Toxicity studies
a) General Toxicity studies.
i) Single-dose
ii) Maximum tolerated dose
iii) Local tolerance
iv) Repeated-dose, 2, 4, 13, 26, 39 or 52 weeks duration
v) Carcinogenicity.
vi) Carcinogenicity studies with genetically modified animal models
b) Genotoxicity testing
i) Ames, HPRT, mouse lymphoma test
ii) Chromosome aberration test in vitro and in vivo (bone marrow)
iii) Micronucleus test in vitro and in vivo”
c) Reproductive toxicology