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Target Organs and Levels of Evidence for TR-452

Toxicology and Carcinogenesis Studies of 2,2-Bis(Bromomethyl)-1,3-Propanediol (FR-1138 ®) (CASRN 3296-90-0) in F344 Rats and B6C3F1 Mice (Feed Studies)

Chemical (Study Title) CASRN	Peer Review Date	Route/Exposure Levels	Study Laboratory
2,2-bis(Bromomethyl)-1,3-propanediol 3296-90-0	11/29/1994	Dosed-Feed R: 0, 2500, 5000, OR 10000 PPM; STOP STUDY: MALES 20000 PPM; 70/GROUP M: 0, 312, 625, OR 1250 PPM; 60/GROUP	Southern Research Institute

Levels of Evidence

Male Rats: Clear Evidence

Type	Organ/Tissue (Lesion)
Neoplastic Lesions	Skin: SQUAMOUS CELL PAPILLOMA 1/51 0/53 2/51 5/55 11/60 OR KERATOACANTHOMA 3/51 5/53 11/51 16/55 10/60 OR TRICHOEPITHELIOMA 0/51 0/53 0/51 1/55 1/60 OR BASAL CELL ADENOMA 0/51 1/53 0/51 3/55 6/60 OR BASAL CELL CARCINOMA 0/51 0/53 2/51 2/55 0/60 OR SQUAMOUS CELL CARCINOMA 0/51 0/53 0/51 0/55 1/60 COMBINED 4/51 6/53 14/51 24/55 21/60 Subcutaneous Tissue: FIBROMA 2/51 8/53 11/51 15/55 7/60 OR FIBROSARCOMA 0/51 1/53 0/51 0/55 1/60 OR SARCOMA 0/51 0/53 2/51 3/55 2/60 COMBINED 2/51 9/53 13/51 16/55 10/60 Mammary Gland: FIBROADENOMA 0/51 4/53 6/51 6/55 5/60 OR ADENOMA 0/51 0/53 1/51 1/55 0/60 COMBINED 0/51 4/53 7/51 7/55 5/60 Zymbal Gland: ADENOMA 0/51 0/53 1/51 3/55 2/60 OR CARCINOMA 2/51 1/53 3/51 2/55 15/60 COMBINED 2/51 1/53 4/51 5/55 15/60 Oral Cavity: SQUAMOUS CELL PAPILLOMA 0/51 4/53 8/51 10/55 12/60 OR SQUAMOUS CELL CARCINOMA 0/51 0/53 1/51 0/55 2/60 COMBINED 0/51 4/53 9/51 10/55 13/60 Esophagus: SQUAMOUS CELL PAPILLOMA 0/51 0/53 1/51 5/55 0/60 Forestomach: SQUAMOUS CELL PAPILLOMA 0/51 0/53 0/51 1/55 5/60 Intestines: ADENOMA 0/51 0/53 3/51 4/51 11/55 OR CARCINOMA 0/51 0/53 0/51 2/51 6/55 COMBINED 0/51 0/53 3/51 6/51 15/55 Mesothelium (Abdominal Cavity/Tunica Vaginalis): MESOTHELIOMA 0/51 3/53 8/51 9/55 26/60 Urinary Bladder: TRANSITIONAL CELL PAPILLOMA 0/51 0/53 1/51 2/55 1/59 OR TRANSITIONAL CELL CARCINOMA 0/51 0/53 0/51 1/55 1/59 COMBINED 0/51 0/53 1/51 3/55 2/59 Lung: ALVEOLAR/BRONCHIOLAR ADENOMA 1/51 0/53 3/51 1/55 4/60 OR ALVEOLAR/BRONCHIOLAR CARCINOMA 0/51 1/53 0/51 3/55 3/60 COMBINED 1/51 1/53 3/51 4/55 7/60 Thyroid Gland Follicular Cell: ADENOMA 0/51 1/53 2/51 2/55 7/59 OR CARCINOMA 0/51 1/53 4/51 1/55 2/59 COMBINED 0/51 2/53 6/51 3/55 9/59 Seminal Vesicle: ADENOMA 0/51 0/53 0/51 0/55 1/59 OR CARCINOMA 0/51 0/53 0/51 0/55 1/59 COMBINED 0/51 0/53 0/51 0/55 2/59 Hematopoietic System: MONONUCLEAR CELL LEUKEMIA 27/51 29/53 40/51 34/55 25/60
May Have Been Related	Kidney Tubular Cell: ADENOMA 0/51 0/53 1/51 3/55 1/59 Pancreas Acinar Cell: ADENOMA 1/51 2/53 4/51 3/53 3/59
Non-Neoplastic Lesions	KIDNEY: FOCAL ATROPHY; PAPILLARY DEGENERATION; PAPILLARY EPITHELIAL HYPERPLASIA; PELVIS, TRANSITIONAL EPITHELIUM, HYPERPLASIA LUNG: ALVEOLAR/BRONCHIOLAR HYPERPLASIA THYROID GLAND: FOLLICULAR CELL HYPERPLASIA SEMINAL VESICLE: HYPERPLASIA PANCREAS: FOCAL HYPERPLASIA FORESTOMACH: MUCOSAL HYPERPLASIA URINARY BLADDER: HYPERPLASIA

Female Rats: Clear Evidence

Type	Organ/Tissue (Lesion)
Neoplastic Lesions	Oral Cavity: SQUAMOUS CELL PAPILLOMA 2/50 2/51 4/53 5/52 OR SQUAMOUS CELL CARCINOMA 0/50 1/51 1/53 1/52 COMBINED 2/50 3/51 5/53 6/52 Esophagus: SQUAMOUS CELL PAPILLOMA 0/50 0/51 1/53 10/52 Mammary Gland: FIBROADENOMA 25/50 45/51 46/53 45/52 Thyroid Gland Follicular Cell: ADENOMA 0/50 0/51 2/53 3/52 OR CARCINOMA 0/50 0/51 0/53 1/52 COMBINED 0/50 0/51 2/53 4/52
Non-Neoplastic Lesions	KIDNEY: FOCAL ATROPHY; PAPILLARY DEGENERATION; PAPILLARY EPITHELIAL HYPERPLASIA

Male Mice: Clear Evidence

Type	Organ/Tissue (Lesion)
Neoplastic Lesions	Harderian Gland: ADENOMA 3/50 6/51 12/50 18/49 OR CARCINOMA 1/50 1/51 4/50 4/49 COMBINED 4/50 7/51 16/50 22/49 Lung: ALVEOLAR/BRONCHIOLAR ADENOMA 12/50 4/51 12/50 21/49 OR ALVEOLAR/BRONCHIOLAR CARCINOMA 3/50 7/51 8/50 11/49 COMBINED 15/50 11/51 16/50 25/49 Kidney Tubular Cell: ADENOMA 0/50 0/51 3/50 2/49
May Have Been Related	Forestomach: SQUAMOUS CELL PAPILLOMA 0/50 3/51 2/50 2/49 OR SQUAMOUS CELL CARCINOMA 0/50 0/51 1/50 2/49 COMBINED 0/50 3/51 3/50 4/49

Female Mice: Clear Evidence

Type	Organ/Tissue (Lesion)
Neoplastic Lesions	Harderian Gland: ADENOMA 2/52 6/50 8/51 15/50 OR CARCINOMA 1/52 6/50 5/51 7/50 COMBINED 3/52 12/50 13/51 19/50 Lung: ALVEOLAR/BRONCHIOLAR ADENOMA 3/52 3/50 9/51 17/50 OR ALVEOLAR/BRONCHIOLAR CARCINOMA 2/52 2/50 6/51 5/50 COMBINED 5/52 5/50 15/51 19/50 Subcutaneous Tissue: SARCOMA 0/52 1/50 4/51 11/50
May Have Been Related	Mammary Gland: CARCINOMA 0/52 0/50 1/51 2/50 Forestomach: SQUAMOUS CELL PAPILLOMA 0/52 1/50 5/51 3/50 Vascular System (Unspecified): HEMANGIOMA AND HEMANGIOSARCOMA 1/52 2/50 0/51 5/50
Non-Neoplastic Lesions	LUNG: ALVEOLAR EPITHELIAL HYPERPLASIA

Chemical (Study Title) CASRN	Peer Review Date	Route/Exposure Levels	Study Laboratory
2,2-bis(Bromomethyl)-1,3-propanediol 3296-90-0		Dosed-Feed R: 0,1250,20000, M: 0,625,10000 PPM/5 PER GROUP	American Biogenics Corp (Bioassay Systems)

Levels of Evidence: None