Objective: To study the effect of Cinnabaris on mouse/rat chromosome damage

and to compare the detection of genotoxicity by short-term and long-term dose administration

exploring the feasibility of integrating micronucleus assay and comet assay into reproductive toxicity test Ⅰ period (male fertility and early embryonic development). Method: Cinnabaris suspension was orally administrated to male mice by ig at doses of 10

5.0

2.5 g ·kg-1respectively (equal to 100

50

and 25 times of the human highest clinical equivalent doses)

after 2 days mice were sacrificed.Cinnabaris suspension was orally administrated to rats by ig at doses of 1.0

0.3

0.1 g ·kg-1respectively (equal to 20

6.4

and 2.0 times of the human highest clinical equivalent doses)

according to the protocol of rat fertility and early embryo development toxicity by ig administration of Cinnabaris

male rats were sacrificed after 42 day’s continuous administration and mating

and female rats after 20 day’s continuous administration and on D15 of pregnancy.Then the bone marrows were taken to do micronucleus assay and comet assay. Result: The micronucleus rates of mice administrated were 0.175%

0.108% and 0.092% respectively

and had statistical significance when compared with the negative control.But in comet assay

the results were negative.The micronucleus rates of rats

which were integrated into the protocol of rat fertility and early embryo development toxicity test

had a tendency of increase as the doses increase

but no statistical significance.But in comet assay

the results showed that both tailed cell numbers and tailed lengths in high and middle dose groups statistically increased in both male and female rats when compared with the negative control. Conclusion: ① Both high dose

short-term and low dose

long-term administrations of Cinnabaris may cause chromosome damage; ② it is feasible that both micronucleus assay and comet assay be integrated into the protocol of rat fertility and early embryo development toxicity test

which is in accordance with the long-term and low-dose administration of traditional Chinese medicine.③ The combination of micronucleus assay and comet assay is of complement in evaluating drug genotoxicity in vivo