Biomedical Engineering Reference
In-Depth Information
TABLE 8.5 Dose-Response Trends in Male Rats in Ramazzini
Foundation Methanol Study
Sex
(Number of
Animals)
Total
Malignant
Tumors
Methanol,
(ppm)
Ear Duct
Carcinomas
Hemolymphoreticular
Neoplasias
20,000
M (100)
70
24
40
5,000
M (100)
64
17
36
500
M (100)
55
13
35
0
M (100)
50
9
28
p
<
0.01 Cochrane-Armitage test for dose-response relationship.
reported in females. The hemolymphorecticular tumor rate in the histori-
cal controls ranges to as high as 25%, so only the top dose is slightly
higher than the top end of historical controls. The top dose is 40 times
higher than the low dose and the increase in hemolymphorecticular
tumors rate in the top dose is only 4%higher than the low dose. Not much
of an increase in hemolymphorecticular tumors rate given the wide dose
range employed in this study.
This study is not the typical design and some questions require
further discussion. It has been suggested that by allowing animal to live
out their life, as done in this study, treatment-related tumors that only
appear in old age can be detected that would be missed in a standard
TABLE 8.6 Dose-Response Trends in Female Rats in Ramazzini
Foundation Methanol Study
Sex
(Number of
Animals)
Total
Malignant
Tumors
Methanol,
(ppm)
Ear Duct
Carcinomas
Hemolymphoreticular
Neoplasias
20,000
F (100)
63
19
28
5,000
F (100)
48
16
24
500
F (100)
48
8
24
0
F (100)
43
9
13
p
<
0.01 Cochrane-Armitage test for dose-response relationship.
p
<
0.05 Cochrane-Armitage test for dose-response relationship.
