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Absence of mutagenic effects of sodium dichloroacetate

A W Fox1, X Yang, H Murli

  • 1Cypros Pharmaceutical Corporation, Carlsbad, California 92008, USA.

Fundamental and Applied Toxicology : Official Journal of the Society of Toxicology
|July 1, 1996
PubMed

Insights

Sodium dichloroacetate (DCA) shows no mutagenic potential in genetic safety tests. Pharmaceutical-grade DCA was evaluated for safety, providing new data on its mutagenicity and clastogenicity.

Area of Science:

  • Pharmacology
  • Toxicology
  • Genetics

Background:

  • Sodium dichloroacetate (DCA) is investigated for potential therapeutic applications in stroke and head injury.
  • Previous studies on DCA's mutagenic potential have yielded conflicting results.
  • Concerns regarding impurities in DCA have complicated safety assessments.

Purpose of the Study:

  • To comprehensively assess the mutagenic and clastogenic potential of pharmaceutical-grade sodium dichloroacetate (DCA).
  • To clarify conflicting data regarding DCA's genotoxicity.
  • To provide robust safety data for DCA's potential clinical use.

Main Methods:

  • A battery of genetic toxicology tests was employed, including the Ames test (Salmonella and E. coli).
  • Locus forward mutation assay in mouse lymphoma cells (L5178Y) was performed.
  • In vitro chromosomal aberration tests in Chinese hamster ovary cells and an in vivo rat bone marrow micronucleus test were conducted.

Main Results:

  • No evidence of mutagenic activity was observed in the Salmonella/E. coli mutation assay.
  • DCA did not induce forward mutations at the thymidine kinase locus in mouse lymphoma cells.
  • No clastogenic effects were detected in the chromosomal aberration tests or the in vivo micronucleus test.

Conclusions:

  • Pharmaceutical-grade sodium dichloroacetate (DCA) demonstrated a lack of mutagenic and clastogenic activity in a comprehensive series of genetic toxicology studies.
  • The absence of genotoxicity suggests that impurities in previously tested DCA materials may have contributed to conflicting findings.
  • These results support the safety profile of pharmaceutical-grade DCA and warrant further investigation for its therapeutic potential in neurological conditions.

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