As Regulators begin to initiate laws and regulations that require the reduction of using live animals for safety studies, more and more companies are looking for valid substitutes that are economical and thorough.
Since the late 1980s, MB Research has been a pioneer in the used and development of in vitro & alternative test methods, reducing the use of live animals in toxicological research.
What are the 3 Rs?
The principle of the 3Rs was first mentioned by William Russell and Rex Burch in 1959. In their book “The Principles of Humane Experimental Technique”, they classified humane techniques under the headings Refinement, Reduction, and Replacement, commonly known now as the 3Rs.
MB Research Laboratories prides itself on pursuing in vitro and alternative toxicological methods that Reduce, Refine and Replace the use of animals in laboratory research and has worked with many leaders in this field to advance the development, validation and regulatory acceptance of in vitro and alternative tests with a goal on replacing laboratory animals in toxicological research.
Hazardous shipping labels can be complex. There are kits that can be purchased that can satisfy regulatory requirements, but getting a kit alone does not provide they well-being you get when the test is performed by an experienced laboratory with a excellent quality assurance follow up and an acutal report.
Weigh of Evidence (WoE) testing with in vitro test methods is now being accepted by European chemical agencies to satisfy REACH requirements. This is especially helpful when specific regulatory guidelines require complex safety testing but no validated in vitro test or alternative assay exists.
WoE must be accompanied with substantial background data to aid in acceptance of our provided safety data. GLPs are a must.
MB Research Labs offers many in vitro test methods that are directly in-line with some regulatory testing requirements as well as novel in vitro test that have not been accepted yet but can still provide a strong case for safety assessments.
Topical application is the main route of skin toxicity, whether it is an intentional or unintentional exposure. Also, many consumer products and cosmetics are applied directly on the skin.
Skin irritation is the production of reversible damage to the skin following application of a test material for up to 4 hours. Signs of skin irritation are erythema or redness, edema or swelling as a result of the test material penetrating the stratified layers of the epidermis.
Skin corrosion is the production of irreversible damage to the skin following application of a test material for up to 4 hours. Signs are necrosis throughout the epidermis and dermis layers of the skin.
Skin sensitization is the induction of an allergic reaction in response to exposure to a test material.
Phototoxicity is a toxic response from a test material applied to the body which is ether elicited or increased after subsequent exposure to light, or that is induced by skin irradiation after systemic administration of a test material.
MB Research Labs has an extensive capabilities list with in vitro assays targeting this areas of skin toxicity. We are able to utilize 3D tissue cultures and cell culture techniques to assess the safety of your test material for skin toxicity.
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is a United States federal law that outlines the basic U.S. pesticide regulation to protect applicators, consumers, and the environment. FIFRA is administered and regulated by the United States Environmental Protection Agency (EPA) and the appropriate state environmental agencies.
MB Research Labs is a GLP Contract Research Laboratory with over 40 years of regulatory toxicology testing experience. With standard and custom protocols, MB Research can assist you with your testing needs for product registration with the EPA. In vivo and In vitro toxicology tests are available.
Pan-American Conference for Alternative Methods (PACAM), April 12-14, 2016, hosted by Johns Hopkins University
MB Research Labs will be attending the PACAM conference. The PACAM brings together experts and stakeholders from across the Americas, with a focus on the Six Rs: Replacement, Reduction, Refinement, Read-across, Relevance, and Roadmaps.
MB Research Labs is serving on the organizing committee. MB Research Chief Scientific Officer, Dr. George DeGeorge and Director of Toxicology, Bennett Varsho, will be presenting informative talks on in vitro toxicology methods: the In Vitro Sensitization Assay (IVSA) and the Human Cell Line Activation Test (h-CLAT) as well as presenting scientific posters.
MB Research Labs, a contract toxicology laboratory, will be presenting a trade show booth at the NYSCC Supplier’s Day in Edison, NJ. We specialize in alternative and in vitro toxicology testing of cosmetics and cosmetic ingredients.
If your looking for eye and skin irritation testing…..we are your lab.
We offer many helpful and cost-effective tests that can aid in formulation and screening of your products.
MB Research provides an extensive array of testing protocols that will help meet your regulatory requirements to ensure safe use of your products.
Rely on our experience in the classification of your fast moving consumer goods using both in vivo and in vitro testing models.
Health, Home, and Hygiene
Liquid and Hand soaps
Household and Industrial Cleansers
In Vivo Toxicology Testing (CPSC, FDA, EPA, OECD, OCSPP)
Acute EPA and OECD Toxicology Testing
Dermal Irritation and Contact Sensitization Studies
Oral and Inhalation Studies
Subchronic & Chronic Toxicology Testing
Mucosal Irritation Studies
Subchronic and chronic toxicology studies are conducted at MB Research and are individually designed for the sponsor in order to comply with specific regulatory requirements and intended use of the test substance. Studies are performed by highly trained and qualified personnel and closely supervised by a Senior Toxicologist at every phase.
Pathological requirements related to studies are under the direction of a Board Certified Veterinary Pathologist.
SOT 55th Annual Meeting, New Orleans, LA, USA. March 13 – 17
Back to New Orleans! This year the annual Society of Toxicology meeting and ToxExpo will be back in the Big Easy…….It will be fun & exciting….as well as informative! Hope to see ya there! Visit us at our Booth #1538.
MB Research Labs will be presenting the following posters on the development of in vitro toxicology test methods and a special inhalation study.
Whole-Body Exposure Methodology to Assess Acute Inhalation Toxicity of OC-Containing Smoke
B. Varsho1, J. Kapeles2, E. Delacruz1, G. DeGeorge1.
MB Research Laboratories, Spinnerstown, PA, United States
Safariland Group, Casper, WY, United States
Oleoresin Capsicum (OC) is an oily resin found in cayenne and other varieties of peppers and is used in law enforcement as a debilitating irritant and inflammatory agent. Although traditionally delivered as a liquid aerosol (“Pepper Spray”), combusted OC carried in smoke from pyrotechnic devices has also proven effective. The short-term inhalation toxicity of OC-containing smoke was assessed using whole-body inhalation exposure methodology. Five male and five female Crl:SD(CD) rats were exposed at a total smoke concentration of 19.4 mg/l for five minutes. Particle size of the smoke was determined using cascade impaction; the mass median aerodynamic diameter (MMAD) was 1.9 µm. The concentration of the total smoke was determined by gravimetric technique, and the corresponding OC concentration in air was calculated based on the fraction of the combusted product containing OC. Animals were observed throughout exposure and daily for 14 days afterward. Body weights were collected on Study Days 0, 7 and 14. Early in the exposure period, all rats displayed avoidant behaviors such as efforts to escape the enclosures within the exposure chamber. By the end of the exposure period, all animals were lethargic, but regained normal activity levels after removal from the chamber and being washed free of smoke residue. All rats displayed no adverse signs at three hours post-exposure. All animals gained weight during the study, and survived to the scheduled necropsy.
Update on the Society of Toxicology – Colgate Palmolive Grant for Alternative Research: In Vitro Co-Culture Assay for Identification of Dermal Sensitizers.
Matthew J. Troese, Lisa Pratt, George L. DeGeorge
MB Research Laboratories, Spinnerstown, PA
This research project combined a 3D reconstructed human epidermal (RHE) tissue that is co-cultured with human plasmacytoid Dendritic Cells (pDCs) for use as an in vitro CoCulture dermal sensitization assay. In this assay, RHE tissues were placed at the air-liquid interface above a media suspension of pDC. The tissues are then exposed to test materials, and after 4 hours of incubation together, the RHE tissues and pDC were separately cultured for an additional 20 hours. The RHE media was analyzed for IL-18 release by ELISA, and the pDC were analyzed for changes in CD86 surface expression by flow cytometry. Two non-sensitizing irritants (Lactic Acid and Phenol), along with two weak/moderate sensitizers: Eugenol and Hexylcinnamaldehyde, and two strong sensitizers: 1-Chloro-2,4-Dinitrobenzene and 4-Nitrobenzyl Bromide were assayed. A positive response from the RHE tissues was determined to be a 2-fold increase in IL-18 secretion, and a 1.5 fold increase in CD86 expression on pDC. Tissue viability was measured using the MTT assay. The responses we obtained in both the RHE tissue versus pDC were very consistent. Increases in both secretion of IL-18 and expression of CD86 were detected after exposure to dermal sensitizers. A prediction model was developed in which a sensitizer result for a chemical is defined as either a positive result in the RHE tissue (IL-18) or a positive result in pDCs (CD86). From three individual experiments, and using a 2×2 contingency table to determine Cooper statistics, we obtained an Accuracy of 100%, 83%, and 83% (89% mean Accuracy). All four of four sensitizers were positively predicted in each experiment (100% Sensitivity). This research was funded by the Society of Toxicology Grant for Alternatives Research (sponsored by Colgate-Palmolive).