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Target Organs and Levels of Evidence for TR-593

TR-593 Toxicology and Carcinogenesis Studies of 2,3-Butanedione (CASRN 431-03-8) in Wistar Han [Crl:WI (Han)] Rats and B6C3F1/N Mice (Inhalation Studies)

Chemical
CASRN
(Study Title)		 Peer Review Date Primary Uses Route/Exposure Levels Study Laboratory
2,3-Butanedione
431-03-8		 07/13/2017 Flavorant. Associated with tobacco: reported either as a natural component of tobacco, pyrolysis product (in tobacco smoke), or additive for one or more types of tobacco products. Inhalation
0, 12.5, 25, or 50 ppm; R&M: 50/sex/species/concentration		 Battelle Northwest Laboratory

Levels of Evidence

Male Rats: Some Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Nasal Cavity: squamous cell carcinoma (0/50, 0/50, 0/50, 3/50); squamous cell papilloma or carcinoma (0/50, 0/50, 0/50, 4/50)
Non-Neoplastic Lesions
  • Nasal Cavity: inflammation, suppurative; respiratory epithelium, hyperplasia; respiratory epithelium, metaplasia, squamous; olfactory epithelium, atrophy; olfactory epithelium, metaplasia, respiratory; olfactory epithelium, necrosis; turbinate, hyperostosis; lamina propria, fibrosis
  • Larynx: inflammation, chronic active; squamous epithelium, hyperplasia; squamous epithelium, ulcer, focal; respiratory epithelium, metaplasia, squamous
  • Trachea: inflammation, chronic active; epithelium, hyperplasia; epithelium, metaplasia, squamous; epithelium, regeneration; epithelium, atrophy; epithelium, necrosis; submucosa, fibrosis
  • Lung: inflammation, suppurative; peribronchial, inflammation, chronic active; bronchus, epithelium, hyperplasia; bronchiole, epithelium, hyperplasia; bronchus, epithelium, atrophy; bronchus, epithelium, regeneration; bronchus, submucosa, fibrosis; alveolus, infiltration cellular, histiocyte; alveolar epithelium, hyperplasia; interstitium, fibrosis
  • Eye: cornea, inflammation, chronic active; anterior chamber, inflammation, suppurative; cornea, epithelium, hyperplasia; cornea, epithelium, ulcer; lens, cataract
Female Rats: Some Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Nasal Cavity: squamous cell carcinoma (0/50, 0/50, 0/50, 3/50)
Non-Neoplastic Lesions
  • Nasal Cavity: inflammation, suppurative; respiratory epithelium, hyperplasia; respiratory epithelium, metaplasia, squamous; olfactory epithelium, atrophy; olfactory epithelium, metaplasia, respiratory; turbinate, hyperostosis; lamina propria, fibrosis
  • Larynx: inflammation, chronic active; squamous epithelium, hyperplasia; squamous epithelium, ulcer, focal; respiratory epithelium, metaplasia, squamous
  • Trachea: inflammation, chronic active; epithelium, hyperplasia; submucosa, fibrosis
  • Lung: inflammation, granulomatous; peribronchial, inflammation, chronic active; bronchus, epithelium, hyperplasia; bronchiole, epithelium, hyperplasia; bronchus, epithelium, atrophy; alveolus, infiltration cellular, histiocyte; interstitium, fibrosis
  • Eye: cornea, inflammation, chronic active; anterior chamber, inflammation, suppurative; iris, inflammation, acute; cornea, epithelium, hyperplasia; cornea, epithelium, ulcer; lens, cataract; unilateral, phthisis bulbi
Male Mice: No Evidence
Type Organ/Tissue (Lesion)
Non-Neoplastic Lesions
  • Nasal Cavity: inflammation, suppurative; respiratory epithelium, metaplasia, squamous; respiratory epithelium, hyperplasia; glands, sinus, metaplasia, respiratory; respiratory epithelium, necrosis; mucosa, regeneration; olfactory epithelium, atrophy; olfactory epithelium, metaplasia, respiratory; olfactory epithelium, necrosis; turbinate, atrophy; turbinate, necrosis; septum, perforation; lamina propria, fibrosis
  • Larynx: inflammation, chronic active; respiratory epithelium, metaplasia, squamous; squamous epithelium, hyperplasia; respiratory epithelium, hyperplasia; respiratory epithelium, necrosis; respiratory epithelium, regeneration
  • Trachea: inflammation, chronic active; lumen, exudate; necrosis; epithelium, regeneration; epithelium, hyperplasia; epithelium, metaplasia, squamous; submucosa, fibrosis; carina, submucosa, fibrosis; carina, submucosa, mineralization; carina, submucosa, inflammation, chronic active
  • Lung: bronchus, epithelium, regeneration; mediastinum, inflammation, chronic active
  • Eye: cornea, inflammation, acute; cornea, mineralization; cornea, epithelium, hyperplasia; anterior chamber, inflammation, suppurative
Female Mice: Equivocal Evidence
Type Organ/Tissue (Lesion)
May Have Been Related
  • Nasal Cavity: adenocarcinoma (0/50, 0/50, 0/50, 2/50)
Non-Neoplastic Lesions
  • Nasal Cavity: inflammation, suppurative; respiratory epithelium, metaplasia, squamous; glands, sinus, metaplasia, respiratory; respiratory epithelium, necrosis; mucosa, regeneration; olfactory epithelium, atrophy; olfactory epithelium, metaplasia, respiratory; olfactory epithelium, necrosis; turbinate, atrophy; turbinate, necrosis; septum, perforation; lamina propria, fibrosis
  • Larynx: inflammation, chronic active; lumen exudate; respiratory epithelium, metaplasia, squamous; squamous epithelium, hyperplasia; respiratory epithelium, necrosis; respiratory epithelium, regeneration
  • Trachea: inflammation, chronic active; lumen, exudate; necrosis; epithelium, regeneration; submucosa, fibrosis; carina, submucosa, fibrosis; carina, submucosa, mineralization
  • Lung: bronchus, epithelium, regeneration; bronchus, submucosal fibrosis; inflammation, suppurative; pleura, inflammation, suppurative; mediastinum, inflammation, suppurative; mediastinum, inflammation, chronic active
  • Eye: cornea, inflammation, acute; cornea, epithelium, ulcer; cornea, necrosis; cornea, mineralization; cornea, epithelium, hyperplasia