10th World Congress on Alternatives and Animal Use in the Life Sciences, Seattle, Washington

In Vitro Toxicology, Not SciFi Anymore
10th World Congress on Alternatives and Animal Use in the Life Sciences

MB Research Labs is honored to be attending the 10th World Congress on Alternatives and Animal Use in the Life Sciences. We will be presenting several posters focusing on the use and development of in vitro and alternative toxicology methods that are used in our laboratories.

Scientific Posters presented by MB Research Labs on the Use and Development of In Vitro and Alternative Toxicology Test Methods

More Information on In Vitro and Alternative Testing….

In Vitro Eye Irritation Testing

In Vitro Eye Irritation Testing-MB Research Labs
In Vitro Eye Irritation Testing- MB Research Labs

In Vitro Eye Irritation Testing

Currently, it is generally accepted that no single in vitro eye irritation test will be able to replace the in vivo Draize eye test
to predict across the entire range of irritation for different chemical classes. Several labs (including MB Research) have been working on strategic combinations of several in vitro and alternative test methods within a (tiered) testing strategy that could replace the Draize Rabbit Eye Test.

Available In Vitro & Alternative Eye Irritation Test Methods

  • OptiSafe™In Vitro Eye Irritation Test
  • 3D Human Ocular Tissue Equivalent Systems – MatTek, EpiSkin
  • HET-CAM – Hen’s Egg Test – Chorioallantoic Membrane (HET-CAM)
  • Bovine Corneal Opacity and Permeability Assay (BCOP)
  • Porcine Cornea Reversibility Assay (PorCORA)
  • Chorioallantoic Membrane Vascular Assay (CAMVA)
  • Replacement Ocular Battery (ROBatt)
  • Keratinocyte/Fibroblast Viability Assay (Neutral Red or MTT)
  • Keratinocyte Proliferation (turnover) Assay

For more info on in vitro and alternative toxicology methods, please see: www.mbresearch.com.

QVC Safety Testing

Consumer Products Safety Testing
QVC Cosmetics and Consumer Products Safety Testing

Need to have a Toxicological Risk Assessment performed for your product before acceptance on QVC?

MB Research offers a wide array of tests available to determine the safety of your cosmetic, personal care or consumer product.  These economic standard in vitro protocols are the perfect set of tests that you may be required to perform.

Contact MB Research Now!

 

OptiSafe – Non-animal Ocular Irritation Test

OptiSafe™ – Non-animal Ocular Irritation Test 

OptiSafe Eye Irritation TestingOptiSafe™ Ocular Irritation Test

MB Research Labs is now offering the new OptiSafe™ – an in vitro test method in which a test substance is applied to a semi-permeable membrane. Damage to macromolecules in the membrane is measured to assess the test substance’s potential to cause eye irritation.

OptiSafe™ Background Information

OptiSafe™ is an acute in vitro irritation test method used to determine the ocular irritation potential based of a test substances utilizing a set of biochemical tests (mostly performed in parallel; “multiplexed”) which evaluate the potential of the test substance ability to disrupt, denature and degrade biological molecules. These measured values are relevant to GHS and EPA standard ocular safety classification systems.

Evaluated Mechanisms of Ocular Injury and Prediction Models

Different ocular irritants including, acids/bases, alcohols/aldehydes/ketones, strong oxidants and reactive chemicals/mixtures, damage the cornea and other tissues through additive and/or synergistic chemical reactions and biophysical effects.

Evaluated mechanisms of injury include:

  • Denaturation of specific water insoluble polymers that model the phospholipid bilayer of cells (which can occur at the corneal epithelium and conjunctiva).
  • Direct denaturation of macromolecules that model ordered collagen (which can occur at the corneal stroma).
  • Indirect denaturation of molecules across a membrane via osmotic effects (osmotic effects across the corneal epithelium and stroma can damage the cornea).
  • Potential to damage tissue via excessive oxidation and reactivity (which can occur at the epithelium, stroma, conjunctiva and iris).
  • Potential to damage tissues via extreme buffering (which can occur at the epithelium, stroma, conjunctiva and iris).

NICEATM reviewed a validation study conducted by the OptiSafe™ test method developer, Lebrun Labs, and concluded that the study data indicated that the OptiSafe™ method compared favorably to other in vitroocular toxicity testing methods. NICEATM is currently coordinating a validation study of the OptiSafe™ test method to demonstrate the reproducibility of the method among Lebrun Labs and two naïve laboratories. The study received support from an NIEHS Small Business Innovation Research grant. The study is ongoing and is expected to be completed in mid-2018.

MB Research Labs is a primary testing source using OptiSafe™ and has been deeply involved in the validation of OptiSafe™.

Utility of OptiSafe™

OptiSafe™ can be used to determine the irritation potential of cosmetics, creams, and a wide variety of consumer products. Results are presented as GHS, EPA classifications, an ocular irritation score and class.

OptiSafe™ can be used for:

  • Screening Finished Products for Ocular Irritation.
  • Ocular safety testing during product development for knowledge based formulation. (Products that irritate do not last long in the marketplace).

The Advantages of OptiSafe™ include:

  • Accurate Ocular Irritancy Test
  • High Sensitivity for Mild and Moderate Irritants
  • Fast Results
  • 1 year shelf life
  • Neither uses nor harms animals

MB Research Labs performs many other in vitro eye and dermal irritation tests for screening of cosmetics, consumer products, pharmaceuticals and chemicals.

www.mbresearch.com

OptiSafe™ is a trademark of Lebrun Labs, LLC and used here with permission.

Test Article Characterization – A GLP Requirement

5 Key Points of Test Article Characterization (TAC)

Test Article Characterization
Good Laboratory Practices (GLP)

Identity

The name under which the article will be tested Include CAS number, lot or batch, if applicable

Composition

The list of ingredients making up the test article

Strength

The stated concentration of an active ingredient in a test article mixture

Purity

The fraction that is the active ingredient (relative to impurities), usually expressed as a percent

Stability

The duration for which the test article will remain undegraded under the storage conditions provided

Why is Test Article Characterization (TAC) necessary?

When a study is conducted according to the Good Laboratory Practices regulations (GLPs), providing characterization of the material to be tested (the test article) to the Testing Facility (MB Research) is required.

Do you have characterization of the test article (e.g., Certificate of Analysis, or similar)?

Yes – Please provide this to MB Research prior to study initiation (signing the protocol, beginning the experiment).

No –Select ‘no test article characterization’ on the Sponsor Request section of the MB Research protocol. No further action is necessary. Refer to the GLP Compliance section below.

If yes, was test article characterization/analysis performed according to Good Laboratory Practices (GLPs), Good Manufacturing Procedures (GMPs), or neither*?

 Please select GLP, GMP, or non-GLP/non-GMP on the Sponsor Request section of the protocol.

Does your TAC include all five of the following GLP-required parameters?

Yes – The study will be in complete GLP compliance. No further action is necessary.

No – Refer to the GLP Compliance section below.

Good Laboratory Practices (GLP) Compliance 


A GLP compliance exception statement appears in the study report when TAC –

(1) is not provided

(2) is not provided prior to study initiation (signing the protocol)

(3) does not include all five of the parameters, and/or

(4) is not performed according to GLPs

MB Research Labs is a contract GLP toxicology lab with over 45yrs of experience in chemical, consumer product and cosmetic safety assessment.

www.mbresearch.com

MB specializes in in vitro toxicology testing and development of alternatives to animal models for toxicological assessments.

 

 

Pharmaceutical Toxicology Testing – MB Research Labs

Pharmaceutical Toxicology Testing
Pharmaceutical Toxicology Testing

Your Trusted Toxicology Testing Partner

We have the Experience.

Since 1972, MB Research Labs is a GLP contract research organization (CRO) that has been performing toxicology (acute, subchronic / chronic) and pharmacology studies for leaders in the pharmaceutical, biotechnology, medical device and agrochemical industries and government agencies.
With a wide range of testing protocols available, MB Research Labs offers comprehensive capabilities to to address your unique needs and goals with speed and accuracy.
Our expertise in many areas of in vivo and in vitro testing, research, and safety evaluations is the foundation upon how MB Research serves the pharmaceutical toxicology testing needs of both government and industry.

Complete support services including consultation, protocol development, quality assurance, analytical chemistry and archive facilities are integral components of studies performed at MB.
Our technical and support procedures are in full compliance with OECD, FDA, and EPA.

Related Toxicology Testing

EPA-OCSPP Testing

  • MB offers GLP Toxicology Testing for pesticides and chemicals.
  • Extensive list of Protocols Available
  • Discount Pricing

Photo-Toxicology

  • In Vitro 3T3 Neutral Red Uptake Phototoxicity Test
  • Monolayer & 3D Tissue Models
  • OECD 432 protocol

In Vitro Toxicology

  • Your Source for In Vitro & Alternatives to Animal Testing.
  • Cost Saving Screening Testing
  • Cosmetics & Personal Care Testing

MB Research Labs is a leader in the use and development of
in vitro and alternative toxicology test methods. We specialize in protocols for Eye and Skin Irritation, Corrosivity, Skin Sensitization, Genotoxicity, and Phototoxicity.

For more info about MB Research.

Chemical Toxicology Testing for Geeks

We Love Chemistry, How About You?

Chemical Toxicology Testing
Chemical Toxicology Testing

Chemical Toxicology Testing Overview

  • Over 45 Yrs Experience. MB Research Labs has been a primary provider of chemical safety testing services to the chemical and consumer products industries.
  • MB Research has been accredited by AAALAC International, a private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs since 1975.
  • Over 50,000 toxicigical studies performed – Extensive expertise in conducting in vivo toxicology
  • Standardized GLP Protocols available for skin and eye irritation, oral and dermal toxicity, dermal sensitization assays and phototoxicity.

Toxicology Testing Experience You Are Looking For.

With a wide range of in vivo and in vitro test protocols available, MB Research Labs offers comprehensive capabilities to address your unique needs and goals.

MB has decades of expertise in many areas of in vivo and in vitro
testing, research, and safety evaluations, MB Research serves the testing needs of both government and industry.  Our complete support services including consultation, protocol development, quality assurance, analytical chemistry and archive facilities are integral components of studies performed at MB.  Our technical and support procedures are in full compliance with OECD, FDA, and EPA.

Chemical toxicology studies are routinely performed on a wide variety of compounds. The selection of specific studies to be conducted is based on the intended use of the compound and the applicable regulatory requirements. Protocols for the most commonly implemented regulatory studies are available upon request.

Related Links

In Vitro Cosmetic Safety Testing – NYSCC 2017

MB Research Labs Goes to NYSCC 2017. Offers Quality In Vitro Testing for Cosmetics.

MB Research Labs Goes to NYSCC 2017
MB Research Goes to NYSCC 2017

Visit MB Research @ Booth#1440 for the latest on In Vitro Cosmetic Safety Testing
New York Society of Cosmetic Chemists Supplier’s Day
May 2-3, 2017, Jacob Javits Convention Center, New York, NY

MB Research Labs is a leader in the use and development of
in vitro and alternative toxicology test methods. We specialize in protocols for Eye and Skin Irritation, Corrosivity, Skin Sensitization, Genotoxicity, and Phototoxicity.

For more info about MB Research.

Alternative Toxicology Testing – Local Lymph Node Assay (BrdU ELISA)

Local Lymph Node Assay BrdU ELISA (LLNA-BrdU ELISA)

The LLNA-BrdU ELISA is conducted at MB Research Labs and is based upon the OECD 442B Testing Guideline.  The LLNA is an alternative toxicology assay for dermal sensitization using CBA/J mice.  The LLNA is an alternative to guinea pig studies that require more animals and long test durations.

LLNA-BrdU ELISA
LLNA-BrdU ELISA

Assay Principle:

To determine the sensitizing potential of topically applied test material utilizing the LLNA, and measurement of lymphocyte proliferation by BrdU incorporation detected by ELISA.

Irritation Screen Test:

An initial Irritation Screen is performed using 3-5 highest achievable  concentrations. The screen consists of 2 animals per concentration that will be dosed in an identical manner to that of the main test. Ear measurements will be taken prior to dosing on Study Days 1 and 3, and prior to euthanasia on Study Day 6.  Measurements taken on Study Days 3 and 6 will be compared to pre- dosing measurements. If there is no effect, or an increase of <25% in ear thickness, the same concentrations will be assayed in definitive test.

However, if significant ear swelling (ES) is present (>25% over control), then an extended screen (Quantitative Irritation Test; QIT) is recommended. The QIT is similar to the Irritation Screen except 4-6 concentrations will be assayed to determine the highest non-irritating concentration.

Definitive Sensitization Test:

The main test will be conducted by topically applying test material to the dorsum of the ears at the 3-5 highest achievable concentrations (100 [liquid only], 50, 25, 10, 5, 2.5, 1, 0.5, etc.), which do not cause severe irritation or overt systemic effects.  Ear measurements will be taken on Study Days 1 (prior to first dosing), 3 (approximately 48 hours after initial dosing) and 6 (prior to euthanasia). Animals will be injected with BrdU on Study Day 5, approximately 24 hours prior to euthanasia. Auricular lymph nodes will be collected on Study Day 6, a single-cell suspension will be created and lymph node cells (LNC) will be assayed for BrdU incorporation via ELISA.

Assay Interpretation:

  • A Positive Response is when a Stimulation Index (SI) is greater than or equal to 1.6 (relative to that of control lymph nodes).
  • A “Borderline Positive Response” is defined as an SI from 1.6 to 1.9; additional information and testing may be needed.
  • A Negative Response is when the SI is <1.6.

For more information about this and other studies, please see:  www.mbresearch.com

56th Society of Toxicology Annual Meeting 2017 – Baltimore, MD – MB Research Labs

MB Research Goes to Baltimore 2017 SOT
56th Annual Meeting – Society of Toxicology

SOT 2017 MB Research Informational Page

MB Research Goes to Baltimore – Society of Toxicology 2017

 

Join Us at the 56th Annual Meeting of the Society of Toxicology and ToxExpo , Baltimore, Maryland, March 12-16, 2017

Stop by Booth#: 2469 and meet some of our Study Directors and Client Services.

Scientific Posters:

The h-CLAT for Assessment of Dermal Sensitization Potency of the OECD Proficiency Chemicals and of Commercially Available Mixtures

Wed 1:15pm-4:30pm. Session: Alternatives to Mammalian Models I, Abstract 2748, Poster Board P116

Further Evaluation of Chemicals and Mixtures for Skin Sensitization Potential and Potency Using a Reconstructed Human Epithelium (RhE) Tissue Model and the IVSA.

Wed 1:15pm to 4:30pm. Session: Autoimmunity/Hypersensitivity, Abstract 2957, Poster Board P508

Historical Performance of Weak Sensitizers in Different Animal Models.

Tues 9:30am-12:45am. Session: Non-Phamaceutical Safety Assessment, Abstract 1873, Poster Board P449

Resolving Corrosive/Severe Irritant Ocular Classifications using an Alternative Dual Ex Vivo Assay System.

Wed 1:15pm-4:30pm. Session: Alternatives to Mammalian Models I, Abstract 2761, Poster Board P129