Registration Dossier
Registration Dossier
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EC number: 200-592-2 | CAS number: 64-73-3
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: actual case report
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 964
- Report date:
- 1963
Materials and methods
Test material
- Reference substance name:
- Demethyl- chlortetracycline HCI
- IUPAC Name:
- Demethyl- chlortetracycline HCI
- Details on test material:
- No data
Constituent 1
Results and discussion
Any other information on results incl. tables
Prenatal administration of tetracycline has previously been reported to cause staining of the infants，teeth. Demethylchlortetracycline has not previously been implicated. Five cases are presented in which demethylchlortetracycline was administered prenatally. In each case, there was staining of those teeth that were undergoing mineralization at the time the drug was administered.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, the repoerted substance dose not induce the adverse effects to the infant’s growth and development.
- Executive summary:
Demethylchlortetracycline when administered 3 to 6 days prior to delivery passes from maternal circulation through the placental barrier and appears in significant blood levels in the newly bom infant.The five cases presented here demonstrate that this drug not only passes to the fetus but becomes incorporated in the developing teeth. The localization of the staining corresponds to those dental areasundergoing mineralization at the time the drug was administered to the mother.
Further studies are underway to determine the extent of this problem and its relationship to dental anomalies and caries. At this point, one can only warn that this drug administered during the last two trimesters of pregnancy may have a dramatic cosmetic eflFect on the infants’deciduous teeth.
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