Registration Dossier
Registration Dossier
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EC number: 231-102-5 | CAS number: 7439-93-2
Health surveillance data
Administrative data
- Endpoint:
- health surveillance data
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1990
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Data not sufficient for evaluation. Case-control study used for read-across. Lithium substance not exactly specified.
Data source
Reference
- Reference Type:
- publication
- Title:
- A Case-Control Study on the Association Between First Trimester Exposure to Lithium and Ebstein's Anomaly
- Author:
- Zalzstein, E. et al.
- Year:
- 1 990
- Bibliographic source:
- THE AMERICAN JOURNAL OF CARDIOLOGY MARCH 15, 1990
Materials and methods
- Study type:
- medical monitoring
- Endpoint addressed:
- developmental toxicity / teratogenicity
Test guideline
- Qualifier:
- no guideline followed
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
Constituent 1
Method
- Type of population:
- other: children with Ebstein's anomaly
- Ethical approval:
- not specified
Results and discussion
- Results:
- No clear causal link between lithium and Ebstein's anomaly was found in this study.
Applicant's summary and conclusion
- Conclusions:
- No causal link between Lithium in drug and Ebstein's anomaly was found in a case control study.
- Executive summary:
In a case-control study, 59 cases of Ebstein's anomaly were analysed and looked for associations with in-utero exposure to lithium. A control group of children born with neuroblastoma was used to overcome the bias towards "underreporting" of drug exposure by mothers of healthy babies. There was one case of lithium exposure in the control group but none in the Ebstein group. Based on the incidence of Ebstein's anomaly (1:20,000) and the estimation that 1:1,000 pregnant women are treated with lithium, the authors conclude that the study with 59 Ebstein cases has the statistical power of 80% to rule out an increased risk for Ebstein's anomaly due to lithium exposure of more than 28-fold at the p=0.05 level. However, no clear conclusion can be drawn that Lithium exposition during pregnancy is linked to an increase rate for Ebstein's anomaly.
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