Table 1.
Incidences of neoplasms and nonneoplastic lesions of the kidney in male F344/N rats exposed to methyl isobutyl ketone by inhalation for two years.
0 ppm | 450 ppm | 900 ppm | 1800 ppm | |
---|---|---|---|---|
Number Examined Microscopically | 50 | 50 | 50 | 50 |
Nephropathy | ||||
Single Sections | 42a (2.0)b | 45 (2.6)▲ | 47 (2.4)▲ | 50* (3.1▲ |
Papilla Mineralization | ||||
Single Sections | 1 (1.0) | 6* (1.2) | 22** (1.6) | 29** (1.5) |
Pelvis Transitional Epithelium Hyperplasia | ||||
Single Sections | 1 (1.0) | 5 (1.8) | 6* (1.2) | 19** (1.4) |
Renal Tubule Hyperplasia | ||||
Single Sections | 1 (2.0) | 11** (3.2) | 3 (2.0) | 18** (2.7) |
Step Sections | 0 | 3 (2.0) | 4 (2.0) | 6* (2.3) |
Single and Step Sections (Combined) | 1 (2.0) | 14* (2.9) | 7* (2.0) | 21** (2.5) |
Renal Tubule Adenomac | ||||
Single Sections | 0* | 0 | 2 (4.7)d | 3 (7.3) |
Step Sections | 2 (4.5)* | 3 (7.2) | 1 (2.4) | 7 (16.8) |
Single and Step Sections (Combined) | 2 (4.5)** | 3(7.2) | 3 (7.1) | 10 (24.0)** |
Renal Tubule Carcinomae | ||||
Single Sections | 0 | 1 (2.4) | 0 | 2 (4.8) |
Step Sections | 0 | 0 | 0 | 0 |
Single and Step Sections (Combined) | 0 | 1 (2.4) | 0 | 2 (4.8) |
Renal Tubule Adenoma or Carcinomaf | ||||
Single Sections | 0* | 1 (2.4) | 2 (4.7) | 4 (9.7) |
Step Sections | 2 (4.5)* | 3 (7.2) | 1 (2.4) | 7 (16.8) |
Single and Step Sections (Combined) | 2 (4.5)** | 4 (9.5) | 3 (7.1) | 11 (26.4)** |
lesion incidence;
average severity grade of lesions in affected animals: 1=minimal, 2=mild, 3=moderate, 4=marked;
Historical incidence for 2-year inhalation studies with chamber controls given NTP-2000 diet (mean ± standard deviation): 3/399 (0.8% ± 1.0%); range, 0%–2%;
survival adjusted incidence (%);
Historical incidence: 1/399 (0.3% ± 0.7%); range, 0%–2%;
Historical incidence: 4/399 (1.0% ± 1.1%); range, 0%–2%;
Increased lesion severity by Mann Whitney U test;
P≤0.05 by the poly-3 test (for trend if assigned to control);
P≤0.01