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Additional toxicological data

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additional toxicological information
Type of information:
experimental study
Adequacy of study:
supporting study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: actual case report

Data source

Reference Type:
Report date:

Materials and methods

Test material

Constituent 1
Reference substance name:
Demethyl- chlortetracycline HCI
Demethyl- chlortetracycline HCI
Details on test material:
No data

Results and discussion

Any other information on results incl. tables

Prenatal administration of tetracycline has previously been reported to cause staining of the infantsteeth. 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

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.