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Related Experiment Videos

Should chloral hydrate be banned?

A D Steinberg1

  • 1MITRE Corporation, McLean, VA 22102.

Pediatrics
|September 1, 1993
PubMed
Summary

Current regulations for environmental chemicals like chloral hydrate may not apply to its medicinal use. Rodent studies show cancer risk only at high doses, and human data show no increased cancer risk from trichloroethylene, its metabolite.

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Area of Science:

  • Toxicology
  • Pharmacology
  • Environmental Health

Background:

  • Current regulations for carcinogenic environmental chemicals assume genotoxicity and human-rodent metabolic similarity.
  • Trichloroethylene (TCE) is regulated based on rodent studies, and its metabolite, chloral hydrate, faces similar scrutiny.
  • Chloral hydrate is a widely used sedative for adults and children.

Purpose of the Study:

  • To assess the safety of chloral hydrate for medicinal use.
  • To evaluate the applicability of current regulatory assumptions to chloral hydrate.
  • To determine if chloral hydrate should be banned based on available data.

Main Methods:

  • Literature analysis of metabolic, toxicologic, and epidemiologic data for TCE and chloral hydrate.
  • Examination of dose-response relationships for chloral hydrate-induced carcinogenesis in rodents.
  • Review of human epidemiologic data on TCE exposure.

Main Results:

  • Rodent studies indicate a nonlinear dose-response for chloral hydrate carcinogenesis, requiring high chronic doses causing cellular necrosis for malignancy induction.
  • Epidemiologic data on humans exposed to significant levels of TCE (metabolized to chloral hydrate) show no increased cancer mortality.
  • The assumptions underlying current environmental chemical regulations are not supported for the medicinal use of chloral hydrate.

Conclusions:

  • A threshold model, rather than a linear extrapolation, is appropriate for assessing chloral hydrate's carcinogenic risk.
  • The available data do not support banning chloral hydrate as a medicine.
  • Potential modifications in the clinical use of chloral hydrate may be warranted.

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