The eyes are one of the most vulnerable parts of our body. They can be exposed to cosmetics and their ingredients through use of products directly (mascaras, eye creams) or accidentally (which may enter the eye). The evaluation of eye irritation potential for a cosmetic product and its ingredients is essential to ensure that the product is safe for consumers to use through intended and foreseeable uses and accidental exposures to the eye.
Based on the mechanism of eye irritation in vivo, many alternative methods have been developed. It is generally believed that a single in vitro test method cannot cover the criteria for damage and inflammation addressed by the regulatory adopted in vivo animal test method (the in vivo rabbit eye test-Draize test OECD TG 405). Therefore, it is recommended to use a testing strategy that combines the advantages of individual in vitro testing methods to address the required ranges of irritation potential and/or chemical classes.
Creative Bioarray can help you design the best testing strategy for the eye irritation and/or damage classification of your products, allowing you to save time and resources. Based on the mechanism of corneal injury, combined with the principles of in vitro methods and the degree of standardized application, we provide customers with the most professional eye irritation test program according to the different needs of customers.
Bovine Corneal Opacity and Permeability (BCOP) Assay
- Uses excised bovine corneas normally discarded
- Corneal swelling, opacity and fluorescein retention are measured
- Optional histopathology can be conducted for additional information
- Applicable to solids, liquids (including semi-solids, creams, and waxes), and mixtures
Chorioallantoic Membrane Vascular Assay (CAMVA)
- Uses fertilized chicken eggs on embryonic day 10 or 14 of development
- Hemorrhaging, capillary injection and/or ghost vessels are measured
- Especially useful for alcohol-containing formulations
Reconstructed Human Cornea-Like Epithelium (RhCE) Test
- Uses human cells to form a stratified, highly differentiated squamous epithelium morphologically similar to that found in the human cornea
- Cellular metabolic rate (MTT or WST-8 assay) is measured
- For the identification of substances not requiring classification and labelling for eye irritation or serious eye damage
- Applicable to solids, semi-solids, liquids, and waxes
Fluorescein Leakage (FL) Test
- Madin-Darby Canine Kidney (MDCK) cells are cultured on permeable inserts.
- The amount of dye passing through the cell layer is measured by fluorescence spectroscopy.
- For the identification of substances causing serious eye damage.
- Applicable to water-soluble chemicals or mixtures. Limitations for colored or highly viscous substances (predictivity is improved by increasing the number of washing steps). Not applicable to strong acids and bases, cell fixatives, or highly volatile substances.
In Vitro Macromolecular Test
- The test is an in chemico macromolecular matrix model composed of lipids, proteins, glycoproteins, carbohydrates, and low molecular weight substances that model the cellular components of the cornea.
- An increase in optical density is measured.
- For the identification of substances causing serious eye damage and substances not requiring classification and labelling for eye irritation or serious eye damage.
- Allowing testing of solids and liquids whose 10% solution/dispersion has a pH in the range 4 ≤ pH ≤ 9. Limitations for intensely colored chemicals, chemicals that cause salting-out precipitation, high concentrations of some surfactants, and highly volatile chemicals.
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