Registration Dossier
Registration Dossier
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EC number: 209-062-5 | CAS number: 554-13-2
Health surveillance data
Administrative data
- Endpoint:
- health surveillance data
- Type of information:
- other: In vitro drug study and Clinical Study
- Adequacy of study:
- supporting study
- Study period:
- 1981
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Remarks:
- Data not sufficient for evaluation.
Data source
Reference
- Reference Type:
- publication
- Title:
- Effects of Psychotropic Drugs on Human Sperm Motility
- Author:
- Levin et al.
- Year:
- 1 981
- Bibliographic source:
- Fertil.Steril. 55:503-506
Materials and methods
- Study type:
- medical monitoring
- Endpoint addressed:
- toxicity to reproduction / fertility
Test material
- Reference substance name:
- Lithium carbonate
- EC Number:
- 209-062-5
- EC Name:
- Lithium carbonate
- Cas Number:
- 554-13-2
- Molecular formula:
- CH2O3.2Li
- IUPAC Name:
- dilithium carbonate
- Test material form:
- solid
Constituent 1
Method
- Type of population:
- other: male patients suffering from clinical depression
- Ethical approval:
- not specified
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- 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.
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