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Target Organs and Levels of Evidence for TR-578

Toxicology and Carinogenesis Studies of Ginkgo Biloba Extract (CASRN 90045-36-6) in F344/N Rats and B6C3F1/N Mice (Gavage Studies)

Chemical (Study Title) CASRN	Peer Review Date	Route/Exposure Levels	Study Laboratory
Ginkgo biloba extract 90045-36-6	02/08/2012	Gavage R: 0, 100, 300, OR 1000 MG/KG; M: 0, 200, 600, OR 2000 MG/KG; 50/SEX/SPECIES/DOSE	Battelle Columbus Laboratory

Levels of Evidence

Male Rats: Some Evidence

Type	Organ/Tissue (Lesion)
Neoplastic Lesions	Thyroid Gland: follicular cell, adenoma 2/50, 1/50, 3/49, 5/45
May Have Been Related	Mononuclear Cell Leukemia: 9/50, 12/50, 22/50, 21/50 Liver: hepatocellular adenoma 0/50, 3/50, 3/50, 0/50
Non-Neoplastic Lesions	Liver: hepatocyte, hypertrophy; bile duct, hyperplasia; oval cell, hyperplasia; degeneration, cystic; necrosis Thyroid gland: follicular cell hypertrophy; follicle, hyperplasia Kidney: severity of nephropathy Nasal Cavity: transitional epithelium, hyperplasia; respiratory epithelium, hyperplasia; olfactory epithelium, atrophy; olfactory epithelium, respiratory metaplasia; nerve, olfactory epithelium, atrophy; olfactory epithelium, pigmentation; inflammation, chronic active; goblet cell, respiratory epithelium, hyperplasia; submucosa, fibrosis

Female Rats: Some Evidence

Type	Organ/Tissue (Lesion)
Neoplastic Lesions	Thyroid Gland: follicular cell, adenoma 1/49, 0/50, 3/49, 1/49; follicular cell, carcinoma 0/49, 0/50, 1/49, 1/49
May Have Been Related	Nasal Cavity: respiratory epithelium, adenoma 0/49, 0/49, 2/50, 0/46
Non-Neoplastic Lesions	Liver: hepatocyte, hypertrophy; bile duct, hyperplasia; fatty change, focal Thyroid gland: follicular cell, hypertrophy Nasal Cavity: transitional epithelium, hyperplasia; respiratory epithelium, hyperplasia; olfactory epithelium, atrophy; olfactory epithelium, respiratory metaplasia; nerve, olfactory epithelium, atrophy; olfactory epithelium, pigmentation; inflammation, chronic active; goblet cell, respiratory epithelium, hyperplasia

Male Mice: Clear Evidence

Type	Organ/Tissue (Lesion)
Neoplastic Lesions	Liver: hepatocellular carcinoma 22/50, 31/50, 41/50, 47/50; hepatoblastoma 3/50, 28/50, 36/50, 38/50 Thyroid Gland: follicular cell, adenoma 0/50, 0/50, 2/50, 2/50
Non-Neoplastic Lesions	Liver: hypertrophy; erythrophagocytosis; hematopoietic cell proliferation; inflammation; necrosis Thyroid gland: follicle hyperplasia; follicular cell hypertrophy Forestomach: inflammation; epithelium hyperplasia; epithelium hyperkeratosis; epithelium ulcer Nasal Cavity: olfactory epithelium, hyaline droplet accumulation; olfactory epithelium, pigmentation

Female Mice: Clear Evidence

Type	Organ/Tissue (Lesion)
Neoplastic Lesions	Liver: hepatocellular adenoma 17/50, 37/50, 41/50, 48/50; hepatocellular carcinoma 9/50, 10/50, 15/50, 44/50; hepatoblastoma 1/50, 1/50, 8/50, 11/50
Non-Neoplastic Lesions	Liver: hypertrophy; erythrophagocytosis; vacuolization cytoplasmic; eosinophilic focus; mixed cell focus Thyroid gland: follicular cell hypertrophy Forestomach: inflammation; epithelium hyperplasia; epithelium hyperkeratosis; epithelium ulcer Nasal Cavity: olfactory epithelium, hyaline droplet accumulation; olfactory epithelium, pigmentation