At our site, we have the capability to run studies up to 90-days in length.  For longer term studies, we have a strong partnership with another leading laboratory.  

Exposure Chambers 

• Nose-only
  • Multiple flow-through chambers that are adaptable to specific study designs
• Whole body
  • Multiple chambers ranging in size from 100 liters to 150 liters 

Material Preparation 

• Capable of ball milling a substance in an inert atmosphere
• Numerous sieves for processing
• Various mills that each use a unique form of milling
• Jet-mill that can grind a substance using particle collision 

Aerosol Generation Equipment 

• Adaptable nebulizer setups that can be modified to your specific test substance
• Collision nebulizer that is capable of delivering low chamber concentrations
• Modified Wright Dust Feeder that is capable of delivering high concentrations of dusts
• Wright Dust Feeder for delivery of powders as a dust
• Jet-mill for grinding and delivery of dusts 

Aerosol Concentration Determination 

• Gravimetric determination using a variety of filters and collection media (e.g., sorbent tubes)
• Chemical analysis is performed by our Analytical Chemistry department in a GLP lab
  • A wide selection of instrumentation is available to accommodate formulations of every type
  • Collection devices ranging from simple filters and sorbent tubes to gas impingers with collection solvents to optimize measurements for your specific test substance
• DustTrak™ is used for real-time monitoring of low concentration materials 

Acute Inhalation

This test will provide information on health hazards likely to arise from a short-term exposure to a test substance by the inhalation route.  Each test is designed to perform a limit test or it can define the medial lethal concentration (LC₅₀) for your product.  

Acute Oral

This test will provide information on health hazards likely to arise from a short-term exposure to a test substance by the oral route.  Each test is designed to perform a limit test or it can define the medial lethal dose (LD₅₀₎ for you product.  

Acute Dermal

This test will provide information on health hazards likely to arise from a short-term exposure to a test substance by the dermal route.  Each test is designed to perform a limit test or it can define the medial lethal dose (LD₅₀) for you product.  

Primary Eye Irritation

To provide information on the irritation likely to arise from a single instillation of a test substance into the eye.  

Primary Skin Irritation

To provide information on the skin irritation likely to arise from a single topical exposure to a test substance. 

Dermal Sensitization

To determine the potential for a test substance to elicit a skin sensitization reaction.

• Local Lymph Node Assay (LLNA)

• Buehler Method

• Magnusson and Kligman Method (M&K)

Our genetic tox studies are conducted in accordance with GLP standards and regulatory guidelines (FDA, EPA, OECD, ICH).  Studies are regularly conducted on pharmaceuticals, chemicals, dietary ingredients and pesticides. Based upon many years of experience, we can advise you on the most suitable protocols to meet your regulatory needs. 

Gene Mutation

• Bacterial Mutation - Ames Mutagenicity (OECD 471)
• Mammalian Mutation Assay: Mouse Lymphoma Assay (OECD 476)

Chromosome Damage

• In Vitro Cytogenics

  • Micronucleus Assay (Chinese Hamster Cell) (OECD 487)
  • Micronucleus Assay (Human Lymphocyte) (OECD 487)
  • Chromosome Aberration Test (Chinese Hamster Cells) (OECD 473)
  • Chromosome Aberration Test (Human Lymphocytes) (OECD 473)
  • Unscheduled DNA Synthesis (UDS) Test (Mammalian Liver Cells) (OECD 482)

• In Vivo Cytogenics

  • Micronucleus Assay (Peripheral Blood) (Rat or Mouse) (OECD 474)
  • Micronucleus Assay (Bone Marrow) (Rat or Mouse) (OECD 474)
  • Chromosome Aberration Test (Mammalian Bone Marrow) (OECD 475)
  • Unscheduled DNA Synthesis (UDS) Test (Mammalian Liver Cells) (OECD 486)

Additional Tests

• • Mouse Spot Study (In Vivo) (OECD 484)
  • Rodent Dominant Lethal Study (In Vivo) (OECD 478) 
  • Mammalian Germ Cell Cytogenetics (In Vivo) (OECD 488)
  • Mouse Heritable Translocation (In Vivo) (OECD 485)
  • Comet Assay (OECD 489)
  • Pig-a Assay

Customized non-GLP screening assays are available upon request.

Let one of the experts at Product Safety Labs help you design a genetic toxicology study. 

Please join us Thursday, November 11th, 2021 from 1:30PM - 2:30PM for a Talking Toxicology Webinar entitled:

Safety of E-Cigarette Products - A Toxicological Challenge

Experimental Models and Atmosphere Generation to Provide Appropriate Safety Data to Regulators

Our webinar will be presented by Dr. Jason Blum, Senior Study Director at Product Safety Labs and Dr. Katherine Knostman with StageBIo.  

Dr. Blum, an expert in acute and repeat dose inhalation toxicology, will be presenting guidance from his experience with developing exposure and atmosphere generation, how to perform inhalation studies with e-cigarettes, the measurement of test atmosphere components and animal model selection.  He will also discuss the details involved in a 90-Day GLP and non-GLP inhalation toxicity study plan. 

Dr. Knostman is an expert in toxicologic pathology, having extensive experience as lead pathologist in preclinical studies for industry and government clients.  She evaluates the pathology associated with inhaled therapeutics, environmental pollutants and tobacco products and today, Dr. Knostman’s presentation will focus on respiratory tissue collection for histopathology, molecular and biochemical assessment and pathologic changes following inhalation exposures important to e-cigarette exposures.

After the presentation, there will be a live Q & A session in which Dr. Blum and Dr. Knostman will address as many of your questions as possible.  This will be an educational and informative event for all attendees.  We look forward to seeing you on November 11th. 

The webinar will be available on-demand through February 12, 2022.