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Target Organs and Levels of Evidence for TR-469

Toxicology and Carcinogenesis Studies of AZT (CASRN 30516-87-1) and AZT/ a-Interferon A/D B6C3F1 Mice (Gavage Studies)

Chemical (Study Title) CASRN	Peer Review Date	Route/Exposure Levels	Study Laboratory
3'-Azido-3'-deoxythymidine (AIDS) 30516-87-1	12/11/1996	Gavage MICE ONLY: 0, 30, 60, OR 120 MG/KG; 50/SEX	Southern Research Institute

Levels of Evidence

Male Mice: Equivocal Evidence

Type	Organ/Tissue (Lesion)
Neoplastic Lesions	Kidney Tubular Cell: ADENOMA 0/50 0/48 0/49 3/50 OR CARCINOMA 0/50 0/48 0/49 1/50 COMBINED 0/50 0/48 0/49 4/50 Harderian Gland: ADENOMA 3/33 2/50 2/50 10/46 OR CARCINOMA 0/33 3/50 2/50 0/46 COMBINED 3/33 5/50 2/50 10/46

Female Mice: Clear Evidence

Type	Organ/Tissue (Lesion)
Neoplastic Lesions	Vagina: SQUAMOUS CELL CARCINOMA 0/50 0/50 5/50 9/50; SQUAMOUS CELL PAPILLOMA OR CARCINOMA 0/50 0/50 5/50 11/50
Non-Neoplastic Lesions	Vagina: EPITHELIAL HYPERPLASIA

Chemical (Study Title) CASRN	Peer Review Date	Route/Exposure Levels	Study Laboratory
Interferon AD (AIDS Initiative) INTERFERONAD	12/11/1996	Subcutaneous Injection MICE ONLY: 500 OR 5000 UNITS 3X/WEEK; 50/SEX/GROUP	Southern Research Institute

Levels of Evidence: None

Chemical (Study Title) CASRN	Peer Review Date	Route/Exposure Levels	Study Laboratory
Interferon AD + 3'-azido-3'-deoxythymidine (AIDS Initiative) INTAZTCOMB	12/11/1996	Subcutaneous Injection and Gavage DUAL ROUTES WITH BOTH COMPOUNDS: AZT: 0, 30, 60, OR 120 (GAV) MG/KG; IFN: 500 OR 5000 UNITS 3X/WEEK	Southern Research Institute

Levels of Evidence: None

Chemical (Study Title) CASRN	Peer Review Date	Route/Exposure Levels	Study Laboratory
Interferon A (AIDS Initiative) 76543-88-9	12/11/1996	Subcutaneous Injection 5000 UNITS 3X A WEEK; 50/SEX/GROUP	Southern Research Institute

Levels of Evidence: None