OBJECTIVE: To probe into the acute toxicity and genotoxicity of duloxetine in adult male mice.METHODS: Acute toxicity test in mice was used to observe the fatality rate and the lethal dose 50（ LD50）. According to bone marrow micronucleus test

sperm malformation test and reproductive and lymphatic organ mass index test

all mice were divided into 6 groups

including negative control group

positive control group

duloxetine group 1

2

3 and 4（ duloxetine 5

10

20 and 40 mg/kg were given respectively）. The effects of different doses of duloxetine on sperm malformation rate

bone marrow micronucleus rate and reproductive and lymphatic organ mass index of mice.RESULTS: The results of acute toxicity test of duloxetine showed that the LD50 of duloxetine administered intragastrically was 188. 3 mg/kg.The results of micronucleus test and sperm malformation test showed that 5

10 and20 mg/kg of duloxetine administered intragastrically（ duloxetine group 1

2 and 3） did not induce the change of sperm malformation rate and bone marrow micronucleus rate

and there was no statistical significance compared with the negative control group（ P>0. 05）.The sperm malformation rate and bone marrow micronucleus rate in duloxetine group4 were higher than those in negative control group

with statistically significant difference（ P <0. 05）. Compared with the negative control group

there was no significant difference in reproductive and lymphatic organ mass indexes of duloxetine group 1

2

3 and 4（ P>0. 05）.CONCLUSIONS: The LD50 of duloxetine was 188. 3 mg/kg by intragastric administration

which is highly safe.Duloxetine showed no reproductive and genotoxicity in mice administered at 5

10 and 20 mg/kg

but had slight potential genetic toxicity in male mice when administered at 40 mg/kg.