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Target Organs and Levels of Evidence for TR-478

Toxicology and Carcinogenesis Studies of Diethanolamine (CASRN 111-42-2) in F344/N Rats and B6C3F1 Mice (Dermal Studies)

Chemical (Study Title)
CASRN
Peer Review Date Route/Exposure Levels Study Laboratory
Diethanolamine
111-42-2
12/10/1997 Topical Application
MR: 0, 16, 32, OR 64 MG/KG; FR: 0, 8, 16, OR 32 MG/KG; MICE: 0, 40, 80, OR 160 MG/KG (50/SEX/SPECIES/GROUP)
Battelle Columbus Laboratory

Levels of Evidence

Male Rats: No Evidence
Type Organ/Tissue (Lesion)
Non-Neoplastic Lesions
  • SKIN: ACANTHOSIS; HYPERKERATOSIS
Female Rats: No Evidence
Type Organ/Tissue (Lesion)
Non-Neoplastic Lesions
  • SKIN: HYPERKERATOSIS
  • KIDNEY: INCREASED SEVERITY OF NEPHROPATHY
Male Mice: Clear Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Liver: ADENOMA 31/50 42/50 49/50 45/50, CARCINOMA 12/50 17/50 33/50 34/50 OR HEPATOBLASTOMA 0/50 2/50 8/50 5/50
  • Kidney Tubular Cell: (SINGLE SECTIONS) ADENOMA 1/50 4/50 6/50 6/50 COMBINED 3/50 5/50 6/50 8/50; (SINGLE AND STEP SECTIONS) ADENOMA 1/50 6/50 8/50 7/50 COMBINED 3/50 7/50 8/50 9/50
Non-Neoplastic Lesions
  • LIVER: CYTOPLASMIC ALTERATION; SYNCYTIAL ALTERATION
  • KIDNEY: TUBULE HYPERPLASIA
  • THYROID GLAND: FOLLICULAR CELL HYPERPLASIA
  • SKIN: HYPERKERATOSIS
Female Mice: Clear Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Liver: ADENOMA 32/50 50/50 48/50 48/50 OR CARCINOMA 5/50 19/50 38/50 42/50
Non-Neoplastic Lesions
  • LIVER: SYNCYTIAL ALTERATION
  • THYROID GLAND: FOLLICULAR CELL HYPERPLASIA
  • SKIN: HYPERKERATOSIS