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
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.
OptiSafe™ is a trademark of Lebrun Labs, LLC and used here with permission.
MB Research Labs Goes to NYSCC 2017. Offers Quality In Vitro Testing for Cosmetics.
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.
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.
Cosmetics are required to be safe when consumers use them according to directions in the labeling, or in the customary or expected way.
To ensure the safety of a cosmetic product, manufacturers may conduct cosmetic safety testing.
Cosmetic products and ingredients (except for color additives) do not require FDA approval before being released on the market.
The FDA does not have a list of mandatory tests required for any particular cosmetic product or ingredient. Action can be taken against the manufacturer of a cosmetic on the market if we have reliable
information to show that a cosmetic does not meet the legal requirement for safety.
Color additives are treated differently. Unlike other cosmetic ingredients, color additives (other than coal-tar hair dyes and related materials)
must be approved by the FDA for the specific intended use before they are permitted in cosmetic products.
Your Cosmetic Safety Testing Partner
MB Research has been conducting product safety assessments for the cosmetics, personal care, chemical and pharmaceutical industries for over 40 years and is often sought out by Cosmetics Industry Leaders to ensure the safety their ingredients and aid in the rapid development of products.
We are a leader in the use and development of In Vitro and Alternative Toxicology Tests and continue to introduce new testing methods regularly.
Cosmetic, Beauty and Healthcare product industries are subject to global regulatory requirements such as the EU Cosmetics Directive (76/768/EEC) in response to growing concern over the safety of cosmetic products and their ingredients.
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.
Safety Testing Capabilities for Cosmetics and Personal Care Products
In order to address the need for alternative to animal toxicology testing by the cosmetic and personal care products industries, MB Research offers a wide array of in vitro toxicology assays used to assure the safety of their products.
Several assays are available for determining the potential of eye and skin irritation. For harsher ingredients, assays are also available for in vitro corrosivity screening. Many of these test methods are based on the use of 3D human tissue constructs that mimic the epithelia layer of skin or the cornea. Some of these 3D tissues are full-thickness that include an endothelial layer of fibroblasts.
Other key test methods include cytotoxicity tests, phototoxicity screening, dermal sensization (skin allergy screening) and genotoxicity(Ames).
In Vitro Toxicology Testing for Personal Care and Cosmetic Products. MB Research Labs offers a wide variety of in vitro and alternative toxicology assays to ensure the safety of the ingredients used in personal care and cosmetic products.