In Vitro Toxicology

In Vitro Toxicology

Enthalpy provides in vitro toxicology services for tobacco, smoke and e-Vapor. With a robust understanding of tobacco products and toxicological sciences, we are able to study early and late genotoxic and cytotoxic effects of individual compounds and various materials (i.e., plant, animal and human tissues, agrochemicals, drugs, personal care products, and natural products). All testing performed in our toxicology department is conducted following GLP guidelines. These capabilities allow us to test products at various physical phases (gas, solid, liquid). We provide testing services to a wide spectrum of customers, including commercial, governmental, and regulatory agencies.

 

Services include, but are not limited to:

  • Mutagenicity (Ames)
  • Cytotoxicity (neutral red uptake)
  • Clastogenicity/aneugenicity (micronucleus) in particulate, vapor, and whole smoke phases
  • Bacteria, yeast, and mold enumeration
  • Irritation tests
  • Sister chromatid exchange (SCE)
  • Assays using animal or human primary or immortalized cell lines
  • 3-D human and animal tissue models
  • Stability testing

Mutagenicity findings are evaluated and interpreted using a proprietary VISITOX interface to the SALM statistical software program developed at the University of North Carolina. This interface is available to independent researchers for the evaluation of their own data through Enthalpy’s secure client login interface.

Enthalpy’s In Vitro Toxicology services fulfill the requirements of:

  • Health Canada
  • ANVISA (Brazil)
  • FDA (USA) HPHC Testing
  • FDA (USA) Substantial Equivalence (SE) Testing

Related