EpiOcular

Development of Sensitive In Vitro Protocols for the Biocompatibility Testing of Medical Devices and Pharmaceuticals Intended for Contact with the Eyes: Acute Irritation and Phototoxicity Assessment

This study introduces a novel in vitro methodology that employs the 3-D reconstructed tissue model, EpiOcular, to assess the irritation and phototoxicity potential of medical devices and drugs in contact with the eye. Our study evaluated diverse test materials, including medical devices, ophthalmological solutions and an experimental drug (cemtirestat), for their potential to cause eye […]

Subcategorization of Eye Irritants Using the EpiOcular Time-to-Toxicity Test

As per OECD TG 405 “Acute Eye Irritation/ Corrosion”, albino rabbits were traditionally used to assess the eye damage/eye irritation of test materials. However, in 2015, OECD TG 492 “Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage” was accepted and validated […]

Determination and Sub-categorization of Ocular Irritants Using the EpiOcular Tissue Model – Prediction Models for Liquids and Solids

Assessment of serious eye damage/eye irritation originally involved the use of laboratory animals (OECD TG 405). In 2015, a new test guideline (OECD TG 492) was accepted which enables the use of an in vitro procedure based on reconstructed human cornea-like epithelium (RhCE) to distinguish between chemicals (substances and mixtures) not requiring classification and those […]

Health safety of parabens evaluated by selected in vitro methods

Seven selected parabens (4 allowed, 3 banned in cosmetics) were tested in order to confirm and expand historical data on their toxicological properties and safety. The aim was to apply novel in vitro methods, which have been sufficiently technically and scientifically validated for the purposes of toxicological testing of chemicals. The study included several toxicological […]

In vitro reconstructed 3D corneal tissue models for ocular toxicology and ophthalmic drug development

Testing of all manufactured products and their ingredients for eye irritation is a regulatory requirement. In the last two decades, the development of alternatives to the in vivo Draize eye irritation test method has substantially advanced due to the improvements in primary cell isolation, cell culture techniques, and media, which have led to improved in […]

In vitro evaluation of immunobiological activity of simple mannolipids

Immunomodulation, cytotoxicity and anti-cancer activity of selected amphiphilic non-ionic (thio)alkyl α-Dmannosides (with aglycone of C6-C12) were investigated in vitro in human cervix epitheloid carcinoma cell line HeLa, murine melanoma cancer cells B16, murine lymphocytic leukemia cell line L1210, murine fibroblast cell line NIH 3 T3 and murine macrophage cell line RAW 264.7. Toxicological studies revealed […]

CON4EI: CONsortium for in vitro Eye Irritation testing strategy – EpiOcular™ time-to-toxicity (EpiOcular ET-50) protocols for hazard identification and labeling of eye irritating chemicals

Assessment of acute eye irritation potential is part of the international regulatory requirements for testing of chemicals. The objective of the CON4EI (CONsortium for in vitro Eye Irritation testing strategy) project was to develop tiered testing strategies for eye irritation assessment for all drivers of classification. A set of 80 reference chemicals (38 liquids and […]

CON4EI: EpiOcular™ Eye Irritation Test (EpiOcular™ EIT) for hazard identification and labeling of eye irritating chemicals

Assessment of the acute eye irritation potential is part of the international regulatory requirements for testing of chemicals. The objective of the CON4EI project was to develop tiered testing strategies for eye irritation assessment. A set of 80 reference chemicals (38 liquids and 42 solids) was tested with eight different methods. Here, the results obtained with the EpiOcular™ […]

Eye irritation testing of nanomaterials using the EpiOcular™ eye irritation test and the bovine corneal opacity and permeability assay

Background: Assessment of eye irritation hazard has long been a core requirement in any chemical legislation. Nevertheless, publications focusing on the eye damaging potential of nanomaterials are scarce. Traditionally, eye irritation testing was performed using rabbits. The OECD Test Guideline 437 Bovine Corneal Opacity and Permeability (BCOP) test method allows determining severely irritating substances without animals, and the […]

IN VITRO APPROACHES FOR PREDICTING IRRITATION POTENTIAL OF TOPICAL EXPOSURES TO THE SKIN AND EYES.

Outline: Focus on topical exposure toxicity measures …Skin ……Corrosion ……Irritation –Chemicals ……Mildness –Formulations …Eye ……Physiology and modes of action –eye irritation ……Human Reconstructed Tissues ………Ingredients ………Mild formulation assessment …BCOP ……Moderate formulation assessment histology Conclusions: Skin Irritation/Corrosion …Validated methods are in place for testing chemicals for corrosion and irritation (EU). …Methods for determining mildness of formulations […]

UPDATE ON VALIDATION STATUS AND INDUSTRY UTILIZATION OF NORMAL HUMAN 3D (NHU-3D) ANIMAL ALTERNATIVE MODELS.

Progress in in vitro tissue engineering over the last several decades has contributed to a significant decrease in animal use for industrial risk and safety assessment of products and ingredients. Mattek Corporation has a long-standing involvement in development, production and validation of animal alternative in vitro models produced from normal human cells (NHu-3D models). The […]

PROGRAM TO REDUCE ANIMAL TESTING FOR EPA REGISTRATIONS OF ANTIMICROBIAL PRODUCTS.

This study by scientists at Proctor & Gamble, S.C. Johnson, the Institute for In Vitro Sciences (IIVS) and The Accord Group, in conjunction with the US EPA, documented how Mattek’s EpiDerm in vitro human skin tissue equivalent and EpiOcular in vitro human corneal tissue equivalent can be used to assess the dermal and eye irritation […]

REGULATORY REQUIREMENTS FOR IN VITRO SYSTEMS TO MEET PERFORMANCE STANDARDS OVER TIME AS WELL AS DURING VALIDATION.

This technical poster by scientists at Mattek Corp. summarized 12-PLUS YEARS (1996-2007) of commercial production QC data for Mattek’s EpiDerm and EpiOcular in vitro human tissue equivalents, and how that data addresses regulatory concerns regarding performance standards of alternative in vitro testing methods over time. In vitro models are being proposed as alternatives to animal […]

HUMANE ENDPOINTS AND ACUTE TOXICITY TESTING.

Evidence of acute toxicity for specific materials was originally provided using large numbers of animals in tests that often resulted in pain, suffering, and/or death to the experimental subjects. Recent research has been directed toward development of alternatives that remove or significantly reduce these effects while providing data indicative of the acute toxicity of the […]

THE Mattek STORY – HOW THE THREE Rs PRINCIPLES LED TO 3-D TISSUE SUCCESS!

FRAME, the UK-based Fund for the Replacement of Animals in Medical Experiments, asked Mattek to contribute an article to a special edition of ATLA, FRAME’s scientific journal, commemorating FRAME’s 40th anniversary. FRAME asked Mattek to focus the article on the successful development of our in vitro 3-D tissues, produced from normal (non-transformed) human cells, as […]

QUALITY ASSURANCE FOR IN VITRO ALTERNATIVE TEST METHODS: QUALITY CONTROL ISSUES IN TEST KIT PRODUCTION.

In vitro toxicology methods are being adopted by regulatory agencies worldwide. Many of these methods have been validated by using proprietary materials, often in the form of test kits. Guidelines for the use of Good Laboratory Practice methods for in vitro methods have been proposed. However, users of the data from these methods also need […]

Preclinical development and ocular biodistribution of gemini-DNA nanoparticles after intravitreal and topical administration: Towards non-invasive glaucoma gene therapy

Gene therapy could offer improvement in the treatment of glaucoma compared to the current standard of lowering intraocular pressure. We have developed and characterized non-viral gemini surfactant-phospholipid nanoparticles (GL-NPs) for intravitreal and topical administration. Optimized GL-NPs (size range 150-180 nm) were biocompatible with rat retinal ganglion (RGC-5) cells with N95% viability by PrestoBlue™assay. GL-NPs carrying […]

OCULAR TOXICITY OF AUTHENTIC LUNAR DUST.

Background: Dust exposure is a well-known occupational hazard for terrestrial workers and astronauts alike and will continue to be a concern as humankind pursues exploration and habitation of objects beyond Earth. Humankind’s limited exploration experience with the Apollo Program indicates that exposure to dust will be unavoidable. Therefore, NASA must assess potential toxicity and recommend […]

COSMETICS EUROPE MULTI-LABORATORY PRE-VALIDATION OF THE EPIOCULAR™ RECONSTITUTED HUMAN TISSUE TEST METHOD FOR THE PREDICTION OF EYE IRRITATION.

Cosmetics Europe, The Personal Care Association (known as Colipa before 2012), conducted a program of  technology transfer andwithin/between laboratory reproducibility of Mattek Corporation’s EpiOcular™  Eye Irritation Test (EIT) as one of the two human reconstructed tissue test methods. This EIT EpiOcular™ used a single exposure period for each chemical and a prediction model based on […]

IN-HOUSE VALIDATION OF THE EPIOCULAR™ EYE IRRITATION TEST AND ITS COMBINATION WITH THE BOVINE CORNEAL OPACITY AND PERMEABILITY TEST FOR THE ASSESSMENT OF OCULAR IRRITATION.

In 2009, the Bovine Corneal Opacity and Permeability (BCOP) test was accepted by the regulatory bodies for the identification of corrosive and severe ocular irritants (Global Harmonised System [GHS] Category 1). However, no in vitro test is currently accepted for the differentiation of ocular irritants (GHS Category 2) and non-irritants (GHS No Category). Human reconstructed […]

PREDICTING EYE IRRITATION OF AGROCHEMICAL FORMULATIONS ACCORDING TO DIFFERENT CLASSIFICATION SCHEMES BY IN VITRO METHODS (BOVINE CORNEAL OPACITY AND PERMEABILITY AND EPIOCULAR EYE IRRITATION TEST).

The bovine corneal opacity and permeability (BCOP) test has been adopted by OECD for the identification of corrosive and severe ocular irritants (GHS category 1) for single component substances and multicomponent formulations. Eye irritation tests with human (EIT) reconstructed tissue models (such as EpiOcular) are capable to predict ocular non‐irritants (GHS no category). Thus the […]

SAFETY TESTING OF REMERGENT™ SKINCARE PRODUCTS.

Remergent products are manufactured by AGI Dermatics under rigorous quality control procedures to ensure safety. Testing begins with the important functional ingredients, which are subjected to the most stringent tests in the industry. The finished Remergent products were subjected to safety testing by two in vitro tests to screen for dermal and ocular irritancy, and […]

STUDIES OF BYSTANDER EFFECTS IN ARTIFICIAL HUMAN 3D TISSUE SYSTEMS USING A MICROBEAM IRRADIATION.

According to the target theory of radiation-induced effects (1), a central tenet of radiation biology, DNA damage occurs during or very shortly after irradiation of the nuclei in targeted cells, and the potential for biological consequences can be expressed within one or two cell generations. A range of evidence has now emerged that challenges the […]

PREDICTION OF OCULAR IRRITATION POTENTIAL OF AIR CARE PRODUCTS USING IN VITRO TOPICAL APPLICATION ASSAYS.

Air care products contain high concentrations of fragrance materials which are generally aqueous insoluble. Predicting the ocular irritancy potential of this product class has been difficult and unreliable using dilution-based assays. This problem suggested that to properly model in vivo exposures, the neat test material must be applied directly to the test tissue. This study […]

REPRODUCIBILITY AND CORRELATION OF EPIOCULAR, A THREE-DIMENSIONAL TISSUE CULTURE MODEL OF HUMAN CORNEAL EPITHELIUM.

The EpiOcular™ tissue model (OCL-200) is an organotypic model of the human corneal epithelium (HCE) cultured from normal human keratinocytes using serum free medium. Paraffin embedded, H&E stained histological cross-sections show the structure of EpiOcular closely parallels that of the HCE; large nucleated basal cells lie beneath 5-6 stratified cell layers which progressively flatten out, […]

A COMPARISON OF IN VITRO EYE IRRITATION TEST DATA FOR ORGANOSILICON COMPOUNDS.

There are increasing efforts towards the development of alternatives to in vivo eye irritation testing in animals for human, scientific and economic reasons. Two commercially available in vitro assays (EpiOcular™ Tissue Model OCL-100 and Skin2™ ZK-1200 Model) and a third published assay, the Bovine Corneal Opacity and Permeability Assay (BCOP), were used to assess the […]

REPRODUCIBILITY AND CORRELATION OF EPIOCULAR™, A THREE-DIMENSIONAL TISSUE CULTURE MODEL OF THE HUMAN CORNEAL EPITHELIUM.

The EpiOcular™ tissue model is an organotypic model of the human corneal epithelium (HCE) cultured from normal human keratinocytes using serum free medium. Paraffin embedded, H&E stained histology cross-sections show the structure of EpiOcular closely parallels that of the HCE; large nucleated basal cells lie beneath 5-6 stratified cell layers which progressively flatten out, ending […]

COLGATE-PALMOLIVE’S PROGRAM – VALIDATE THE EPlOCULAR HUMAN TISSUE CONSTRUCT MODEL (OCL-200).

The objective of this corporate-based program was to formally validate the EpiOcular™ model’s ability to predict the eye irritation potential of surfactants and surfactant-based formulations, As defined by the Interagency Coordinating Committee on the Validation of Alternative Methods (NIH Publication No.97-3981), a validated method is one for which the reliability and relevance for a specific […]

The EpiOcular Eye Irritation Test (EIT) for Hazard Identification and Labelling of Eye Irritating Chemicals: Protocol Optimisation for Solid Materials and the Results after Extended Shipment

The 7th Amendment to the EU Cosmetics Directive and the EU REACH Regulation have reinforced the need for in vitro ocular test methods. Validated in vitro ocular toxicity tests that can predict the human response to chemicals, cosmetics and other consumer products are required for the safety assessment of materials that intentionally, or inadvertently, come […]

DI-PPG-2-MYRETH-10 ADIPATE REDUCES IRRITATION AND INFLAMMATION CAUSED BY COSMETIC PRODUCTS.

RL Goldemberg has stated that nonionic surfactants – particularly ethoxylated esters – act as counter irritants in amphoteric/anionic shampoo systems; several studies in our laboratories have demonstrated this desirable property (ethoxylated modified glycerides, and PEG-150 Pentaerythrityl Tetrastearate). In the search for new molecules, we synthesized an alkoxylated myristyl alcohol derivative Di-PPG-2-Myreth-10 Adipate (DMA). DMA is […]

EYE AND SKIN IRRITATION IN 3-D HUMAN TISSUE CONSTRUCTS USING MTT AND ATP ENDPOINTS.

This study by scientists at Beauty Avenues and the Institute for In Vitro Sciences (IIVS) demonstrated that Mattek’s EpiDerm in vitro 3-D human skin tissue equivalent and EpiOcular in vitro 3-D human corneal tissue equivalent can be used, if/when necessary, with the ATP tissue viability assay in addition to the industry-standard MTT tissue viability assay. […]

GENOTOXICITY TESTING USING THE NORMAL HUMAN CELL BASED 3D EPITHELIAL MODELS.

Safety assessment of new products for human use requires genotoxicity testing to ensure their non-carcinogenicity. Current in vitro genotoxicity assays have low specificity resulting in unacceptably high rates of false positives. Moreover, starting in 2009, in vivo genotoxicity testing was banned by the 7th Amendment to the Cosmetics Directive. Since epithelial tissues have the highest […]

DEMONSTRATING THE OCULAR SAFETY OF AN EYE COSMETIC PRODUCT USING ALTERNATIVES TO ANIMAL EYE IRRITATION TESTS.

Previous studies have reported the use of the Tissue Equivalent Assay (TEA) and clinical eye irritation tests for assessing the ocular safety of various consumer products. In lieu of rabbit eye irritation testing, a tiered approach was employed to assess the ocular safety of a new mascara formula. After review of available ingredient eye irritation […]

EVALUATION OF MTT METABOLISM AS A MEANINGFUL INDICATOR OF VIABILTY IN HUMAN CORNEAL EPITHELIAL TISSUE MODELS.

Cellular viability is routinely measured by the uptake and reduction of tetrazolium salt (MTT) to an insoluble formazan dye by cellular microsomal enzymes. With the emerging utilization of tissue equivalent models, the MTT assay has often been used for measuring cellular viability, however it has recently been reported that MTT only measures the viability in […]

EVALUATING THE OCULAR IRRITATION POTENTIAL OF 54 TEST ARTICLES USING THE EPIOCULAR™ HUMAN TISSUE CONSTRUCT MODEL (OCL-200).

Colgate-Palmolive is sponsoring a research program to validate the use of the EpiOcular™ Model in evaluating the eye irritation potential of surfactants. Previously, in a study that demonstrated the reliability of the EpiOcular Model, four laboratories using a formal and detailed study protocol tested 19 test materials. In the current study, two laboratories (Institute for […]

ASSESSMENT OF OCULAR IRRITATION RANGES OF MARKET-LEADING COSMETIC AND PERSONAL-CARE PRODUCTS USING AN IN VITRO TISSUE EQUIVALENT.

The cosmetics and personal-care industry has focused considerable effort on the search for replacements for traditional animal-based safety tests. In vitro models have been found to be particularly useful for the assessment of eye irritation potential. Scientists in the Cell Biology & In Vitro Toxicology Dept., Avon Products, Inc. have used the Mattek EpiOcular™ OCL-200 […]

THE EFFECTS OF KNOWN EYE IRRITANTS ON THE SKINETHIC™ AND EPIOCULAR™ MODELS OF CORNEAL EPITHELIUM.

Information in the literature suggests that the most promising developments in in vitro ocular irritation assays are those involving 3-dimensional (3-D) models of the cornea1-5. In this study, the effects of materials of known ocular irritancy on two commercial models of corneal epithelium, the SkinEthic™ human corneal epithelium (HCE) and the EpiOcular™ model (Mattek) were […]

COMPARATIVE EVALUATION OF FIVE IN VITRO TESTS FOR ASSESSING THE EYE IRRITATION POTENTIAL OF HAIR-CARE PRODUCTS.

This study compared five methods, the isolated rabbit eye (IRE), bovine cornea! opacity and permeability (BCOP), EpiOcular™, fluorescein leakage (FL) and neutral red release (NRR) assays, for predicting the eye irritation potential of hair-care formulations. Ten shampoo and seven conditioner formulations of known ocular irritation potential were tested. Each group included a market-acceptable formulation as […]

THE EPIOCULAR TISSUE MODEL: IN VIVO VERSUS IN VITRO DRAIZE SCORES FOR CONSUMER PRODUCTS.

EpiOcular™ (OCL-200) is an organotypic tissue model of the human corneal epithelium (HCE) cultured from normal human keratinocytes using serum free medium. H&E stained histological cross-sections show that the structure of EpiOcular closely parallels that of the human corneal epithelium. Previously, a prediction equation for eye irritation, Draize score (MMAS) = -4.74 + 101.7/ √ET-50, […]

THE APPLICATION OF REFERENCE STANDARDS IN THE PREVALIDATION AND VALIDATION OF IN VITRO TESTS FOR EYE IRRITATION.

The present project arose out of the proposals of a working group on reference standards established by ECVAM in 1997. The primary objective of this pilot study was to determine whether the current approach of using in vitro data to make safety assessment decisions, employed in-house by many companies, could be accepted in a regulatory […]

COLGATE-PALMOLIVE’S PROGRAMME TO VALIDATE THE EPIOCULAR HUMAN TISSUE CONSTRUCT MODEL (OCL-200).

Currently, no alternative to the Draize eye test has been validated and ac-cepted by any regulatory body. The objective of this corporate-based programme was to formally validate the EpiOcular™ model’s ability to predict the eye irritation potential of surfactants and surfactant-based formulations. Developed by Mattek, EpiOcular is a three-dimensional organotypic model of the human corneal […]

THE EPIOCULAR PREDICTION MODEL: A REPRODUCIBLE IN VITRO MEANS OF ASSESSING OCULAR IRRITANCY POTENTIAL.

The EpiOcular™ tissue model (OCL-200) is an organotypic model of the human corneal epithelium (HCE) cultured from normal human keratinocytes using serum-free medium. Haematoxylin and Eosin stained histological sections show the structure of EpiOcular to closely parallel that of the HCE. During 1998, 85 lots of OCL-200 were produced and monitored using the MTT assay. […]

THE EPIOCULAR PREDICTION MODEL – A REPRODUCIBLE IN VITRO MEANS OF ASSESSING OCULAR IRRITANCY POTENTIAL.

The EpiOcular™ tissue model (OCL-200) is an organotypic model of the human corneal epithelium (HCE) cultured from normal human keratinocytes using serum free medium. Paraffin embedded, H&E stained histological cross-sections show the structure of EpiOcular closely parallels that of the HCE. During 1996 and 1997, 47 and 82 lots, respectively, of the OCL-200 model were […]

FURTHER EVALUATION OF THE EPIDERM AND EPIOCULAR IN VITRO IRRITATION MODELS.

Both EpiDerm™ and EpiOcular™ commercially available in vitro models for assessing the skin and eye irritation potential, respectively, of chemicals. The EpiDerm and EpiOcular tissue models are organotypic three-dimensional human skin and corneal analogues derived from human epidermal keratinocytes. Both are colorimetric cytotoxicity models based on the ability of chemically exposed tissues to reduce MTT. […]

DEVELOPMENT OF IMPROVED EPIOCULAR™ TEST PROTOCOLS FOR SCREENING OF SEVERE OCULAR IRRITANTS.

This study by scientists at Mattek Corp. demonstrated how Mattek’s EpiOcular in vitro human corneal tissue equivalent, in addition to being an excellent test for determining the ocular irritation of ultra-mild to moderate irritants, can also be used to measure the ocular irritation potential of severe irritants by making several changes to the testing protocol. […]

THE EYE IRRITATION TESTING OF THE ORGANIC SOLVENTS ON IN VITRO TEST USING 3-D CORNEAL MODEL.

It has been reported that many in vitro test alternatives to the Draise eye irritation testing (Draize test) are able to evaluate irritation due to surfactants, but not organic solvents. We therefore examined an in vitro test using a 3-D corneal model as an alternative to the Draize test mainly to evaluate irritation caused by […]

IN VITRO METHODS FOR ASSESSING OCULAR IRRITANCY OF COSMETICS.

This study by scientists at Institute Dr. Schrader Creachem GmbH demonstrated that Mattek’s EpiOcular in vitro human cornel tissue equivalent can be used to test the ocular irritancy of a variety of products and has an advantage versus other in vitro test methods because the test materials, including cosmetics, are analyzed directly on human tissues, […]

THE EPIOCULAR PREDICTION MODEL: AN ACCURATE, REPRODUCIBLE IN VITRO MEANS OF ASSESSING OCULAR IRRITANCY POTENTIAL.

The EpiOcular™ tissue model (OCL-200) is an organotypic model of the human corneal epithelium (HCE) cultured from normal human keratinocytes using serum free medium. Paraffin embedded, H&E stained histological cross sections show the structure of EpiOcular closely parallels that of the HCE; large nucleated basal cells lie beneath 5-6 stratified cell layers which progressively flatten […]

EPIOCULAR HUMAN CELL CONSTRUCT: TISSUE VIABILITY AND HISTOLOGICAL CHANGES FOLLOWING EXPOSURE TO SURFACTANTS.

EVALUATION OF THE EPIOCULAR TISSUE MODEL AS AN ALTERNATIVE TO THE DRAIZE EYE IRRITATION TEST.

Cosmetic ingredients were tested to determine the ability of the EpiOcular™ tissue model to predict eye irritation potential. In vitro results were compared with historical Draize eye irritation records. Forty-three samples, consisting of 40 cosmetic raw ingredients of different type and physical form (i.e. liquids, powders, gels) were evaluated. Using the MTT cytoxicity assay, an […]

LONG TERM REPRODUCIBILITY OF EPIOCULAR™, A THREE-DIMENSIONAL TISSUE CULTURE MODEL OF THE HUMAN CORNEAL EPITHELIUM.

This study by scientists at Mattek Corp. summarizes Mattek’s 10-plus YEAR EpiOcular in vitro 3-D human corneal tissue equivalent reproducibility data. Long-term reproducibility is important not only to Mattek Customers, but also to European (ECVAM) and US (ICCVAM) regulators. Regulators constantly stress the need for superior reproducibility of in vitro tissue equivalents, not only during […]

EPIOCULAR PREDICTION MODEL. A REPRODUCIBLE IN VITRO TISSUE CULTURE MEANS OF PREDICTING DRAIZE SCORES.

The EpiOcular™ tissue model (OCL-200) is an organotypic model of the human corneal epithelium (HCE) cultured from normal human keratinocytes using serum free medium. Parafin embedded, H&E stained histology cross-sections show the structure of EpiOcular closely parallels that of the HCE; large nucleated basal cells lie beneath 5-6 stratified cell layers which progressively flatten out, […]

COMPARATIVE ASSESSMENT OF TWO EYE AREA COSMETIC FORMULATIONS THROUGH EVALUATION OF ALTERNATIVE EYE IRRITATION METHODS RELATIVE TO ENDPOINTS MEASURED IN A HUMAN CLINICAL SUB-ACUTE STUDY DESIGN.

Evaluating ocular irritation of eye-area cosmetics is essential to their safety assessment. Although eye-area formulations are designed to be mild, subjective/objective ocular responses can limit their acceptability. This study evaluated two similar formulations by comparing alternative assays, selected for their ability to distinguish milder effects, to human objective and subjective endpoints assessed by a sub-acute […]

PROSPECTIVE VALIDATION STUDY OF RECONSTRUCTED HUMAN TISSUE MODELS FOR EYE IRRITATION TESTING.

ECVAM/Colipa RhT test methods prospective validation study: The objective of the Eye Irritation Validation Study (EIVS) is to formally evaluate the scientific validity of the SkinEthicTM Human Corneal Epithelium (HCE) Short Exposure (SE), Long Exposure (LE) and test strategy and the EpiOcularTM Eye Irritation Test (EIT) through an inter-laboratory ring trial study, to promote international […]

DEVELOPMENT OF THE EPIOCULAR™ EYE IRRITATION TEST FOR HAZARD IDENTIFICATION AND LABELLING OF EYE IRRITATING CHEMICALS IN RESPONSE TO THE REQUIREMENTS OF THE EU COSMETICS DIRECTIVE AND REACH LEGISLATION.

The recently implemented 7th Amendment to the EU Cosmetics Directive and the EU REACH legislation have heightened the need for in vitro ocular test methods. To address this need, the EpiOcular™ eye irritation test (EpiOcular-EIT), which utilises the normal (non-transformed) human cell-based EpiOcular tissue model, has been developed. The EpiOcular-EIT prediction model is based on […]

NON-ANIMAL METHODS FOR TOXICITY TESTING: EYE IRRITATION CORROSION.

One component in the safety assessment of many types of products is the evaluation of their potential to cause eye injury. Eye irritation is defined as “the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application” […]

USE OF HPLC/UPLC INSTEAD OF PHOTOMETRY FOR EVALUATION OF MTT IN IN VITRO IRRITATION ASSAYS BASED ON HUMAN RECONSTRUCTED TISSUE FOR ASSESSMENT OF COLOURED TEST MATERIALS.

This study by researchers at several Procter & Gamble research facilities in the European Union utilized Mattek’s EpiOcular in vitro 3-D human corneal tissue equivalent to demonstrate that the use of HPLC/UPLC technology can extend the applicability of the MTT reduction assay to test materials that are intrinsically coloured and that may interfere with evaluation […]

TESTING OF THE EPIOCULAR TISSUE MODEL FOLLOWING EXTENDED SHIPPING TIMES.

This study by scientists at Kurabo Industries (Japan) and Mattek Corp. demonstrated that Mattek’s EpiOcular in vitro human corneal tissue equivalent can be shipped long distances for extended shipping times and still meet intra- and inter-lot functional QC testing specifications. The EpiOcular tissue model has been commercially available since 1996 and is used extensively by […]

PREDICTION OF OCULAR IRRITATION POTENTIAL OF SURFACTANTS-BASED FORMULATIONS AT DIFFERENT CONCENTRATIONS USING THE EPIOCULAR MODEL.

This study by scientists at Mary Kay, Inc. demonstrated that Mattek’s EpiOcular in vitro human corneal tissue equivalent was able to distinguish between the sensory discomfort levels of 2 surfactants-based facial cleansers at specific concentrations in addition to accurately predicting the ocular irritation potential of these personal care products. Evaluating ocular irritation is essential to […]

COLIPA PROGRAM ON OPTIMIZATION OF EXISTING IN VITRO EYE IRRITATION ASSAYS FOR ENTRY INTO FORMAL VALIDATION: TECHNOLOGY TRANSFER AND INTRA/INTER LABORATORY EVALUATION OF EPIOCULAR ASSAY FOR CHEMICALS.

This study by scientists at Mary Kay, Inc., COLIPA (European Cosmetics Association), Procter & Gamble Co. and Mattek Corp. demonstrated that Mattek’s EpiOcular in vitro human corneal tissue equivalent is a very accurate and reproducible in vitro model for the determination of human eye irritation. Study Results: 99.7% agreement in irritation prediction in 298 independent […]

THE UTILIZATION OF THE EPIOCULAR HUMAN TISSUE MODEL TO ASSESS AND COMPARE THE IRRITATION POTENTIAL OF MULTIPLE SURFACTANT SYSTEMS USED IN SHAMPOOS AND FACIAL CLEANSERS.

This study by scientists at Alberto-Culver Company and the Institute for In Vitro Sciences demonstrated that Mattek’s EpiOcular in vitro human corneal tissue equivalent is an excellent in vitro model for performing the ocular safety evaluation of multiple surfactant systems used in shampoos and facial cleansers. Assuring the safety of cosmetics and personal care products […]

EXPANDED UTIILZATION OF THE EPIOCULAR HUMAN TISSUE MODEL FOR OCULAR IRRITATION TESTING.

This study by Mattek Corp. scientists demonstrated that a new protocol developed for Mattek’s EpiOcular human corneal tissue equivalent was able to determine the ocular irritancy potential of industrial chemicals spanning a range of chemical categories and irritancies. 76 chemical including alcohols, hydrocarbons, amines, esters, and ketones were evaluated using the straightforward MTT tissue viability […]

EXPERIENCES IN THE DEVELOPMENT AND UTILIZATION OF AN IN VITRO SAFETY TESTING PROGRAM FOR HAIR CONDITIONERS.

This study by scientists at Alberto-Culver Co. and the Institute for In Vitro Sciences (IIVS) demonstrated that major personal care and cosmetics companies are basing their internal ocular product safety evaluation programs on Mattek’s EpiOcular in vitro human corneal tissue equivalent as a reliable replacement for animal-based studies. Assuring the safety of cosmetics and personal […]

USE OF THE EPIOCULAR ASSAY FOR PRECLINICAL QUALIFICATION OF FORMULAS FOR HUMAN CLINICAL STUDIES.

This study by researchers at Mary Kay Cosmetics demonstrated that Mattek’s EpiOcular human cornea-like tissue construct can be used to accurately predict the irritation potential of cosmetic products designed to be applied on human skin immediately adjacent to the eye (in vitro test results were compared to human clinical testing). Cosmetic products applied around the […]

HIGH-THROUGHPUT IN VITRO MODELS OF HUMAN EPIDERMIS AND OCULAR EPITHELIUM FOR PRECLINICAL SAFETY AND EFFICACY TESTING OF CONSUMER PRODUCTS AND PHARMACEUTICALS.

This study by scientists at Mattek Corp. demonstrated that Mattek’s EpiDerm in vitro 3-D human skin tissue equivalent and Mattek’s EpiOcular in vitro 3-D human corneal tissue equivalent can be produced in a 96-well high-throughput microwell plate format in a highly reproducible manner, enabling the use of this format to help eliminate sample throughput bottlenecks […]

MATTEK’S TISSUE MODELS: NEW DEVELOPMENTS.

Mattek commercially offers three organotypic tissue models for irritancy and mechanistic studies: 1) EpiDerm™, a highly differentiated, keratinocyte-only model of the epidermis, 2) MelanoDerm™, a second generation version of EpiDerm in which functioning melanocytes have been incorporated, and 3) EpiOcular™, a three-dimensional, non-cornified epithelial tissue model which has been useful in predicting ocular irritancy in […]

INITIAL CHARACTERIZATION OF A NEW MODEL FOR OCULAR IRRITANCY TESTING.

A three dimensional, tissue culture construct, EpiDerm-SCA (EpiOcular™), based on neonatal foreskin-derived normal human epidermal keratinocytes (NHEK) is under development by Mattek Corporation. Cultured using serum free media in easily handled Millicell® CM (Millipore Corp.) cell culture inserts, the model allows application of liquid and solid test materials (potential ocular irritants) directly to the apical […]

EURL ECVAM – Cosmetics Europe Prospective validation study of EpiOcular™ EIT & SkinEthic™ HCE

A prospective validation study of two Reconstructed human Tissuebased in vitro test methods (EpiOcular™ EIT and SkinEthic™ HCE) was conducted by EURL ECVAM and Cosmetics Europe to evaluate their usefulness to identify chemicals as either not classified for serious eye damage/eye irritation (No Category) or as classified (Category1/Category 2) within UN GHS, in the framework […]

UPDATE OF THE COLIPA EYE IRRITATION TASK FORCE STRATEGY AND PROGRAMME FOR DEVELOPMENT OF IN VITRO METHODS.

Colipa (European Cosmetics Association) is conducting an eye irritation programme for development of in vitro methods to replace the Draize rabbit eye test (now banned for evaluating cosmetic ingredients). This programme is focused on identification of new in vitro test systems/endpoints that use a thorough understanding of mechanisms of eye injury/recovery to predict human ocular […]

TRANSCORNEAL IONTOPHORESIS FOR DELIVERY OF CIPROFLOXACIN HYDROCHLORIDE.

Purpose: To investigate the feasibility of utilizing iontophoresis for delivery of ciprofloxacin hydrochloride to the anterior chamber of the eye and to carry out systematic studies to investigate the effect of electrical protocol on the transcorneal drug delivery. Materials and Methods: Effect of current density (0.75 mA/cm2 to 6.25 mA/cm2 applied for 5 minutes) on […]

NVC-422: TOWARDS DEVELOPING PRECLINICAL INFECTED TISSUE MODELS.

Background: P. aeruginosa and S. aureus are opportunistic human pathogens implicated in many clinical diseases of the eye and skin, including keratitis and impetigo, respectively. Infection can involve destruction of underlying tissue by toxins to exacerbate tissue damage, leading to erosive disease. Developing infected tissue models provide a platform for assessing antimicrobial efficacy and toxicity […]

USE OF EPIDERM FULL THICKNESS TISSUE FOR ANTI-AGING STUDIES.

This study by scientists at Arch Personal Care Products demonstrated that Mattek’s EpiDermFT full-thickness in vitro human skin tissue equivalent can be used to measure the effect of a new topically applied formulation on the elastin content in human skin’s extracellular matrix. Mattek’s EpiDerm and EpiOcular in vitro tissues were also used to show this […]