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
|