Comprehensive In Vitro Toxicology Testing
Labstat offers a broad range of in vitro toxicology testing services for tobacco, nicotine, and cannabis products that provide accurate, defensible data at each stage of your product’s lifecycle, from prototype to stewardship. Whether you need regulatory testing with competitive turnaround time or contract research, our expert team can help.
Technical Expertise to Help You
Since our inception in 1976, we’ve built a foundation of technical knowledge that our clients have leveraged for their product development and regulatory evaluations. Use our expertise to benefit your business.
Comprehensive portfolio of in vitro toxicology and other services for tobacco/nicotine and cannabis products, including chemistry, microbiology, assistance with testing for PMTA and other regulatory submissions, stability studies, contract research, and more.
Expert advice on assay selection and cell lines for prototype/product development and regulatory testing.
Real-time industry insights garnered from our ongoing partnerships with regulatory agencies and subject matter experts.
Access to a multidisciplinary team of professionals, including toxicologists, chemists, microbiologists, engineers, flavor experts, and regulatory consultants.
We Test Nearly Every Tobacco, Nicotine, & Cannabis Product
Our toxicology testing lab provides service for all types of tobacco, nicotine, and cannabis products, including conventional products, Reduced Risk Tobacco Products (including MRTP), cannabis vapes, and more.
Electronic cigarettes
Nicotine gum
Waterpipe
E-liquids
Roll your own and other non-factory-made products
Nicotine lozenges
Heat-not-burn tobacco products
Cigarettes and cigars
Modern oral
Smokeless tobacco
Toxicology Testing of Multiple Matrices
We have the instrumentation and expertise to test a variety of matrices, helping you obtain the data you need to support your safety and quality goals.
Smoke
Aerosol
- Variable puffing regimes and collections
- Ethanol and straight aerosol collection methods
Neat Materials
Smokeless/Nicotine Pouch Extracts
Regulatory In Vitro Toxicology Testing
Our in vitro toxicology services for regulatory purposes provide defensible data, whether you are submitting to the FDA (PMTA, MRTP, Substantial Equivalence), Health Canada, EU TPD, ANVISA, or other regulatory agencies. Regulatory in vitro toxicology assays are offered as either non-GLP or GLP. The assays offered include:
Ames Assay
- Bacterial reverse mutation test used to evaluate the mutagenic potential of chemical compounds.
- Frequently used as an initial screen to evaluate the mutagenic potential of a test item.
- Plate incorporation method with and without metabolic activation (phenobarbital-induced S9) using five different Salmonella typhimurium strains – TA98, TA100, TA102, TA1535, TA1537 (each strain has a different sensitivity).
- Health Canada T-501 or OECD 471 methods available.
In Vitro Micronucleus Assay
- The micronucleus test (MN) is used to determine the genotoxicity of a test item by evaluating the presence of micronuclei. Micronuclei are produced from DNA breakage (clastogens) or whole chromosomes produced by disruption of the mitotic apparatus (aneugens).
- Several cell lines available:
- CHO
- TK6
- V79
- Health Canda T-503 or OECD 487 methods available.
- Micronuclei assessment by manual slide scoring or flow cytometry.
- We offer a standard method with flow cytometry or a high-throughput version.
- We offer a standard method with flow cytometry or a high-throughput version.
Neutral Red Uptake Assay
- Quantitative assay to determine the number of viable cells in a culture.
- Cytotoxicity of a test item is assessed by the ability of cells to incorporate and bind the eurhodin dye neutral red in the lysosomes.
- Several cell lines available:
- BALB/c 3T3
- A549
- CHO-WBL
- Health Canada T-502 or OECD 129
Mouse Lymphoma Assay
- Mammalian cell gene mutation assay.
- Detects mutations in the thymidine kinase (Tk) gene.
- Tk mutations can be gene mutations and/or chromosomal mutations.
- Cell line used:
- L5178Y TK+/- clone (3.7.2C)
- OECD 490 method available (micro plate assay).
Toxicology Testing Services for Research & Development
During research & development, high through-put and cost-effectiveness are key to screening your prototypes and assessing risk prior to large-scale production.
In addition to the in vitro toxicology assays listed above, we offer the following to help you acquire vital data prior to regulatory testing:
ToxTracker® Suite of Genotoxicity Assays
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- Stem cell-based reporter assays that provide information on a sample’s mode-of-action (MOA), helping you assess the genotoxic potential of a new formulation and make better risk assessments.
- Unsurpassed sensitivity (95%) and specificity (94%).
- Excellent predictor for regulatory in vivo genotoxicity assays.
- Rapid and cost effective.
- Validated and application under review with OECD.
ToxTracker:
Six fluorescent reporter cell lines in a single assay; activation of the reporters can indicate DNA damage, protein damage, or oxidative stress.
ToxTracker AO
Capable of identifying genotoxic effects that are indirectly caused by oxidative stress.
ToxTracker ACE
Different fluorescent reporter cell lines with extensive cell cycle analysis and polyploids analysis to differentiate between anugenic or clastogenic genotoxins.
Toxicology Assays Coming Soon
2024
- XTT/WST8 Assay
- Cell Transformation Assay
2025
- Cell Proliferation
- Mono/Co-cultures
- Lung-on-Chip
- Whole Smoke
Data Integrity for Regulatory Compliance and R&D
Our processes follow rigorous standards and are designed to ensure data integrity. This helps you get accurate, reliable information about your prototypes and when making regulatory submissions.
Extensive quality management system
that governs our infrastructure, IT systems, and SOPs
ISO 17025 Accredited
21 CFR Part 58 (Good Laboratory Practices)
OECD GLP Adherence
Working toward recertification in 2024
Submissions
for Health Canada, U.S. FDA, EU TPD, ANVISA, and other regulatory agencies
How Can Our Toxicology Testing Services Help You?
Complete the form to let us know how our toxicology test lab can help you.