANDIBLE 1027 H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VI - 100 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643489 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN,.SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, ' PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. NECROSIS, FOCAL, minimal. KIDNEYS : NEPHROPATHY, CHRONIC PROGRESSIVE, minimal. THYROID GLAND : ALTERATION, COLLOID, minimal. No Microscopic Abnormality Observed : NOSE, MANDIBLE 1028 'CompanySanitized. Does not conta ^^ . ^ _ H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643329 Terminal Sacrifice Killed on Day : 181 Exposure Group : THREE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, " "PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE Histopathology : THYROID GLAND : ALTERATION, COLLOID, mild. NOSE : DEGENERATION, AMELOBLASTS, minimal. 1029 Company-SanBhed.Does not con - H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643332 . Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, - PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : . LIVER : HYPERTROPHY, HEPATOCYTE, CENTRILOBULAR, THYROID GLAND : ALTERATION, COLLOID, minimal. UTERUS ; DILATATION, LUMEN, mild. NOSE : DEGENERATION, AMELOBLASTS, mild. MANDIBLE : DEGENERATION, AMELOBLASTS, mild. mild. 643332 Continued on the next page .... 1030 CompanySanfflared. Does not cont H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings Animal Ref . Microscopic & Macroscopic Findings 643332 Continued from previous page Histopathology : No Microscopic Abnormality Observed : KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH MODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLAMDS, SCIATIC NERVE, PITUITARY GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), " OVARIES, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW 643340 Found Dead Duration of dosing-days: 69 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : ADRENAL GLANDS : LARGE, BILATERAL, moderate. WHOLE BODY : Autolysis: tissues taken, severe. 643340 No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, Continued on the next page .... ^- Does not H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643340 Continued from previous page Gross Pathology : No Macroscopic Abnormality Observed : PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE Histopathology : SPLEEN : DEPLETION, LYMPHOID, mild. JEJUNUM : AUTOLYSIS: NECROPSY AND HISTOLOGY PERFORMED, THYMUS : ATROPHY, severe. PARATHYROID GLANDS : NOT PRESENT. EYE(S) WITH OPTIC NERVE : AUTOLYSIS: NECROPSY AND HISTOLOGY PERFORMED, NOSE : INFLAMMATION, DEGENERATION, MANDIBLE : SUBACUTE/CHRONIC, minimal. AMELOBLASTS, mild. NOT PRESENT. moderate. mild. 643340 Continued on the next page .... 1032 CompanySanitized. Does not ^ n H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643340 Continued from previous page Histopathology : No Microscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, . EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW 643341 - "Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYMX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE 643341 Continued on the next page .... 1033 Company Sanitized. Does no H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643341 Continued from previous page Histopathology : LIVER : HYPERTROPHY, HEPATOCYTE, CENTRILOBUIAR, SPLEEM : NOT PRESENT. THYROID GLAND : ALTERATION, COLLOID, minimal. UTERUS : DILATATION, LUMEN, minimal. NOSE : DEGENERATION, AMELOBLASTS, mild. MANDIBLE : DEGENERATION, AMELOBLASTS, mild. mild. No Microscopic Abnormality Observed : KIDNEYS,- LUNGS, HEART, SKELETAL MUSCLE, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW 1034 Company SanRbed. Does not c .. _ _ H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643345 Terminal Sacrifice Killed on Day : 125 Exposure Group : ONE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS. LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH .NODE, SALIVARY GLANDS. MANDIBUIAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, -"PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. THYROID GLAND : ALTERATION, COLLOID, minimal. NOSE : DEGENERATION, AMELOBLASTS, mild. No Microscopic Abnormality Observed : KIDNEYS, MANDIBLE 1035 Company SanRIzed. Does pet caw ^ 1 H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643347 Terminal Sacrifice Killed on Day : 125 Exposure Group : ONE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, " -PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, NOSE : DEGENERATION, SUBACUTE/CHRONIC, minimal. AMELOBLASTS, minimal. No Microscopic Abnormality Observed : KIDNEYS, THYROID GLAND, MANDIBLE 1036 CompanySanitized. Doe* not T-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643351 Terminal Sacrifice Killed on Day : 125 Exposure Group : ONE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE. SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, - -PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAMD (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : THYROID GLAND : ALTERATION, COLLOID, minimal. No Microscopic Abnormality Observed : LIVER, KIDNEYS, NOSE, MANDIBLE 1037 Qompany Sanft'zed. Does not co ' d H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643356 Terminal Sacrifice Killed on Day : 181 Exposure Group : THREE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS. MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, " "PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE Histopathology : THYROID GLAND : ALTERATION, COLLOID, moderate. NOSE : INFLAMMATION, SUBACUTE/CHRONIC, mild. DEGENERATION, AMELOBLASTS, minimal. HYPERPLASIA/SQUAMOUS METAPLASIA, TRANSITIONAL CELL, mild. 1038 Company Sanitized. Does not con H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643358 Terminal Sacrifice Killed on Day : 125 Exposure Group : ONE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, -PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. KIDNEYS : NEPHROPATHY, CHRONIC PROGRESSIVE, minimal. THYROID GLAND : ALTERATION, COLLOID, minimal. NOSE : DEGENERATION, AMELOBLASTS, mild. No Microscopic Abnormality Observed : MANDIBLE 1039 Compsmy Sa'r't'red. Does not con H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 nig/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643359 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, - -PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : 643359 LIVER : HYPERTROPHY, HEPATOCYTE, CENTRILOBULAR, minimal. INFLAMMATION. SUBACUTE/CHRONIC, minimal. THYROID GLAND : HYPERTROPHY, FOLLICULAR, minimal. ALTERATION, COLLOID, minimal. PARATHYROID GLANDS : NOT PRESENT. NOSE : DEGENERATION, AMELOBLASTS, mild. MANDIBLE : DEGENERATION, AMELOBLASTS, mild. Continued on the next page .... 1040 Company SanWzed. Does not H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643359 Continued from previous page Histopathology : No Microscopic Abnormality Observed : KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW 643368 " Accidentally Killed Duration of dosing-days: 53 Exposure Group : REPRODUCTION Animal is signed off from necropsy Gross Pathology : ESOPHAGUS : PUNCTURE, GAVAGE SKIN : STAIN. RED, PERINEUM. ERROR. 643368 No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, Continued on the next page .... 1041 Company Sanitized. Does not con e H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643368 Continued from previous page Gross Pathology : No Macroscopic Abnormality Observed : THYROID GLAND, PARATHYROID GLANDS, TRACHEA, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE Histopathology : KIDNEYS : AUTOLYSIS: NECROPSY AND HISTOLOGY PERFORMED, SPLEEN : - -DEPLETION, LYMPHOID, mild. JEJUNUM : AUTOLYSIS: NECROPSY AND HISTOLOGY PERFORMED, THYMUS : ATROPHY, severe. ESOPHAGUS : INFLAMMATION, SUBACUTE/CHRONIC, severe. BONE MARROW : HYPERPLASIA, GRANULOCYTIC, severe. NOSE : DEGENERATION. AMELOBLASTS, mild. MANDIBLE : NOT PRESENT. mild. moderate. 643368 Continued on the next page .... 1042 Company Sanitized. Does not co H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643368 Continued from previous page Histopathology : No Microscopic Abnormality observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM 643370 ""Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy , Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE 643370 Continued on the next page .... 1043 Company Sanitized. Does not cont H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643370 Continued from previous page Histopathology : LIVER : HYPERTROPHY, HEPATOCYTE, CENTRILOBULAR, mild. INFLAMMATION, SUBACUTE/CHRONIC, minimal. KIDNEYS : INPARCT, minimal. NEPHROPATHY, CHRONIC MESENTERIC LYMPH NODE : PROGRESSIVE, minimal. NOT PRESENT. PARATHYROID GLANDS : NOT PRESENT. EYE-(S) WITH OPTIC NERVE : OPTIC NERVE NOT PRESENT. NOSE : DEGENERATION. AMELOBLASTS, mild. MANDIBLE : DEGENERATION, AMELOBLASTS, mild. No Microscopic Abnormality Observed : LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW 1044 'fcuiqpdilySanitized. Does not cont 24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643388 Terminal Sacrifice . Killed on Day : 181 Exposure Group : THREE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, . "PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE Histopathology : THYROID GLAND : ALTERATION, COLLOID, NOSE : HYPERPLASIA/SQUAMOUS minimal. mild. METAPLASIA, TRANSITIONAL CELL, 1045 Company Sanitized. Does not con H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643404 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, - KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, --PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS. URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : HYPERTROPHY, HEPATOCYTE, CENTRILOBULAR, mild. INFLAMMATION, SUBACUTE/CHRONIC, minimal. KIDNEYS : NEPHROPATHY, CHRONIC PROGRESSIVE, moderate. THYROID GLAND : HYPERTROPHY, FOLLICULAR, minimal. NOSE : DEGENERATION, AMELOBLASTS, mild. 643404 Continued on the next page 1046 Company Sanitized. Does not co -24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643404 Continued from previous page Histopathology : No Microscopic Abnormality Observed : LUMGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, MANDIBLE 643408 -"Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE. SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE 643408 Continued on the next page .... 1047 1 H-24516: SubchronicToxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643408 Continued from previous page Histopathology : LIVER : HYPERTROPHY, HEPATOCYTE, CENTRILOBULAR, minimal. INFLAMMATION, SUBACUTE/CHRONIC, minimal. KIDNEYS : NEPHROPATHY, CHRONIC PROGRESSIVE, minimal. THYROID GLAND : HYPERTROPHY, FOLLICULAR, minimal. ALTERATION, COLLOID, minimal. NOSE : DEGENERATION, AMELOBLASTS, mild. MANDIBLE : NOT PRESENT. No Microscopic Abnormality Observed ; LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA. BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, PARATHYROID GLAMDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW 1048 ------s^.o----- H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643423 Terminal Sacrifice Killed on Day : 125 Exposure Group : ONE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIM, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, --PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. KIDNEYS : NEPHROPATHY, CHRONIC PROGRESSIVE, minimal. THYROID GLAND : ALTERATION, COLLOID, minimal. No Microscopic Abnormality Observed : NOSE, MANDIBLE 1049 ,^,,^.-----rt-"T H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643435 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAMD, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY - GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : : 643435 LIVER : HYPERTROPHY, HEPATOCYTE, CENTRILOBULAR, mild. INFLAMMATION, SUBACUTE/CHRONIC, minimal. PANCREAS : ATROPHY, minimal. THYROID GLAND : HYPERTROPHY, FOLLICULAR, minimal. ALTERATION, COLLOID, minimal. UTERUS : DILATATION, LUMEN, minimal. URINARY BLADDER : NOT PRESENT. Continued on the next page .... 1050 Company Sanitized. Does not contain ^ H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643435 Continued from previous page Histopathology : NOSE : DEGENERATION, MANDIBLE : DEGENERATION, AMELOBLASTS, AMELOBLASTS, mild. minimal. No Microscopic Abnormality Observed : KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN. SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, FEMUR/KNEE JOINT, STERNUM, BONE MARROW 643441 Terminal Sacrifice Killed on Day : 125 Exposure Group : ONE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : 643441 No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, Continued on the next page .... 1051 Company Sanitized. Does not ^ H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643441 Continued from previous page Gross Pathology : No Macroscopic Abnormality Observed : THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, -- FATTY CHANGE, KIDNEYS : SUBACUTE/CHRONIC, minimal. MEDIAN CLEFT, minimal. NEPHROPATHY, CHRONIC PROGRESSIVE, minimal. THYROID GLAND : ALTERATION, COLLOID, minimal. NOSE : DEGENERATION, AMELOBLASTS, minimal. No Microscopic Abnormality Observed : MANDIBLE 1052 Company Sanitized. Does not c /r^r'^'i. H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643444 Terminal Sacrifice Killed on Day : 125 Exposure Group : ONE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality.Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON. RECTUM, MESEMTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, .. PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. NECROSIS, FOCAL, minimal. : KIDNEYS : NEPHROPATHY, CHRONIC PROGRESSIVE, minimal. THYROID GLAND : ALTERATION, COLLOID, minimal. NOSE : DEGENERATION, AMELOBLASTS, minimal. No Microscopic Abnormality Observed : MAMDIBLE 1053 Company Sanitized. Does H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643446 Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, " PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : 643446 LIVER : HYPERTROPHY, HEPATOCYTE, CENTRILOBULAR, minimal. INFLAMMATION, SUBACUTE/CHRONIC, minimal. PANCREAS : ATROPHY, minimal. THYROID GLAND : HYPERTROPHY, FOLLICULAR, minimal. ALTERATION, COLLOID, mild. PARATHYROID GLANDS : NOT PRESENT. EYE(S) WITH OPTIC NERVE : OPTIC NERVE NOT PRESENT. Continued on the next page .... 1054 Company Sanitized. Does not con H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 ing/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643446 . Continued from previous page Histopathology ; NOSE : DEGENERATION. MANDIBLE : DEGENERATION, AMELOBLASTS, AMELOBLASTS, mild. minimal. No Microscopic Abnormality Observed : KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE. SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, -" SCIATIC NERVE, PITUITARY GLAND, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW 643450 Terminal Sacrifice Killed on Day : 181 Exposure Group : THREE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : 643450 No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, Continued on the next page .... 1055 tSompanySanitized, Does not H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643450 Continued from previous page Gross Pathology : No Macroscopic Abnormality Observed : THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE Histopathology : THYROID GLAND : ALTERATION, COLLOID, mild. NO'SE : INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERPLASIA/SQUAMOUS METAPLASIA, TRANSITIONAL minimal. CELL, 643456 Terminal Sacrifice Killed on Day : 125 Exposure Group : ONE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : 643456 No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, Continued on the next page .... 1056 Company Sanitized. Does not co ^ ^ H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643456 Continued from previous page Gross Pathology : No Macroscopic Abnormality Observed : THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. KIJ3NEYS : NEPHROPATHY, CHRONIC PROGRESSIVE, minimal. THYROID GLAND : ALTERATION, COLLOID, minimal. NOSE : DEGENERATION, AMELOBLASTS, mild. INFLAMMATION, SUBACUTE/CHRONIC, NASOLACRIMAL DUCT, mild. No Microscopic Abnormality Observed : MANDIBLE 1057 Company Sanitized. Doe H H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL AMIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643466 . Terminal Sacrifice Killed on Day : 93 Exposure Group : 90-DAY EXPOSURE Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM. ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : 643466 LIVER : HYPERTROPHY, HEPATOCYTE, CENTRILOBULAR, minimal. INFLAMMATION, SUBACUTE/CHRONIC, minimal. KIDNEYS : NEPHROPATHY, CHRONIC PROGRESSIVE, minimal. MESENTERIC LYMPH NODE : NOT PRESENT. THYROID GLAND : HYPERTROPHY, FOLLICULAR, minimal. ALTERATION, COLLOID, mild. EYE(S) WITH OPTIC NERVE : OPTIC NERVE NOT PRESENT. Continued on the next page .... 1058 Company Sanitized. Does no ' H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 nig/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643466 Continued from previous page Histopathoiogy : NOSE : DEGENERATION, MANDIBLE : DEGENERATION, AMELOBLASTS, AMELOBLASTS, mild. minimal. No Microscopic Abnormality Observed : LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, -" PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW 643474 Terminal Sacrifice Killed on Day : 125 Exposure Group : ONE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : 643474 No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM. PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, Continued on the next page .... 1059 Company SanWzed. Doe 6). H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643474 Continued from previous page Gross Pathology : No Macroscopic Abnormality Observed : THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, THYROID GLAND : ALTERATION, COLLOID, minimal. minimal. No Microscopic Abnormality Observed : KIDNEYS, NOSE, MANDIBLE 643481 Terminal Sacrifice Killed on Day : 125 Exposure Group : ONE-MONTH RECOVERY Animal is signed, off from necropsy Gross Pathology : 643481 No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, Continued on the next page .... 1060 Company Sanitized. Does not 0 H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643481 Continued from previous page Gross Pathology : No Macroscopic Abnormality Observed : THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE Histopathology : LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. KIDNEYS.: NEPHROPATHY, THYROID GLAND : CHRONIC PROGRESSIVE, minimal. ALTERATION, COLLOID, moderate. NOSE : DEGENERATION, AMELOBLASTS, mild. No Microscopic Abnormality Observed : MANDIBLE 1061 Company Sanitized. Does not cont e H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS Dose Group : VIII - 250 mg/kg/day Sex: Females Animal Ref Microscopic & Macroscopic Findings 643487 . Terminal Sacrifice Killed on Day : 181 Exposure Group : THREE-MONTH RECOVERY Animal is signed off from necropsy Gross Pathology : No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, - " PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE. SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE Histopathology : THYROID GLAND : ALTERATION, COLLOID, mild. No Microscopic Abnormality Observed : NOSE 1062 APPENDIX 0 REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHTS OF PI MALE RATS 1063 Company SanHIzed. Does not contain TSCA CB) H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHTS OF Pi MALE RATS EXPLANATORY NOTES Notes: Test Days 75-89 = Cohabitation period d^ 1064 Company Sanllzed. Does not contain TSCA CBI INDIVIDUAL BODY WEIGHTS (grams) OF Pi MALE RATS GROUP: 1-0 DOSE: 0 MG/KG/DAY TEST DAYS: ANIMAL NUMBER 643239 643270 643148 643284 643229 643196 643176 643218 643207 643280 643271 643211 643163 643197 643242 643251 643155 643147 643276 643254 78 85 92 99 106 602 .8 514 .2 515 .9 624 .5 465 .5 441 .0 522 .9 564 .4 507 .3 560 .0 635 .1 525 .9 651 .7 565 .1 587 .4 524 .9 582 .0 562 .8 677 .2 482 .3 614 .2 539 .7 520 .4 644 .1 480 .7 454 .9 533 .6 575 .4 522 .7 578 .7 636 .5 540 .9 675 .1 580 .0 591 .1 539 .2 597 .9 574 .2 696 .9 494 .6 627 .7 552 .6 539 .2 647 .5 484 .6 465 .7 556 .8 595 .5 528 .4 586 .8 649 .3 551 .5 692 .9 596 .4 617 .3 557 .9 601 .1 587 .9 716 .4 512 .6 625 .4 562 .6 556 .3 664 .9 506 .3 482 .6 569 .3 608 .0 538 .7 598 .1 669 .5 570 .5 704 .6 604 .4 627 .2 563 .1 613 .8 600 .1 725 .5 522 .5 648. 8 569. 4 569. 5 681. 1 513. 3 493. 0 575. 8 626. 0 541. 9 614. 9 676. 4 582. 0 716. 0 617. 4 637. 9 577. 1 631. 2 605. 8 738. 2 536. 8 1065 Company Sanflzed. Does not contain TSCA CBI INDIVIDUAL BODY WEIGHTS (grams) OF P^ MALE RATS GROUP: III-O DOSE: 25 MG/KG/DAY TEST DAYS: 78 85 92 99 106 ANIMAL NUMBER 643287 643188 643230 643170 643144 643277 643214 643261 643166 643153 643177 643198 643291 643184 643167 643223 643233 643183 643219 643263 469 .8 626 .4 495 .5 570 .3 477 .4 606 .8 566 .9 589 .6 549 .5 529 .1 558 .2 623 .5 574 .0 464 .8 554 .3 517 .3 465 .1 584 .7 569 .3 484 .8 473 .5 641 .6 513 .5 568 .3 485 .6 619 .3 567 .9 607 .3 568 .7 542 .3 578 .2 637 .1 581 .1 460 .9 579 .6 525 .8 480 .6 582 .7 590 .0 502 .0 480 .6 660 .3 530 .1 583 .2 496 .3 642 .7 583 .2 624 .1 580 .6 558 .4 585 .8 643 .9 596 .7 472 .6 583 .1 530 .9 493 .3 594 .2 615 .9 520 .0 490 .8 679 .0 538 .7 597 .3 504 .1 662 .5 595 .4 646 .7 597 .8 577 .8 583 .8 653 .0 614 .6 495 .0 597 .7 533 .7 511 .3 605 .3 629 .5 529 .5 495 .4 695 .9 541 .3 610 .4 513 .9 676 .7 612 .9 657 .4 613 .5 588 .6 592 .1 660 .5 623 .5 476 .9 605 .2 544 .7 518 .4 614 .2 636 .2 532 .8 1066 Company San't'zed. Does not contain TSCA CBI INDIVIDUAL BODY WEIGHTS (grams) OF Pi MALE RATS ' GROUP: V-0 DOSE: 100 MG/KG/DAY TEST DAYS: ANIMAL NUMBER 643313 643182 643146 643312 643199 643267 643216 643244 643245 643301 643200 643255 643157 643238 643227 643164 643154 643156 643208 643190 78 85 92 99 106 511. 6 566. 3 558. 8 512. 4 543. 0 547. 4 592. 5 507. 2 466. 6 545. 1 560. 7 601. 1 552. 8 538. 6 568. 5 592. 7 499. 6 606. 0 526. 7 553. 2 515.1 S90.0 576.7 523.6 556.5 568.7 614.7 516.6 474.0 561.9 576.0 600.0 571.6 546.3 582.1 604.7 505.8 618.5 530.6 551.9 527 .8 604 .1 597 .7 533 .3 551 .1 572 .7 622 .7 529 .3 489 .0 581 .2 592 .4 619 .0 585 .7 538 .2 591 .1 616 .0 520 .2 633 .6 531 .9 552 .4 538 .8 630 .8 611 .8 541 .9 552 .8 584 .7 629 .1 551 .4 496 .6 586 .5 605 .6 637 .4 599 .9 538 .8 601 .2 626 .2 495 .1 645 .2 540 .9 567 .7 536 .6 636 .4 610 .9 550 .9 554 .2 561 .4 581 .4 542 .0 493 .4 600 .9 610 .9 640 .7 605 .3 537 .4 616 .0 640 .0 497 .4 637 .4 465 .9 563 .9 1067 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL BODY WEIGHTS (grams) OF Pi MALE RATS GROUP: VII-0 DOSE: 250 MG/KG/DAY TEST DAYS: ANIMAL NUMBER 643289 643171 643158 643249 643161 643248 643285 643278 643299 643274 643192 643222 643160 643191 643203 643282 643302 643317 643281 78 85 92 99 106 403 .6 536 .3 577 .3 499 .4 505 .7 429 .6 443 .1 490 .4 477 .9 491 .0 542 .1 513 .5 481 .5 509 .4 513 .3 578 .4 433 .6 447 .6 530 .5 431 .4 572 .0 596 .1 528 .9 542 .4 457 .8 457 .6 501 .4 506 .7 508 .7 563 .5 512 .7 485 .4 519 .2 539 .0 599 .4 473 .5 472 .1 538 .9 440 .0 592 .9 615 .9 554 .9 567 .1 464 .5 473 .0 507 .7 516 .6 511 .0 579 .1 529 .7 489 .5 538 .3 559 .3 626 .8 500 .5 478 .8 544 .8 449 .3 611 .8 624 .7 565 .8 576 .1 419 .4. 480 .5 523 .8 524 .6 515 .1 597 .4 536 .6 498 .4 528 .8 574 .6 654 .0 524 .6 486 .1 548 .6 454 .2 627 .6 632 .1 576 .7 587 .0 397 .7 495 .4 534 .0 538 .4 518 .9 604 .5 538 .3 505 .3 529 .7 584 .5 674 .5 540 .6 496 .8 560 .8 APPENDIX P REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHT GAINS OF Pi MALE RATS ^'Bompany^anllf1e.Deoge,s not contain TSCA CBT H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHT GAINS OF Pi MALE RATS EXPLANATORY NOTES Test Days 75-89 = Cohabitation period 1070 INDIVIDUAL BODY WEIGHT GAINS (grams) OF Pi MALE RATS GROUP: 1-0 DOSE: 0 MG/KG/DAY TEST DAYS: ANIMAL NUMBER 643239 643270 643148 643284 643229 643196 643176 643218 643207 643280 643271 643211 643163 643197 643242 643251 643155 643147 643276 643254 78-85 85-92 92-99 99-106 78-106 11.4 25.5 4.5 19.6 15.2 13.9 10.7 11.0 15.4 18.7 1.4 15.0 23.4 14.9 3.7 14.3 15.9 11.4 19.7 12.3 13.5 12.9 18.8 3.4 3.9 10.8 23.2 20.1 5.7 8.1 12.8 10.6 17.8 16.4 26.2 18.7 3.2 13.7 19.5 18.0 -2.3 10.0 17.1 17.4 21.7 16.9 12.5 12.5 10.3 11.3 20.2 19.0 11.7 8.0 9.9 5.2 12.7 12.2 9.1 9.9 23.4 6.8 13.2 16.2 7.0 10.4 6.5 18.0 3.2 16.8 6.9 11.5 11.4 13.0 10.7 14.0 17.4 5.7 12.7 14.3 46.0 55.2 53.6 56.6 47.8 52.0 52.9 61.6 34.6 54.9 41.3 56.1 64.3 52.3 50.5 52.2 49.2 43.0 61.0 54.5 1071 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL BODY WEIGHT GAINS (grams) OF Pi MALE RATS ' GROUP: III-O DOSE: 25 MG/KG/DAY TEST DAYS: ANIMAL NUMBER 643287 643188 643230 643170 643144 643277 643214 643261 643166 643153 643177 643198 643291 643184 643167 643223 643233 643183 643219 643263 78-85 85-92 92-99 99-106 78-106 3 .7 15 .2 18 .0 -2 .0 8 .2 12 .5 1 .0 17 .7 19 .2 13 .2 20 .0 13 .6 7 .1 -3 .9 25 .3 8 .5 15 .5 -2 .0 20 .7 17 .2 7 .1 18 .7 16 .6 14 .9 10 .7 23 .4 15 .3 16 .8 11 .9 16 .1 7 .6 6 .8 15 .6 11 .7 3 .5 5 .1 12 .7 11 .5 25 .9 18 .0 10 .2 18 .7 8 .6 14 .1 7 .8 19 .8 12 .2 22 .6 17 .2 19 .4 -2 .0 9 .1 17 .9 22 .4 14 .6 2 .8 18 .0 11 .1 13 .6 9 .5 4.6 16.9 2.6 13.1 9.8 14.2 17.5 10.7 15.7 10.8 8.3 7.5 8.9 -18.1 7.5 11.0 7.1 8.9 6.7 3.3 25.6 69.5 45.8 40.1 36.5 69.9 46.0 67.8 64.0 59.5 33.9 37.0 49.5 12.1 50.9 27.4 53.3 29.5 66.9 48.0 1072 Company Sanitized. Does not contain TSCACB1 INDIVIDUAL BODY WEIGHT GAINS (grams) OF Pi MALE RATS GROUP: V-0 DOSE: 100 MG/KG/DAY TEST DAYS: ANIMAL NUMBER 643313 643182 . 643146 643312 643199 643267 643216 643244 643245 643301 643200 643255 643157 643238 643227 643164 643154 643156 643208 643190 78 -85 85 -92 92 -99 99 -106 78 -106 3 .5 23 .7 17 .9 11 .2 13 .5 21 .3 22 .2 9 .4 7 .4 16 .8 15 .3 -1 .1 18 .8 7 .7 13 .6 12 .0 6 .2 12 .5 3 .9 -1 .3 12 .7 14 .1 21 .0 9 .7 -5 .4 4 .0 8 .0 12 .7 15 .0 19 .3 16 .4 19 .0 14 .1 -8 .1 9 .0 11 .3 14 .4 15 .1 1 .3 0 .5 11 .0 26 .7 14 .1 8 .6 1 .7 12 .0 6 .4 22 .1 7 .6 5 .3 13 .2 18 .4 14 .2 0 .6 10 .1 10 .2 -25 ,1 11 .6 9 .0 15 .3 -2 .2 5 .6 -0 .9 9 .0 1 .4 -23 .3 -47 .7 -9 .4 -3 .2 14 .4 5 .3 3 .3 5 .4 -1 .4 14 .8 13 .8 2 .3 -7 .8 -75 .0 -3 .8 25 .0 70 .1 52 .1 38 .5 11 .2 14 .0 -11 .1 34 .8 26 .8 55 .8 50 .2 39 .6 52 .5 -1 .2 47 .5 47 .3 -2 .2 31 .4 -60 .8 10 .7 1073 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL BODY WEIGHT GAINS (grams) OF Pi MALE RATS GROUP: VI I-0 DOSE: 250 MG/KG/DAY TEST DAYS: ANIMAL NUMBER 643289 643171 643158 643249 643161 643248 643285 643278 643299 643274 643192 643222 643160 643191 643203 643282 643302 643317 643281 78-85 85-92 92-99 99-106 78-106 27 .8 35 .7 18 .8 29 .5 36 .7 28 .2 13 .9 11 .0 28 .8 17 .7 21 .4 -0 .8 3 .9 9 .8 25 .7 21 .0 39 .9 24 .5 8 .4 8 .6 20 .9 19 .8 26 .0 24 .7 6 .7 15 .4 6 .3 9 .9 2 .3 15 .6 17 .0 4 .1 19 .1 20 .3 27 .4 27 .0 6 .7 5 .9 9 .3 18 .9 8 .8 10 .9 9 .0 -45 .1 7 .5 16 .1 8 .0 4 .1 18 .3 6 .9 8 .9 -9 .5 15 .3 27 .2 24 .1 7 .3 3 .8 4 .9 15 .8 7 .4 10 .9 10 .9 -21 .7 14 .9 10 .2 13 .8 3 .8 7 .1 1 .7 6 .9 0 .9 9 .9 20 .5 16 .0 10 .7 12 .2 50 .6 91 .3 54 .8 77 .3 81 .3 -31 .9 51 .7 43 .6 60 .5 27 .9 62 .4 24 .8 23 .8 20 .3 71 .2 96 .1 107 .0 49 .2 30 .3 1074 Company Sanitized. Does not contain TSCA CBI APPENDIX Q REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHTS OF Pi FEMALE RATS DURING GESTATION 1075 Company Sanitized. Does not contain TSCA CBI H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHTS OF Pi FEMALE RATS DURING GESTATION EXPLANATORY NOTES Footnotes a No litter delivered; data excluded from statistical analysis. b No gestation data since no copulation plug was observed; no litter was delivered. c Data not collected due to error. d No litter delivered, however, implants were observed at necropsy. Data was excluded from statistical analysis. e No gestation data since no plug was observed, however a Utter was delivered. / Dam delivered prior to collection of Day 21 G body weight. g Accidentally killed Test Day 91 (Day 14G). 1076 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL BODY WEIGHTS (grams) OF Pi FEMALE RATS DURING GESTATION GROUP: II-O DOSE: 0 MG/KG/DAY GESTATION DAYS: ANIMAL NUMBER 6433523 643343 643459 6433943 643480 6433192' 643350S 643363 643397 643421 643420s 643419 643414^ 643401 643455 643378 643393^ 643447 643478 643386 14 21 306.1 274.2 318.3 302.2 304.6 306.1 336.7 311.1 269.9 365.6 357.8 343.8 269.6 281.1 359.5 322.0 281.7 287.7 328.9 294.4 355.7 333.8 334.7 311.0 361.8 332.2 301.7 403.0 396.0 381.6 299.9 313.9 383.3 350.3 308.9 308.0 339 .3 322 .4 382 .0 344 .3 363 .5 327 .3 400 .1 369 .3 339 .6 426 .8 428 .2 416 .5 332 .9 340 .2 419 .9 394 .3 340 .8 337 .5 322.7 394.4 478.0 349.9 451.6 318.2 476.5 -C -C 397.9 533.9 370.9 421.3 444.7 471.9 -C 433.1 426.7 1077 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL BODY WEIGHTS (grams) OF Pi FEMALE RATS DURING GESTATION GROUP: IV-0 DOSE: 25 MG/KG/DAY GESTATION DAYS: ANIMAL NUMBER 643399 643334 643464 643369 643490 643342 643438 6434453 643418 643325 643479 6434033 643376 643422'^ 643452 643475 643372 643400 643395 643457 0 7 14 21 307 .2 292 .4 327 .7 309 .8 301 .0 345 .8 306 .5 391 .8 303 .8 363 .9 - 297 .8 315 .9 349 .0 336 .1 345 .7 315 .4 275 .4 289 .7 307 .2 341 .6 317 .4 348 .1 352 .4 340 .4 375 .2 325 .8 415 .8 335 .6 404 .7 - 323 .0 336 .2 374 .6 375 .7 374 .3 339 .9 287 .3 316 .7 339 .9 366 .8 358 .6 386 .5 386 .7 375 .9 412 .3 345 .9 434 .8 364 .5 388 .7 - 333 .3 368 .6 401 .0 392 .3 383 .9 358 .4 322 .4 339 .3 368 .8 447 .7 C C - 499. .2 437 .9 511 .0 408 .7 422 .7 451 .1 555 .5 - 313 .9 f - 400 .1 445 .3 386 .7 489 .6 371 .4 C C - 1078 Company SanTzed. Does not conta'n TSCA CBI INDIVIDUAL BODY WEIGHTS (grams) OF PI FEMALE RATS DURING GESTATION GROUP: VI-0 DOSE: 100 MG/KG/DAY GESTATION DAYS: ANIMAL NUMBER 643320 6434883 643428 643439 643353 6433853 643339 6434733 643337 643416 643407 6433573 643331 643427 643470^ 643434 643349 643454 643333 643460 0 7 14 21 312 .5 288 .9 321 .4 294 .8 310 .0 310 .4 304 .7 274 .2 315 .0 271 .5 326 .2 278 .6 313 .6 271 .9 - 297 .8 304 .1 312 .3 266 .4 309 .6 338 .6 311 .2 348 .9 327 .5 346 .8 312 .8 333 .5 288 .1 341 .1 301 .1 358 .4 283 .3 336 .7 299 .6 - 338 .9 345 .1 342 .2 311 .5 331 .7 371 .2 433 .2 326 .3 308 .7 379 .2 455 .2 360 .1 463 .4 381 .7 452 .3 331 .6 301 .9 363 .9 C - 301 .6 296 .6 377 .7 . C 329 .5 385 .2 405 .3 C - 287 .5 282 .7 366 .4 410 .5 333 .8 381 .4 - - 362 .3 376 .0 . 373 .7 345 .5 363 .1 454 .8 498 .7 C - 373 .0 451 .8 1079 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL BODY WEIGHTS (grams) OF Pi FEMALE RATS DURING GESTATION GROUP: VIII-0 DOSE: 250 MG/KG/DAY GESTATION DAYS: ANIMAL NUMBER 643467 643443 643417 643413 643338 643335^ 643468 643440 643430^ 643431-b 643326 643365 643375 643328 6433483 643346 643449 643429 6434243 0 7 14 21 276.6 255.0 331.7 284.5 295.4 - 273.8 292.0 272.4 - 312.0 318.5 312.8 302.1 265.7 307.5 328.1 314.1 240.8 319.8 300.5 364.9 307.1 322.1 - 310.0 327.6 280.6 - 325.1 350.8 361.7 346.1 276.0 263 .6 361.6 348.0 267.8 345.2 336.0 399.2 341.1 354.6 - 347.3 363.4 282.2 - 362.0 369.8 401.2 384.5 283.4 -9 386.4 382.6 281.8 436.3 415.1 495.7 433.6 447.5 - 440.3 476.6 267.0 - 443.6 435.4 -C -C 283.7 -g 493.9 371.4 283.8 1080 Company Sand-zed. Does not contain TSCA CBI APPENDIX R REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHT GAINS OF Pi FEMALE RATS DURING GESTATION 1081 Company Sanitized. Does not contain TSCA CBI H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHT GAINS OF Pi FEMALE RATS DURING GESTATION EXPLANATORY NOTES Footnotes a No litter delivered; data excluded from statistical analysis. b No gestation data since no copulation plug was observed; no litter was delivered. c Data not collected due to error. d No litter delivered, however, implants were observed at necropsy. Data was excluded from statistical analysis. e No gestation data since no plug was observed, however a litter was delivered. / Dam delivered prior to collection of day 21 G body weight. g Accidentally killed Test Day 91 (Day 14G). 1082 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL BODY WEIGHT GAINS (grams) OF Pi FEMALE RATS DURING GESTATION GROUP: II-O DOSE: 0 MG/KG/DAY GESTATION DAYS: ANIMAL NUMBER 6433523 643343 643459 6433943 643480 6433192? 6433503 643363 643397 643421 6434203 643419 643414'3 643401 643455 643378 643393^ 643447 643478 643386 0-7 7-14 14-21 0-21 22 .8 20 .2 37 .4 31 .6 30 .1 4 .9 25 .1 21 .1 31 .8 37 .4 38 .2 37 .8 30 .3 32 .8 23 .8 28 .3 27 .2 20 .3 10 .4 28 .0 26 .3 10 .5 28 .8 16 .3 38 .3 37 .1 37 .9 23 .8 32 .2 34 .9 33 .0 26 .3 36 .6 44 .0 31 .9 29 .5 -16 .6 72 .0 96 .0 5 .6 88 .1 -9 .1 76 .4 C a - -28 .9 105 .7 -45 .6 88 .4 104 .5 52 .0 -C 92 .3 89 .2 16 .6 120 .2 159 .7 47 .7 147 .0 12 .1 139 .8 -C -C 32 .3 176 .1 27 .1 151 .7 163 .6 112 .4 -C 151 .4 139 .0 1083 Company Sanitized. Does not contain TSCACBI INDIVIDUAL BODY WEIGHT GAINS (grams) OF Pi FEMALE RATS DURING GESTATION GROUP: IV-0 . DOSE: 25 MG/KG/DAY GESTATION DAYS: ANIMAL NUMBER 643399 643334 643464 643369 643490 643342 643438 643445s 643418 643325 643479S 6434033 643376 643422^ 643452 643475 643372 643400 643395 643457 0 -7 7-14 14-21 0-21 34 .4 25 .0 20 .4 42 .6 39 .4 29 .4 19 .3 24 .0 31 .8 40 .8 - 25 .2 20 .3 25 .6 39 .6 28 .6 24 .5 11 .9 27 .0 32 .7 25.2 41.2 38.4 34.3 35.5 37.1 20.1 19.0 28.9 -16.0 - 10.3 32.4 26.4 16.6 9.6 18.5 35.1 22.6 28.9 80.9 -C -C 112.5 62.0 98.7 62.8 -12.1 86.6 166.8 - -19.4 f -0.9 53.0 2.8 131.2 49.0 -C -C 140.5 -C -C 189.4 136.9 165.2 102.2 30.9 147.3 191.6 - 16.1 f 51.1 109.2 41.0 174.2 96.0 -C -C 1084 S.n^.O---------"^01'1 Company INDIVIDUAL BODY WEIGHT GAINS (grams) OF Pi FEMALE RATS DURING GESTATION GROUP: VI-0 DOSE: 100 MG/KG/DAY GESTATION DAYS: ANIMAL NUMBER 643320 643488-3 643428 643439 643353 6433853 643339 6434733 643337 643416 643407 643357^ 643331 643427 643470^ 643434 643349 643454 643333 643460 0-7 7- 14 14-21 0-21 26.1 22.3 27.5 32.7 36.8 2.4 28.8 13.9 26.1 29.6 32.2 4.7 23.1 27.7 41.1 41.0 29.9 45.1 22.1 32 .6 15 .1 30 .3 32 .6 34 .9 18 .8 30 .4 13 .5 36 .6 28 .4 46 .9 4 .2 29 .7 34 .2 23 .4 30 .9 31 .5 34 .0 31 .4 62.0 -17.6 76.0 103.3 70.6 -29.7 -C -5.0 -C 55.7 -C -4.8 44.1 47.6 92.5 122.7 -C 27.5 88.7 120.7 19.8 133.8 168.6 142.3 -8.5 c 22.4 -C 113.7 -C 4.1 96.9 109.5 157.0 194.6 -C 106.6 142.2 1085 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL BODY WEIGHT GAINS (grams) OF Pi FEMALE RATS DURING GESTATION GROUP: VIII-0 DOSE: 250 MG/KG/DAY GESTATION DAYS: AMIMAL NUMBER 643467 643443 643417 643413 643338 6433356 643468 643440 6434303 643431^ 643326 643365 643375 643328 6433483 643346 643449 643429 6434243 0-7 7-14 14-21 0- 21 43.2 45.5 33,2 22.6 26.7 - 36.2 35.6 8.2 - 13.1 32.3 48.9 44.0 10.3 -43.9 33.5 33.9 27.0 25.4 35.5 34.3 34.0 32.5 - ' 37.3 35.8 1.6 - 36.9 19.0 39.5 38.4 7.4 -g 24.8 34.6 14.0 91.1 79.1 96.5 92.5 92.9 - 93.0 113.2 -15.2 - 81.6 65.6 -C -C 0.3 -9 107.5 -11.2 2.0 159 .7 160 .1 164 .0 149 .1 152 .1 - 166 .5 184 .6 -5 .4 - 131 .6 116 .9 C - C - 18 .0 - 9 165 .8 57 .3 43 .0 1086 Company Sanitized. Does not contain TSCACB1 APPENDIX S REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHTS OF Pi FEMALE RATS DURING LACTATION 1087 Company Sanitized. Does not contain TSCA CSS H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHTS OF Pi FEMALE RATS DURING LACTATION EXPLANATORY NOTES Footnotes a No litter delivered. b No litter delivered, however, implants were observed at necropsy. Data was excluded from statistical analysis. c Found Dead Test Day 99 (Day 22G). d Accidentally killed Test Day 91 (Day 14G). e Found dead Test Day 106 (Lactation Day 0). 1088 Company Sanded. Does not contain T8CA C6) INDIVIDUAL BODY WEIGHTS (grams) OF Pi FEMALE RATS DURING LACTATION GROUP: II-O DOSE: 0 MG/KG/DAY LACTATION DAYS: 0 ANIMAL NUMBER 7 14 21 643352^ 643343 643459 6433943 643480 6433193 6433503 643363 643397 643421 6434203 643419 643414-13 643401 643455 643378 6433933 643447 643478 643386 297.4 360.5 331.7 367.4 356.1 320.1 412.6 312.9 305.9 389.9 387.7 320.5 329.0 319.1 378.4 353.2 335.8 392.7 361.0 380.0 300.2 320.1 398.0 324.1 327.2 372.2 376.9 321.5 339.2 392.4 358.8 283.8 414.8 338.7 343.3 375.9 -387.2 355.5 347.9 336.3 377.8 330.8 379.1 361.1 286.3 402.9 324.0 331.8 376.7 365.9 339.1 354.3 1089 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL BODY WEIGHTS (grams) OF Pi FEMALE RATS DURING LACTATION GROUP: IV-0 DOSE: 25 MG/KG/DAY LACTATION DAYS: ANIMAL NUMBER 643399 643334 643464 643369 643490 643342 643438 6434453 643418 643325 643479 643403s 643376 643422^ 643452 643475 643372 643400 643395 643457 14 21 340 .9 328 .5 369 .8 360 .2 325 .7 381 .6 336 .3 - 352 .7 435 .4 341 .2 - 343 .9 - 324 .7 367 .9 363 .1 301 .4 336 .2 368 .5 352 .7 346 .8 306 .1 375 .6 354 .9 377 .3 339 .9 - 353 .4 434 .8 301 .7 - 337 .0 - 334 .1 372 .6 347 .0 322 .5 345 .5 370 .5 387 .6 370 .7 385 .7 398 .1 388 .4 397 .8 368 .7 - 368 .1 431 .8 370 .2 - 371 .9 - 375 .4 394 .0 374 .3 344 .7 364 .6 383 .5 342 .4 355 .0 391 .5 377 .9 353 .7 381 .8 352 .0 - 346 .4 405 .7 358 .6 - 366 .9 - 375 .0 388 .9 346 .7 356 .0 350 .5 371 .1 1090 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL BODY WEIGHTS (grams) OF Pi FEMALE RATS DURING LACTATION GROUP: VI-0 DOSE: 100 MG/KG/DAY LACTATION DAYS: ANIMAL NUMBER 643320 6434883 643428 643439 643353 6433853 643339 643473s 643337 643416 643407 6433573 643331 643427 6434703 643434 643349 643454 643333 643460 14 21 376.8 - 354.8 353.1 379.7 - 338.5 - 367.8 330.7 318.1 - 294.7 292.9 - 335.9 354.1 - 270.6 353.6 371.7 - 374.9 353.0 374.0 _ 346.9 - 373.5 319.5 328.4 - 345.0 334.4 - 355.2 369.3 - 341.2 313.3 370.7 - 390.6 374.6 393.0 - 378.5 - 389.2 350.1 341.4 - 379.3 341.2 - 376.9 390.1 - 371.2 353.0 367.8 - 380.6 363.0 360.9 - 353.0 - 381.7 341.5 356.3 - 378.3 329.2 - 360.8 365.2 - 346.8 360.0 1091 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL BODY WEIGHTS (grams) OF Pi FEMALE RATS DURING LACTATION GROUP: VIII-0 DOSE: 250 MG/KG/DAY LACTATION DAYS: ANIMAL NUMBER 643467 643443 643417 643413 643338 643335 643468 643440 643430^ 6434313 643326 643365 643375 643328 6433483 643346'3 643449 643429 6434243 14 21 345 .3 316 .1 388 .9 324 .2 328 .8 328 .7 319 .8 345 .3 336 .2 353 .2 365 .3 327 .5 363.0 350 .1 331 .3 408 .9 343 .5 341 .2 359 .9 322 .9 304 .2 348 .6 353 .4 366 .3 340 .3 370.6 362 .8 352 .8 415 .0 348 .9 371 .8 319 .0 348 .4 384 .3 375 .2 371 .2 368 .3 305 .6 391.2 345 .4 259 .3 306 .4 283 .6 357 .6 362 .4 319 .3 390 .6 361 .5 380 .5 378 .7 312 .4 377.1 1092 Company Sanitized. Does not contain TSCA CBf APPENDIX T REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHT GAINS OF Pi FEMALE RATS DURING LACTATION 1093 Company Sanitized. Does not contain TSCACM ^T H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHT GAINS OF Pi FEMALE RATS DURING LACTATION EXPLANATORY NOTES Footnotes a No litter delivered. b No litter delivered, however, implants were observed at necropsy. Data were excluded from statistical analysis. c Found Dead Test Day 99 (Day 22G). d Accidentally killed Test Day 91 (Day 14G). e Found Dead Test Day 106 (Lactation Day 0). 1094 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL BODY WEIGHT GAINS (grams) OF Pi FEMALE RATS DURING LACTATION GROUP: II-O DOSE: 0 MG/KG/DAY LACTATION DAYS: ANIMAL NUMBER 6433523 643343 643459 . 6433943 643480 6433193 6433503 643363 643397 643421 6434203 643419 643414h 643401 643455 643378 6433933 643447 643478 643386 0-7 7-14 14-21 0-21 - 21.7 17.9 - 21.5 - - 12.6 -55.9 0.0 _ -14.6 - 11.2 21.3 -17.7 - -10.8 1.0 10.2 - 16.7 14.3 - 7.8 - - 12.4 58.6 -36.3 - 16.8 - 14.6 16.1 3.7 - 10.3 34.0 8.7 - 0.5 -14.9 . -30.2 - - -13.3 2.3 2.5 - -11.9 - -14.7 -11.5 0.8 - -21.3 -16.4 6.4 - 38.9 17.3 - -0.9 - - 11.7 5.0 -33.8 - -9.7 - 11.1 25.9 -13.2 - -21.8 18.6 25.3 1095 Company Sanitized. Does not contain TSCA CBl INDIVIDUAL BODY WEIGHT GAINS (grams) OF P^ FEMALE RATS DURING LACTATION GROUP: IV-0 DOSE: 25 MG/KG/DAY LACTATION DAYS: ANIMAL NUMBER 643399 643334 643464 643369 643490 643342 643438 643445^ 643418 643325 643479 643403^ 643376 643422^ 643452 643475 643372 643400 643395 643457 0-7 7-14 14-21 0-21 11.8 18.3 63.7 15.4 29.2 -4.3 3.6 0.7 -0.6 39.5 -6.9 9.4 4.7 16.1 21.1 9.3 2.0 34 .9 23 .9 79 .6 22 .5 33 .5 20 .5 28 .8 14 .7 -3 .0 68.5 34 .9 41 .3 21 .4 27 .3 22 .2 19 .1 13 .0 -45.2 -15.7 5.8 -20.2 -34.7 -16.0 -16.7 -21.7 -26.1 -11.6 -5.0 -0.4 -5.1 -27.6 11.3 -14.1 -12.4 1.5 26.5 21.7 17.7 28.0 0.2 15.7 -6.3 -29.7 17.4 23.0 50.3 21.0 -16.4 54.6 -14.3 2.6 1096 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL BODY WEIGHT GAINS (grams) OF Pi FEMALE RATS DURING LACTATION GROUP: VI-0 DOSE: 100 MG/KG/DAY LACTATION DAYS: ANIMAL NUMBER 643320 6434883 643428 643439 643353 6433853 643339 6434733 643337 643416 643407 6433573 643331 643427 6434703 643434 643349 643454 643333 643460 0 -7 -5 .1 - 20 .1 -0 .1 -5 .7 - 8 .4 - 5 .7 -11 .2 10 .3 - 50 .3 41 .5 - 19 .3 15 .2 - 70 .6 -40 .3 7-14 14- 21 0-21 -1.0 - 15.7 21.6 19.0 - 31.6 - 15.7 30.6 13.0 - 34.3 6.8 - 21.7 20.8 - 30.0 39.7 -2 .9 - -10 .0 -11 .6 -32 .1 - -25 .5 - -7 .5 -8 .6 14 .9 - -1 .0 -12 .0 - -16 .1 -24 .9 - -24 .4 7 .0 -9.0 - 25.8 9.9 -18.8 - 14.5 - 13.9 10.8 38.2 - 83.6 36.3 - 24.9 11.1 - 76.2 6.4 1097 CgoommnpwanvySSa"ann*ii(gMeJ-d.l9Dooaesno ^i c-on<tainwT<SC^A^OgB( 7 INDIVIDUAL BODY WEIGHT GAINS (grams) OF Pi FEMALE RATS DURING LACTATION GROUP: VIII-0 DOSE: 250 MG/KG/DAY LACTATION DAYS: ANIMAL NUMBER 643467 643443 643417 643413 643338 643335 643468 643440 6434303 6434313 643326 643365 643375 643328 6433483 643346^ 643449 643429 6434243 0-7 7-14 14-21 0-21 4 .8 15 .2 20 .0 19 .3 12 .4 31 .2 3 .1 -41 .1 - - 12 .4 0 .2 1 .0 12 .8 - - 7 .6 - - 12 .7 21 .5 6 .1 5 .4 30 .6 -40 .9 25 .5 80 .1 - - 26 .6 17 .8 2 .0 -34 .7 - - 20 .6 - - -17. 4 -93. 5 -108. 6 -65. 3 -14. 2 43. 4 -29. 1 6. 3 - - -13. 7 9. 3 10. 4 6. 8 - - -14. 1 - - 0. 1 -56. 8 -82. 5 -40. 6 28. 8 33. 7 -0. 5 45. 3 - - 25. 3 27. 3 13. 4 -15. 1 - - 14. 1 - - 1098 Company Sanitized. Does not contain TSCA CB1 APPENDIX U REPRODUCTIVE TOXICOLOGY INDIVIDUAL DAILY FOOD CONSUMPTION BY Pi FEMALE RATS DURING GESTATION 1099 Company Sanitized. Does not contain TSCA CBI H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 REPRODUCTIVE TOXICOLOGY INDIVIDUAL DAILY FOOD CONSUMPTION BY Pi FEMALE RATS DURING GESTATION EXPLANATORY NOTES Footnotes a No litter delivered; data excluded from statistical analysis. b No gestation data since no plug was observed; no litter was delivered. c No litter delivered, however, implants were observed at necropsy. Data were excluded from statistical analysis. d No gestation data since no plug was observed, however a litter was delivered. e Accidentally killed Test Day 91 (Day 14G). 1100 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL DAILY FOOD CONSUMPTION (grams) BY Pi FEMALE RATS DURING GESTATION GROUP: II-O DOSE: 0 MG/KG/DAY GESTATION DAYS: ANIMAL NUMBEF| 6433523 643343 643459 6433943 643480 643319^ 6433503 643363 643397 643421 6434203 643419 643414^ 643401 643455 643378 643393^ 643447 643478 643386 0 -7 24 .5 20 .9 26 .3 27 .7 15 .4 21 .6 29 .6 25 .9 23 .3 34 .6 30 .0 30 .8 25 .5 23 .2 . 27 .5 27 .2 25 .3 21 .8 7- 14 14-2 1 25 .8 25 .1 27 .7 25 .9 30 .3 26 .3 32 .5 28 .1 27 .9 35 .1 32 .3 29 .4 29 .0 37 .1 32 .6 31 .4 27 .2 22 .7 19. 8 25. 0 25. 2 25. 4 9. 0 21. 8 30. 1 28. 4 26. 2 22. 1 31. 2 23. 6 29. 4 24. 6 28. 8 30. 9 26. 3 23. 8 0- 21 23 .4 23 .7 26 .4 26 .4 18 .2 23 .2 30 .7 27 .5 25 .8 30 .6 31 .2 27 .9 28 .0 28 .3 29 .6 29 .8 26 .3 22 .8 1101 Company Sanitized. Does not contain TSCA CBt INDIVIDUAL DAILY POOD CONSUMPTION (grams) BY Pi FEMALE RATS DURING GESTATION GROUP: IV-0 DOSE: 25 MG/KG/DAY GESTATION DAYS: ANIMAL NUMBER 643399 643334 643464 643369 643490 643342 643438 643445s 643418 643325 643479..d 643403^ 643376 643422C 643452 643475 643372 643400 643395 643457 0 -7 23 .8 24 .1 ..23 .4 27 .6 27 .8 28 .5 20 .4 26 .1 25 .2 32 .1 - 22 .9 22 .6 24 .1 27 .1 26 .7 21 .5 23 .7 24 .0 25 .5 7-1.4 14- 21 28. 3 26. 0 26. 1 27. 4 28. 8 28. 9 22. 4 28. 4 26. 5 35. 4 - 22. 9 24. 6 31. 2 27. 4 26. 2 22. 3 24. 1 23. 5 28. 5 27 .8 27 .3 27 .1 24 .6 27 .0 29 .1 26 .4 6 .5 24 .8 37 .1 - 19 .5 26 .4 29 .3 26 .6 24 .4 32 .5 25 .0 22 .9 26 .4 0- 21 26 .6 25 .8 25 .5 26 .5 27 .9 28 .8 23 .1 20 .3 25 .5 34 .9 - 21 .7 24 .6 28 .2 27 .0 25 .8 25 .4 24 .3 23 .5 26 .8 1102 Company Sanitized. Does not contain TSCA C31 INDIVIDUAL DAILY FOOD CONSUMPTION (grams) BY Pi FEMALE RATS DURING GESTATION GROUP: VI-0 DOSE: 100 MG/KG/DAY GESTATION DAYS: ANIMAL NUMBER 643320 6434883 643428 643439 643353 6433853 643339 6434733 643337 643416 643407 643357S 643331 643427 64347023 643434 643349 643454 643333 643460 0- 7 7-1.4 14-2 1 0- 21 26. 8 22. 5 25. 6 25. 2 28. 3 21. 0 26. 8 22. 3 23. 3 24. 9 27. 9 17. 7 22. 9 22. 8 - 30. 0 25. 6 26. 7 26. 9 23. 8 32. 4 24. 2 27. 7 28. 8 30. 1 22. 4 27. 6 22. 8 29. 8 27. 5 30. 7 21. 2 27. 2 25. 0 - 28. 0 26. 7 28. 1 29. 8 . 26. 9 29. 5 16. 8 26. 7 28. 1 30. 5 18. 3 28. 7 19. 0 33. 4 27. 0 26. 8 18. 2 22. 3 23. 4 - 26. 3 21. 5 26. 6 26. 6 28. 1 29 .6 21 .2 26 .7 27 .4 29 .6 20 .6 27 .7 21 .3 28 .8 26 .4 28 .5 19 .1 24 .1 23 .7 - 28 .1 24 .6 27 .1 27 .8 26 .3 1103 Company Sanitized. Does not contain TSCA CSf INDIVIDUAL DAILY FOOD CONSUMPTION (grams) BY Pi FEMALE RATS DURING GESTATION GROUP: VIII-0 DOSE: 250 MG/KG/DAY GESTATION DAYS: ANIMAL NUMBER 643467 643443 643417 643413 643338 643333d 643468 643440 643430^ 643431^ 643326 643365 643375 643328 6433483 643346 643449 643429 6434243 0 -7 7- 14 14-2 1 0-21 32 .1 25 .5 27 .0 29 .1 25 .3 26 .7 28 .9 25 .4 25 .1 29 .6 27 .7 30 .5 24 .0 14 .3 31 .0 22 .5 19 .4 30 .2 . 26 .3 26 .4 28 .6 29 .4 27 .7 29 .5 22 .1 27 .7 30 .5 31 .7 32 .2 24 .2 36 .8 26 .1 25 .3 22 .7 31. 7 23. 8 24. 3 18. 7 32. 4 28. 9 26. 3 17. 3 28. 7 27. 0 30. 0 27. 0 23. 9 -e 28. 8 . 17. 3 21. 0 31.3 25.2 25.9 25.5 29.0 27.8 28.2 21.6 27.2 29.0 29.8 29.9 24.0 -e 28.7 21.7 21.0 1104 Company Sanitized. Does not contain TSCA CBI APPENDIX V REPRODUCTIVE TOXICOLOGY INDIVIDUAL CLINICAL OBSERVATIONS IN Pi MALE RATS 1105 Company Sanitized. Does not contain TSCA CBl INDIVIDUAL CLINICAL OBSERVATIONS IN Pi MALE RATS GROUP: 1-0 DOSE: 0 MG/KG/DAY ANIMAL NUMBER OBSERVATION FIRST DAY OBSERVED LAST DAY OBSERVED 643239 643270 643148 643284 643229 643196 643176 643218 643207 643280 643271 . 643211 643163 643197 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108 ALOPECIA RIGHT FRONT PAW(S) ALOPECIA BOTH FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 108 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 85 85 92 108 1106 Company Sanitized. Does not contain TSCA CO) INDIVIDUAL CLINICAL OBSERVATIONS IN PI MALE RATS GROUP: 1-0 DOSE: 0 MG/KG/DAY AMIMAL NUMBER OBSERVATION FIRST DAY OBSERVED LAST DAY OBSERVED 643242 643251 643155 643147 643276 643254 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 1107 Company Sanitized. Does not contain TSCACBI INDIVIDUAL CLINICAL OBSERVATIONS IN Pi MALE RATS GROUP: III-O DOSE: 25 MG/KG/DAY ANIMAL NUMBER OBSERVATION FIRST DAY OBSERVED LAST DAY OBSERVED 643287 643188 643230 643170 643144 643277 643214 643261 643166 643153 643177 643198 643291 643184 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107 .NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 1108 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL CLINICAL OBSERVATIONS IN Pi MALE RATS GROUP: III-O DOSE: 25 MG/KG/DAY ANIMAL NUMBER OBSERVATION FIRST DAY OBSERVED LAST DAY OBSERVED 643167 643223 643233 643183 643219 643263 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 1109 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL CLINICAL OBSERVATIONS IN Pi MALE RATS GROUP: V-0 DOSE: 100 MG/KG/DAY ANIMAL NUMBER OBSERVATION FIRST DAY OBSERVED LAST DAY OBSERVED 643313 643182 643146 643312 643199 643267 643216 643244 643245 643301 643200 643255 643157 643238 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107 ALOPECIA BOTH FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 107 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108 ALOPECIA LEFT FRONT PAW(S) ALOPECIA LEFT FRONT LEG(S) SACRIFICED BY DESIGN TEST DAY 108 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED, SACRIFICED BY DESIGN TEST DAY 109 85 107 85 108 85 108 1110 Company SanilAeti. uues ut contain TSCACBI INDIVIDUAL CLINICAL OBSERVATIONS IN Pi MALE RATS GROUP: V-0 DOSE: 100 MG/KG/DAY ANIMAL NUMBER OBSERVATION FIRST DAY OBSERVED LAST DAY OBSERVED 643227 643164 643154 643156 643208 643190 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 1111 Company Sanitized. Does not contain TSCA CB( INDIVIDUAL CLINICAL OBSERVATIONS IN Pi MALE RATS GROUP: VI I-0 DOSE: 250 MG/KG/DAY ANIMAL NUMBER OBSERVATION FIRST DAY OBSERVED LAST DAY OBSERVED 643289 643171 643158 643249 643161 643248 643285 643278 643299 643274 643192 643222 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107 COLORED DISCHARGE RIGHT EYE(S) RED TEETH CLIPPED ALOPECIA BOTH FRONT LEG(S) ALOPECIA BOTH FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 107 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107 TEETH CLIPPED SACRIFICED BY DESIGN TEST DAY 107 TEETH CLIPPED COLORED DISCHARGE NOSE BLACK COLORED DISCHARGE BOTH EYE(S) TEETH CROOKED COLORED DISCHARGE RIGHT EYE(S) SACRIFICED BY DESIGN TEST DAY RED RED 108 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108 TEETH CLIPPED SACRIFICED BY DESIGN TEST DAY 108 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 85 92 85 85 99 107 99 107 85 85 85 92 99 106 99 106 99 108 108 108 85 85 1112 Company Sanitized. Does noi contain TSCA CBI INDIVIDUAL CLINICAL OBSERVATIONS IN Pi MALE RATS GROUP: VI I-0 DOSE: 250 MG/KG/DAY ANIMAL NUMBER OBSERVATION FIRST DAY OBSERVED LAST DAY OBSERVED 643160 643191 643203 643282 643302 643317 643281 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 TEETH CLIPPED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109 85 92 113 Company S^,t..eQ. uoes noi contain TSCACBI H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-5386 APPENDIX W REPRODUCTIVE TOXICOLOGY INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING GESTATION 1114 Company Sanitized. Does not contain TSCACBl H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations REPRODUCTIVE TOXICOLOGY DuPont-5386 INDIVIDUAL CLINICAL OBSERVATIONS DM Pi FEMALE RATS DURING GESTATION Footnotes EXPLANATORY NOTES a Copulation plug observed but no litter delivered. b Data not collected on day 21 due to error. c No litter delivered, however, implantation sites observed at necropsy. Notes This appendix includes only signs from rats with copulation plug observed. 1115 Company Sanitized. Does not contain TSCA CB1 H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-5386 INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING GESTATION GROUP: II-O DOSE: 0 MG/KG/DAY ANIMAL NUMBER OBSERVATION FIRST DAY OBSERVED LAST DAY OBSERVED 6433523 643343 643459 643394s 643480 6433503 643363 643397^ 64342123 6434203 NO NO NO NO NO NO NO NO NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED ALOPECIA RIGHT FRONT LEG ALOPECIA RIGHT FRONT PAW 643419 ALOPECIA RIGHT SHOULDER SORE RIGHT SHOULDER ABNORMALITIES DETECTED 664433440114C ABNORMALITIES DETECTED ABNORMALITIES DETECTED 643455 ABNORMALITIES DETECTED 643378 ABNORMALITIES DETECTED 664433447487^ ABNORMALITIES DETECTED ABNORMALITIES DETECTED 643386 ABNORMALITIES DETECTED 21 21 21 21 21 21 21 21 11 Company Sanitized. Does not contain TSCACBI H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-5386 INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING GESTATION GROUP: IV-0 DOSE: 25 MG/KG/DAY ANIMAL NUMBER OBSERVATION FIRST DAY OBSERVED LAST DAY OBSERVED 643399 643334b 643464^ 643369 643490 643342 643438 6434453 643418 643325 6434033 643376 643422C 643452 643475 643372 643400 643395^ 643457^ NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED ALOPECIA RIGHT FRONT LEG(S) ALOPECIA BOTH FRONT LEG(S) NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED 14 21 1117 Company Sanitized. Does not contain TSCA CBI H-24516: Subchionic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-5386 INDIVIDUAL CLINICAL OBSERVATIONS IN PI FEMALE RATS DURING GESTATION GROUP: VI-0 DOSE: 100 MG/KG/DAY AMIMAL NUMBER OBSERVATION FIRST DAY OBSERVED LAST DAY OBSERVED 643320 6434883 643428 643439 643353 6433853 64333923 643473s 643337^ 643416 643407^ 6433573 643331 643427 643434 643349 643454!) 643333 643460 NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED STAINED ABDOMEN YELLOW NO ABNORMALITIES DETECTED ALOPECIA LEFT FRONT LEG(S) STAINED PERINEUM YELLOW NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED FOUND DEAD 03/20/01 (Test Day 99) NO ABNORMALITIES DETECTED ALOPECIA LEFT FRONT LEG(S) ALOPECIA BOTH FRONT LEG(S) 14 22 22 14 21 1118 Company Sanitized. Does not contain TSCA CBI H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-5386 INDIVIDUAL CLINICAL OBSERVATIONS IN P^ FEMALE RATS DURING GESTATION GROUP: VIII-0 DOSE: 250 MG/KG/DAY ANIMAL NUMBER OBSERVATION FIRST DAY OBSERVED LAST DAY OBSERVED 643467 ALOPECIA LEFT HIND QUARTERS 21 ALOPECIA RIGHT SIDE(S) 21 643443 NO ABNORMALITIES DETECTED 643417 NO ABNORMALITIES DETECTED 643413 NO ABNORMALITIES DETECTED 643338 NO ABNORMALITIES DETECTED 643468 NO ABNORMALITIES DETECTED 643440 NO ABNORMALITIES DETECTED 6434303 STAINED PERINEUM YELLOW WET PERINEUM 643326 NO ABNORMALITIES DETECTED 643365 NO ABNORMALITIES DETECTED 643375 NO ABNORMALITIES DETECTED 643328 NO ABNORMALITIES DETECTED 6433483 NO ABNORMALITIES DETECTED 643346 ACCIDENTALLY KILLED 03/12/01 (Test Day 91) 14 14 643449 NO ABNORMALITIES DETECTED 643429 ALOPECIA BOTH REAR LEG(S) ALOPECIA RIGHT FRONT LEG(S) TEETH CLIPPED ALOPECIA RIGHT FRONT PAW(S) DIARRHEA WET UNDERBODY STAINED PACE BROWN WEAK 0 21 0 14 0 0 21 21 21 21 21 21 21 21 21 21 6434243 NO ABNORMALITIES DETECTED 1119 Company Sanitized. Does not contain TSCA CBI APPENDIX X REPRODUCTIVE TOXICOLOGY INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING LACTATION 1120 Company Sanitized. Does not contain TSCACBI ^^ H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations __________DuPont-5386 REPRODUCTIVE TOXICOLOGY INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING LACTATION EXPLANATORY NOTES Footnotes a No copulation plug was observed, however, a litter was delivered. b Found dead prior to collection of Day 0 lactation clinical signs. Note This appendix includes clinical observations from lactating rats only. % 1121 Company Sanitized. Does not contain TSCA CBl INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING LACTATION GROUP: I.I-O DOSE: 0 MG/KG/DAY ANIMAL NUMBER OBSERVATION FIRST DAY OBSERVED LAST DAY OBSERVED 643343 643459 643480 643363 643397 643421 643419 643401 643455 643378 643447 643478 643386 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122 MO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 121 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 125 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122 ALOPECIA LEFT FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 126 21 21 1122 Company Sanitized. Does not contain TSCACBl INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING LACTATION GROUP: IV-0 DOSE: 25 MG/KG/DAY ANIMAL NUMBER OBSERVATION FIRST DAY OBSERVED LAST DAY OBSERVED 643399 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 132 643334 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120 643464 DISCHARGE VAGINAL OPENING RED SACRIFICED BY DESIGN TEST DAY 121 643369 ALOPECIA BOTH FRONT PAW(S) 21 SACRIFICED BY DESIGN TEST DAY 119 643490 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 119 643342 ALOPECIA BOTH FRONT LEG(S) 21 SACRIFICED BY DESIGN TEST DAY 123 643438 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 121 643418 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 125 643325 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 123 6434793 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120 643376 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120 643452 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120 643475 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120 643372 ALOPECIA BOTH FRONT PAW(S) 21 SACRIFICED BY DESIGN TEST. DAY 122 1123 .Company Sanitized. Does not contain TSCACBI INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING LACTATION GROUP: IV-0 DOSE: 25 MG/KG/DAY ANIMAL NUMBER OBSERVATION FIRST DAY OBSERVED LAST DAY OBSERVED 643400 643395 643457 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 121 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120 1124 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING LACTATION GROUP: VI-0 DOSE: 100 MG/KG/DAY ANIMAL NUMBER OBSERVATION FIRST DAY OBSERVED LAST DAY OBSERVED 643320 643428 643439 643353 643339 643337 643416 643407 643331 643427 643434 643349 643333 643460 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122 ALOPECIA BOTH FRONT LEG(S) SACRIFICED BY DESIGN TEST DAY 120 COLORED DISCHARGE NOSE BROWN ABNORMAL GAIT OR MOBILITY HUNCHED OVER DISCHARGE VAGINAL OPENING RED SACRIFICED BY DESIGN TEST DAY 120 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122 ALOPECIA BOTH FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 121 ALOPECIA RIGHT FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 120 ALOPECIA BOTH FRONT LEG(S) SACRIFICED BY DESIGN TEST DAY 120 21 14 21 21 21 21 1125 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING LACTATION GROUP: VII I-0 DOSE: 250 MG/KG/DAY ANIMAL NUMBER OBSERVATION FIRST DAY OBSERVED LAST DAY OBSERVED 643467 643443 643417 643413 643338 6433353 643468 643440 643326 643365 643375 643328 643449 64342927 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 125 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 119 TEETH CLIPPED ALOPECIA RIGHT FRONT LEG(S) ALOPECIA LEFT FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 119 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 121 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 125 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 121 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 121 NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST. DAY 125 FOUND DEAD TEST DAY 106 7 7 14 21 21 21 1126 Company Sanitized. Does not contain TSCA CBI APPENDIX Y INDIVIDUAL ANIMAL ESTROUS CYCLE PARAMETERS DURING PREMATING AND COHABITATION IN Pi FEMALE RATS 1127 Company Sanitized. Does not contain TSCA CBI H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 INDIVIDUAL ANIMAL ESTROUS CYCLE PARAMETERS DURING PREMATING AND COHABITATION IN PI FEMALE RATS EXPLANATORY NOTES Footnotes: a Mean cycle length was not calculable due to insufficient data. b No evidence of copulation was found; animal was not pregnant. c No precoital interval could be calculated since no evidence of copulation was found. d No evidence of copulation was found, but animal was pregnant. Data were excluded from statistical analysis since the animal was pregnant during part of the estrous cycle evaluation. Abbreviations: -- = No Data 1128 Company Sao.tAed. uos nu contain TSCA CBI ANIMAL NUMBER 643421 643397 643363 643350 643319^ 643480 643394 643459 643343 643352 643386 643478 643477 64339323 643378 643455 643401 643414 643419 643420 INDIVIDUAL ANIMAL ESTROUS CYCLE PARAMETERS DURING PREMATING AND COHABITATION GROUP II-O: 0 MG/KG/DAY NUMBER OF DAYS OF DATA ( SELECTION PERCENT OF DAYS IN ESTRUS PERCENT OF DAYS IN DIESTRUS PERCENT OF DAYS IN PROESTRU!3 W AN CYICLE LEKIGTH (da>ys) PRECOITAL INTERVAL (days) 23 22 65 22 23 50 25 24 64 27 89 7 35 71 23 24 21 75 25 20 68 21 19 71 24 21 75 22 27 73 29 : 24 59 25 24 68 23 17 78 35 26 54 27 22 67 24 25 58 23 26 65 22 32 50 25 24 56 30 23 63 13 3. 80 2 27 4. 00 2 12 4. 00 4 4 -- -a 6 6 10 .50 ---C 4 4. 00 3 12 4. 50 5 10 5. 33 1 4 4. 50 3 0 4. 00 1 17 4. 60 8 8 4. 00 4 4 4. 00 2 20 4. 00 ---C 11 4.25 6 17 5. 00 4 9 5. 00 3 18 4. 00 1 20 4. 00 4 13 6. 50 10 1129 C.mp,S^ed.D.esnot^"TSC*CB. INDIVIDUAL ANIMAL ESTROUS CYCLE PARAMETERS DURING PREMATING AND COHABITATION GROUP IV-0: 25 MG/KG/DAY ANIMAL NUMBER NUMBER OP DAYS OF DATA CX)LLECTION PERCENT OF DAYS IN ESTRUS PERCENT OP DAYS IN DIESTRUS PERCENT OF DAYS IN PROESTRUi3 M EAN C^FCLE LENGTH (days) PRECOITAL INTERVAL (days) 643325 26 643418 27 643445 24 643438 24 643342 26 643490 22 643369 22 643464 23 643334 23 643399 34 643457 23 643395 23 643400 24 643372 25 643475 21 643452 22 643422 24 643376 23 643403 22 64347913 35 31 58 26 70 17 71 8 79 31 54 23 73 36 59 13 78 22 70 18 68 22 74 13 70 25 67 24 48 19 67 27 55 29 54 22 57 5 73 17 74 12 5 .00 5 4 4 .20 7 13 4 .00 3 13 7 .33 3 15 4 .00 5 5 4 .00 1 5 5 .00 1 9 4 .00 2 9 4 .00 2 15 4 .83 13 4 4 .00 2 17 5 .00 2 8 4 .00 3 28 4 .00 4 14 4 .67 1 18 4 .67 1 17 3 .80 3 22 4 .00 3 23 4 .50 1 9 4 .75 ---C 1130 Sanitized. Does not contain TSCACB1 Company ANIMAL NUMBER 643416 643337 643473 643339 643385 643353 643439 643428 643488 643320 643460 643333 643454 643349 643434 643470C 643427 643331 643357 643407 INDIVIDUAL ANIMAL ESTROUS CYCLE PARAMETERS DURING CREMATING AND COHABITATION GROUP VI-0: 100 MG/KG/DAY NUMBER OF DAYS OP DATA CX3LLECTION PERCENT OF DAYS IN ESTRUS PERCENT OF DAYS IN DIESTRUS PERCENT OF DAYS IN PROESTRUS MEAN CYI=LE LEN[GTH (da.ys) PRECOITAL INTERVAL (days) 25 20 76 4 5. 00 4 23 22 65 13 5. 00 2 25 24 68 8 4. 75 4 23 22 70 9 4. 25 2 21 24 67 10 5. 00 1 22 27 55 18 4. 67 1 25 20 60 20 4. 00 4 25 8 80 12 6. 67 4 25 28 60 12 4. 50 4 25 24 64 12 4. 75 4 21 10 62 29 3. 75 1 22 27 55 18 4. 33 1 23 26 61 13 4. 50 2 24 25 63 13 4. 00 3 25 20 76 4 4. 00 4 35 91 9 0 a -- ---C 24 8 71 21 6. 00 3 22 9 77 14 4. 00 1 22 32 55 14 4. 00 1 23 30 65 4 5. 00 2 1131 C<npy S,n,.^. "" COTtaI" TSCACBI ANIMAL NUMBER 643431-1' 643430 643440 643468 643335'3 643338 643413 643417 643443 643467 643424 643429 643449 643346 643348 643328 643375 643365 643326 INDIVIDUAL ANIMAL ESTROUS CYCLE PARAMETERS DURING PREMATING AND COHABITATION GROUP VIII-0: 250 MG/KG/DAY NUMBER OP DAYS OF DATA COLLECTION IPERCENT OF I3AYS IN ESTRUS PERCENT OF DAYS IN DIESTRUS PERCENT OF DAYS IN PROESTRUE! M EAN CTFCLE LENGTH (days) PRECOITAL INTERVAL (days) 35 23 69 9 5 .33 --c 22 18 68 14 4 .33 1 24 13 79 8 9 .50 4 --c 27 7 78 15 6 .00 6 33 12 88 0 6 .00 24 21 67 13 4 .25 4 25 24 72 4 4 .00 4 22 23 59 18 4 .00 1 22 32 55 14 3 .75 1 27 7 70 22 4 .00 6 22 32 68 0 4 .33 1 29 10 69 21 4 .40 8 27 26 67 7 3 .67 7 22 14 82 5 4 .00 2 24 25 71 4 4 .00 4 23 17 70 13 5 .33 2 23 13 74 13 5 .00 2 24 25 58 17 5 .00 4 25 24 64 12 4 .00 4 1132 Company Sanitized. Does not contain TSCACBl APPENDIX Z INDIVIDUAL ANIMAL ESTROUS CYCLE STAGES DURING PREMATING AND COHABITATION IN Pi FEMALE RATS 1133 company Sanitized. Does not contain TSCA CBl INDIVIDUAL ANIMAL ESTROUS CYCLE STAGES DURING PREMATING AND COHABITATION IN Pi FEMALE RATS EXPLANATORY NOTES Notes: Test Days 54-75 Test Days 75-88 Prematmg Cohabitation period Abbreviations: D = Diestrus E = Estrus P = Pi-oestrus X = No sample or stage could not be defined from sample. Footnotes: a No evidence of copulation was found; animal was not pregnant. b No evidence of copulation was found; animal was pregnant. 1134 Company Sanitized. Does not contain TSCA CBl H-24516: SubchronicToxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL ESTROUS CYCLE STAGES DURING PREMATING AND COHABITAT GROUP II-O: 0 MG/KG/DAY 1135 Wi^I^teeAWi.^^ H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL ESTROUS CYCLE STAGES DURING PREMATING AND COHABITATI GROUP IV-0: 25 MG/KG/DAY 1136 .CompanySanitized, Does not cont I /H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL ESTROUS CYCLE STAGES DURING PREMATING AND COHABITAT GROUP VI-0: 100 MG/KG/DAY ANIMAL TEST DAYS NUMBER 541551561571581591606|116216316416516616716|f8i9|7017117217317417517617717817890|18118218 643416 miBalBlljBi|IH|^^ gtera^iffl lipl liliBaMliBlliMBaii'] IS1iil 643337MaifI|| lligii:iiii iiilllEiii|llB8^aiAlii:E>j!l;m:!lJ 643473 11!i|3a||ii|a|liJB31pl|Bl|8| 643339 ^|i|^Jia|iHH i|jMi|graEiH^ ririBiaiA _ _ 643385 llgfallill g|lil|IH]i|xra^aJ|!^ijffiJJidl5iii.B^^ 643353 Ml^^igiSQll^jllHHiBj'l^ __ ____ 643439 'D i3J D |D |b2lD I D ID 13 D ID ID 13 D ID D|D' UJ 643428 8iil|lijB|E 643488|!aal||!'Ii| 643320|a||l|ai |ijp _^______plilgll^tBglialiitEtM j_iI3_ll_l^_J!_!^_|J_Ji_PEllgllilD^^,ii^ 64346o|iJJN| |D|D|D|DBaD|DBaD|xE|D|Di3aaD|PBa 643333pJigJ ' i^'i^iiEi^ '"^T'yl 643454 PpB 643349|^Jg|ffi3 llBllpl^p^^iBlft* |g^ 643434||El,pSlM|Ji llN3Nlaabi|ia!^ 664433442770|Bi!jr;aDte|lB!iiaali|iIaP|lBii|B^ i_____ Sill 64333lp|5Bili|!i|lHBiJM^ 643357 fcaip!paa||ai^^|^ b434U7B|'!i)||biiia 1137 H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL ESTROUS CYCLE STAGES DURING PREMATING AND COHABITAT GROUP VIII-0: 250 MG/KG/DAY 1138 Company Sanitized. Does not con APPENDIX AA REPRODUCTIVE TOXICOLOGY INDIVIDUAL ANIMAL SPERM MOTILITY DATA IN Pi MALE RATS 1139 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL ANIMAL SPERM MOTILITY DATA IN Pi MALE RATS GROUP 1-0 0 MG/KG/DAY Animal Number 643239 643270 643148 643284 643229 643196 643176 643218 643207 643280 Percent Motile 93 90 95 99 96 91 86 94 95 94 GROUP III-0 25 MG/KG/DAY Animal Number 643287 643188 643230 643170 643144 643277 643214 643261 643166 643153 Percent Motile 89 92 78 98 95 92 91 93 96 98 GROUP V-0 100 MG/KG/DAY Animal Number 643313 643182 643146 643312 643199 643267 643216 643244 643245 643301 Percent Motile 96 91 96 84 93 95 96 92 98 92 GROUP VII-0 250 MG/KG/DAY Animal Number Percent Motile 643289 80 643171 89 643158 97 643249 95 643161 95 643248 92 643285 81 643278 89 643299 97 643274 88 1140 Company Sanitized. Does not contain TSCA CBI APPENDIX BB INDIVIDUAL ANIMAL SPERM MORPHOLOGY DATA IN Pi MALE RATS 1141 Company Sanitized. Does not contain TSCACBI INDIVIDUAL ANIMAL SPERM MORPHOLOGY DATA IN Pi MALE RATS GROUP 1-0: 0 MG/KG/DAY Animal Number 643239 643270 643148 643284 643229 643196 643176 643218 643207 643280 Total Normal 199 200 195 197 199 198 197 197 196 198 Tail Abnormal 1 0 0 0 1 0 1 0 2 0 Head Abnormal 0 0 5 3 0 2 2 3 2 2 Tail & Head Abnormal 0 0 0 0 0 0 0 0 0 0 Percent Normal 99.5 100.0 97.5 98.5 99.5 99.0 98.5 98.5 98.0 99.0 0: 25 MG/KG/DAY Animal Number 643287 6431P,8 643230 643170 643144 643277 643214 643261 643166 643153 Total Normal 199 . 199 198 198 199 199 192 200 198 197 Tail Abnormal 0 0 0 0 0 1 2 0 0 1 Head Abnormal 1 1 2 2 1 0 6 0 2 2 Tail & Head Abnormal 0 0 0 0 0 0 0 0 0 0 Percent Normal 99.5 99.5 99.0 99.0 99.5 99.5 96.0 100.0 99.0 98.5 1142 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL ANIMAL SPERM MORPHOLOGY DATA IN Pi MALE RATS GROUP V-0: 100 MG/KG/DAY Animal Number 643313 643182 643146 643312 643199 643267 643216 643244 643245 643301 Total Normal 195 198 198 200 199 199 199 198 198 199 Tail Abnormal 0 1 1 0 0 0 0 1 1 0 Head Abnormal 5 1 1 0 1 1 1 1 1 1 Tail & Head Abnormal 0 0 0 0 0 0 0 0 0 0 Percent Normal 97.5 99.0 99.0 100.0 99.5 99.5 99.5 99.0 99.0 99.5 GROUP VII- 0: 250 MG/KG/DAY Animal Number Total Normal 643289 196 643171 193 643158 199 643249 200 643161 197 643248 200 643285 197 643278 198 643299 200 643274 197 Tail Abnormal 2 6 1 0 0 0 0 0 0 0 Head Abnormal 2 1 0 0 3 0 3 2 0 3 Tail & Head Abnormal 0 0 0 0 0 0 0 0 0 0 Percent Normal 98.0 96.5 99.5 100.0 98.5 100.0 98.5 99.0 100.0 98.5 1143 Company Sanitized. Does not contain TSCA CBl APPENDIX CC INDIVIDUAL ANIMAL SPERM AND SPERMATID COUNTS IN Pi MALE RATS 1144 Company Sanitized. Does not contain TSCACBl INDIVIDUAL ANIMAL SPERM AND SPERMATID COUNTS (Millions) IN Pi MALE RATS GROUP 1-0: 0 MG/KG/DAY Animal Number Epididymal Sperm Per cauda Per g cauda 643239 643270 643148 643284 643229 643196 643176 643218 643207 643280 311.0 299.3 256.0 254.9 311.0 341.4 332.0 332.0 282.9 266.6 1067.8 1249.0 758.6 858.1 1002.4 1154.4 1195.5 1216.1 869.1 938.2 GROUP III-O-0: 25 MG/KG/DAY Animal Number Epididymal Sperm Per cauda Per g cauda 643287 643188 643230 643170 643144 643277 643214 643261 643166 643153 274.2 229.1 272.4 346.0 280.6 225.6 280.6 254.9 337.9 296.9 1191.1 850.8 906.7 1045.1 1131.3 836.3 934.9 899.9 1238.4 948.4 Testicular Spermatids Per testis Per g testis 109.9 128.0 147.9 131.0 144.4 151.4 146.7 103.5 118.7 119.3 69.0 81.3 90.0 84.2 86.4 103.0 100.5 65.4 75.1 89.8 Testicular Spermatids Per testis Per g testis 114.0 112.2 118.7 136.8 107.0 152.6 122.8 124.5 114.6 114.6 94.8 66.5 74.0 79.8 88.4 110.5 79.6 86.2 81.4 83.3 1145 Company Sanitized. Does not contain TSCA CB1 INDIVIDUAL ANIMAL SPERM AND SPERMATID COUNTS (Millions) IN Pi MALE RATS GROUP V-0: 100 MG/KG/DAY Animal Number Epididymal Sperm Per cauda Per g cauda 643313 643182 643146 643312 643199 643267 643216 643244 643245 643301 339.0 285.3 301.6 240.8 261.9 321.5 187.1 249.0 281.7 312.1 1239.5 945.8 970.4 723.6 879.6 1054.7 690.2 884.2 910.9 1198.6 GROUP VI I--00: 250 MG/KG/DAY Animal Number Epididymal Sperm Per cauda Per 9 cauda 643289 643171 643158 643249 643161 643248 643285 643278 643299 643274 368.3 282.9 327.3 328.5 426.7 244.3 231.5 318.0 245.5 218.6 1280.8 894.7 884.9 977.7 1116.7 906.9 742.6 897.5 859.3 895.6 Testicular Spennatids Per testis Per g testis 154.3 158.4 166.0 135.0 168.4 154.9 163.7 162.5 166.6 169.5 106.3 101.0 103.1 81.1 98.0 91.4 108.3 102.6 106.1 112.8 Testicular Spennatids Per testis Per 9 testis 144.4 119.8 133.9 122.2 161.3 154.3 166.0 169.5 151.4 142.6 96.1 94.0 79.1 81.5 101.8 99.4 110.8 87.3 91.3 90.7 1146 Company Sanitized. Does not contain TSCA CBI APPENDIX DD REPRODUCTIVE TOXICOLOGY INDIVIDUAL MATING DATA AND GESTATION LENGTH: Pi GENERATION 1147 Company Sanitized. Does not contain TSCA CBI H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 REPRODUCTIVE TOXICOLOGY INDIVIDUAL MATING DATA AND GESTATION LENGTH: Pi GENERATION EXPLANATORY NOTES Notes: Column labeled "Plug Observed" + indicates that a copulatory plug was observed indicates that no copulatory plug was observed Column labeled "Litter Produced" + indicates that a litter was produced indicates that no litter was produced Footnotes: a No litter delivered, however, implantation sites were observed at necropsy. b No copulation plug was observed, however, a litter was delivered. Gestation length unknown. c Found dead on Day 22G (Test Day 99). d Accidentally killed on Day 14G (Test Day 91). e Found dead on Lactation Day 0 (Test Day 106). 1148 Company Sanitized. Does not contain TSCA CErf FEMALE ANIMALtt 643352 643343 643459 643394 643480 643319 643350 643363 643397 643421 643420 643419 6434143 643401 643455 643378 643393 643447 643478 643386 INDIVIDUAL MATING DATA AND GESTATION LENGTH: Pi GENERATION GROUPS: 11-0,1-0 DOSE: 0 MG/KG/DAY MALE #1 ANIMAL# 643239 643270 643148 643284 643229 643196 643176 643218 643207 643280 643271 643211 643163 643197 643242 643251 643155 643147 643276 643254 PLUG OBSERVED + + + + + - + + + + + + + + + + .' + + + MALE #2 ANIMAL* PLUG OBSERVED LITTER PRODUCED - + + - + - + + + - + - + + + - + + + GESTATION LENGTH(days) -- 23 23 -- 23 --- 22 22 22 -- 22 -- 22 22 23 -- 22 22 22 1149 Company Sanitized. Does not contain TSCA C6l FEMALE ANIMAL# 643399 643334 643464 643369 643490 643342 643438 643445 643418 643325 643479b 643403 643376 6434223 643452 643475 643372 643400 643395 643457 INDIVIDUAL MATING DATA AND GESTATION LENGTH: Pi GENERATION GROUPS: IV-0,111-0 DOSE: 25 MG/KG/DAY MALE ftl ANIMAL* 643287 643188 643230 643170 643144 643277 643214 643261 643166 643153 643177 643198 643291 643184 643167 643223 643233 643183 643219 643263 PLUG OBSERVED + + + + + + + + + + - + + + + + + + + + MALE #2 ANIMALft PLUG OBSERVED LITTER PRODUCED + + + + + + + - + + + - + - + + + + + + GESTATION LENGTH(days) 23 22 23 22 22 22 22 -- 22 22 --- 21 -- 23 23 22 22 22 22 t 1150 Company Sanitized. Does not contain TSCACSf FEMALE ANIMALft 643320 643488 643428 643439 643353 643385 643339 643473 643337 643416 643407 643357 643331 643427 643470 643434 643349 6434540 643333 643460 INDIVIDUAL MATING DATA AND GESTATION LENGTH: Pi GENERATION GROUPS: VI-0,V-0 DOSE: 100 MG/KG/DAY MALE ttl ANIMALft 643313 643182 643146 643312 643199 643267 643216 643244 643245 643301 643200 643255 643157 643238 643227 643164 643154 643156 643208 643190 PLUG OBSERVED + + + + + + + + + + + + + + - + + + + + MALE #2 ANIMALtt PLUG OBSERVED LITTER PRODUCED + - + + + - + - + + + - + + - + + - + + GESTATION LENGTH(days) 22 -- 22 22 23 -- 22 2--2 22 22 2-3- 23 2-2- 22 2-3- 23 1151 Company Sanitized. Does not contain TSCA CBI FEMALE ANIMAL# 643467 643443 643417 643413 643338 6433356 643468 643440 643430 643431 643326 643365 643375 643328 643348 643346'^ 643449 6434296 643424 INDIVIDUAL MATING DATA AND GESTATION LENGTH: Pi GENERATION GROUPS: VIII-0,VII-0 DOSE: 250 MG/KG/DAY MALE #1 ANIMAL# 643289 643171 643158 643249 643161 643274 643248 643285 643278 643299 643192 643222 643160 643191 643203 643282 643302 643317 643281 PLUG OBSERVED + + + + + - + + + - + + + + + + + + + MALE #2 ANIMAL# PLUG OBSERVED LITTER PRODUCED + + + + + + + + - - + + + + - - + + - GESTATION LENGTH(days) 23 22 22 22 22 -- 23 22 --- 22 22 23 23 --- 22 23 -- 1152 Company Sanitized. Does not contain TSCA CBI APPENDIX EE REPRODUCTIVE TOXICOLOGY INDIVIDUAL IMPLANTATION SITE DATA AND IMPLANTATION EFFICIENCY 1153 Company Sanitized. Does not contain TSCACBl H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 REPRODUCTIVE TOXICOLOGY INDIVIDUAL IMPLANTATION SITE DATA AND IMPLANTATION EFFICIENCY EXPLANATORY NOTES Footnotes: a No implantation efficiency can be calculated. b No litter produced; no implantation efficiency calculated. c Found dead Day 22G (Test Day 99); the uterus contained 17 fetuses. d Accidentally killed Day 14G (Test Day 91); the uterus contained 12 fetuses. e Found dead Lactation Day 0 (Test Day 106). Abbreviations: -- = No data 1154 Company San-rtized. Does not contain TSCA Cffl INDIVIDUAL IMPLANTATION SITE DATA AND IMPLANTATION EFFICIENCY GROUPS: II-O DOSE: 0 MG/KG/DAY Animal Number Pups Bom Number of Implantation Sites Implantation Efficiency 643343 12 10 643459 15 16 643480 15 15 643363 17 18 643397 16 17 643421 12 13 643419 16 15 643414^ 0 2 643401 15 16 643455 16 16 643378 8 8 643447 19 19 643478 15 15 643386 15 16 ---a 93.8 100.0 94.4 94.1 92.3 ---a 93.8 100.0 100.0 100.0 100.0 93.8 1155 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL IMPLANTATION SITE DATA AND IMPLANTATION EFFICIENCY GROUPS: IV-0 DOSE: 25 MG/KG/DAY Animal Number Pups Born Number of Implantation Sites Implantation Efficiency 643399 14 17 643334 15 16 643464 14 14 643369 18 14 643490 . 14 14 643342 16 16 643438 14 17 643418 15 15 643325 15 16 643479 7 9 643376 15 16 64342223 0 2 643452 12 15 643475 2 4 643372 17 18 643400 15 15 643395 8 8 643457 16 16 82.4 93.8 100.0 ---a 100.0 100.0 82.4 100.0 93.8 77.8 93.8 --- 80.0 50.0 94.4 100.0 100.0 100.0 1156 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL IMPLANTATION SITE DATA AND IMPLANTATION EFFICIENCY GROUPS: VI-0 DOSE: 100 MG/KG/DAY Animal Number Pups Bom Number of Implantation Sites Implantation Efficiency 643320 6 643428 14 643439 14 643353 9 643339 15 643337 15 643416 6 643407 16 643331 9 643427 14 643434 16 643349 18 643454C --- 643333 7 643460 14 15 16 16 11 16 . 17 8 14 12 15 14 18 17 9 14 40.0 87.5 87.5 81.8 93.8 . 88.2 75.0 ---a 75.0 93.3 ---a 100.0 --- 77.8 100.0 1157 Company Sanitized. Does not contain TSCA CB( INDIVIDUAL IMPLANTATION SITE DATA AND IMPLANTATION EFFICIENCY GROUPS: VIII-0 DOSE: 250 MG/KG/DAY Animal Number Pups Bom Number of Implantation Sites Implantation Efficiency 643467 13 12 643443 12 11 643417 10 13 643413 12 12 643338 14 16 643335 14 16 643468 14 18 643440 18 18 643326 14 16 643365 9 8 643375 5 14 643328 11 12 643346^ --- 12 643449 17 17 6434296 16 15 ---a ---a 76.9 100.0 87.5 87.5 77.8 100.0 87.5 ---a 35.7 91.7 --- 100.0 ---a 1158 Company Sanitized. Does not contain TSCA CB( APPENDIX FF REPRODUCTIVE TOXICOLOGY INDIVIDUAL PUP SURVIVAL: Fi GENERATION 1159 Company Sanitized. Does not contain TSCA CBl H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations REPRODUCTIVE TOXICOLOGY INDIVIDUAL PUP SURVIVAL: Fi GENERATION EXPLANATORY NOTES DuPont-5386 Footnotes: a No litter delivered. b Found dead test day 99 (Day 22G). c Accidentally killed test day 91 (Day 14G); no litter was delivered. d Found dead test day 106 (Lactation Day 0); data excluded from statistical analysis. e Number bom includes 13 unsexable fetuses. 1160 Company Sanitized. Does not contain TSCA CBt ANIMAL NUMBER 6433523 643343 643459 6433943 643480 643319s 6433503 643363 643397 643421 6434203 643419 6434143 643401 643455 643378 6433933 643447 643478 643386 BORN 12 15 - .15 - - 17 16 12 - 16 - 15 16 8 - 19 15 15 INDIVIDUAL PUP SURVIVAL: Fi GENERATION GROUP: II-O DOSE: 0 MG/KG/DAY NUMBE19. OF PUPS BORN P RECULLING POSTCULLI1W ALIVE DAY 4 DAY 4 DAY 7 DAY 14 DAY 21 . 12 12 8 8 8 8 15 15 8 8 8 8 - - - - - - 15 15 8 8 8 8 - - - - - - - - - - - - 17 17 8 8 8 8 16 16 8 8 8 8 12 12 8 8 8 8 - - - - - - 16 16 8 8 8 8 - - - - - - 15 15 8 8 8 8 15 15 8 8 8 8 8 8 8 8 8 8 - - - - - - 19 19 8 8 8 8 15 15 8 8 8 8 15 15 8 8 8 8 1161 Company Sanitized. Does not contain TSCA CBI ANIMAL NUMBER 643352s 643343 643459 643394s 643480 643319s 643350s 643363 643397 643421 643420s 643419 643414s 643401 643455 643378 643393s 643447 643478 643386 BORM 6 12 - 6 - - 7 8 6 - 11 - 12 10 5 - 12 8 10 INDIVIDUAL PUP SURVIVAL: Fi GENERATION GROUP: II-O DOSE: 0 MG/KG/DAY NUMBEI1 OF MALE 1?UPS BORN P RECULLING POSTCULLI1re ALIVE DAY 4 DAY 4 DAY 7 DAY 14 DAY 21 6 6 4 4 4 4 12 12 5 5 5 5 - - - - - - 6 6 4 4 4 4 - - - - - - - - - - - - 7 7 4 4 4 4 8 8 4 4 4 4 6 6 4 4 4 4 - - - - - - 11 11 4 4 4 4 - - - - - - 12 12 5 5 5 5 9 9 4 4 4 4 5 5 5 5 5 5 - - - - - - 12 12 4 4 4 4 8 8 4 4 4 4 10 10 4 4 4 4 1162 Company Sanitized. Does not contain TSCA CBl ANIMAL NUMBER 6433523 643343 643459 6433943 643480 643319s 6433503 643363 643397 643421 6434203 643419 643414s 643401 643455 643378 6433933 643447 643478 643386 BORN 6 3 - 9 - 10 8 6 - 5 - 3 6 3 - 7 7 5 INDIVIDUAL PUP SURVIVAL: Fi GENERATION GROUP: II-O DOSE: 0 MG/KG/DAY NUMBER OF FEMAL1E PUPS BORN PIIECULLING POSTCULLI1TO ALIVE DAY 4 DAY 4 DAY 7 DAY 14 DAY 21 . 6 6 4 4 4 4 3 3 3 3 3 3 .- - - 9 9 4 - - - - - - 4 4 4 - - - - - - - - 10 10 4 4 4 4 8 8 4 4 4 4 6 6 4 4 4 4 - - - - - - 5 5 4 4 4 4 - - - - - 3 3 3 3 3 3 S 6 4 4 4 4 3 3 3 3 3 3 - - - - - - 7 7 4 4 4 4 7 7 4 4 4 4 5 5 4 4 4 4 1163 Company Sanitized. Does not contain TSCA CBl ANIMAL NUMBER 6433523 643343 643459 6433943 643480 6433193 6433503 643363 643397 643421 6434203 643419 6434143 643401 643455 643378 6433933 643447 643478 643386 INDIVIDUAL PUP SURVIVAL: Fi GENERATION GROUP: II-O DOSE: 0 MG/KG/DAY NUMBER OF PUPS SEX RATIO (MALES) % BORN ALIVE 0-4 DAY VIABILITY 0.50 0.80 0.40 0.41 0.50 0.50 0.69 0.80 0.63 0.63 0.63 0.53 0.67 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 93.8 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 LACTATION INDEX 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 1164 Company Sanitized. Does not contain TSCA CBI ANIMAL NUMBER 6433523 643343 643459 6433943 643480 643319s 643350a 643363 643397 643421 6434203 643419 6434143 643401 643455 643378 6433933 643447 643478 643386 INDIVIDUAL PUP SURVIVAL: Fi GENERATION GROUP: II-O DOSE: 0 MG/KG/DAY % BORN ALIVE NUMBER OP MALE PUPS 0-4 DAY VIABILITY LACTATION INDEX 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 90.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 1165 Company Sanitized. Does not contain TSCA CSK ANIMAL NUMBER 6433523 643343 643459 643394S 643480 6433193 6433503 643363 643397 643421 6434203 643419 6434143 643401 643455 643378 6433933 643447 643478 643386 INDIVIDUAL PUP SURVIVAL: Pi GENERATION GROUP: II-O DOSE: 0 MG/KG/DAY BORN ALIVE NUMBER OF FEMALE PUPS 0-4 DAY VIABILITY LACTATION INDEX 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 1166 Company Sanitized. Does not contain TSCA Cfif ANIMAL NUMBER 643399 643334 643464 643369 643490 643342 643438 6434453 643418 643325 643479 6434033 643376 6434223 643452 643475 643372 643400 643395 643457 BORN 14 15 14 18 14 16 14 - 15 15 7 - 15 - 12 2 17 15 8 16 INDIVIDUAL PUP SURVIVAL: Fi GENERATION GROUP: IV-0 DOSE: 25 MG/KG/DAY NUMBEI? OF PUPS BORN P RECULLING POSTCULLIIre ALIVE DAY 4 DAY 4 DAY 7 DAY 14 14 14 8 8 8 15 15 8 8 8 14 14 8 8 8 18 18 8 8 8 14 14 8 8 8 16 16 8 8 8 14 13 8 8 8 - - - - - 15 13 8 8 B 15 15 8 8 B 7 7 7 7 7 - - - - - 14 14 8 8 8 - - - - - 12 12 8 8 8 2 2 2 2 2 17 17 8 8 8 14 12 8 8 8 8 8 8 8 8 16 15 8 8 8 DAY 21 8 8 8 8 8 8 8 - 8 8 7 - 8 - 8 2 8 8 8 8 1167 Company Sanitized. Does not contain TSCA CBI ANIMAL NUMBER 643399 643334 643464 643369 643490 643342 643438 643445s 643418 643325 643479 6434033 643376 6434223 643452 643475 643372 643400 643395 643457 BORN 6 10 5 7 10 8 6 - 8 11 1 - 11 - 7 0 10 9 4 10 INDIVIDUAL PUP SURVIVAL: Fi GENERATION GROUP: IV-0 DOSE: 25 MG/KG/DAY NUMBEI1 OF MALE 1PUPS BORN P RECULLING POSTCULLI11G ALIVE DAY 4 DAY 4 DAY 7 DAY 14 6 6 4 4 4 10 10 4 4 4 5 5 4 4 4 7 7 4 4 4 10 10 4 4 4 8 8 4 4 4 6 6 4 4 4 - - - - - 8 7 4 4 4 11 11 4 4 4 1 1 1 1 1 - - - - - 10 10 4 4 4 - - - - - 7 7 4 4 4 0 0 0 0 0 10 10 4 4 4 8 8 4 4 4 4 4 4 4 4 10 10 4 4 4 DAY 21 4 4 4 4 4 4 4 - 4 4 1 - 4 - 4 0 4 4 4 4 1168 Company Sanitized. Does not contain TSCA CBI ANIMAL NUMBER 643399 643334 643464 643369 643490 643342 643438 6434453 643418 643325 643479 643403s 643376 643422^ 643452 643475 643372 643400 643395 643457 BORN 8 5 9 11 4 8 8 - 7 4 6 - 4 - 5 2 7 6 4 6 INDIVIDUAL PUP SURVIVAL: Fi GENERATION GROUP: IV-0 DOSE: 25 MG/KG/DAY NUMBE1? OF FEMAI^E PUPS BORN P RECULLING POSTCULL][NG ALIVE DAY 4 DAY 4 DAY 7 DAY 14 8 8 4 4 4 5 5 4 4 4 9 9 4 4 4 11 11 4 4 4 4 4 4 4 4 8 8 4 4 4 8 7 4 4 4 - - - - - 7 6 4 4 4 4 4 4 4 4 6 6 6 6 6 - - - - - 4 4 4 4 4 - - - - - 5 5 4 4 4 2 2 2 2 2 7 7 4 4 4 6 4 4 4 4 4 4 4 4 4 6 5 4 4 4 DAY 21 4 4 4 4 4 4 4 - 4 4 6 - 4 - 4 2 4 4 4 4 1169 Company Sanitized. Does noi contain TSCA CBI ANIMAL NUMBER 643399 643334 643464 643369. 643490 643342 643438 6434453 643418 643325 643479 643403s 643376 6434223 643452 643475 643372 643400 643395 643457 INDIVIDUAL PUP SURVIVAL: Pi GENERATION GROUP: IV-0 DOSE: 25 MG/KG/DAY NUMBER OF PUPS SEX RATIO (MALES) % BORN ALIVE 0-4 DAY VIABILITY 0.43 0.67 0.36 0.39 0.71 0.50 0.43 0.53 0.73 0.14 0.73 0.58 0.00 0.59 0.60 0.50 0.63 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 93.3 100.0 100.0 100.0 93.3 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 92.9 86.7 100.0 100.0 100.0 100.0 100.0 100.0 85.7 100.0 93.8 LACTATION INDEX 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 1170 Company Sanitized. Does not contain TSCA CBI ANIMAL NUMBER 643399 643334 643464 643369 643490 643342 643438 6434453 643418 643325 643479 643403^ 643376 6434223 643452 643475 643372 643400 643395 643457 INDIVIDUAL PUP SURVIVAL: E\ GENERATION GROUP: IV-0 DOSE: 25 MG/KG/DAY BORN ALIVE NUMBER OP MALE PUPS 0-4 DAY VIABILITY LACTATION INDEX 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 90.9 100.0 100.0 88.9 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 87.5 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 1171 Company Sanitized. Does not contain TSCA CBI ANIMAL NUMBER 643399 643334 643464 643369 643490 643342 643438 6434453 643418 643325 643479 6434033 643376 6434223 643452 643475 643372 643400 643395 643457 INDIVIDUAL PUP SURVIVAL: Fi GENERATION GROUP: IV-0 DOSE: 25 MG/KG/DAY % BORN ALIVE NUMBER OF FEMALE PUPS 0-4 DAY VIABILITY LACTATION INDEX 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 87.5 85.7 100.0 100.0 100.0 100.0 100.0 100.0 66.7 100.0 83.3 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 1172 Company Sanitized. Does not contain TSCA CBt ANIMAL NUMBER 643320 643488'' 643428 643439 643353 6433853 643339 6434733 643337 643416 643407 643357s 643331 643427 6434703 643434 643349 643454^ 643333 643460 BORN 6 - 14 14 9 - 15 - 15 6 16 - 9 14 - 16 18 - 7 14 INDIVIDUAL PUP SURVIVAL: Fi GENERATION GROUP: VI-0 DOSE: 100 MG/KG/DAY NUMBEI^ OF PUPS BORN P RECULLING POSTCULLII1G ALIVE DAY 4 DAY 4 DAY 7 DAY 14 4 4 4 4 4 - - - - - 14 14 8 8 8 10 10 8 8 8 9 9 8 8 8 - - - - - 15 15 8 8 8 - - - - - 15 15 8 8 8 6 5 5 5 5 16 0 0 0 0 - - - - - 0 0 0 0 0 14 14 8 8 8 - - - - - 16 16 8 8 8 18 17 8 8 8 - - - - - 7 7 7 7 7 14 14 8 8 8 DAY 21 4 - 8 8 8 - 8 - 8 5 0 - 0 8 - 8 8 - 7 8 1173 Company Sanitized. Does not contain TSCA CBI ANIMAL NUMBER 643320 6434883 643428 643439 643353 6433853 643339 643473s 643337 643416 643407 6433573 643331 643427 643470s 643434 643349 643454-1' 643333 643460 BORN 3 - 7 9 5 - 6 - 8 5 7 - 4 5 - 6 7 3e 7 INDIVIDUAL PUP SURVIVAL: Pi GENERATION GROUP: VI-0 DOSE: 100 MG/KG/DAY NOMBE1a OF MALE 1PUPS BORN E'RECULLING POSTCULLIIrc ALIVE DAY 4 DAY 4 DAY 7 DAY 14 DAY 21 2 2 2 2 2 2 - - - - - - 7 7 4 4 4 4 7 7 5 5 5 5 5 5 4 4 4 4 - - - - - - 6 6 4 4 4 4 - - - - - - 8 8 4 4 4 4 5 4 4 4 4 4 7 0 0 0 0 0 - - - - - - 0 0 0 0 0 0 5 5 4 4 4 4 - - - - - - 6 6 4 4 4 4 7 6 4 4 4 4 3 3 3 3 3 3 7 7 4 4 4 4 1174 Company Sanitized. Does not contain TSCA CBI ANIMAL NUMBER 643320 643488s 643428 643439 643353 643385s 643339 643473s 643337 643416 643407 643357s 643331 643427 6434703 643434 643349 643454^ 6433336 643460 BORN 3 - 7 5 4 - 9 - 7 1 9 - 5 9 - 10 11 46 7 INDIVIDUAL PUP SURVIVAL: Pi GENERATION GROUP: VI-0 DOSE: 100 MG/KG/DAY NOMBE]1 OF FEMAL1S PUPS BORN P RECULLING POSTCULLI1TO ALIVE DAY 4 DAY 4 DAY 7 DAY 14 2 2 2 2 2 - - - - - 7 7 4 4 4 3 3 3 3 3 4 4 4 4 4 - - - - - 9 9 4 4 4 - - - - - 7 7 4 4 4 1 1 1 1 1 9 0 0 0 0 - - - - - 0 0 0 0 0 9 9 4 4 4 - - - - - 10 10 4 4 4 11 11 4 4 4 - - - - - 4 4 4 4 4 7 7 4 4 4 DAY 21 2 - 4 3 4 - 4 - 4 1 0 - 0 4 - 4 4 - 4 4 1175 Company Sanitized. Does not contain TSCA CBI ANIMAL NUMBER 643320 6434883 643428 643439 643353 6433853 643339 6434733 643337 643416 643407 6433573 643331 643427 64347Q3 643434 643349 643454b 643333 643460 INDIVIDUAL PUP SURVIVAL: Fi GENERATION GROUP; VI-0 DOSE: 100 MG/KG/DAY NUMBER OF PUPS SEX RATIO (MALES) % BORN ALIVE 0-4 DAY VIABILITY 0.50 0.50 0.64 0.56 0.40 0.53 0.83 0.44 0.44 0.36 0.38 0.39 0.43 0.50 66.7 100.0 71.4 100.0 100.0 100.0 100.0 100.0 0.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 83.3 0.0 100.0 100.0 94.4 100.0 100.0 LACTATION INDEX 100.0 100.0 100.0. 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 1176 Company Sanitized. Does not contain TSCA CBl ANIMAL NUMBER 643320 6434883 643428 643439 643353 6433853 643339 6434733 643337 643416 643407 643357s 643331 643427 6434703 643434 643349 643454^' 643333 643460 INDIVIDUAL PUP SURVIVAL: Pi GENERATION GROUP: VI-0 DOSB: 100 MG/KG/DAY % BORN ALIVE NUMBER OF MALE PUPS 0-4 DAY VIABILITY LACTATION INDEX 66.7 100.0 77.8 100.0 100.0 100.0 100.0 100.0 0.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 80.0 0.0 100.0 100.0 85.7 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 1177 Company Sanitized. Does not contain TSCA CBl ANIMAL NUMBER 643320 6434883 643428 643439 643353 6433853 643339 643473s 643337 643416 643407 6433573 643331 643427 6434703 643434 643349 64345423 643333 643460 INDIVIDUAL PUP SURVIVAL: Pi GENERATION GROUP: VI-0 DOSE: 100 MG/KG/DAY BORN ALIVE NUMBER OF FEMALE PUPS 0-4 DAY VIABILITY LACTATION INDEX 66.7 100.0 60.0 100.0 100.0 100.0 100.0 100.0 0.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 0.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 1178 Company Sanitized. Does not contain TSCA CBl ANIMAL NUMBER BORN 643467 . 13 643443 12 643417 10 643413 12 643338 14 643335 14 643468 14 643440 18 6434303 - 6434313 - 643326 14 643365 9 643375 5 643328 11 6433483 - 643346C - 643449 17 643429d'e 16 6434243 - INDIVIDUAL PUP SURVIVAL: Pi GENERATION GROUP: VII I-0 DOSE: 250 MG/KG/DAY NUMBEI1 OF PUPS BORN P'RECULLING POSTCULLIIrc ALIVE DAY 4 DAY 4 DAY 7 DAY 14 13 13 8 8 8 12 12 8 8 8 10 10 8 8 8 12 12 8 8 8 14 14 8 8 8 14 14 8 8 8 14 14 8 8 8 18 18 8 8 8 - - - - - - - - - - 13 12 8 8 8 8 8 8 8 8 1 1 1 0 0 11 8 8 8 8 - - - - - - - - - - 17 17 8 8 8 0 - - - - - - - - - DAY 21 8 8 8 8 8 8 8 8 - - 8 8 0 8 - - 8 - - 1179 Company Sanitized. Does not contain TSCA CBI ANIMAL NUMBER 643467 643443 643417 643413 643338 643335 643468 643440 6434303 6434313 643326 643365 643375 643328 643348s 643346'' 643449 643429d 6434243 BORN 8 7 6 7 8 7 9 9 - - 8 4 3 6 - - 10 0 - INDIVIDUAL PUP SURVIVAL: Fi GENERATION GROUP: VIII-0 DOSE: 250 MG/KG/DAY NUMBEIt OF MALE PCrps BORN PRECULLING POSTCULLING1 ALIVE DAY 4 DAY 4 DAY 7 DAY 14 DAY 21 8 8 4 4 4 4 7 7 4 4 4 4 6 6 4 4 4 4 7 7 4 4 4 4 8 8 4 4 4 4 7 7 4 4 4 4 9 9 4 4 4 4 9 9 4 4 4 4 - - - - - - - - - - - - 7 6 4 4 4 4 3 3 3 3 3 3 .0 0 0 0 0 0 6 4 4 4 4 4 - - - - - - - - - - - - 10 10 4 4 4 4 0 - - - - - - - - - - - 1180 Company Sanitized. Does not contain TSCA CBl ANIMAL NUMBER 643467 643443 643417 643413 643338 643335 643468 643440 6434303 6434313 643326 643365 643375 643328 6433483 643346 643449 643423d 643424s BORN 5 5 4 5 6 7 5 9 - - 6 5 2 5 - - 7 3 - INDIVIDUAL PUP SURVIVAL: F^ GENERATION GROUP: VIII-0 DOSE: 250 MG/KG/DAY NUMBEI? OF FEMAL1S PUPS BORN P RECULLING POSTCULLI11G ALIVE DAY 4 DAY 4 DAY 7 DAY 14 5 5 4 4 4 5 5 4 4 4 4 4 4 4 4 5 5 4 4 4 6 6 4 4 4 7 7 4 4 4 5 5 4 4 4 9 9 4 4 4 - - - - - - - - - - 6 6 4 4 4 5. 5 5 5 5 1 1 1 0 0 5 4 4 4 4 - - - - - - - - - - 7 7 4 4 4 0 - - - - - DAY 21 4 4 4 4 4 4 4 4 - - 4 5 0 4 - - 4 - 1181 Company Sanitized. Does not contain TSCA Cffl ANIMAL NUMBER 643467 643443 643417 643413 643338 643335 643468 643440 6434303 6434313 643326 643365 643375 643328 6433483 643346 643449 643429'^ 6434243 INDIVIDUAL PUP SURVIVAL: Fi GENERATION GROUP: VIII-0 DOSE: 250 MG/KG/DAY NUMBER C>P PUPS E3EX RATIO1 (MALES) % BORN AiLIVE (3-4 DAY VIAABILITY 0. 62 0. 58 0. 60 0. 58 0. 57 0. 50 0. 64 0. 50 - - 0. 57 0. 44 0. 60 0. 55 - - 0. 59 0. 00 - 100. 0 100. 0 100. 0 100. 0 100. 0 100. 0 100. 0 100. 0 - - 92. 9 88. 9 20. 0 100. 0 - - 100. 0 0. 0 - 100. 0 100. 0 100. 0 100. 0 100. 0 100. 0 100. 0 100. 0 - - 92. 3 100. 0 100. 0 72. 7 - - 100. 0 - - LACTATION INDEX 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 - - 100.0 100.0 0.0 100.0 - - 100.0 - - 1182 Company Sanitized. Does not contain TSCA CBI ANIMAL NUMBER 643467 643443 643417 643413 643338 643335 643468 643440 6434303 6434313 643326 643365 643375 643328 643348s 643346 643449 643429'3 6434243 INDIVIDUAL PUP SURVIVAL: Fi GENERATION GROUP: VIII-0 DOSE: 250 MG/KG/DAY % BORN ALIVE NUMBER OF MALE PUPS 0-4 DAY VIABILITY LACTATION INDEX 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 87.5 75.0 0.0 100.0 85.7 100.0 66.7 100.0 100.0 100.0 100.0 100.0 100.0 1183 Company Sanitized. Does not contain TSCA CBI ANIMAL NUMBER 643467 643443 643417 643413 643338 643335 643468 643440 6434303 6434313 643326 643365 643375 643328 643348s 643346C 643449 643423d 6434243 INDIVIDUAL PUP SURVIVAL: Fi GENERATION GROUP: VIII-0 DOSE: 250 MG/KG/DAY % BORN ALIVE NUMBER OP FEMALE PUPS 0-4 DAY VIABILITY LACTATION INDEX 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0. 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 50.0 100.0 100.0 100.0 100.0 80.0 100.0 100.0 0.0 100.0 100.0 0.0 100.0 100.0 1184 Company Sanitized. Does not contain TSCA CBl APPENDIX GG REPRODUCTIVE TOXICOLOGY INDIVIDUAL PUP WEIGHTS: Fi GENERATION 1185 Company Sanitized. Does not contain TSCA CBI H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations REPRODUCTIVE TOXICOLOGY INDIVIDUAL PUP WEIGHTS: Fi GENERATION EXPLANATORY NOTES DuPont-5386 Footnotes: a No litter delivered. b Two pups were missexed; data excluded from male and female mean pup weights. c One pup was missexed; data excluded from male and female mean pup weights. d No male pups bom. e No live pups at birth. / Found dead Day 22G (Test Day 99). g Recording error, data excluded. h No male pups bom alive. i Accidentally killed Day 14G (Test Day 91). j Found dead Lactation Day 0 (Test Day 106). k No live pups on Lactation Day 4. 7 No live pups on Lactation Day 7. 1186 Company Sanitized. Does not contai,"TSCACB< H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-5386 Animal Number 6433523 643343 643459 6433943 Individual Pup Weights (grams): Lactation Day 0 FI Generation Group: 11 - 0 Dose: 0 mg/kg/day Pup Sex 7 .90 7 .40 8 .20 7 .10 7 .50 6 .90 8 .30 8 .40 7 .60 7 .00 7 .20 7 .50 7 .40 7 .00 8 .00 7 .30 7 .40 8 .40 Pup Number 6789 7 .70 7 .40 7 .70 8.10 8.20 8.30 10 8.70 11 8.10 12 8.10 643480 6433193 6 .50 7 .20 8 .50 8 .40 8 .00 7 .40 7 .40 8 .10 8 .00 7 .30 7 .90 7 .90 7.80 7.90 7.70 643350a 643363 643397 643421 6 .70 6 .60 7 .10 6 .50 7 .00 6 .70 7 .10 6 .20 7 .20 6 .70 6 .70 6 .50 6 .20 6 .20 7 .30 7 .20 5 .90 6 .30 6 .80 6 .40 7 .50 6 .90 6 .30 6 .10 6 .40 6 .30 6 .30 6 .10 6 .60 6 .20 6 .40 6 .00 7 .00 6 .30 6 .70 6 .60 6.60 6.20 7.00 5.60 6.40 7.10 6.50 6.00 6.20 1187 Company Sanitized. Does not contah. TCCA CB H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-5386 In.dividiial Puip Wei<?hlts (grams]1: Lac ta,tioi1 Day 0 FI Geneiration Animal Number Eiup S ex 1 643420a Groui?: II -0 2 3 4 Dose;: 0 m g/kgAlay Pup Mumber 5 6 7 8 9 10 11 12 643419 6434143 7.50 5.60 7.20 6.50 7.30 6.50 6.90 6.00 7 .00 6 .00 7.10 6.60 6.00 5.60 6.90 6.40 643401 643455 643378 6433933 6.10 5.30 7.00 6.40 8.70 8.10 6.20 5.80 6.50 5.90 9.20 6.60 6.20 5.60 6.60 6.30 7.90 7.90 6.30 6.90 6.50 7.90 6 .10 6 .60 6 .70 8 .40 6.90 7.10 5.90 6.00 7.00 6.20 7.20 6.40 6.90 5.40 6.10 5.90 643447 643478 643386 6.60 6.20 6.00 5.70 6.40 5.90 6.30. 6.60 7.20 6.00 6.30 6.20 6.20 6.20 6.50 6.40 6.30 5.70 6.50 6.40 6.60 6.50 6.30 6.30 6 .70 6 .40 6 .50 5 .40 6 .40 6 .00 7.00 6.60 6.20 6.40 6.70 7.20 6.50 6.80 5.80 6.10 6.50 5.60 7.00 6.60 6.40 5.50 6.30 7.10 6.50 1188 Company Sanitized. Does not contain TSCA CBI H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-5386 Animal Number 643399^ 643334 643464 643369 643490 643342 643438 6434453 In div'idlual PiUp KFei.ght 8 (graims) : La.ctat:icin D.ay O F 1 G<ine'rat ion Gr(3U]3: 1\r-Q Do,se: ; !5 mg/ kg /dasr E Tip S ex : L 7. 30 7. 50 6. 30 6. 30 8. 10 6. 90 6. 50 6. 00 7. 00 6. 60 7. 60 6. 20 6. 20 6. 00 2 8 .10 7 .40 7 .10 6 .40 7 .50 7 .40 6 .90 5 .70 6 .90 6 .40 7 .20 6 .90 6 .30 6 .30 3 8 .00 7 .50 6 .20 6 .20 7 .40 6 .90 6 .80 6 .00 6 .60 5 .70 7 .40 7 .30 5 .80 5 .90 4 7 .60 8 .10 7 .30 6 .40 8 .20 7 .20 6 .10 6 .50 6 .40 6 .40 6 .00 6 .30 5 .80 6 .10 Pup Numb er 5 6 7 7 .50 6 .60 6 .20 8 .20 7 .60 6 .50 6.20 6 .90 6 .20 6 .50 5 .90 6 .00 5 .40 7.60 6.60 6.90 7.00 5.80 6.80 6.90 6.70 6.00 5.60 7 .80 7 .00 7 .20 6 .80 6 .10 6 .60 6 .90 6 .60 6 .10 8 7 .50 6 .40 7 .50 6 .20 6 .70 6 .90 7 .10 6 .40 9 7 .00 7 .00 6 .80 5 .10 6 .00 10 7 .00 6 .00 6 .00 11 5.60 643418 643325 6. 80 7. 00 7. 20 6. 80 6 .80 6 .10 6 .60 6 .80 6 .30 6 .60 7 .50 5 .80 4 .30 6 .60 7 .10 7 .20 6 .90 6 .30 7 .10 6.70 6.00 6.90 6 .80 6 .40 7 .00 6 .90 7 .50 6 .90 6 .70 7.30 1189 company saniti2ed- Does not contain TSCA CBl H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-5386 Animal Number 643479 6434033 Individual PiUp Vrei<3ht s (grcims) : Lactat:ion D ay O FI G(in<;rat ion Grcsup: IVr-0 Do se: ;25 mg/ kg /dair P up Puip Numbier S ex l 2 3 J l 5 6 7 8 9 8.30 7.00 7.50 7 .70 7. 60 7.20 7.20 10 11 643376 643422s 6.90 6.00 6.70 6.50 7 .40 6 .70 6. 50 6. 90 7.40 6.60 7.40 6 .80 6.90 7 .10 643452 643473d 643372 643400 643395C 643457 7.50 6.70 7.30 7.50 7 .00 6 .50 7. 30 7. 10 7.90 6.50 7.80 6.60 7.40 7.60 6.60 5.60 5.90 7.50 6.40 6.30 6.40 7.00 6.90 7.00 6.00 5.40 6.30 6.50 6.00 6.00 6 .50 5 .80 6 .00 5 .40 6 .10 6 .60 6 .40 6 .20 7. 00 6. 20 5. 50 5. 60 6. 90 6. 00 5. 80 7.30 6.60 5.90 4.10 6.20 6.10 6.00 7.10 7.10 5.90 5.10 5.90 5.50 7.50 6.90 5.50 5.80 6 .00 5 .70 5 .90 6.70 6.50 7 .20 6 .90 1190 capawswllwl^'M^rscAcal H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): Lactation Day 0 PI Generation Group: VI - 0 Dose: 100 mg/kg/day DuPont-5386 Animal Number 643320 643488s 643428 643439 643353 6433853 643339 6434733 643337 643416 Pup Sex 7.20 8.00 7.00 7.30 Pup Number 567 10 11 6.40 6.00 6.80 6.70 9.10 7.50 6.70 6.00 7.00 5.50 7.50 8.40 6.70 6.70 6.10 5.30 8.90 7.40 7.00 6.40 5.70 8.30 7,10 6.00 7.20 6.40 8.30 6.50 6.80 6.90 6.40 6.80 6.80 7.40 6.80 6.50 6.30 6.20 6.70 6.90 6.50 6.30 6.70 6.40 6.20 6.20 6.50 5.80 6.40 6.50 7.00 6.00 6.20 5.50 6.20 6.60 6.40 7.10 6.80 6.50 7.60 6.40 6.50 7.00 7.20 6.10 6.60 5.20 7.20 1191 Company Sanitized. Does not contain TSCA CBI H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Animal Number 643407 643357'' Individual Pup Weights (grams): Lactation Day 0 FI Generation Group: VI - 0 Dose: 100 mg/kg/day Pup Number Pup 5 6 7 8 Sex 5.70 5.00 5.30 4.50 6.50 5.40 5.70 4.90 6.30 5.20 5.70 5.20 5.70 6.00 6.10 5.40 6433310 643427 6434703 7.70 6.80 7.10 6.70 7.10 6.70 6.70 7.80 7.30 7.00 7.00 7.10 7.10 7.10 643434 643349 643454^' 6.70 5.50 6.50 6.20 5.70 6.00 5.90 6.10 6.50 5.50 6.20 6.10 6.50 6.20 6.30 6.00 5.60 5.70 6.40 5.60 6.50 6.20 6.30 6.70 6.70 6.30 6.00 6.50 5.60 5.80 6.20 6433339 643460 8.20 7.60 8.20 7.50 7.60 7.20 8.70 7.70 8.20 7.30 8.20 7.70 7.30 7.10 DuPont-5386 10 11 5.90 6.40 6.00 1192 Company Sanitized. Does not contain TSCA CBI H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Animal Number 643467 643443 643417 643413 643338 643335 643468 643440 6434303 Ind;Lvidual Pup W(iights (grams).: L actaticm Day 0 FI General;ion Grc3Up: V III-O Dose;; 250 mg/kg/clay Pup N umber Pup Sex l 2 3 4 5 6 7 8 7.20 6.90 7.00 6.80 6.30 7.50 6.80 5.30 6.80 6.60 6.90 6.00 7.80 7.50 6.30 6.00 6.60 6.90 6.20 6.60 6.10 5.40 7.00 6.40 6.30 5.50 6.80 6.10 7.50 6.80 6.60 6.10 7.00 6.80 7.20 6.70 8.00 5.70 6.10 6.70 6.90 6.20 6.30 6.50 7.80 7.60 6.40 6.10 7.30 6.30 7.20 6.00 8.10 7.40 7.20 6.80 6.90 6.80 7.30 6.40 7.80 6.50 6.30 5.80 7.40 7.00 6.40 6.70 5.90 7..30 5.90 6.60 5.70 6.60 5.90 6.30 7.50 6.30 5.80 7.10 7.10 6.00 6.70 7.40 6.80 6.50 5.40 7.60 6.80 5.60 7.10 7.10 5.30 6.60 6.80 5.90 6.80 6.10 6.50 7.50 6.80 7.10 7.00 6.60 6434313 DuPont-5386 9 10 7.60 6.10 5.60 1193 Company Sanitized. Does not contain TSCA CBI H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 Individual Pup Weights (grams): Lactation Day 0 FI Generation Group: VIII-p Dose: 250 mg/kg/day Animal Number 643326 643365 12345678 Pup Sex 5.70 6.30 6.90 6.60 6.50 7.60 6.20 6.10 7.90 6.90 5.50 Pup Number --^---------- 6.50 6.30 6.50 6.00 6.20 643375A 7.00 6.50 7.00 7.20 7.50 643328 6433483 5.30 5.80 5.30 5.30 5.60 6.00 5.50 4.90 5.20 5.20 5.00 5.50 9 10 6433461 643449 643429J 6.40 5.70 6.80 5.70 6.20 6.20 6.70 5.90 6.80 6.10 6.10 5.60 5.70 6.20 6.50 5.80 6.10 6434243 1194 Company Sanitized. Does not contain TSCA CB( H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): FI Generation Lactation Day 4 Preculling Group: II-O Dose: 0 mg/kg/day DuPont-5386 Animal Number 643352s 643343 643459 643394s 643480 643319s 6433503 643363 643397 643421 I?up Piip Number !ex 1 2 3 4 1 5 6 7 8 9 10 11 12 12 .10 12 .10 11 .10 12 .30 13 .00 11 .90 12 .30 10 .10 12 .70 12 .00 10 .90 13 .20 12 .30 12 .10 13 .80 12 .20 11 .10 13 .50 12 .60 12 .10 14 .20 12.10 13.00 12.70 13.80 13.60 13.30 14 .60 14 .20 13 .30 11 .70 13 .90 12 .90 13 .40 14 .30 12 .70 12 .50 13 .20 12 .30 12.20 12.40 12.40 10 .20 10 .90 10 .60 9. 20 11 .20 9. 10 10 .90 10 .40 12 .00 10 .90 9. 20 9. 90 10 .20 10 .30 11 .60 11 .50 11 .20 10 .90 11 .10 9. 50 12 .80 11 .30 8. 60 10 .20 11 .40 10 .40 11 .90 11 .40 9. 80 10 .20 12 .70 10 .40 11 .70 10 .50 11 .60 10 .10 10.70 11.00 10.40 9.70 9.90 11.90 10.80 9.20 10.90 1195 Company Sanitized. Does not contain TSCA CB( H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-5386 Individual Pup Weights (grams): FI Generation Lactation Day 4 Preculling Group: 11 - 0 Dose: 0 mg/kg/day Animal Pup Number Sex 6434203 Pup Number 6 7 8 9 10 11 12 643419 6434143 12.70 12.50 11.60 9.70 10.60 12.80 10.60 9.80 12.10 10.80 9.90 11.50 11.40 11.10 11.20 9.80 643401 643455 643378 643393s 10.10 9.00 10.10 9.30 14.10 15.50 10.30 9.10 9.80 10.30 15.50 12.80 10.00 8.40 10.50 9.70 13.40 15.70 11.00 10.90 9.70 16.60 10.10 11.50 10.60 14.70 9.70 11.30 10.30 9.80 11.60 10.00 10.60 9.60 10.30 10.20 10.70 9.70 643447 643478 643386 10.70 9.50 11.70 10.80 11.20 9.50 10...80 10.80 11.20 10.10 10.40 10.00 9.90 9.80 11.40 10.00 10.40 9.60 9.60 9.40 10.40 10.50 11.60 10.50 9.50 9.90 11.90 10.50 10.50 9.60 9.70 10.00 10.90 10.30 10.90 6.30 9.80 11.90 11.60 11.10 11.00 11.30 9.80 9.90 10.20 11.00 9.40 10.90 9.90 1196 Company Sanitized. Does not contain TSCA CBl H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations lir In dividijal PULp Ktei<ght,S (;graims ) : F] Ge'iteration ]Lactatioia. D.ay 4 Ereicul ig GR(3OT IV -0 DO;SE: !5 ]MG/ KG/DAY DuPont-5386 Animal Number 643399 643334 643464 643369 643490 643342 643438 6434453 643418 643325 Pup PuP ^rumber Siex 1 2 3 4 5 6 7 8 9 10 11 13 .50 11 .20 10 .70 10 .00 13 .20 13 .00 10 .20 9. 50 9. 90 9. 00 13 .00 12 .10 10 .00 9. 90 13 .80 12 .40 10 .00 10 .80 13 .90 11 .70 10 .70 8. 50 10 .10 8. 00 11 .20 11 .40 10 .20 10 .10 12 .40 12 .30 10 .00 10 .20 12 .20 11 .80 9. 40 9. 40 9. 90 8. 30 10 .80 12 .00 11 .00 10 .80 12 .40 12 .60 10 .70 9. 70 13.20 11 .80 9. 70 9. 10 8. 70 8. 30 10.20 10 .40 10 .90 9. 90 12 .60 11 .80 10 .80 10 .00 12 .50 12 .60 9. 90 6. 90 10 .50 10 .00 11 .80 9. 60 10 .50 12 .10 12 .90 11 .30 11 .80 11 .50 11 .20 9. 40 12 .60 10 .50 10 .50 9. 80 11 .60 11 .00 12 .00 9. 80 10 .20 10 .10 12 .50 11 .70 10 .30 11.50 10.90 11.90 10.20 9.70 12.10 11.20 10.30 11.50 9.40 9.80 10.80 10.20 10.20 10.50 11 .70 11 .10 11 .40 12 .90 11 .30 11 .00 13 .50 11 .40 11 .00 10 .10 12 .30 12 .30 10 .80 11 .20 13 .00 11 .90 11 .20 11 .70 12 .80 11 .60 10 .60 13 .60 6. 10 12 .60 13.20 12.80 12.90 12.80 1197 Company Sanitized. Does not contain TSCA Cflt H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-5386 Animal Number 643479 643403s Individual Pup Weights (grams): FI Generation Lactation Day 4 Preculling Group: IV-0 Dose: 25 mg/kg/day EUp PU;p hlumber S!ex 1 2 3 4 5 6 7 8 9 15 .40 12 .70 14 .50 13 .70 13 .70 14 .40 14 .20 10 11 643376 643422^ 10 .40 11 .40 11 .10 10 .50 10 .50 10 .80 11.10 9. 50 10 .50 10 .00 10 .10 9.80 9.70 11.70 643452 643473d 643372 643400 643395 643457 12 .40 12 .40 11 .80 11 .50 12 .70 12 .30 11.10 11 .60 12 .70 11 .00 11 .70 11 .70 15 .10 10 .10 10 .30 7. 70 8. 60 12 .60 13 .20 11 .70 11 .00 13 .50 10 .20 10 .90 8. 70 8. 00 13 .80 13 .20 12 .00 10 .30 11 .10 10 .10 7. 10 8. 10 13 .40 14 .40 11 .10 10 .50 11 .10 10 .90 9. 70 7. 80 13 .00 12 .90 12 .60 11 .20 10 .40 9. 20 9. 00 11 .30 11 .70 10 .00 9. 50 9. 30 11 .20 12.20 8.60 8.60 11.60 11.00 7.90 10.80 11.00 10.50 9.60 11.50 1198 Company Sanitized. Does not contain TSCA CBl H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-5386 Animal Number 643320 6434883 Individual Pup Weights (grams): FI Generation Lactation Day 4 Preculling Group: VI - 0 Dose: 100 mg/kg/day Pup Number Pup 1 2 3 4 Sex 13.50 15.10 14.10 14.00 5 6 7 8 9 10 11 643428 643439 643353 643385a 643339 643473s 643337 643416 11.20 9.10 10.20 12.00 14.40 10.80 11.00 10.50 13.60 13.30 16.70 13.70 10.90 10.60 12.40 10.40 14.70 15.40 9.90 11.10 13.30 16.50 14.60 10.40 9.10 10.20 15.80 10.70 11.00 13.60 10.20 10.20 12.30 10.50 10.60 11.70 11.20 11.30 10.40 11.00 11.10 9.60 10.30 8.40 9.90 11.20 10.60 10.90 11.00 10.60 13.30 10.70 11.40 11.40 13.40 12.70 12.00 13.90 11.90 10.70 13.80 12.00 11.70 11.50 8.90 12.50 11.50 11.10 1199 Company Sanitized. Does not contain TSCA ftal H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-5386 Animal Pup Number Sex 643407^ 6433573 Individual Pup Weights (grams): FI Generation Lactation Day 4 Preculling Group: VI-0 Dose: 100 mg/kg/day Pup Number 5678 10 n 643331S 643427 643470a 643434 643349 643454f 643333 643460 12.50 11.70 11.00 12.10 11.50 11.90 11.30 11.60 11.90 13.10 11.70 11.70 11.40 12.00 9.90 8.50 10.90 9.00 8.90 9.50 10.10 10.60 10.00 6.90 10.20 8.30 10.30 10.80 10.40 10.00 9.40 9.10 9.80 8.40 8.80 7.10 8.60 10.50 8.80 8.90 8.70 9.00 9.80 9.80 9.00 8.90 8.10 15.60 14.80 12.90 12.10 14.60 13.40 12.40 12.20 13.80 14.00 12.20 11.30 13.50 11.80 12.40 12.90 12.00 12.80 12.20 12.60 11.90 1200 Company Sanitized. Does not contain TSCACB1 H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-5386 Ind ividual PUp w<iiglits (grams] : FI Gen.era1:ioi3 Lac tat3Lon Day 4 Pre<=Ul]Ling Gnoup: V III -0 Animal PU]P Number Se:C 1 2 3 4 Dose ! 41250 mg/ kg/(lay Pup N umbisr 5 6 7 8 9 10 643467 643443 643417 643413 643338 643335 643468 643440 6434303 10.00 8.50 11.20 12.30 9.50 9.50 10.80 9.40 11.40 11.10 10.40 10.40 11.80 9.00 11.60 9.00 10.70 8.30 12.10 11.00 13.80 6.80 12.70 11.30 12.00 11.60 10.20 8.80 12.20 9.60 9,. 90 9.90 9. 90 10 .30 11 .90 12 .30 9. 30 8. 30 11 .90 10 .70 11 .30 11 .20 9. 20 8. 40 10 .20 11 .40 10 .30 10 .60 9. 10 8. 80 11 .90 12 .00 7. 20 11 .80 12 .70 11 .40 11 .30 11 .50 11 .70 10 .50 10 .40 11 .20 11 -20 10 .50 8.60 10.00 12.80 11.60 9.40 9.20 11.60 11.70 9.80 11.40 9.60 12.50 11.00 10.00 9.70 7. 90 12 .40 10 .70 12 .30 10 .40 9. 30 11 .00 10 .50 11 .70 10 .90 9. 00 9. 70 13 .30 10 .90 11 .00 12 .10 10 .10 9. 60 10 .30 10 .30 8. 60 10 .70 8. 20 10 .80 11 .00 10.80 11.10 10.20 6434313 1201 Company Sanitized. Does not contain TSCA CBl H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Animal Number 643326 643365 643375h 643328 6433483 Individual Pup Weights (grams): FI Generation Lactation Day 4 Preculling Group: VIII-0 Dose: 250 mg/kg/day Pup Sex Pup Number 5 6 11.40 11.70 10.80 9.90 11.00 10.10 11.10 9.70 10.90 11.10 11.30 11.30 11.40 11.30 10.80 9.80 10.50 10.20 10.90 10.30 4.80 10.10 9.80 11.30 11.70 11.40 9.20 7.90 11.40 6433461 643449 643429 J 6434243 11.10 9.50 12.20 10.80 10.30 10.40 11.30 10.10 9.90 8.00 9.70 8.60 8.40 8.60 10.10 DuPont-5386 10 9.70 8.60 1202 Company Sanitized. Does not contain TSCA CM H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 Individual Pup Weights (grams): PI Generation Lactation Day 4 Postculling Group: II-0 Dose: 0 mg/kg/day Animal Number 6433523 643343 643459 6433943 1 2 3 4 5 Pup Number Pup ------------ Sex 13.00 12.30 12.20 12.60 12.10 11.90 12.10 12.10 12.30 13.80 13.50 14.20 12.70 12.30 10.10 13.20 643480 6433193 14.60 13.40 13.30 14.30 13.90 13.20 12.90 12.20 6433503 643363 643397 643421 10.20 10.40 10.60 10.90 11.20 10.90 10.90 9.50 12.00 11.30 9.20 10.20 11.10 11.00 12.80 9.70 11.20 10.20 12.70 9.20 10.40 10.80 9.80 10.10 1203 Company Sanitized. Does not contain TSCA CBf H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): FI Generation Lactation Day 4 Postculling Group: II-O Dose: 0 mg/kg/day Animal Number 6434203 643419 6434143 643401 643455 643378 6433933 643447 643478 643386 Pup Sex 11.60 11.40 Pup Number 2 3 4 10.60 10.60 12.10 11.10 11.20 9.80 11.00 9.00 10.90 10.30 14.10 15.50 10.10 9.10 11.50 9.70 15.50 12.80 9.80 8.40 11.30 9.70 13.40 15.70 10.00 11.60 10.60 16.60 10.20 14.70 10.80 9.50 11.20 10.10 11.20 9.50 6.30 10.80 10.40 10.50 10.50 10.00 9.90 9.80 10.90 10.30 10.90 10.50 10.90 9.90 11.90 11.60 11.10 9.60 DuPont-5386 1204 TSCACBl Company Sanitized. Does not contain H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): PI Generation Lactation Day 4 Postculling Group: IV-0 Dose: 25 mg/kg/day Animal Number 643399 643334 643464 643369 643490 643342 643438 6434453 ETip Pilp N[un>er 4 5 6 ;ex 1 2 3 13 .80 12 .40 12 .60 12 .10 12 .40 12 .30 12 .60 11 .80 10 .70 10 .80 11 .00 10 .30 10 .80 10 .20 9. 70 10 .00 13 .90 12 .20 13 .20 12 .50 11 .80 12 .60 12 .00 11 .90 10 .20 10 .70 9. 40 11 .50 8. 50 10 .20 10 .20 9. 40 9. 90 8. 70 10 .50 10 .20 9. 00 8. 00 8. 30 8. 30 10 .80 10 .00 12 .50 12 .10 11 .40 12 .00 10 .50 11 .70 10 .20 11 .00 9. 60 10 .50 10 .80 9. 90 10 .50 9. 80 643418 643325 11 .30 11 .00 11 .40 12 .90 10 .80 10 .10 12 .80 11 .40 11 .60 11 .20 13 .60 12 .30 6. 10 11 .70 13 .20 11 .90 DuPont-5386 1205 ^^s^.--------^^081 H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): FI Generation Lactation Day 4 Postculling Group: IV-0 Dose: 50 nig/kg/day Animal Number 643479 643403a 2 3 4 5 6 Pup Sex 1 Pup Number 15.40 12.70 14.50 13.70 13.70 14.40 14.20 643376 6434223 10.40 11.10 10.50 11.70 9.50 10.50 10.00 10.10 643452 643475d 643372 643400 643395 643457 12.40 12.40 11.50 12.70 11.60 12.70 11.70 11.70 15.10 11.10 10.30 8.70 8.60 12.60 13.20 11.70 11.00 13.50 10.40 10.90 7.10 8.00 13.80 13.20 12.00 10.30 12.20 10.10 9.00 8.10 13.40 14.40 11.10 10.50 11.00 9.20 7.90 7.80 13.00 12.90 11.20 11.20 DuPont-5386 1206 Company Sanitized. Does not contain TSCA CBl H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): FI Generation Lactation Day 4 Postculling Group: VI - 0 Dose: 100 mg/kg/day Animal Number 643320 643488a Pup PVip t lumb er Sex 1 2 3 4 5 13 .50 14 .10 15 .10 14 .00 643428 643439 643353 6433853 643339 6434733 643337 643416 11 .00 10 .50 10 .20 12 .00 14 .40 10 .80 9. 90 10 .60 13 .60 13 .30 16 .70 13 .70 10 .40 11 .10 13 .30 10 .40 16 .50 15 .40 10 .20 11 .00 10 .20 15 .80 14 .60 13.60 10 .50 11 .00 10 .60 9. 60 11 .20 9. 90 10 .40 11 .20 12 .70 12 .00 13 .30 10 .70 11 .90 11 .70 13 .40 11 .50 8. 90 13 .90 12 .50 11 .50 13 .80 DuPont-5386 1207 Company Sanitized. Does not contain TSCACBl H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): FI Generation Lactation Day 4 Postculling Group: VI-0 Dose: 100 mg/kg/day Animal Number 643407^ 6433573 1 2 3 4 5 Pup Number Pup ------------ Sex 643331 643427 6434703 643434 643349 643454-^ 643333 643460 12.50 11.70 11.00 12.10 11.60 11.90 11.70 11.40 9.90 6.90 10.10 9.00 10.00 7.10 10.40 8.30 10.30 8.70 9.80 8.90 9.40 9.80 8.60 8.90 15.60 14.80 12.40 12.10 14.60 13.40 12.20 11.30 13.80 14.00 12.90 12.20 13.50 12.80 11.90 DuPont-5386 1208 Company Sanitized. Does not contain TSCA CBI H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): FI Generation Lactation Day 4 Postculling Group: Animal Number 643467 643443 643417 643413 643338 643335 643468 643440 6434303 VIII-0 Pup Sex 1 10 .70 8. 30 11 .20 12 .30 9. 50 9. 50 11 .90 11 .30 12 .00 11 .60 10 .40 10 .40 12 .20 9. 60 9. 90 10 .60 Dose: 250 mg/kg/day Pilp t lumber 2 3 4 5 9. 90 10 .30 12 .10 11 .00 13 .80 6. 80 9. 20 10 .70 11 .30 11 .20 11 .70 8. 80 11 .70 11 .40 10 .30 10 .50 7. 90 8. 80 12 .80 12 .30 9. 30 8. 30 12 .30 11 .40 11 .30 11 .50 11 .40 8. 40 9. 60 11 .20 10 .00 9. 70 9. 70 10 .00 12 .40 12 .00 7.20 11 .80 10 .90 11 .60 11 .70 9. 30 11 .00 10 .50 8. 20 11 .00 10 .80 11 .00 6434313 DuPont-5386 1209 Company Sanitized. Does not contain TSCA CBI H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): FI Generation Lactation Day 4 Postculling Group: VIII-0 Dose: 1000 mg/kg/day Animal Number 643326 643365 643375A 643328 6433483 2 3 4 5 Pup Number Pup Sex 11.00 10.90 11.40 10.90 11.70 11.30 10.50 10.30 10.80 11.10 11.30 9.90 9.70 11.30 10.80 10.20 4.80 10.10 9.80 11.30 11.70 11.40 9.20 7.90 11.40 6433462 643449 643429J 12.20 11.30 9.90 10.10 10.40 10.10 8.00 8.60 6434243 DuPont-5386 1210 Company Sanitized. Does not contain TSCA CBt H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): Lactation Day 7 PI Generation Group: II-0 Animal Pup Number Sex 643352s 643343 643459 6433943 19.40 18.40 22.70 17.10 Dose: 0 mg/kg/day Pup Number 2 3 4 5 18.70 19.60 19.70 19.00 18.70 18.80 21.50 22.70 22.40 20.30 20.70 19.00 643480 643319s 21.20 19.60 23.10 21.40 20.20 22.20 22.90 20.10 6433503 643363 643397 643421 19 .40 17 .10 17 .60 16 .90 16 .00 14 .50 16 .90 16 .30 20 .00 19 .40 13 .70 15 .00 20 .70 18 .20 22 .10 18 .80 14 .40 15 .10 18 .90 18 .50 18 .30 18 .10 16 .90 15 .80 DuPont-5386 1211 Company Sanitized. Does not contain TSCA CBl H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): Lactation Day 7 FI Generation Group: II-0 Animal Pup Number Sex 643420s 643419 643414s 19 .50 16 .20 Dose: 0 mg/kg/day Pup Number 2 3 4 5 17 .90 20 .00 18 .20 19 .00 18 .40 18 .70 643401 643455 643378 643393s 17 .00 14 .80 16 .90 14 .70 19 .40 18 .40 17 .50 15 .50 17 .40 15 .70 20 .50 22 .00 17 .00 15 .90 17 .20 17 .30 19 .60 22 .00 17 .40 16 .50 15 .10 23 .00 16.60 19.70 643447.. 643478 643386 18 .50 17 .20 16 .70 15 .80 18 .80 16 .80 18 .70 18 .70 17 .10 16 .40 19 .00 17 .40 18 .30 15 .80 17 .50 15 .70 19 .60 15 .40 15 .70 17 .20 15 .60 15 .20 18 .80 17 .90 DuPont-5386 1212 Company Sanitized. Does not contain TSCA CBf H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): Lactation Day 7 FI Generation Group: IV-Q Dose: 25 mg/kg/day Animal Number 643399 643334 643464 643369 643490 643342 643438 6434453 I ?up PiJlp li[unit:>er 4 5 6 i3ex 1 2 3 19 .70 21 .30 19 .50 19 .00 19 .30 19 .70 19 .20 18 .80 17 .60 18 .00 19 .30 19 .40 16 .70 14 .40 18 .90 15 .80 16 .90 17 .30 19 .10 18 .00 16 .50 16 .50 16 .30 17 .10 15 .90 17 .70 16 .30 17 .50 15 .00 14 .60 16 .40 16 .40 15 .20 17 .00 17 .20 16 .90 14 .90 15 .60 16 .00 15 .70 16 .80 18 .20 16 .40 17 .10 18 .00 19 .40 17 .50 15 .80 17 .90 18 .80 16 .40 16 .70 19 .30 18 .30 18 .40 17 .40 643418 643325 9. 20 17 .20 19 .00 21 .70 19 .30 17 .70 22 .30 19 .60 17 .80 18 .80 20 .70 21 .90 18 .80 18 .20 22 .80 19 .70 DuPont-5386 1213 Company Sanitized. Does not contain TSCA CBl H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): Lactation Day 7 PI Generation Group: IV-0 Dose: 25 mg/kg/day Animal Number 643479 6434033 2 3 4 5 6 Pup Sex 1 Pup Number 22 .50 21 .00 21 .40 19 .10 18 .10 19 .60 20 .50 643376 643422s 17 .70 19 .20 15 .60 16 .80 15 .00 16 .60 15 .10 17 .20 643452 643475'3 643372 643400 ; 643395 643457 19 .40 20 .10 19 .60 18 .00 18 .30 19 .30 18 .40 18 .20 22 .50 17 .90 17 .10 12 .50 13 .40 19 .40 19 .90 19 .90 18 .20 20 .60 17 .00 17 .00 14 .40 11 .90 20 .90 19 .00 20 .80 18 .10 18 .80 15 .50 13 .00 12 .80 20 .40 18 .70 19 .00 17 .80 17 .90 15 .80 10 .60 12 .20 21 .20 20 .40 17 .90 17 .30 DuPont-5386 t 1214 Company Sanitized. Does not contain TSCA CBl H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): Lactation Day 7 PI Generation Group: VI - 0 Dose: 100 mg/kg/day Animal Number 643320 643488a Pup Number Pup 2 3 4 5 Sex 22.50 21.20 21.30 22.60 643428 643439 643353 6433853 643339 6434733 643337 643416 17 .10 17 .70 20 .50 17 .10 23 .50 20 .80 17 .40 17 .80 16 .90 18 .00 23 .30 22 .40 18 .10 18 .50 20 .80 20 .00 21 .30 20 .50 17 .80 16 .90 16 .90 23 .50 16 .20 20.00 17.70 18.10 17.10 17.00 17.50 16.00 17.50 16.30 20.30 18.50 17.70 15.00 19.40 19.50 18.10 21.70 19.40 19.20 20.10 15.70 19.00 DuPont-5386 1215 Company Sanitized. Does not contain TSCA CSl H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): Lactation Day 7 F^ Generation Group: VI - 0 Dose: 100 mg/kg/day Animal P UP Pilp t lumbisr Number S ex 1 2 3 4 5 643407^ 6433573 6433316 643427 643470s 643434 643349 643454^^ 19 .80 19 .10 17 .80 19 .00 19 .50 19 .30 19.20 19.30 17 .10 14 .10 16 .60 15 .40 14 .90 15 .80 17 .60 13 .70 15 .90 11 .40 17 .60 14 .80 16.90 10.70 15.40 14.00 643333 643460 20 .90 20 .60 16 .20 14 .30 22 .70 19 .70 16 .00 15 .00 20 .20 21 .30 15 .90 15 .10 19.50 15.50 13.90 DuPont-5386 1216 Company Sanitized. Does not contain TSCA CBt H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): Lactation Day 7 PI Generation Group: VIII-0 Animal Number 643467 643443 643417 643413 643338 643335 643468 643440 6434303 Pup Sex 1 12 .40 11 .50 18 .80 18 .10 20 .00 15 .00 13 .10 16 .80 16 .50 16 .70 19 .50 17 .20 13 .80 16 .40 12 .20 12 .70 Dose: 250 mg/kg/day I >up t lumbe r 2 3 4 5 10 .20 13 .60 20 .10 19 .00 12 .90 17 .20 18 .10 16 .50 15 .90 16 .00 19 .60 15 .40 11 .80 16 .10 11 .80 12 .30 13 .50 15 .60 19 .60 19 .50 9. 60 11 .80 16 .20 16 .90 15 .80 14 .00 18 .30 17 .60 17 .10 12 .00 12 .80 10 .80 13 .80 11 .30 20 .20 19 .50 14 .90 9..80 18 .40 15 .20 16 .30 16 .50 17 .80 15 .20 17 .90 17 .20 11 .70 11 .90 643431s DuPont-5386 1217 Company Sanitized. Does not contain TSCA CBl H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): Lactation Day 7 FI Generation Group: VIII-0 Animal Number 643326 643365 643375h'l Pup Sex 14.80 17.70 14.90 12.60 Dose: 250 mg/kg/day Pup Number 3 4 17.10 16.70 14.10 13.90 18.40 17.80 14.80 12.90 16.90 15.80 13.60 14.60 643328. 643348s 12.20 17.60 15.00 16.00 16.20 17.30 17.30 14.60 643346-1 643449 643429-? 15,20 15.80 20.30 17.10 17.60 15.30 15.80 13.50 643424s DuPont-5386 1218 Company Sanitized. Does not contain TSCA CBI H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): F^ Generation Lactation Day 14 Group: II-O Dose: 0 mg/kg/day Animal Number 6433523 643343 643459 643394s 2 3 4 5 Pup Sex Pup Number 37.90 40.90 39.20 38.70 36.00 38.10 37.20 37.30 43.70 43.10 44.50 40.60 46.10 36.00 40.60 40.50 643480 6433193 43.30 44.50 45.00 41.90 43.70 43.30 46.30 43.90 6433503 643363643397 643421 38 .20 39 .60 41 .00 34 .80 30 .60 31 .60 42 .30 38 .80 33 .30 35 .80 33 .30 30 .60 43 .10 36 .80 34 .60 33 .10 30 .30 32 .10 41 .00 40 .10 37 .20 35 .20 34 .80 32 .10 DuPont-5386 1219 Company Sanitized. Does not contain TSCA CB( H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Wteiglits (gr ams ): L.actciti(3n D ay 14 FI Generation Group: II-O D ose : 01 me(/kg/day Animal P Up Piup 1iuiribe'r Number S ex l 2 3 4 5 6434203 643419 643414s 43 .30 38 .50 42 .10 41 .10 42 .90 40 .70 41 .60 41 .30 643401 643455 643378 643393s 35 .70 35 .00 36 .20 32 .30 36 .70 40 .10 35 .70 31 .30 35 .30 30 .60 38 .90 39 .60 36 .30 33 .80 35 .30 34 .50 38 .10 33 .60 37 .40 30 .50 35 .20 37 .30 35.30 40.60 643447 643478 643386 39 .50 34 .00 36 .90 37 .20 39 .80 37 .10 37 .50 36 .40 37 .60 36 .50 39 .20 39 .60 37 .30 35 .50 38 .80 38 .80 40 .20 37 .50 34 .30 38 .00 38 .70 37 .40 40 .90 37 .40 DuPont-5386 1220 Company Sanitized. Does not contain TSCA CBI H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup 1Wei(3ht.3 (gr,a.ms,) : ]Lad;at.ioni D,ay :L4 FI Generation Group: IV-0 DO!se: K )0 mg/kg/day Animal Number I ?up Siex l Pilp K[umbfsr 2 3 4 5 6 643399 643334 643464 643369 643490 643342 643438 6434453 39 .90 37 .40 38 .30 37 .10 38 .30 37 .50 36 .00 35 .30 35 .10 33 .80 39 .30 39 .80 34 .90 37 .10 39 .00 37 .30 38 .50 34 .60 40 .10 38 .20 37 .90 37 .20 37 .70 34 .80 41 .70 38 .90 33 .80 34 .40 39 .10 38 .70 37 .60 38 .00 38 .20 37 .90 35 .70 34 .40 34 .30 33 .70 38 .20 40 .30 37 .70 36 .50 37. 20 36. 90 38. 20 35. 30 41. 10 37. 40 38. 30 36. 20 36. 50 36. 30 42. 70 39. 10 36. 90 32. 90 643418 643325 39 .00 37 .60 47 .10 43 .20 37 .80 36 .10 42 .80 45 .20 38 .30 37 .90 46 .90 46 .40 25. 10 38. 10 44. 90 40. 60 DuPont-5386 1221 Company Sanitized. Does not contain TSCA CBl H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): F]_ Generation Lactation Day 14 Group: IV-0 Dose: 100 mg/kg/day Animal Number 643479 6434033 Pup Sex Pup Number 3 4 39.90 35.10 35.90 40.20 36.70 31.30 34.40 643376 6434223 34.70 34.40 33.70 39.90 31.20 31.00 35.80 32.20 643452 643475d 643372 643400 . 643395 643457 36.30 38.00 36.70 36.90 36.40 37.00 35.80 34.60 39.80 38.40 35.40 32.20 32.20 37.50 37.30 40.10 38.30 38, 50 39, 60 35, 80 29 90 30 00 36 80 35 30 40 80 38 60 37.00 33.90 27.30 28.90 36.50 37.00 39.30 38.70 37.00 32.60 30.70 29.50 38.20 36.10 36.30 37.80 DuPont-5386 1222 Company Sanitized. Does not contain TSCA Cfil H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): FI Generation Lactation Day 14 Group: VI - 0 Dose: 100 mg/kg/day Animal Number 643320 6434883 Pup Number Pup 2 3 4 5 Sex 44.60 43.00 43.90 41.20 643428 643439 643353 6433853 643339 6434733 643337 643416 36 .10 36 .20 36 .40 38 .80 40 .20 35 .40 36 .40 34 .40 37 .80 35 .00 38 .40 36 .20 33 .60 32 .70 38.70 34 .80 39 .60 31.40 34 .50 33 .60 32 .50 39 .80 38 .30 38.80 36.10 38.00 38.90 37.10 39.50 34.20 35.50 35.80 38.40 38.50 36.20 32.40 41.30 37.70 36.10 38.80 39.60 35.30 40.70 33.20 38.10 DuPont-5386 1223 Company Sanitized. Does not contain TSCA CBI H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): FI Generation Lactation Day 14 Group: VI - 0 Dose: 100 nig/kg/day Animal Ptip PVlp I tunib er Number S!ex 1 2 3 4 5 643407^ 6433573 6433318 643427 6434703 643434 643349 643454f 643333 643460 35. 70 39 .90 36 .20 36.80 36. 50 37 .40 38 .20 36.70 31. 60 23. 50 28. 30 30. 10 34 .40 27 .90 34 .30 32 .20 37 .10 30 .30 34 .40 31 .10 34.30 32.60 32.00 29.90 36. 30 38. 80 33. 40 32. 10 38 .00 35 .80 34 .90 32 .20 40 .30 35 .70 33 .20 32 .50 35.60 34.90 33.40 DuPont-5386 1224 H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): FI Generation Lactation Day 14 Group: VIII-0 Animal Number 643467 643443 643417 643413 643338 643335 643468 643440 643430s Pup Sex 1 30 .40 25 .50 35 .10 32 .20 34 .40 31 .50 28 .90 25 .80 30 .70 31 .60 29 .60 29 .60 32 .80 36 .90 28 .10 28 .50 Dose: 1000 mg/kg/day t >up ^luinbe:r 2 3 4 5 25 .60 34 .10 34 .00 34 .90 26 .90 19 .60 25 .90 26 .90 33 .00 29 .80 31 .30 27 .10 37 .70 35 .20 26 .90 25 .50 16 .70 30 .50 35 .30 32 .50 20 .50 27 .90 28 .00 26 .60 31 .00 32 .20 31 .20 29 .00 28 .10 33 .60 26 .00 29 .00 24 .30 23 .60 34 .80 33 .80 28 .20 ; 24 .90 22 .30 26 .30 33 .10 31 .50 29 .90 26 .80 35 .70 31 .10 30 .10 29 .70 643431s DuPont-5386 1225 Company Sanltbed. Does not contain TSCA< H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): FI Generation Lactation Day 14 Group: VIII-0 Dose: 1000 mg/kg/day Animal Number 643326 643365 643375^ 1 Pup Sex 33.40 30.70 30.00 28.00 Pup Number 2 3 4 32.50 31.70 29.30 29.00 32.50 33.10 23.30 28.20 30.20 31.80 26.90 c 26.90 643328 643348s 20.80 21.90 27.40 23.60 24.10 26.40 25.20 25.60 6433461 643449 643429J 35.50 35.20 36.60 33.00 31.80 28.80 33.30 31.60 6434243 DuPont-5386 1226 H-24516: Subchronic Toxicity . 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): FI Generation Lactation Day 21 Group: II-O Dose: 0 mg/kg/day Animal Number 643352s 643343 643459 643394s 2 3 4 5 Pup Number Pup Sex 66 .50 64 .30 65 .60 62. 70 58 .70 61 .00 64 .00 59. 30 72 .00 67 .80 69 .90 71. 70 74.60 67 .40 65 .60 59 .10 643480 643319s 70.90 72.50 79.00 72.80 77.40 71.50 73.20 67.40 6433503 643363 643397 643421 67. 60 65. 30 62. 20 55. 60 45. 70 45. 30 68 .30 61 .80 60 .10 57 .60 47 .60 47 .70 66 .30 65 .20 58 .10 57 .40 44 .20 44 .10 73 .60 62 .00 64 .60 55 .10 49 .50 45 .90 DuPont-5386 1227 CompanySanitized. Does not contain TSCA CB, H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): FI Generation Lactation Day 21 Group: II-O Dose: 0 mg/kg/day Animal Number 6434203 643419 6434143 2 3 4 5 Pup Number Pup Sex 62.50 62.30 66.30 63.70 66.80 58.60 63.70 60.50 643401 643455 643378 6433933 57 .70 56 .20 56 .90 54 .20 66 .70 65 .50 61 .00 56 .00 55 .20 49 .50 61 .60 54 .30 56 .20 50 .30 48 .40 57 .50 60 .40 63 .10 57 .40 58.10 54 .00 46 .50 59 .60 67.20 643447643478 643386 58 .80 58 .60 63 .80 58 .60 66 .90 64 .40 62 .60 50 .70 59 .00 61 .30 67 .90 59 .70 56 .20 57 .50 61 .30 63 .50 66 .30 60 .60 59 .50 58 .40 59 .70 58 .50 63 .00 58 .30 DuPont-5386 1228 Company Sanitized. Does not contain TSCA CB H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): PI Generation Lactation bay 21 GROUP: IV-0 DOSE: 25 MG/KG/DAY Animal Number 643399 643334 643464 643369 643490 643342 643438 643445' 643418 643325 Pup Sex Pup Number 3 4 59.80 59.40 60.30 61.00 70.50 65.20 63.30 56.80 55.20 56.40 67.50 61.70 54.30 62.00 65 50 62 60 61 90 61 80 66 90 61 80 59 50 54 60 65 40 57 20 61 10 61 80 63, 00 53, 90 65.20 64.90 61.30 56.60 67.80 63.70 57.20 55.70 53.80 52.70 67.80 61.90 56.80 58.50 67.50 61.40 63.20 58.50 68.10 63.90 56.40 56.30 58.10 54.50 64.50 65.10 62.00 59.10 61.60 57.00 68.70 66.40 39.30 56.20 77.90 66.60 59.40 56.10 70.10 72.30 60.20 59.90 72.90 69.00 DuPont-5386 1229 Company Sanitized. Does not contain TSCA CB1 H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): FI Generation Lactation Day 21 Group: IV-Q Dose: 25 mg/kg/day Animal Number 643479 643403s 3 4 5 6 Pup Number Pup Sex 70.90 60.40 69.60 60.20 66.10 61.20 60.50 643376 6434223 54.00 56.60 58.00 64.30 49.50 55.70 50.10 44.80 643452 643475d 643372 643400 643395 643457 62.50 66.60 60.90 61.70 60.40 60.30 61.00 58.40 66.50 62.00 55.60 47.00 45.60 61.00 60.50 57.00 56.90 67.00 66.20 58.00 47.30 43.90 60.60 56.80 61.40 55.60 62.80 61.10 51.90 48.20 58.30 58.80 58.40 58.80 64.80 56.50 42.10 46.70 59.50 56.00 63.50 59.00 DuPont-5386 1230 Company Sanitized. Does not contain TSCA CBf H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): FI Generation Lactation Day 21 Group: VI - 0 Dose: 100 mg/kg/day Animal Number 643320 643488a Pup Sex 1 Pup Number 2 3 4 5 68 .50 60 .50 60 .60 65 .70 643428 643439 643353 643385a 643339 6434733 643337 643416 58 .40 54 .00 59 .00 60 .40 65 .80 64 .30 57 .10 56 .70 61 .40 56 .50 60 .30 50 .20 58 .70 54 .20 55 .10 53 .10 66 .10 59 .70 52 .10 52 .10 60 .40 66 .30 59 .00 48.20 59 .40 60 .30 56 .60 56 .60 53 .10 58 .80 57 .70 55 .80 62 .60 55 .90 61 .30 54 .30 64 .20 61 .40 64 .50 64 .40 52 .80 63 .30 60 .70 62 .50 59 .90 DuPont-5386 1231 Company Sanitized. Does not contain TSCA CB( H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individual Pup Weights (grams): FI Generation Lactation Day 21 Group: VI - 0 Dose: 100 mg/kg/day Animal Elip Pilp Ilurnber Number S;ex 1 2 3 4 5 643407^ 6433573 643331 643427 643470s 643434 643349 643454^ 643333 643460 63 .10 60.80 61 .70 57 .30 62 .40 57 .80 66 .00 60 .40 59 .20 38 .90 43 .90 46 .30 50 .30 45 .30 56 .30 48 .90 56 .10 48 .00 51 .60 51 .60 53 .40 51 .50 55 .80 49 .30 58 .80 59 .60 63 .20 55 .70 66 .70 61 .60 64 .90 57 .00 63 .70 60 .10 64 .50 56 .00 56 .10 59 .60 60 .10 DuPont-5386 1232 Company Sanitized. Does not contain TSCA CBI H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations Individi13.1 Pui3 Wei.ghtis (gi-ams ): Lac;tat:ion r)ay 21 1?'! Generation Group: VIII--0 Animal PiIP Number S(iX ; 1 643467 643443 643417 643413 643338 643335 643468 643440 6434303 43 .70 45 .10 38 .10 35 .60 32 .00 33 .60 31 .20 36 .10 49 .60 50 .30 54 .60 49 .00 43 .40 60 .30. 45 .00 44 .60 643431s I tose : 2"50 mgr/kg/day I 'up Kfumbe]r 2 3 4 5 54 .00 43 .00 39 .20 35 .10 23 .00 22 .10 39 .50 34 .20 50 .30 46 .10 50 .80 45 .50 59 .10 52 .80 46 .60 48 .90 29 .80 54 .60 35 .70 35 .70 29 .00 30 .30 37 .00 34 .60 52 .80 51 .70 56 .90 49 .00 57 .80 55 .70 53 .60 50 .70 42. 60 58. 40 41. 30 39. 70 40. 00 27. 90 40. 80 35. 80 50. 70 47. 60 50. 70 45. 20 52. 40 45. 60 48. 50 49. 00 DuPont-5386 1233 osipany SanHIzed. Does not contain TSCA CBI H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 Individual Pup Weights (grams): FI Generation Lactation Day 21 Group: VIII-0 Dose: 250 mg/kg/day Animal Number 643326 643365 643375^ 1 1 2 3 4 5 Pup Number Pup ------------ Sex 53.70 53.50 49.40 51.20 55.40 50.60 53.50 52.20 39.90 47.10 46.50 44.70 41.80 42.90 44.00 43.60 643328 6433483 34.60 47.50 41.00 43.40 45.50 39.70 45.60 40.40 6433462 643449 643429J 52.40 53.10 60.40 55.70 47.40 58.40 54.30 51.50 6434243 1234 Company Sanitized. Does not contain TSCA CBI APPENDIX HH REPRODUCTIVE TOXICOLOGY INDIVIDUAL LITTER CLINICAL OBSERVATIONS: Fi GENERATION 1235 H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 REPRODUCTIVE TOXICOLOGY INDIVIDUAL LITTER CLINICAL OBSERVATIONS: Fi GENERATION EXPLANATORY NOTES Footnotes a No live pups bom 1236 '"contain TSCACBt ANIMAL NUMBER INDIVIDUAL LITTER CLINICAL OBSERVATIONS: Fi GENERATION GROUP: II-O DOSE: 0 MG/KG/DAY LACTATION DAY SIGN INCIDENCE OBSERVATIONS 643343 643459 643480 643363 643397 643421 643419 643401 643455 643378 643447 643478 643386 NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED 1237 -^^^Sf SanKteeA ^ ^ ^^, INDIVIDUAL UTTER CLINICAL OBSERVATIONS: F^ GENERATION GROUP: IV-0 DOSE: 25 MG/KG/DAY ANIMAL NUMBER LACTATION DAY SIGN INCIDENCE OBSERVATIONS 643399 643334 643464 643369 643490 643342 643438 643418 643325 643479 643376 643452 643475 643372 643400 643395 643457 NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED . NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED 1238 comPanySanHfced. "ow not contain TSC/ ANIMAL NUMBER INDIVIDUAL LITTER CLINICAL OBSERVATIONS: Fi GENERATION GROUP: VI-0 DOSE: 100 MG/KG/DAY LACTATION DAY SIGN INCIDENCE OBSERVATIONS 643320 643428 643439 643353 643339 643337 643416 643407 6433313 643427 643434 643349 643333 643460 NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED 1239 Company Sanitized. Does not contain TSCA CBI ANIMAL NUMBER INDIVIDUAL LITTER CLINICAL OBSERVATIONS: Fi GENERATION LACTATION DAY GROUP: VIII-0 DOSE: 250 MG/KG/DAY SIGN INCIDENCE OBSERVATIONS 643467 NO ABNORMALITIES DETECTED 643443 NO ABNORMALITIES DETECTED 643417 DAY 21 3 OF 8 2 OF 8 DISCHARGE NOSE BLACK WEAK LITTER SUMMARY: 3 2 DISCHARGE NOSE WEAK DAY 21 PUP DATA: PUP: a b C DISCHARGE WEAK DISCHARGE WEAK DISCHARGE NOSE NOSE NOSE BLACK BLACK BLACK 643413 NO ABNORMALITIES DETECTED 643338 NO ABNORMALITIES DETECTED 643335 NO ABNORMALITIES DETECTED 643468 NO ABNORMALITIES DETECTED 643440 NO ABNORMALITIES DETECTED 643326 NO ABNORMALITIES DETECTED 643365 NO ABNORMALITIES DETECTED 643375 NO ABNORMALITIES DETECTED 643328 NO ABNORMALITIES DETECTED 643449 NO ABNORMALITIES DETECTED 6434293 1240 Company Sanitized. Does not contain TSCA CBl APPENDIX n REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHTS: Fi GENERATION 1241 Company Sanitized. Does not contain TSCA CBI H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations____________DuPont-5386 REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHTS: Fi GENERATION EXPLANATORY NOTES Notes Day of weaning = Test Day 1. a No data due to weighing error. 1242 Company Sanitized. Does not contain TSCA CBl INDIVIDUAL BODY WEIGHTS (grams) OF Fi MALE RATS GROUP: 1-1 DOSE: 0 MG/KG/DAY DAYS ON TEST: ANIMAL NUMBER 647068 647069 647070 647071 647072 647073 647074 647075 647076 647077 647078 647079 647080 1 8 15 22 29 36 62 .7 74 .6 73 .2 73 S 64 .6 49 .5 63 .7 58 .1 54 .0 67 .2 59 .5 59 .7 63 .0 103 .2 132 .2 118 .0 130 .1 115 .0 94 .7 107 .2 98 .9 93 .7 114 .4 101 .1 95 .2 109 .0 156 .5 207 .8 182 .8 201 .1 181 .8 156 .0 176 .4 154 .7 153 .0 179 .9 167 .6 158 .8 162 .3 204 .0 279 .5 248 .8 264 .2 243 .5 213 .7 250 .0 215 .9 218 .3 250 .6 227 .3 228 .7 227 .5 251. 7 352. 7 310. 2 336. 7 307. 8 265. 6 325. 4 257. 3 279. 2 282. 6 273. 9 302. 6 285. 8 303 .9 411 .7 326 .6 333 .8 367 .0 325 .4 314 .3 323 .3 284 .7 366 .5 349 .4 325 .9 302 .2 1243 Company Sanitized. Does not contain TSCA CBI DAYS ON TEST: ANIMAL NUMBER 647123 647124 647125 647126 647127 647128 647129 647130 647131 647132 647133 647134 647135 647136 647137 647138 INDIVIDUAL BODY WEIGHTS (grams) OF Fi MALE RATS GROUP: III-l DOSE: 25 MG/KG/DAY 1 8 15 22 29 36 67 .5 63 .2 68 .1 56 .4 58 .1 64 .5 62 .0 60 .2 72 .9 70 .9 64 .3 61 .7 64 .8 42 .1 59 .5 63 .5 106 .2 108 .5 103 .3 97 .6 103 .5 105 .7 102 .2 107 .1 122 .8 113 .1 104 .3 108 .7 103 .4 73 .3 95 .2 108 .2 176 .4 172 .2 158 .8 156 .8 166 .5 163 .7 167 .0 168 .5 187 .5 176 .0 165 .5 170 .8 164 .4 118 .6 145 .1 165 .0 230 .8 236 .4 213 .2 215 .0 225 .8 232 .3 234 .8 237 .5 242 .4 231 .0 224 .4 231 .7 229 .1 171 .6 207 .3 220 .4 301 .6 282 .6 278 .2 276 .4 290 .2 247 .0 260 .1 293 .3 319 .2 285 .7 280 .5 308 .6 279 .2 222 .2 261 .9 272 .8 a 343.9 304.5 336.7 348.4 341.2 283.5 363.8 383.2 341.5 302.5 376.1 311.9 276.8 324.0 339.1 1244 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL BODY WEIGHTS (grams) OF Fi MALE RATS GROUP: V-l DOSE: 100 MG/KG/DAY DAYS ON TEST: ANIMAL NUMBER 647184 647185 647186 647187 647188 647189 647190 647191 647192 647193 647194 647195 1 8 15 22 29 36 60.5 52.1 48.2 66.3 56.6 60.7 59.9 66.0 53.4 55.8 63.7 59.6 99.6 92.8 81.8 114.4 98.8 106.5 98.0 109.8 96.1 94.4 104.7 108.8 151.8 150.0 135.3 181.3 167.6 168.7 158.9 175.1 157.7 150.7 165.0 173.0 217.6 212.6 203.5 244.6 221.1 231.2 223.3 237.6 225.3 210.1 223.4 225.2 264.4 279.5 232.7 315.5 302.2 267.4 280.7 275.2 286.7 274.0 288.7 283.9 276.6 298.2 259.1 382.7 375.5 299.1 300.9 305.1 300.2 300.1 313.4 314.5 1245 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL BODY WEIGHTS (grams) OF Fi MALE RATS GROUP: VII-1 DOSE: 250 MG/KG/DAY DAYS ON TEST: ANIMAL NUMBER 647230 647231 647232 647233 647234 647235 647236 647237 647238 647239 647240 647241 1 8 15 22 29 36 42.6 41.3 40.0 40.8 50.7 50.7 52.4 48.5 51.2 46.5 43.4 55.7 86.3 91.5 96.7 82.1 96.4 85.3 87.4 83.9 84.8 80.3 80.5 100.9 137.5 144.5 170.4 139.6 158.8 143.5 143.3 139.6 131.4 135.8 133.4 155.8 203.2 211.9 224.0 197.3 221.1 200.7 209.1 210.9 190.5 202.0 187.0 214.3 258.8 272.7 344.6 252.2 281.3 255.5 259.0 242.8 239.8 270.4 245.1 246.2 318.3 331.9 417.0 280.9 296.9 275.0 318.9 265.3 299.5 277.7 313.3 327.4 1246 Company Sanitized. Does not contain TSCA CBl INDIVIDUAL BODY WEIGHTS (grams) OF Fi FEMALE RATS GROUP: II-1 DOSE: 0 MG/KG/DAY DAYS ON TEST: ANIMAL NUMBER 647277 647278 647279 647280 647281 647282 647283 647284 647285 647286 647287 647288 647289 1 8 15 22 29 36 59.3 59.1 67.4 62.0 55.1 45.9 60.5 50.3 46.5 63.1 58.4 58.5 58.3 96.0 103.1 103.8 99.6 96.4 84.1 93.2 85.0 78.1 95.5 102.2 94.0 91.4 130.3 139.6 136.8 143.7 144.1 132.3 139.9 122.5 121.7 137.1 156.4 135.0 126.3 156.9 160.9 152.2 180.4 185.9 163.3 179.6 158.2 155.0 181.8 185.8 167.0 150.2 177.1 182.7 170.8 199.8 204.7 192.7 207.7 173.2 176.8 210.2 217.7 194.6 161.6 203.4 201.4 179.7 221.4 219.6 212.8 219.6 200.7 191.0 211.6 231.0 213.7 176.7 1247 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL BODY WEIGHTS (grams) OP Fi FEMALE RATS GROUP: IV-1 DOSE: 25 MG/KG/DAY DAYS ON TEST: ANIMAL NUMBER 647326 647327 647328 647329 647330 647331 647332 647333 647334 647335 647336 647337 647338 647339 647340 647341 647342 1 8 15 22 29 36 61 .4 58 .5 63 .9 56 .3 54 .5 65 .1 59 .1 59 .9 69 .0 60 .5 44 .8 58 .4 67 .0 56 .5 46 .7 56 .0 59 .0 91 .7 97 .0 98 .2 96 .0 92 .1 106 .5 98 .1 99 .4 108 .8 100 .3 77 .6 95 .5 99 .0 87 .9 79 .5 86 .7 97 .5 138 .6 143 .9 137 .7 146 .2 141 .0 158 .4 150 .9 145 .1 171 .7 140 .9 114 .8 137 .8 137 .1 124 .0 120 .6 123 .3 140 .4 161 .4 186 .5 168 .8 181 .1 176 .9 212 .3 196 ,4 180 .0 220 .4 162 .9 137 .3 171 .9 171 .9 155 .7 150 .5 151 .1 168 .3 186 .1 204 .9 192 .1 209 .8 201 .1 246 .4 223 .6 191 .4 232 .3 171 .7 146 .5 195 .8 200 .7 174 .7 172 .1 180 .4 196 .1 -a 223.5 206.5 228.5 223.2 283.9 242.1 203.7 280.7 197.7 164.9 222.7 218.1 196.8 192.7 196.2 219.3 1248 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL BODY WEIGHTS (grams) OF Pi FEMALE RATS GROUP: VI-1 . DOSE: 100 MG/KG/DAY DAYS OH TEST: ANIMAL NUMBER 647394 647395 647396 647397 647398 647399 647400 647401 647402 647403 647404 647405 1 8 15 22 29 36 65 .7 52 .1 53 .1 59 .0 55 .8 62 .5 54 .3 60 .4 51 .5 49 .3 56 .1 60 .1 101 .8 88 .9 90 .3 91 .5 96 .1 84 .0 86 .5 97 .6 87 .6 77 .8 84 .3 98 .2 143 .2 135 .5 131 .5 125 .9 138 .5 142 .2 132 .0 141 .8 130 .8 117 .1 123 .9 141 .0 167 .7 166 .5 164 .1 161 .1 177 .8 184 .3 166 .2 177 .2 170 .3 142 .0 160 .1 173 .0 193 .1 194 .3 185 .0 167 .7 211 .5 209 .8 190 .3 204 .7 200 .8 159 .8 181 .8 198 .3 213.2 215.3 206.8 194.1 235.8 235.6 215.2 222.1 219.3 173.7 196.9 222.9 1249 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL BODY WEIGHTS (grams) OP Pi FEMALE RATS GROUP: VIII-1 DOSE: 250 MG/KG/DAY DAYS ON TEST: 1 ANIMAL NUMBER 8 15 22 29 36 647436 647437 647438 647439 647440 647441 647442 647443 647444 647445 647446 647447 58.4 39.7 27.9 35.8 47.6 45.2 45.6 49.0 52.2 43.6 40.4 51.5 97.2 88.5 68.1 70.4 78.5 76.6 77.8 80.2 84.9 69.1 73.8 94.5 142.1 124.3 117.6 113.2 125.8 123.3 118.3 . 124.3 127.3 115.4 124.6 141.4 176.2 157.1 166.1 143.3 167.8 162.1 153.4 157.1 157.0 158.3 163.2 178.9 203.5 190.5 210.4 170.6 190.7 189.6 164.3 183.4 173.4 186.7 190.3 199.1 197.3 194.5 238.3 193.8 219.7 209.0 187.7 210.1 206.9 217.1 202.0 198.8 1250 Company Sanitized. Does not contain TSCA CBl APPENDIX JJ REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHT GAINS: Fi GENERATION 1251 Company Sanitized. Does not contain TSCA CBI H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHT GAINS: Fi GENERATION EXPLANATORY NOTES Notes Day of weaning = Test Day 1. a No data due to weighing error. 1252 Company Sanitized. Does not contain TSCA CBl INDIVIDUAL BODY WEIGHT GAINS (grams) OP F^ MALE RATS GROUP: 1-1 DOSE: 0 MG/KG/DAY DAYS ON TEST: ANIMAL NUMBER 647068 647069 647070 647071 647072 647073 647074 647075 647076 647077 647078 647079 647080 1- 8 8-1 5 15-2:2 22-2 9 29-3 6 1-36 40 .5 57 .6 44 .8 56 .5 50 .4 45 .2 43 .5 40 .8 39 .7 47 .2 41 .6 35 .5 46 .0 53 .3 75 .6 64 .8 71 .0 66 .8 61 .3 69 .2 55 .8 59 .3 65 .5 66 .5 63 .6 53 .3 47 .5 71 .7 66 .0 63 .1 61 .7 57 .7 73 .6 61 .2 65 .3 70 .7 59 .7 69 .9 65 .2 47 .7 73 .2 61 .4 72 .5 64 .3 51 .9 75 .4 41 .4 60 .9 32 .0 46 .6 73 .9 58 .3 52 .2 59 .0 16 .4 -2 .9 59 .2 59 .8 -11 .1 66 .0 5 .5 83 .9 75 .5 23 .3 16 .4 241.2 337.1 253.4 260.2 302.4 275.9 250.6 265.2 230.7 299.3 289.9 266.2 239.2 1253 Company Sanitized. Does not contain TSCA COl INDIVIDUAL BODY WEIGHT GAINS (grams) OF Pi MALE RATS GROUP: III-l DOSE: 25 MG/KG/DAY DAYS ON TEST: ANIMAL NUMBER 647123 647124 647125 647126 647127 647128 647129 647130 647131 647132 647133 647134 647135 647136 647137 647138 1- 8 8-15 15-22 22-29 29-36 1-36 38 .7 45 .3 35 .2 41 .2 45 .4 41 .2 40 .2 46 .9 49 .9 42 .2 40 .0 47 .0 38 .6 31 .2 35 .7 44 .7 70.2 63.7 55.5 59.2 63.0 58.0 64.8 61.4 64.7 62.9 61.2 62.1 61.0 45.3 49.9 56.8 54.4 64.2 54.4 58.2 59.3 68.6 67.8 69.0 54.9 55.0 58.9 60.9 64.7 53.0 62.2 55.4 70.8 46.2 65.0 61.4 64.4 14.7 25.3 55.8 76.8 54.7 56.1 76.9 50.1 50.6 .54.6 52.4 -a 61.3 26.3 60.3 58.2 94.2 23.4 70.5 64.0 55.8 22.0 67.5 32.7 54.6 62.1 66.3 -a 280.7 236.4 280.3 290.3 276.7 221.5 303.6 310.3 270.6 238.2 314.4 247.1 234.7 264.5 275.6 1254 not contain TSCACBl Company Sanitized. Does INDIVIDUAL BODY WEIGHT GAINS (grams) OF Fi MALE RATS GROUP: V-l DOSE: 100 MG/KG/DAY DAYS ON TEST: ANIMAL NUMBER 1-8 8-15 15-22 22-29 29-36 1-36 647184 647185 647186 647187 647188 647189 647190 647191 647192 647193 647194 647195 39.1 40.7 33.6 48.1 42.2 45.8 38.1 43.8 42.7 38'.6 41.0 49.2 52.2 57.2 53.5 66.9 68.8 62.2 60.9 65.3 61.6 56.3 60.3 64.2 65.8 62.6 68.2 63.3 53.5 62.5 64.4 62.5 67.6 59.4 58.4 52.2 46.8 66.9 29.2 70.9 81.1 36.2 57.4 37.6 61.4 63.9 65.3 58.7 12.2 18.7 26.4 67.2 73.3 31.7 20.2 29.9 13.5 26.1 24.7 30.6 216.1 246.1 210.9 316.4 318.9 238.4 241.0 239.1 246.8 244.3 249.7 254.9 1255 Company Sanitized. Does not contain TSCA CBl INDIVIDUAL BODY WEIGHT GAINS (grams) OF Fi MALE RATS GROUP: VI I-1 DOSE: 250 MG/KG/DAY DAYS ON TEST: ANIMAL NUMBER 1-8 8-15 15-22 22-29 29-36 1-36 647230 647231 647232 647233 647234 647235 647236 647237 647238 647239 647240 647241 43.7 50.2 56.7 41.3 45.7 34.6 35.0 35.4 33.6 33.8 37,1 45.2 51.2 53.0 73.7 57.5 62.4 58.2 55.9 55.7 46.6 55.5 52.9 54.9 65.7 67.4 53.6 57.7 62.3 57.2 65.8 71.3 59.1 66.2 53.6 58.5 55.6 60.8 120.6 54.9 60.2 54.8 49.9 31.9 49.3 68.4 58.1 31.9 59.5 59.2 72.4 28.7 15.6 19.5 59.9 22.5 59.7 7.3 68.2 81.2 275.7 290.6 377.0 240.1 246.2 224.3 266.5 216.8 248.3 231.2 269.9 271.7 1256 Company Sanitized. Does not contain TSCA CBl INDIVIDUAL BODY WEIGHT GAINS (grams) OF Fi FEMALE RATS GROUP: II-l DOSE: 0 MG/KG/DAY DAYS ON TEST: ANIMAL NUMBER 1-8 8-15 15-22 22-29 29-36 1-36 647277 647278 647279 647280 647281 647282 647283 647284 647285 647286 647287 647288 647289 36.7 44.0 36.4 37.6 41.3 38.2 32.7 34.7 31.6 32.4 43.8 35.5 33.1 34 .3 36 .5 33 .0 44 .1 47 .7 48 .2 46 .7 37 .5 43 .6 41 .6 54 .2 41 .0 34 .9 26 .6 21 .3 15 .4 36 .7 41 .8 31 .0 39 .7 35 .7 33 .3 44 .7 29 .4 32 .0 23 .9 20 .2 21 .8 18 .6 19 .4 18 .8 29 .4 28 .1 15 .0 21 .8 28 .4 31 .9 27 .6 11 .4 26 .3 18 .7 8 .9 21 .6 14 .9 20 .1 11 .9 27 .5 14 .2 1 .4 13 .3 19 .1 15 .1 144.1 142.3 112.3 159.4 164.5 166.9 159.1 150.4 144.5 148.5 172.6 155.2 118.4 1257 Company Sanitized. Does not contain TSCA CBl INDIVIDUAL BODY WEIGHT GAINS (grams) OF FI FEMALE RATS GROUP: IV-1 DOSE: 25 MG/KG/DAY DAYS ON TEST: ANIMAL NUMBER 1-8 8-15 15-22 22-29 29-36 1-36 647326 647327 647328 647329 647330 647331 647332 647333 647334 647335 647336 647337 647338 647339 647340 647341 647342 30 .3 38 .5 34 .3 39 .7 37 .6 41 .4 39 .0 39 .5 39 .8 39 .8 32 .8 37 .1 32 .0 31 .4 32 .8 30 .7 38 .5 46 .9 46 .9 39 .5 50 .2 48 .9 51 .9 52 .8 45 .7 62 .9 40 .6 37 .2 42 .3 38 .1 36 .1 41 .1 36 .6 42 .9 22 .8 42 .6 31 .1 34 .9 35 .9 53 .9 45 .5 34 .9 48 .7 22 .0 22 .5 34 .1 34 .8 31 .7 29 .9 27 .8 27 .9 24 .7 18 .4 23 .3 28 .7 24 .2 34 .1 27 .2 11 .4 11 .9 8 .8 9 .2 23 .9 28 .8 19 .0 21 .6 29 .3 27 .8 -a 18.6 14.4 18.7 22.1 37.5 18.5 12.3 48.4 26.0 18.4 26.9 17.4 22.1 20.6 15.8 23.2 -a 165.0 142.6 172.2 168.7 218.8 183.0 143.8 211.7 137.2 120.1 164.3 151.1 140.3 146.0 140.2 160.3 1258 CompanySanitized. Does not contain TSCA CBI INDIVIDUAL BODY WEIGHT GAINS (grams) OF Fi FEMALE RATS GROUP: VI-1- DOSE: 100 MG/KG/DAY DAYS ON TEST: ANIMAL NUMBER 1-8 8-15 15-22 22-29 29-36 1-36 647394 647395 647396 647397 647398 647399 647400 647401 647402 647403 647404 647405 36.1 36.8 37.2 32.5 40.3 21.5 32.2 37.2 36.1 28.5 28.2 38.1 41.4 46.6 41.2 34.4 42.4 58.2 45.5 44.2 43.2 39.3 39.6 42.8 24.5 31.0 32.6 35.2 39.3 42.1 34.2 35.4 39.5 24.9 36.2 32.0 25.4 27.8 20.9 6.6 33.7 25.5 24.1 27.5 30.5 17.8 21.7 25.3 20.1 21.0 21.8 26.4 24.3 25.8 24.9 17.4 18.5 13.9 15.1 24.6 147.5 163.2 153.7 135.1 180.0 173.1 160.9 161.7 167.8 124.4 140.8 162.8 1259 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL BODY WEIGHT GAINS (grams) OF Fi FEMALE RATS GROUP: VIII-1 DOSE: 250 MG/KG/DAY DAYS ON TEST: AMIMAL NUMBER 1-8 8-15 15-22 22-29 29-36 1-36 647436 647437 647438 647439 647440 647441 647442 647443 647444 647445 647446 647447 38.8 48.8 40.2 34.6 30.9 31.4 32.2 31.2 32.7 25.5 33.4 43.0 44.9 35.8 49.5 42.8 47.3 46.7 40.5 44.1 42.4 46.3 50.8 46.9 34.1 32.8 48.5 30.1 42.0 38.8 35.1 32.8 29.7 42.9 38.6 37.5 27.3 33.4 44.3 27.3 22.9 27.5 10.9 26.3 16.4 28.4 27.1 20.2 -6.2 4.0 27.9 23.2 29.0 19.4 23.4 26.7 33.5 30.4 11.7 -0.3 138.9 154.8 210.4 158.0 172.1 163.8 142.1 161.1 154.7 173.5 161.6 147.3 1260 Company Sanitized. Does not contain TSCA CBI APPENDIX KK REPRODUCTIVE TOXICOLOGY INDIVIDUAL FOOD CONSUMPTION: Fi GENERATION 1261 Company Sanitized. Does not contain TSCA CBf H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 REPRODUCTIVE TOXICOLOGY INDIVIDUAL FOOD CONSUMPTION: Fi GENERATION EXPLANATORY NOTES Notes Day of weaning = Test Day 1. 1262 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL FOOD CONSUMPTION (grams/day) BY Fi MALE RATS GROUP: 1-1 DOSE: 0 MG/KG/DAY DAYS ON TEST: ANIMAL NUMBER 647068 647069 647070 647071 647072 647073 647074 647075 647076 647077 647078 647079 647080 1-8 8- 15 15-22 22-29 29-36 1- 36 12.3 15.2 12.7 15.3 12.6 14.4 12.0 12.7 11.0 13.5 12.0 11.1 12.0 20 .5 22 .8 20 .1 23 .6 20 .0 18 .8 20 .6 18 .7 18 .2 19 .6 20 .3 18 .6 18 .0 20.4 27.3 25.1 27.1 23.6 23.3 25.1 22.7 22.9 25.5 23.7 24.1 23.8 22.9 30.3 26.7 31.1 26.1 24.8 30.3 23.9 27.8 25.0 25.6 29.5 27.0 25.6 9.2 26.1 24.4 10.2 9.5 21.8 12.8 23.3 30.9 31.0 26.2 25.8 20 .3 21 .0 22 .2 24 .3 18 .5 18 .2 22 .0 18 .2 20 .6 22 .9 22 .5 21 .9 21 .4 1263 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL FOOD CONSUMPTION (grams/day) BY Fi MALE RATS GROUP: III-l DOSE: 25 MG/KG/DAY DAYS ON TEST: ANIMAL NUMBER 647123 647124 647125 647126 647127 647128 647129 647130 647131 647132 647133 647134 647135 647136 647137 647138 1 -8 8- 15 15- 22 22- 29 29- 36 1-,36 11 .5 11 .9 11 .7 11 .0 11 .5 13 .2 12 .2 13 .3 14 .1 12 .2 11 .8 14 .1 11 .9 9 .8 10 .9 14 .0 19 .4 19 .6 18 .0 17 .2 18 .1 19 .2 19 .3 20 .1 20 .4 18 .9 18 .8 21 .2 19 .6 15 .1 15 .3 19 .0 23 .5 23 .1 21 .8 21 .4 22 .7 24 .6 24 .9 24 .5 25 .0 22 .0 21 .9 24 .6 25 .0 19 .8 20 .6 22 .2 26 .7 24 .3 25 .0 25 .7 25 .6 21 .6 24 .1 28 .1 28 .8 22 .7 23 .8 31 .2 25 .4 22 .5 22 .8 24 .7 46 .6 26 .5 24 .0 2 .3 7 .8 28 .6 22 .8 31 .1 28 .5 25 .9 22 .9 14 .4 25 .2 25 .2 25 .4 15 .5 25 .5 21 .1 20 .1 15 .5 17 .1 21 .4 20 .7 23 .4 23 .4 20 .3 19 .8 21 .1 21 .4 18 .5 19 .0. 19 .1 1264 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL FOOD CONSUMPTION (grams/day) BY Fi MALE RATS GROUP: V-l DOSE: 100 MG/KG/DAY DAYS ON TEST: ANIMAL NUMBER 647184 647185 647186 647187 647188 647189 647190 647191 647192 647193 647194 647195 1-8 8-15 15-22 22-29 29-36 1-36 10.7 11.6 9.6 13.7 12.0 12.4 11.5 12.9 11.1 11.3 11.6 15.6 16.9 18.6 17.4 20.9 20.6 20.9 19.1 20.6 18.4 17.1 18.7 21.2 21.7 24.4 24.9 26.0 24.2 25.9 25.2 24.7 24.4 21.8 23.3 22.8 25.0 29.4 26.0 29.3 30.2 26.1 28.2 26.2 29.5 26.3 27.2 24.5 21.1 25.7 23.5 17.7 15.4 27.2 25.2 25.4 24.6 24.9 26.2 25.5 19.1 21.9 20.3 21.5 20.5 22.5 21.8 22.0 21.6 20.3 21.4 21.9 1265 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL POOD CONSUMPTION (grams/day) BY Fi MALE RATS GROUP: VI I-1 DOSE: 250 MG/KG/DAY DAYS ON TEST: ANIMAL NUMBER 647230 647231 647232 647233 647234 647235 647236 647237 647238 647239 647240 647241 1-8 8-15 15-22 22-29 29-36 1-36 12.0 12.8 12.5 10.9 12.9 10.3 11.0 10.3 11.2 11.2 10.1 12.8 18.0 15.0 19.4 16.9 19.5 16.8 17.9 17.3 17.2 15.7 16.2 18.5 23.4 22.4 24.7 20.8 25.3 21.6 23.3 24.5 21.4 23.2 20.1 22.4 26.0 28.1 34.5 24.1 28.7 24.3 26.0 24.7 24.8 27.4 23.6 22.7 28.0 4.2 8.1 23.0 24.2 23.9 28.3 23.5 25.7 24.7 26.5 28.0 21.5 16.5 19.8 19.1 22.2 19.4 21.3 20.1 20.1 20.4 19.3 20.9 1266 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL POOD CONSUMPTION (grams/day) BY Fi FEMALE RATS GROUP: II-l DOSE: 0 MG/KG/DAY DAYS ON TEST: ANIMAL NUMBER 1-8 8-15 15-22 22-29 29-36 1-36 647277 647278 647279 647280 647281 647282 647283 647284 647285 647286 647287 647288 647289 12.1 12.5 11.2 11.0 11.9 11.4 10.8 12.4 9.6 11.'0 13.2 11.4 11.0 16.1 17.1 15.8 15.6 16.9 16.3 16.6 15.3 15.4 15.5 20.9 17.0 15.2 18.6 16.6 15.4 17.5 18.6 17.7 20.1 17.9 17.7 18.3 18.9 17.7 16.3 18.5 17.1 14.9 17.9 18.7 18.8 20.1 16.7 17.2 20.6 20.9 18.3 16.0 19.5 17.7 15.4 17.8 18.5 18.5 18.5 17.4 17.3 17.8 20.4 18.3 15.5 17.0 16.2 14.6 16.0 16.9 16.5 17.2 15.9 15.5 16.6 18.9 16.6 14.8 1267 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL FOOD CONSUMPTION (grams/day) BY Fi FEMALE RATS GROUP: IV-1 DOSE: 25 MG/KG/DAY DAYS ON TEST: ANIMAL NUMBER 1-8 8-15 15-22 22-29 29-36 1-36 647326 647327 647328 647329 647330 647331 647332 647333 647334 647335 647336 647337 647338 647339 647340 647341 647342 9.9 12.8 12.2 11.6 10.9 13.3 11.6 12.3 12.3 13.1 9.0 11.8 10.5 10.7 10.2 10.8 11.9 16 .8 16 .9 16 .4 16 .2 15 .4 19 .3 18 .4 16 .1 20 .2 18 .2 13 .7 17 .1 16 .3 14 .9 15 .4 15 .1 16 .7 17 .3 19 .9 17 .4 18 .4 18 .3 23 .4 22 .4 17 .4 23 .3 17 .2 14 .9 19 .9 17 .3 16 .6 16 .3 15 .8 17 .0 17 .3 18 .1 17 .4 19 .7 18 .2 23 .0 21 .5 16 .9 22 .3 16 .2 14 .4 20 .2 18 .1 15 .8 16 .8 16 .8 17 .6 46.8 19.4 17.2 20.4 18.8 25.9 23.7 14.7 27.0 18.0 15.5 22.5 17.3 15.4 17.2 16.6 18.1 21.6 17.4 16.1 17.3 16.3 21.0 19.5 15.5 21.0 16.5 13.5 18.3 15.9 14.7 15.2 15.0 16.2 1268 Company Sanitized. Does not contain TSCA CBf INDIVIDUAL FOOD CONSUMPTION (grams/day) BY Fi FEMALE RATS GROUP: VI-1, DOSE: 100 MG/KG/DAY DAYS ON TEST: ANIMAL NUMBER 1-8 8-15 15-22 22-29 29-36 1-36 647394 647395 647396 647397 647398 647399 647400 647401 647402 647403 647404 647405 11.4 11.7 11.1 10.7 12.8 7.9 10.5 13.5 13.1 9.4 9.4 11.7 15.7 16.3 1.6.6 14.3 16.0 18.3 16.4 17.7 16.2 15.6 15.1 18.4 16.5 17.7 19.8 17.0 18.5 19.9 19.5 19.7 19.6 15.5 16.9 20.9 16.8 19.0 19.5 16.1 20.1 21.3 20.3 19.6 19.7 15.8 17.5 21.5 17.7 19.4 19.9 16.0 19.8 21.5 19.7 20.2 19.9 15.6 17.1 20.9 15.6 16.8 17.4 14.8 17.5 17.8 17.3 18.1 17.7 14.4 15.2 18.7 1269 Company Sanitized. Does not contain TSCA CBI INDIVIDUAL FOOD CONSUMPTION (grams/day) BY Pi FEMALE RATS GROUP: VIII-1 DOSE: 250 MG/KG/DAY DAYS ON TEST: ANIMAL NUMBER 1-8 8-15 15-22 22-29 29-36 1-36 647436 647437 647438 647439 647440 647441 647442 647443 647444 647445 647446 647447 12.0 12.8 10.2 9.7 10.2 9.6 10.6 9.6 11.3 8.5 9.0 12.2 17.7 15.7 14.8 14.6 15.1 14.5 14.9 16.0 16.8 14.5 16.5 18.5 18.5 17.6 18.6 16.6 18.6 17.5 17.2 17.2 16.4 12.0 19.6 19.6 19.8 19.8 19.5 17.5 19.4 17.6 17.1 18.0 16.7 18.9 19.0 20.5 16.5 14.2 19.4 18.4 19.8 17.9 17.0 18.9 18.3 19.6 20.2 17.5 16.9 16.0 16.5 15.4 16.6 15.4 15.4 15.9 15.9 14.7 16.9 17.7 1270 Company Sanitized. Does not contain TSCA CBl APPENDIX LL REPRODUCTIVE TOXICOLOGY INDIVIDUAL CLINICAL OBSERVATIONS: Fi GENERATION 1271 Company Sanitized. Does not contain TSCA CBI H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 REPRODUCTIVE TOXICOLOGY INDIVIDUAL CLINICAL OBSERVATIONS: Fi GENERATION EXPLANATORY NOTES Notes Day of weaning = Test Day 1. t 1272 Company Sanitized. Does not contain TSCA CBI ANIMAL NUMBER INDIVIDUAL CLINICAL OBSERVATIONS IM Fi MALE RATS GROUP: 1-1 DOSE: 0 MG/KG/DAY OBSERVATION FIRST DA1f OBSERVED LAST DAY OBSERVED 647068 647069 647070 647071 647072 647073 647074 647075 647076 647077 647078 647079 647080 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 19 19 19 19 18 18 20 20 19 19 19 19 19 19 19 19 20 20 20 20 20 20 27 27 20 20 1273 Company Sanitized. Does not contain TSCA CBl ANIMAL NUMBER INDIVIDUAL CLINICAL OBSERVATIONS IN Fi MALE RATS GROUP: ni-1 DOSE: 25 MG/KG/DAY OBSERVATION FIRST DA^ir OBSERVED LAST DAY OBSERVED 647123 647124 647125 647126 647127 647128 647129 647130 647131 647132 647133 647134 647135 647136 647137 647138 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 14 14 20 20 21 21 21 21 21 21 22 22 20 20 23 23 24 24 21 21 22 22 20 20 20 20 27 27 26 26 22 22 1274 Company Sanitized. Does not contain TSCA CBI ANIMAL NUMBER INDIVIDUAL CLINICAL OBSERVATIONS IN Fi MALE RATS GROUP: V-l DOSE: 100 MG/KG/DAY OBSERVATION FIRST DAY OBSERVED LAST DAY OBSERVED 647184 647185 647186 647187 647188 647189 647190 647191 647192 647193 647194 647195 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 20 20 25 25 2? 29 20 20 23 23 22 22 27 27 20 20 23 23 27 27 20 20 22 22 1275 Company Sanitized. Does not contain TSCA CBI ANIMAL NUMBER INDIVIDUAL CLINICAL OBSERVATIONS IN Fi MALE RATS GROUP: VII-1 DOSE: 250 MG/KG/DAY OBSERVATION FIRST DAY OBSERVED LAST DAY OBSERVED 647230 647231 647232 647233 647234 647235 647236 647237 647238 647239 647240 647241 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40 24 24 21 21 20 20 24 24 23 23 20 20 21 21 23 23 24 24 24 24 27 27 21 21 1276 Company Sanitized. Does not contain TSCA CBI ANIMAL NUMBER INDIVIDUAL CLINICAL OBSERVATIONS IN Fi FEMALE RATS GROUP: II-l DOSE: 0 MG/KG/DAY OBSERVATION FIRST DAY OBSERVED LAST DAY OBSERVED 647277 647278 647279 647280 647281 647282 647283 647284 647285 647286 647287 647288 647289 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 10 10 14 14 12 12 12 12 13 13 13 13 12 12 18 18 12 12 12 12 12 12 1277 Company Sanitized. Does not contain TSCA CBf ANIMAL NUMBER INDIVIDUAL CLINICAL OBSERVATIONS IN Fi FEMALE RATS GROUP: IV-1 DOSE: 25 MG/KG/DAY OBSERVATION FIRST DAY OBSERVED LAST DAY OBSERVED 647326 647327 647328 647329 647330 647331 647332 647333 647334 647335 647336 647337 647338 647339 647340 647341 647342 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE ALOPECIA BOTH FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY '40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 12 12 11 11 19 19 12 12 15 15 13 13 11 11 12 12 13 13 40 40 11 11 11 11 13 13 12 12 11 11 11 11 13 13 1278 Company Sanitized. Does not contain TSCA CBI H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL CLINICAL OBSERVATIONS IN Fi FEMALE RATS GROUP: VI-1 DOSE: 100 MG/KG/DAY DuPont-5386 ANIMAL NUMBER OBSERVATION FIRST DAY OBSERVED LAST DAY OBSERVED 647394 647395 647396 647397 647398 647399 647400 647401 647402 647403 647404 647405 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 12 12 17 17 11 11 10 10 12 12 14 14 12 12 13 13 11 11 12 12 11 11 10 10 1279 Company Sanitized. Does not contain TSCA CBI ANIMAL NUMBER INDIVIDUAL CLINICAL OBSERVATIONS IN Fi FEMALE RATS GROUP: VIII-1 DOSE: 250 MG/KG/DAY OBSERVATION FIRST DAY OBSERVED LAST DAY OBSERVED 647436 647437 647438 647439 647440 647441 647442 647443 647444 647445 647446 647447 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL .PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40 10 10 11 11 20 20 11 11 13 13 12 12 12 12 12 12 12 12 14 14 12 12 11 11 1280 Company Sanitized. Does not contain TSCA CBI