On Sep. 28,2018, California Governor Jerry Brown signed the California Cruelty-Free Cosmetics Act (California SB-1249), a bill banning the sale of cosmetics that undergo animal testing, making California the first state to approve such a ban.
The California Cruelty-Free Cosmetics Act makes it unlawful for cosmetic manufacturers to sell any cosmetic in California if the final product or any component of the product was tested on animals and goes into effect Jan. 1, 2020.
Products that have undergone testing on animals before that date can still be sold in California. Earlier in the month, the bill passed the state legislature after it was narrowed in scope.
Are You Ready With In Vitro Testing?
I Love In Vitro Toxicology
MB Research Labs is positioned to help manufacturers with a suite of in vitro and alternative (non-animal) tests for cosmetic safety testing. MB has over 45 years of toxicology testing experience and over 25 years of testing using non-animal test methods.
The Organization for Economic Co-Operation and Development (OECD) has prescribed the use of a weight-of-evidence (WoE) analysis, integrated with a sequential testing strategy, for the classification of acute eye hazards. The October 2017 revision to the Health Effects Test Guideline No. 405 outlines a stepwise strategy that includes Step 6, “Perform validated and accepted in vitro or ex vivo ocular test(s),” specifying only four possible tests: three designed to identify severe eye irritation/ corrosion (GHS Category 1) and one to identify non-irritants (GHS No Category), the top-down and bottom-up approaches, respectively. The GHS Category 2 (eye irritant) classification is impossible by any one bottom-up or top-down test.
Dual Assays
The EpiOcular™ Eye Irritation Test; EIT (OECD 492), as a bottom-up test, either determines a material to be No Category, or that it causes eye effects, but cannot discriminate between eye irritation, serious eye damage, and corrosion.
Conversely, the top-down Bovine Corneal Opacity and Permeability; BCOP Test (OECD 437), is used for ruling in or ruling out Category 1 effects (serious eye damage/corrosion). By using a dual-assay/approach system – the combination of the EIT and BCOP test – we have determined, with a high degree of accuracy, GHS Acute Eye Hazard Category 2 chemicals that cause reversible irritation to the eye.
Double Elimination
A Double Elimination occurs when a BCOP test rules out GHS Category 1 (severe irritation/corrosion) and the EIT rules out GHS No Category (non-irritant), analysis of the combined results concludes the only other possible designation – Category 2 (irritant). The classification defaults to Category 2A for labeling and handling purposes because at present differentiation between category 2A and 2B cannot be made. Using this approach, we correctly identified 87% of the Category 2A/B chemicals as Category 2 after testing 42 chemicals (nine, 15, and 18 in Category 1, 2A/B, and No Category, respectively).
As a result of this analysis, we are encouraged by the potential of the BCOP-EIT dual-assay system, coupled with WoE evaluation, to correctly assign unknowns into GHS Category 1, Category 2A, and No Category Acute Eye Hazards without the use of less predictive and more expensive in vitro tests. Moreover, in keeping with the OECD’s recommendations, we predict that such a system would greatly reduce reliance on the Draize Rabbit Eye Tests.
MB Research offers Quality In Vitro Testing for Cosmetics.
Visit MB Research @ Booth#1549 for the latest on In Vitro Cosmetic Safety Testing
New York Society of Cosmetic Chemists Supplier’s Day
May 15-16, 2018, 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.
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
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
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.
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.
5 Key Points of Test Article Characterization (TAC)
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.
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.
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.
OptiSafe™
