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Target Organs and Levels of Evidence for TR-589

TR-589 Toxicology Studies of a Pentabromodiphenyl Ether Mixture [DE-71 (Technical Grade)] (CAS No. 32534-81-9) in F344/N Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of a Pentabromodiphenyl Ether Mixture [DE-71 (Technical Grade)] in Wistar Han [Crl:WI(Han)] Rats and B6C3F1/N Mice (Gavage Studies)

Chemical
CASRN
(Study Title)		 Peer Review Date Primary Uses Route/Exposure Levels Study Laboratory
Pentabromodiphenyl Ether (Technical) (DE 71)
32534-81-9		 06/25/2015 Flame retardant Gavage
M: 0, 3, 30, or 100 mg/kg; 50/sex/dose		 Southern Research Institute

Levels of Evidence

Male Mice: Clear Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Liver: hepatocellular adenoma 23/50 35/50 49/50 40/50 hepatocellular carcinoma 18/50 15/50 30/50 45/50 hepatocellular adenoma or carcinoma 31/50 40/50 49/50 47/50 hepatoblastoma 1/50 1/50 16/50 5/50 hepatocellular adenoma, hepatocellular carcinoma, or hepatoblastoma 31/50 40/50 49/50 47/50
Non-Neoplastic Lesions
  • Liver: centrilobular, hepatocyte, hypertrophy; clear cell focus; necrosis, focal; Kupffer cell, pigmentation
  • Thyroid gland: follicle, hypertrophy
  • Forestomach: epithelium, hyperplasia; inflammation
  • Adrenal cortex: hypertrophy, diffuse
  • Testes: germinal epithelium, atrophy
Female Mice: Clear Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Liver: hepatocellular adenoma 5/50 7/49 32/50 46/49 hepatocellular carcinoma 4/50 2/49 6/50 27/49 hepatocellular adenoma or carcinoma 8/50 8/49 33/50 47/49
Non-Neoplastic Lesions
  • Liver: centrilobular, hepatocyte, hypertrophy; eosinophilic focus; fatty change; Kupffer cell, pigmentation
  • Thyroid gland: follicle, hypertrophy
  • Forestomach: epithelium, hyperplasia
  • Adrenal cortex: hypertrophy, diffuse


Chemical
CASRN
(Study Title)		 Peer Review Date Primary Uses Route/Exposure Levels Study Laboratory
Pentabromodiphenyl Oxide (Technical) (DE 71)
32534-81-9		 06/02/2015 Flame retardant Gavage
R: 0, 3, 15, or 50 mg/kg; 50/sex/dose		 Southern Research Institute

Levels of Evidence

Male Rats: Clear Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Liver: hepatocellular adenoma or carcinoma 3/49 2/50 4/50 9/50; hepatocholangioma, hepatocellular adenoma, or hepatocellular carcinoma 3/49 2/50 4/50 11/50
  • Thyroid Gland Follicular Cell: adenoma 1/45 3/45 2/48 6/46
  • Pituitary Gland: (pars distalis): adenoma 19/49 12/49 22/50 35/50
Non-Neoplastic Lesions
  • Liver: eosinophilic focus; hepatocyte, hypertrophy; fatty change
  • Thyroid gland: follicle, hypertrophy
  • Kidney: hydronephrosis
  • Parotid salivary gland: atrophy; cytoplasmic vacuolization
  • Prostate gland: inflammation, chronic active
  • Preputial gland: duct, ectasia
  • Thymus: atrophy
  • Forestomach: epithelium hyperplasia
Female Rats: Clear Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Liver: cholangiocarcinoma 0/50 0/49 0/50 2/47 hepatocholangioma 0/50 0/49 0/50 8/47 hepatocellular adenoma 3/50 2/49 8/50 16/47 hepatocellular carcinoma 0/50 0/49 1/50 6/47 hepatocellular adenoma or carcinoma 3/50 2/49 8/50 17/47) hepatocholangioma, hepatocellular adenoma, or hepatocellular carcinoma 3/50 2/49 8/50 21/47
May Have Been Related
  • Uterus: stromal polyp or stromal sarcoma (original and residual evaluations, combined) 4/50 12/50 12/50 9/49
Non-Neoplastic Lesions
  • Liver: hyperplasia, nodular; eosinophilic focus; hepatocyte, hypertrophy; fatty change; oval cell, hyperplasia
  • Thyroid gland: follicle, hypertrophy; follicular cell hyperplasia
  • Uterus: squamous metaplasia
  • Cervix: squamous hyperplasia
  • Kidney: hydronephrosis
  • Adrenal cortex: focal hyperplasia