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.
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.
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.