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Diss Factsheets

Toxicological information

Health surveillance data

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Administrative data

health surveillance data
Type of information:
other: In vitro drug study and Clinical Study
Adequacy of study:
supporting study
Study period:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Data not sufficient for evaluation.

Data source

Reference Type:
Effects of Psychotropic Drugs on Human Sperm Motility
Levin et al.
Bibliographic source:
Fertil.Steril. 55:503-506

Materials and methods

Study type:
medical monitoring
Endpoint addressed:
toxicity to reproduction / fertility

Test material

Constituent 1
Chemical structure
Reference substance name:
Lithium carbonate
EC Number:
EC Name:
Lithium carbonate
Cas Number:
Molecular formula:
dilithium carbonate
Test material form:


Type of population:
other: male patients suffering from clinical depression
Ethical approval:
not specified

Results and discussion

Applicant's summary and conclusion

The study demonstrated reduced sperm viability in men under lithium therapy (serum levels: 22-52 mg/L, equivalent to 3.2-7.5 mmol/L). However, the number of cases is low (n=4) and the significance of these isolated findings is limited.
Executive summary:

The effects of acute treatment of depressed patients with lithium carbonate on sperm function were investigated. In addition, it was studied the direct in vitro effects of a variety of neurotropic agents on sperm motility. There were no significant differences in sperm count, viability, or motility between a group of patients diagnosed as having clinical depression and a group of semen donors with normal sperm characteristics. Three weeks of continuous therapy with lithium carbonate resulted in a significant decrease in sperm viability but no significant change in sperm count or motility. The in vitro drug studies demonstrated that lithium carbonate had no effect on motility.

The effect noted does not allow any conclusion as the number of cases is very low and confounding factors were not considered.