In Vitro Toxicology
Overview
Our team of scientists has a robust understanding of both tobacco products and toxicological sciences. 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.
TOBACCO PRODUCTS, TOBACCO CIGARETTE SMOKE CONDENSATE (CSC), AND ENDS E-LIQUID & AEROSOL
Enthalpy Specialty Labs is the largest independent tobacco, smoke and e-vapor testing lab in the U.S. offering regulatory and research services to commercial, governmental, academic and regulatory agencies since 2000. We are an International Organization for Standardization (ISO)-17025 accredited lab offering comprehensive and exhaustive analysis of cigarette smoke, filler, smokeless tobacco, e-liquid, ENDS aerosol, and pouches in vitro testing (artificial saliva extractions). We also offer toxicological product stability testing.
REGULATORY IN VITRO TOXICOLOGY TESTING
- Mutagenicity (Ames test (OECD TG471))
- Genotoxicity (In vitro Micronucleus assay (OECD TG487))
- Cytotoxicity (Neutral Red Uptake assay (OCED TG129))
We are continually expanding our testing capabilities. Other assays include in vitro Micronucleus assay by flow cytometry (upcoming) and assays using animal or human cell lines.
| ASSAY | CELL LINE & ASSAY TYPE | E-LIQUID | ENDS CONDENSATE | CIGARETTE CONDENSATE | SMOKE / AEROSOL |
|---|---|---|---|---|---|
| AMES-GLP | Bacterial strains (TA97a, TA98, TA100, TA102, TA1535, TA1537) | X | X | X | |
| AMES-non-GLP | Bacterial strains (TA97a, TA98, TA100, TA102, TA1535, TA1537) | X | X | X | |
| Vitrocell® AMES | Bacterial strains (TA97a, TA98, TA100, TA102, TA1535, TA1537) | X | |||
| NRU-GLP | Balb/c 3T3 fibroblasts, A549 human lung, CHO-K1 cell lines | X | X | X | |
| NRU-non-GLP | Balb/c 3T3 fibroblasts, A549 human lung, CHO-K1 cell lines | X | X | X | |
| Vitrocell® NRU | A549 human lung cell line | X | |||
| MN-GLP | TK-6 human lymphoblast cell line | X | X | X | |
| MN-non-GLP | TK-6 human lymphoblast cell line | X | X | X | |
| Vitrocell® MN | V79 hamster cell line | X |
Enthalpy provides in vitro toxicology testing of tobacco products, tobacco cigarette smoke condensate (CSC), and Electronic Nicotine Delivery Systems (ENDS) products (e-liquid and aerosol) and fulfills the requirements of:
- Health Canada,
- GLP (21 CFR Part 58),
- OECD testing guideline recommendations for FDA PMTA, MRTP, and SE applications.
Our clients benefit from both the quality of our testing and client-focused service including responsive turnaround, best-in-class testing support, innovative science, regulatory expertise and high quality data.
TESTING IN SUPPORT OF IN VITRO TOXICOLOGY
We have a well-equipped smoke/aerosol testing lab offering high throughput testing of various physical phases of tobacco and e-vapor products using a variety of smoke and aerosol trapping and collection methods (Electrostatic precipitation, Pad/Impinger Collection in DMSO, Ethanol, etc.) using ISO, Canadian Intense, and various custom vapor regimes.
VITROCELL® AEROSOL EXPOSURE SYSTEM
Enthalpy Specialty Labs also has the capability to perform toxicology testing using Vitrocell® technology where cells are exposed directly to the smoke or aerosol. We have a specific in-line Vitrocell® exposure system dedicated for ENDS aerosol testing and a separate one for cigarette smoke.
We look forward to speaking with you about how Enthalpy can make the difference for your next project. Please Contact Us for more information.