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OptiSafe – Non-animal Ocular Irritation Test

OptiSafe™ – Non-animal Ocular Irritation Test

OptiSafe Eye Irritation Testing OptiSafe™ 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)

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

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 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.

In Vitro Cosmetic Safety Testing – NYSCC 2017

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

Cosmetic Safety Testing - 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

Your Cosmetic Safety Testing Experts.

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.

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

Toxicology Testing Services – Your Expert Toxicologist

Your Expert Source for Acute Toxicology Testing

Over 45 Years of Toxicology Testing – Chemicals, Pharmaceuticals, Cosmetics, Household Products, Personal Care Products

MB Research Laboratories, a GLP contract research Toxicology laboratory, has been conducting acute, subchronic / chronic toxicological and pharmacological studies since 1972. MB Research provides industry-leading general toxicology services for the pharmaceutical, biotechnology, medical device and agrochemical industries and government agencies. Routine and non-traditional toxicology studies are performed, custom testing services to meet specific testing needs is available.

Study Directors and technicians strive to consistently deliver exemplary results to support both Good Laboratory Practices(GLP) and non-GLP Toxicology studies. With a wide range of in vivo and in vitro test protocols available, MB Research Labs offers comprehensive Toxicology Testing capabilities to address your unique needs and goals. With 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.

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.

MB Research Labs

Video Link: Replacing Animal Testing with Cultured Human Cells

Great video on advancement of in vitro alternative testing methods in Europe.

EuroNews Knowledge – Replacing Animal Testing with Cultured Human Cells

MB Research Labs is a leader in the US for development and validation of in vitro alternative test methods that reduce/replace the need for using live animals in product safety testing of consumer products, chemicals, pharmaceuticals and cosmetics.

More information about MB Research Labs and our Toxicology Testing Services….

Phototoxicity Testing Services – 3T3 NRU PT

Phototoxicity / Phototoxicology Testing

MB Research Labs is a leading in vitro toxicology laboratory that offers toxicological testing services to the cosmetic, chemical and pharmaceutical industries.

One of the more important assays offered in the 3T3 Neutral Red Uptake Phototoxicity (3T3 NRU PT) Assay. The 3T3NRUPT is used to screen test materials for the potential of causing photoirritation after exposure to the material and sunlight.

The 3T3 NRU PT was developed and validated in a joint EU/COLIPA project from 1992-1997. In 1996, the 3T3 NRU PT was recommended by OECD as an in vitro approach for the assessment of chemicals phototoxicity potential. In April 2004, the 3T3 NRU PT protocol was finalized and adopted as the OECD 432 protocol, In Vitro 3T3 NRU phototoxicity test.

The 3T3 NRU PT can be utilized to identify the phototoxic effect of a test substance induced by the combination of test substance and light and is based on the comparison of the cytotoxic effect of a test substance when tested after the exposure and in the absence of exposure to a non-cytotoxic dose of UVA/vis light. Cytotoxicity is expressed as a concentration-dependent reduction of the uptake of the vital dye – Neutral Red.

Substances that are phototoxic in vivo after systemic application and distribution to the skin, as well as compounds that could act as phototoxicants after topical application to the skin can be identified by the test. The reliability and relevance of the 3T3 NRU PT have been evaluated and has been shown to be predictive when compared with acute phototoxicity effects in vivo in animals and humans.

For more information about the 3T3 NRU PT and MB Research Labs….