Damian Applied Toxicology, LLC

 

      Drug Impurity Risk Assessment


  • Elemental impurity risk assessment per ICH/FDA Guidance Q3D

  • Calculation of Compound-Specific Acceptable Intakes for mutagenic drug impurities per ICH/FDA Guidance M7

  • Calculation of Permitted Daily Exposures (PDEs) for residual solvent impurities in drugs per ICH/FDA Guidance Q3C

Other Specialty Areas

  • Workers' compensation cases (chemical exposures only)
  • Pesticide risk assessments
  • Honey bee risk assessments
  • Toxicity literature searches and reviews
  • Crystalline silica exposure and toxicity
  • Beryllium exposure and toxicity
  • Microcystin (blue-green algae) exposure and toxicity

(530) 220-0454

Proposition 65, Food Safety, and Consumer Product 

   Risk Assessment

Computational and Predictive Toxicology (Predicting the Toxicity of

    Novel Chemicals and Drugs Using QSAR and Read-Across Methods)


Contaminated Site Risk Assessment



 



 

  • Chemically contaminated foods and nutritional supplements
  • Expert witness/litigation support
  • Risk assessments for chemicals in cosmetics, fragrances and other personal care products including Cosmetic Product Safety Reports per European Union Regulation 1223/2009
  • GRAS (Generally Recognized as Safe) food safety expert panels and toxicology support for new nutritional supplements and medical foods
  • Proposition 65 compliance evaluations, including Maximum Allowable Dose Level (MADL) and No Significant Risk Level (NSRL) development for listed chemicals lacking Safe Harbor Levels
  • Labeling of Hazardous Art Materials Act (LHAMA) evaluations
  • Expert witness/litigation support

  • Health risk-based site closure strategy to support Brownfield site redevelopment

  • Mine and smelter site health and ecological risk assessments

  • Probabilistic (Monte Carlo) risk assessments

  • Industrial site health and ecological risk assessments

  • Vapor intrusion and indoor air health risk assessments

  • Hazardous waste site risk assessments

  • Radionuclide site risk assessments

  • Ecorisk-based cleanup levels for radionuclides

  • Health risk-based cleanup level development

  • Regulatory agency negotiation and response to comments

  • Third-party independent review of risk assessments

 

Damian Applied Toxicology, LLC has applied toxicology and risk assessment expertise to a wide variety of health and environmental chemical exposure issues. Representative examples of these services include:

  

Our Services

  • Leadscope Model Applier (bacterial mutagenicity per FDA/ICH Guidance M7)
  • OECD QSAR Toolbox (mammalian and aquatic/ecotoxicity, environmental fate properties)
  • PBT Profiler (persistence, bioaccumulation and toxicity profile)
  • AIM (chemical analog identification methodology)
  • EPI Suite (environmental fate properties)
  • OncoLogic (carcinogenicity)
  • Toxtree (mammalian toxicity)
  • ECOSAR (aquatic/ecotoxicity)