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
|