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Target Organs and Levels of Evidence for TR-440

Toxicology and Carcinogenesis Studies of Ozone (CASRN 10028-15-6) and Ozone/NNK (CASRN 10028-15-6/64091-91-4) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)

Chemical (Study Title)
CASRN		 Peer Review Date Route/Exposure Levels Study Laboratory
Ozone
10028-15-6		 11/16/1993 Inhalation
R&M: 0, 0.12, 0.5, OR 1.0 PPM (50/SEX/SPECIES/GROUP)		 Battelle Northwest Laboratory

Levels of Evidence

Male Rats: No Evidence
Type Organ/Tissue (Lesion)
Non-Neoplastic Lesions
  • NOSE: (2 YR. STUDY) GOBLET CELL AND LATERAL WALL HYPERPLASIA; SQUAMOUS METAPLASIA
  • LARYNX: (2 YR. STUDY) SQUAMOUS METAPLASIA
  • LUNG: (2 YR. STUDY) METAPLASIA; INTERSTITIAL FIBROSIS
Female Rats: No Evidence
Type Organ/Tissue (Lesion)
Non-Neoplastic Lesions
  • NOSE: (2 YR. STUDY) GOBLET CELL AND LATERAL WALL HYPERPLASIA; SQUAMOUS METAPLASIA
  • LARYNX: (2 YR. STUDY) SQUAMOUS METAPLASIA
  • LUNG: (2 YR. STUDY) METAPLASIA; INTERSTITIAL FIBROSIS
Male Mice: Equivocal Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Lung: (2 YR. STUDY) AVEOLAR/BRONCHIOLAR ADENOMA 6/50 9/50 12/50 11/50 OR ALVEOLAR/BRONCHIOLAR CARCINOMA 8/50 4/50 8/50 10/50 COMBINED 14/50 13/50 18/50 19/50
Non-Neoplastic Lesions
  • NOSE: (2 YR. STUDY) HYPERPLASIA; SQUAMOUS METAPLASIA
  • LARYNX: (2 YR. STUDY) HYPERPLASIA
  • LUNG: (2 YR. STUDY) HISTIOCYTIC INFILTRATION; METAPLASIA
Female Mice: Some Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Lung: (2 YR. STUDY) ALVEOLAR/BRONCHIOLAR ADENOMA 4/50 5/50 5/49 8/50 OR ALVEOLAR/BRONCHIOLAR CARCINOMA 2/50 2/50 5/49 8/50 COMBINED 6/50 7/50 9/49 16/50
Non-Neoplastic Lesions
  • NOSE: (2 YR. STUDY) HYPERPLASIA; SQUAMOUS METAPLASIA
  • LARYNX: (2 YR. STUDY) HYPERPLASIA
  • LUNG: (2 YR. STUDY) HISTIOCYCTIC INFILTRATION; METAPLASIA


Chemical (Study Title)
CASRN		 Peer Review Date Primary Uses Route/Exposure Levels Study Laboratory
Ozone
10028-15-6		 11/16/1993 Pollution control, waste treatment, chemical synthesis, sterilization where residuals of other chemicals would be objectionable, odor control, bleaching waxes, clay, textiles, paper pulp, oils, control of algae, mold, and bacteria. 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
R&M: 0, 0.5, OR 1.0 PPM (50/SEX/SPECIES/GROUP)		 Battelle Northwest Laboratory

Levels of Evidence

Male Rats: No Evidence
Type Organ/Tissue (Lesion)
Non-Neoplastic Lesions
  • NOSE: (LIFETIME STUDY) GOBLET CELL AND LATERAL WALL HYPERPLASIA; SQUAMOUS METAPLASIA
  • LARYNX: (LIFETIME STUDY) SQUAMOUS METAPLASIA
  • LUNG: (LIFETIME STUDY) METAPLASIA; HISTIOCYTIC INFILTRATION; INTERSTITIAL FIBROSIS
Female Rats: No Evidence
Type Organ/Tissue (Lesion)
Non-Neoplastic Lesions
  • NOSE: (LIFETIME STUDY) GOBLET CELL AND LATERAL WALL HYPERPLASIA; SQUAMOUS METAPLASIA
  • LARYNX: (LIFETIME STUDY) SQUAMOUS METAPLASIA
  • LUNG: (LIFETIME STUDY) METAPLASIA; HISTIOCYTIC INFILTRATION; INTERSTITIAL FIBROSIS
Male Mice: Equivocal Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Lung: (LIFETIME STUDY) ALVEOLAR/BRONCHIOLAR ADENOMA 8/49 8/49 9/50 OR ALVEOLAR/BRONCHIOLAR CARCINOMA 8/49 15/49 18/50 COMBINED 16/49 22/49 21/50
Non-Neoplastic Lesions
  • NOSE: (LIFETIME STUDY) HYPERPLASIA; SQUAMOUS METAPLASIA
  • LARYNX: (LIFETIME STUDY) HYPERPLASIA; SQUAMOUS CELL METAPLASIA
  • LUNG: (LIFETIME STUDY) HISTIOCYTIC INFILTRATION; METAPLASIA
Female Mice: Some Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Lung: (LIFETIME STUDY) ALVEOLAR/BRONCHIOLAR ADENOMA 3/50 3/49 11/50 OR ALVEOLAR/BRONCHIOLAR CARCINOMA 3/50 5/49 2/50 COMBINED 6/50 8/49 12/50
Non-Neoplastic Lesions
  • NOSE: (LIFETIME STUDY) HYPERPLASIA; SQUAMOUS METAPLASIA
  • LARYNX: (LIFETIME STUDY) HYPERPLASIA; SQUAMOUS CELL METAPLASIA
  • LUNG: (LIFETIME STUDY) HISTIOCYTIC INFILTRATION; METAPLASIA


Chemical (Study Title)
CASRN		 Peer Review Date Primary Uses Route/Exposure Levels Study Laboratory
Ozone/NNK
OZONNNKCOMB		 11/16/1993 Byproduct of tobacco smoke. 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
MALE RATS ONLY: 0, 0.5 PPM OZONE WITH 0, 0.1, 1.0 MG/KG NNK BY S.C. INJECTION (20 WEEKS ONLY)		 Battelle Northwest Laboratory

Levels of Evidence

Type Organ/Tissue (Lesion)
Note
  • IN A COCARCINOGENICITY STUDY, OZONE DID NOT ENHANCE NNK-INDUCED PULMONARY NEOPLASMS IN MALE RATS