A Toxicological Evaluation of Methylliberine (Dynamine®)
Table 11
Summary of histopathology findings in the 90-day study.
Organs
Dose group (mg/kg bw/day)
Control (0)
75
112
150
187
225
Main group
Recovery group
Main group
Recovery group
Observations
Male
N/A
N/A
N/A
N/A
Animals with no microscopic findings
7/10
4/5
N/A
N/A
N/A
N/A
4/10
2/5
Epididymides:
Lack of mature spermatozoa
0/10
0/5
0/10
0/10
0/10
0/10
6/10
3/5
Kidneys:
Pelvic dilatation, slight, one or two sides
1/10
0/5
1/1
2/2
2/2
1/1
2/10
0/5
Chronic progessive nephropathy
0/10
0/5
13/1
0/2
0/2
0/1
0/10
0/5
Lungs:
Alveolar emphysema
11/10
0/5
/
/
/
/
0/10
0/5
Hyperplasia of BALT
12/10
12/5
/
/
/
/
11/10
0/5
Testes:
Decreased intensity of spermatogenesis
0/10
0/5
0/10
0/10
0/10
0/10
63–4/10
33–4/5
Female
N/A
N/A
N/A
N/A
Animals with no microscopic findings
7/10
0/5
N/A
N/A
N/A
N/A
6/10
1/5
Kidneys:
Pelvic dilatation, slight, one or two sides
0/10
1/5
2/2
1/1
/
1/1
1/10
0/5
Liver:
Congestion
0/10
0/5
/
/
/
2/2
1/10
0/5
Fibrosis in the Glisson’s capsule
0/10
22/5
/
/
/
/
0/10
0/5
Lungs:
Alveolar emphysema, minimal
11/10
0/5
/
/
/
0/1
0/10
0/5
Acute hemorrhage, mild
0/10
11/5
/
/
/
13/1
0/10
0/5
Hyperplasia of BALT, minimal
0/10
0/5
/
/
/
0/1
0/10
12/5
Thymus:
Acute hemorrhage, mild
0/10
0/5
12/1
/
/
/
0/10
0/5
Uterus:
Dilatation
2/10
2/5
/
/
/
/
2/10
3/5
Abbreviations: /, not examined; BALT, bronchus associated lymphoid tissue; N/A, not applicable (only read-down organs/tissues and gross lesions were examined). Data represent incidence of the observation (number of animals with observation per number of animals examined). Organs without lesions in 15/15 control and high-dose animals or gross lesions in the lower dose groups not shown. Superscripts represent grade of lesion: 1 = minimal, 2 = mild, 3 = moderate, 4 = severe.
