https://ntp.niehs.nih.gov/go/926982

Target Organs and Levels of Evidence for TR-600

TR-600 Toxicology and Carcinogenesis Studies of Di-n-butyl Phthalate (CASRN 84-74-2) Administered in Feed to Sprague Dawley(Hsd:Sprague Dawley SD) Rats and B6C3F1/N Mice

Chemical
CASRN
(Study Title)		 Peer Review Date Route/Exposure Levels Study Laboratory
Dibutyl Phthalate
84-74-2		 04/02/2021 Dosed-Feed
R: 0, 300, 1000, 3000, or 10,000 ppm; M: 0, 1000, 3000, or 10,000 ppm; 50/sex/species/group		 Battelle Columbus Laboratory

Levels of Evidence

Male Rats: Equivocal Evidence
Type Organ/Tissue (Lesion)
May Have Been Related
  • Pancreas Acinar Cell: acinus adenoma (4/49, 4/50, 3/50, 1/50, 10/49)
Non-Neoplastic Lesions
  • Testis: edema (includes bilateral); germinal epithelium, atrophy (includes bilateral); interstitial cell, hyperplasia, diffuse, bilateral; interstitial cell, hyperplasia, focal (includes bilateral); rete testis, fibrosis (includes bilateral); rete testis, sperm granuloma; seminiferous tubule, dysgenesis (includes bilateral)
  • Epididymis: hypospermia (includes bilateral)
  • Prostate gland: decreased secretory fluid
  • Seminal vesicle: decreased secretory fluid
  • Pituitary gland: pars distalis, hypertrophy
  • Liver: hepatocyte, cytoplasmic alteration
Other Considerations
  • Testis: small (1/48, 0/49, 4/48, 2/49, 36/46); enlarged (0/48, 0/49, 1/48, 1/49, 1/46); fluid or blood filled (1/48, 0/49, 0/48, 1/49, 3/46); right, not present (0/48, 0/49, 0/48, 0/49, 2/46); right or left; abdominal; undescended (1/48, 3/49, 2/48, 2/49, 29/46); right or left; inguinal; undescended (1/48, 0/49, 0/48, 0/49, 7/46); right or left; abdominal or inguinal; undescended (2/48, 3/49, 2/48, 2/49, 32/46)
  • Epididymis: small (0/48, 0/49, 3/48, 0/49, 27/46); right, agenesis (0/48, 0/49, 0/48, 0/49, 2/46)
  • Prostate gland: small (0/48, 0/49, 1/48, 2/49, 4/46); right or left, ventral, dorsal or lateral, agenesis (0/48, 0/49, 0/48, 1/49, 2/46)
  • Seminal vesicle: small (1/48, 2/49, 2/48, 1/49, 7/46)
  • Vas deferens: right, not present (0/48, 0/49, 0/48, 0/49, 2/46)
  • Gubernaculum: right, not present (0/48, 0/49, 0/48, 0/49, 1/46)
Female Rats: No Evidence
Type Organ/Tissue (Lesion)
Non-Neoplastic Lesions
  • Liver: hepatocyte, cytoplasmic alteration; bile duct, hyperplasia
Male Mice: No Evidence
Type Organ/Tissue (Lesion)
Non-Neoplastic Lesions
  • Testis: germinal epithelium, degeneration (includes bilateral)
  • Epididymis: duct, exfoliated germ cell (includes bilateral)
  • Liver: hepatocyte, cytoplasmic alteration; hepatocyte, multinucleated
Female Mice: No Evidence
Type Organ/Tissue (Lesion)
Non-Neoplastic Lesions
  • Liver: hepatocyte, cytoplasmic alteration
  • Kidney: renal tubule, hyperplasia