OptiSafe™

Non-Animal Ocular Irritation Test

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OptiSafe™ Test Method

OptiSafe™ is an in vitro screening 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.

Utility of OptiSafe™

OptiSafe™ can be used to determine the irritation potential of cosmetics, creams, and a wide variety of consumer products. According to the kit manufacturer, results can be 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

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 vitro ocular 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™.

45yrs Experience in Toxicology Testing

Your Trusted in vitro Toxicity Testing Partner.

Call for Quote or for more information about your in vitro toxicity testing needs:US 1-215-536-4110 Or Contact MB.

EPA-OCSPP Testing

  • GLP Toxicity Testing for pesticides and chemicals.
  • Extensive list of Protocols Available
  • Discount Pricing
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Phototoxicity Testing

  • in vitro 3T3 Neutral Red Uptake Phototoxicity Test
  • Monolayer & 3D Tissue Models
  • OECD 432 protocol
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in vitro Toxicology

  • Your Expert Source for in vitro & Alternatives Toxicology Testing.
  • Cost Saving Screening Testing
  • Cosmetics & Personal Care Testing
LEARN MORE

In Vitro/Alternative Ocular Irritation Assays

MB Research Labs conducts Good Laboratory Practice (GLP) compliant in vitro toxicology assays as well as low-cost screening studies for clients in the cosmetic, consumer product, chemical, biotech and pharmaceutical industries.

Three Dimensional Human Ocular Tissue Equivalent Systems

  • MatTek EpiOcular™, SkinEthic corneocyte models
  • These models mimic characteristics of the epithelium of the eye
  • Unique properties of 3D models allow test articles to be applied topically, allowing testing of solids, organics, and insoluble materials

Bovine Corneal Opacity and Permeability Assay (BCOP)

  • Draize Rabbit Eye Test Alternative
  • Uses excised bovine corneas normally discarded
  • Measures two endpoints; 1) changes in opacity, reflecting protein denaturation and corneal injury, and 2) fluorescent dye permeability reflecting damage to corneal epithelium
  • Optional histological endpoint is available (H & E staining)
  • Measurement of pro-inflammatory mediators in liberated corneal cells (by flow cytometry or ELISA)
  • See ROBatt- proposed tiered testing strategy for Draize Rabbit Eye Test Replacement.

Hen's Egg Test-Chorioallantoic Membrane (HET-CAM)

  • Draize Rabbit Eye Test Alternative
  • Uses fertilized chicken eggs on embryonic day 10 or 14 of development
  • Measures hemodynamic effects, injury, and anti-angiogenic effects to the membrane microvasculature
  • Especially useful for alcohol-containing formulations

Chorioallantoic Membrane Vascular Assay (CAMVA)

  • Uses fertilized chicken eggs on embryonic day 10 or 14 of development
  • Measures hemodynamic effects, injury, and anti-angiogenic effects to the membrane microvasculature
  • Especially useful for alcohol-containing formulations
  • See ROBatt- proposed tiered testing strategy for Draize Rabbit Eye Test Replacement.

Porcine Cornea Reversibility Assay (PorCORA)

  • Draize Ocular Irritation Alternative
  • Measures recovery of corneal epitheilum after topical dosing to discriminate between severe irritation or ocular corrosivity
  • See ROBatt- proposed tiered testing strategy for Draize Rabbit Eye Test Replacement.

Replacement Ocular Battery (ROBatt)

  • Tiered Testing Strategy aimed to replace Draize Rabbit Eye Test
  • Uses suite of ocular irritation alternative test methods to effectively screen test materials and classify them in accordance to existing regulatory classes (GHS, EPA, EU)
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