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https://ntp.niehs.nih.gov/go/10965

Target Organs and Levels of Evidence for TR-397

Toxicology and Carcinogenesis Studies of C.I. Direct Blue 15 (CASRN 2429-74-5) in F344 Rats (Drinking Water Studies)

Chemical (Study Title)
CASRN
Peer Review DatePrimary UsesRoute/Exposure LevelsStudy Laboratory
C.I. Direct blue 15
2429-74-5
11/19/1990Dye for silk, wool, viscose, leather, paper, cellulose fibers. Biological stain. Tint for cinematographic films. Dosed-Water
RATS ONLY: 0,630,1250,2500 PPM (70,45,75,70 PER GROUP RESPECTIVELY)
Hazleton, Vienna

Levels of Evidence

Male Rats: Clear Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Skin: BASAL CELL ADENOMA 2/50 8/35 23/65 26/50, BASAL CELL CARCINOMA 0/50 2/35 4/65 10/50, COMBINED 2/50 9/35 27/65 28/50; SEBACEOUS GLAND ADENOMA 0/50 1/35 7/65 3/50; SQUAMOUS CELL PAPILLOMA 2/50 3/35 5/65 8/50, SQUAMOUS CELL CARCINOMA 0/50 1/35 7/65 13/50, COMBINED 2/50 4/35 11/65 19/50
  • Zymbal Gland: ADENOMA 0/50 2/35 2/65 4/50, CARCINOMA 1/50 3/35 8/65 17/50, COMBINED 1/50 5/35 10/65 20/50
  • Preputial Gland: ADENOMA 6/49 2/35 12/64 8/48, CARCINOMA 2/49 3/35 11/64 1/48, COMBINED 8/49 5/35 23/64 9/48
  • Liver: NEOPLASTIC NODULE 0/50 6/35 8/65 7/50, CARCINOMA 0/50 0/35 1/65 4/50, COMBINED 0/50 6/35 9/65 11/50
  • Oral Cavity: SQUAMOUS CELL PAPILLOMA 0/50 9/35 18/65 15/50, SQUAMOUS CELL CARCINOMA 1/50 1/35 6/65 2/50, COMBINED 1/50 10/35 24/65 17/50
  • Large Intestines: ADENOMATOUS POLYP 0/50 2/35 2/65 5/50, ADENOCARCINOMA 0/50 0/35 4/65 5/50, COMBINED 0/50 2/35 6/65 10/50
May Have Been Related
  • Hematopoietic System: MONONUCLEAR CELL LEUKEMIA 17/50 19/35 28/65 20/50
  • Brain: ASTROCYTOMA 0/50 1/35 1/65 2/50
Non-Neoplastic Lesions
  • PREPUTIAL GLAND: ECTASIA
  • LIVER: CYSTIC DEGENERATION; FOCAL CELLULAR ALTERATIONS; REGENERATION
  • SKIN: BASAL CELL HYPERPLASIA
  • ZYMBAL GLAND: ECTASIA; SQUAMOUS HYPERPLASIA
Female Rats: Clear Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Skin: SQUAMOUS CELL PAPILLOMA 0/50 2/35 5/65 5/50, SQUAMOUS CELL CARCINOMA 0/50 0/35 1/65 0/50, COMBINED 0/50 2/35 6/65 5/50
  • Zymbal Gland: ADENOMA 0/50 1/35 5/65 3/50, CARCINOMA 0/50 4/35 7/65 14/50, COMBINED 0/50 4/35 11/65 17/50
  • Clitoral Gland: ADENOMA 5/50 5/31 12/64 12/50, CARCINOMA 2/50 6/31 12/64 15/50, COMBINED 7/50 11/31 24/64 27/50
  • Liver: NEOPLASTIC NODULE 0/50 0/35 2/65 4/50, CARCINOMA 0/50 0/35 0/65 1/50, COMBINED 0/50 0/35 2/65 5/50
  • Oral Cavity: SQUAMOUS CELL PAPILLOMA 2/50 3/35 12/65 9/50, SQUAMOUS CELL CARCINOMA 0/50 1/35 8/65 6/50, COMBINED 2/50 4/35 19/65 15/50
  • Large Intestines: ADENOMATOUS POLYP 0/50 0/35 3/65 1/50; ADENOCARCINOMA 0/50 0/35 1/65 3/50
  • Uterus/Cervix: ADENOMA 0/50 0/35 1/65 1/50, ADENOCARCINOMA 1/50 0/35 0/65 3/50, COMBINED 1/50 0/35 1/65 4/50
  • Hematopoietic System: MONONUCLEAR CELL LEUKEMIA 7/50 13/35 27/65 15/50
Non-Neoplastic Lesions
  • CLITORAL GLAND: SQUAMOUS HYPERPLASIA
  • LIVER: FOCAL CELLULAR ALTERATIONS; REGENERATION
  • ZYMBAL GLAND: ECTASIA; HYPERPLASIA