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Target Organs and Levels of Evidence for TR-479

Toxicology and Carcinogenesis Studies of Coconut Oil Acid Diethanolamine Condensate (CASRN 68603-42-9) in F344/N Rats and B6C3F1 Mice (Dermal Studies)

Chemical (Study Title) CASRN	Peer Review Date	Route/Exposure Levels	Study Laboratory
Coconut oil acid diethanolamine condensate 68603-42-9	12/10/1997	Topical Application R: 0, 50, or 100 mg/kg M: 0, 100, or 200 mg/kg (50 sex/species/group)	Battelle Columbus Laboratory

Levels of Evidence

Male Rats: No Evidence

Type	Organ/Tissue (Lesion)
Non-Neoplastic Lesions	Skin: epidermal hyperplasia; sebaceous gland hyperplasia; parakeratosis; hyperkeratosis

Female Rats: Equivocal Evidence

Type	Organ/Tissue (Lesion)
May Have Been Related	Kidney Tubular Cell: adenoma or carcinoma (standard evaluation 0/50, 2/50, 0/50; standard and extended evaluations combined 0/50, 4/50, 1/50)
Non-Neoplastic Lesions	Skin: epidermal hyperplasia; sebaceous gland hyperplasia; parakeratosis; hyperkeratosis Forestomach: chronic active inflammation; epithelial hyperplasia; epithelial ulcer
	Kidney: severity of nephropathy

Male Mice: Clear Evidence

Type	Organ/Tissue (Lesion)
Neoplastic Lesions	Liver: adenoma 22/50, 35/50, 45/50; hepatoblastoma 1/50, 1/50, 10/50; hepatocellular adenoma, carcinoma, or hepatoblastoma 29/50, 39/50, 49/50 Kidney Tubular Cell: adenoma 1/50, 1/50, 7/50; renal tubule adenoma or carcinoma 1/50, 1/50, 9/50
Non-Neoplastic Lesions	Liver: eosinophilic foci Skin: epidermal hyperplasia; sebaceous gland hyperplasia; hyperkeratosis; ulcer Thyroid gland: follicular cell hyperplasia

Female Mice: Clear Evidence

Type	Organ/Tissue (Lesion)
Neoplastic Lesions	Liver: adenoma 32/50, 44/50, 43/50; hepatocellular carcinoma 3/50, 21/50, 32/50; hepatocellular adenoma, carcinoma, or hepatoblastoma 33/50, 46/50, 48/50
Non-Neoplastic Lesions	Skin: epidermal hyperplasia; sebaceous gland hyperplasia; hyperkeratosis; chronic active inflammation; parakeratosis Thyroid gland: follicular cell hyperplasia