Visit MB Research Labs in San Antonio, Texas Mar 11th-15th, 2018 for the SOT 57th Annual Meeting and ToxExpo.
Come on by Booth #550 to get the latest on In Vitro/Alternative Toxicology Testing and Research performed at MB Research Labs.
http://www.mbresearch.com #mbresearch #invitrotox
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.
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.
For more info on in vitro and alternative toxicology methods, please see: www.mbresearch.com.
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.
#mbresearch #invitrotox
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™ 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.
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.
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™.
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.
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.
IdentityThe name under which the article will be tested Include CAS number, lot or batch, if applicable
CompositionThe list of ingredients making up the test article
StrengthThe stated concentration of an active ingredient in a test article mixture
PurityThe fraction that is the active ingredient (relative to impurities), usually expressed as a percent
StabilityThe duration for which the test article will remain undegraded under the storage conditions provided
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.
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.
Please select GLP, GMP, or non-GLP/non-GMP on the Sponsor Request section of the protocol.
Yes – The study will be in complete GLP compliance. No further action is necessary.
No – Refer to the GLP Compliance section below.
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.
MB specializes in in vitro toxicology testing and development of alternatives to animal models for toxicological assessments.
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.
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.
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.
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.
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.
To determine the sensitizing potential of topically applied test material utilizing the LLNA, and measurement of lymphocyte proliferation by BrdU incorporation detected by ELISA.
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.
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.
For more information about this and other studies, please see: www.mbresearch.com