Skip to Main Navigation
Skip to Page Content
COVID-19 is an emerging, rapidly evolving situation.

Get the latest public health information from CDC and research information from NIH.

U.S. flag

An official website of the United States government

Dot gov

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Share This:
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 Date Route/Exposure Levels Study Laboratory
C.I. Direct blue 15
2429-74-5		 11/19/1990 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
Type Organ/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
Type Organ/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