BOVINE CORNEAL OPACITY AND PERMEABILITY ASSAY - RESULTS OF A TWO LABORATORY REPRODUCIBILITY STUDY
Published: March 8th, 2010 | Category: IIVS Publications
Source: SOT
The Bovine Corneal Opacity and Permeability assay (BCOP), an internationally recognized alternative to the Draize eye irritation test, uses excised bovine corneas to predict ocular irritation. Originally developed by Gautheron (1992) and utilizing the irritation class prediction established by Sina (1994), BCOP has been used independently at MB Res...
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An Evaluation of the EpiDerm™ Corrosivity and Corrositex® Assays for Predicting Skin Corrosivity of Chemical Products with Extreme Alkaline pH
Published: March 8th, 2010 | Category: IIVS Publications
Source: SOT
The purpose of this study was to evaluate the EpiDerm™ Corrosivity (OECD 431) and Corrositex® Time Monitor (OECD 435) as in vitro
methods to predict skin corrosivity for extreme pH (≥ 11.5) products. Extreme pH can be a useful predictor of irritation but may lead to over classification in weakly buffered systems. Hazard classification guidel...
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MEDIA REFINEMENT FOR A LONG TERM CORNEAL CULTURE MODEL OF EYE IRRITATION AND POST-TREATMENT RECOVERY
Published: March 5th, 2010 | Category: IIVS Publications
Long Term Corneal Culture has been proposed as an in vitro alternative to evaluate potential eye irritation and to measure chemical toxicity and post-exposure recovery up to 22 days. Excised porcine corneas mounted on 1% agar-gelatin mixture were cultured
in two types of culture media for up to 21 days. Previous culture procedures resulted in sign...
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EFFECTS OF COLLECTION, TRANSPORTATION, AND BCOP METHODOLOGY ON BOVINE CORNEAL HISTOLOGY EVALUATION
Published: October 5th, 2009 | Category: IIVS Publications
The bovine corneal opacity and permeability (BCOP) assay Gautheron, 1992 & Sina, 1995), is used as an in vitro eye irritation screen for industrial hygiene, product development, and safety testing by measuring changes in corneal opacity, and permeability to fluorescein after chemical exposure. Histopathology has been used in BCOP studies to detect ...
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IN VITRO EYE AND SKIN IRRITATION ASSESSMENT OF CONSUMER PRODUCTS CONTAINING VOLATILE ORGANIC COMPOUNDS (VOCS) IN 3-D TISSUE CONSTRUCTS: MODIFIED DOSE PROTOCOL
Published: October 5th, 2009 | Category: IIVS Publications
The Alberto-Culver Company uses a topical application time-to-toxicity protocol in in vitro 3-D human ocular and epidermal tissue constructs to assess the irritancy of a wide range of product formulations and ingredients. The irritation of some products with VOCs (e.g. hair sprays, mousses, etc.) has been over-predicted by these methods relative to...
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EYE AND SKIN IRRITATION IN 3-D HUMAN TISSUE CONSTRUCTS USING MTT AND ATP ENDPOINTS
Published: October 5th, 2009 | Category: IIVS Publications
In vitro eye and skin model assays are typically used to assure safety prior to consumer use by employing them in product development to support the creation of products with minimal irritation potential. As part of a high quality program, the test systems are constantly monitored for applicability, investigated for potential limitations, and conti...
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RESULTS OF A TWO LABORATORY REPRODUCIBILITY STUDY USING A HARMONIZED BOVINE CORNEAL OPACITY AND PERMEABILITY (BCOP) PROTOCOL
Published: October 5th, 2009 | Category: IIVS Publications
The Bovine Corneal Opacity and Permeability assay (BCOP), an internationally recognized alternative to the Draize eye irritation test, uses excised bovine corneas to predict ocular irritation. Originally developed by Gautheron (1992) and utilizing the irritation class prediction established by Sina (1994), BCOP has been used independently at MB Res...
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Histological Evaluation of the Effects of Transport on Bovine Corneas for Ocular Safety Assessments
Published: March 30th, 2009 | Category: IIVS Publications
The bovine corneal opacity and permeability (BCOP) assay, originally developed by Gautheron (1992) and Sina (1995) has been used as an in vitro eye irritation screen for industrial hygiene, product development and safety testing. It has recently been validated as a screen for corrosive or severe irritation by ICCVAM and ECVAM. The assay measures ch...
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Eye and Skin Irritation in 3-D Tissue Constructs Using MTT and ATP Endpoints
Published: March 30th, 2009 | Category: IIVS Publications
The irritation potential of formulations and ingredients for industrial screening and product development is often conducted using in vitro 3-D human ocular and epidermal tissue constructs. To predict irritation potential after chemical exposure, tissue viability is typically determined by the ability of live cells to reduce MTT. Toxic exposures re...
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Use of Histology in BCOP Assay Timeline Poster Presented
Published: September 18th, 2008 | Category: IIVS Publications
A poster showing the progression from creation of the Bovine Corneal Opacity and Permeability (BCOP) assay through conclusions from the June 2008 histology users group meeting will be presented this weekend in Linz at the 15th Congress on Alternatives to Animal Testing. Please contact us if you would like more information on the assay or the use of...
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The Development and Utilization of an In Vitro Safety Testing Program for Hair Conditioners
Published: April 14th, 2008 | Category: IIVS Publications
Source: Presented at the 47th Annual Society of Toxicology Meeting
Assuring the safety of cosmetics and personal care products without testing in animals has long been the goal of many international companies. This concern has become even more important with the requirement of the Seventh Amendment to the Cosmetics Directive that after 2009 animal testing cannot be used to assess the eye or skin irritation potenti...
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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
Published: April 14th, 2008 | Category: IIVS Publications
Source: Presented at the 47th Annual Society of Toxicology Meeting
Assuring the safety of cosmetics and personal care products without testing in animals is a primary goal for Alberto-Culver Company. In addition, the Seventh Amendment to the Cosmetics Directive requires that after 2009, animal testing cannot be used to assess the eye or skin irritation potential of either cosmetic formulations or ingredients. To a...
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Experiences In The Development And Utilization Of An In Vitro Safety Testing Program For Hair Conditioners
Published: September 20th, 2007 | Category: IIVS Publications
Source: 6th World Congress on Alternatives and Animal Use in the Life Sciences, Tokyo, Japan 2007
Assuring the safety of cosmetics and personal care products without testing in animals has long been the goal of many international companies. This concern has become even more important with the requirement of the Seventh Amendment to the Cosmetics Directive that after 2009 animal testing cannot be used to assess the eye or skin irritation potenti...
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ESAC has endorsed 5 new alternative testing methods
Published: June 6th, 2007 | Category: Non-IIVS Publications
Source: European Centre for the Validation of Alternative Methods
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The ECVAM Scientific Advisory Committee (ESAC) has announced the validation of five new in vitro tests. The tests include EpiDerm® and Bovine Corneal Opacity and Permeability (BCOP).
For more information click the Read More below. In the new window select Publications which is located in the menu at the top of the webs...
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Fragrance Impact On Marketed Air Freshener Products By BCOP Assay And Histology
Published: August 24th, 2006 | Category: IIVS Publications
Source: Presented at the Society of Toxicology Annual Meeting, 2006
An exploratory in vitro eye irritation study of marketed solid and liquid air fresheners was conducted to investigate the impact of fragrance/fragrance type on overall eye irritation for specific product forms. The Bovine Corneal Opacity and Permeability (BCOP) assay was selected to evaluate eye irritation potential due to its robustness and abilit...
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Application Of Histological Evaluation To Enhance The Bovine Opacity And Permeability (BCOP) Assay
Published: August 24th, 2006 | Category: IIVS Publications
Source: Presented at the Society of Toxicology Annual Meeting, 2006
The BCOP assay was optimized to its present form by Drs. Pierre Gautheron and Joe Sina to address ocular irritation potential of pharmaceutical intermediates and is now widely applied across industries and chemical/formulation classes. Membrane lysis, protein coagulation, and saponification are common modes of action that lead to ocular irritation....
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IIVS Newsletter November 2005
Published: November 30th, 2005 | Category: IIVS Publications
Source: IIVS
IIVS progress on optimization of Alternative Tests,
ICCVAM Expert Panel Reviews BRD Addenda,
Standards for In Vitro Tests, and more.
...
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The EpiOcular model – protocol, performance and experience
Published: August 26th, 2005 | Category: IIVS Publications
Source: Practical Training Workshop on In Vitro Eye Irritation Methods, August 26, 2006, Berlin, Germany
Practical Training Workshop on In Vitro Eye Irritation Methods
Co-sponsored by:
Institute for In Vitro Sciences, IIVS (Gaithersburg, USA)
Beiersdorf AG (Hamburg, Germany)
BfR-ZEBET (Berlin, Germany)
SCOPE: The Workshop aims at practical training in most frequently used in vitro methods for
prediction of eye irritation potential. Primary focus...
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The BCOP – protocol, performance and experience
Published: August 26th, 2005 | Category: IIVS Publications
Source: Practical Training Workshop on In Vitro Eye Irritation Methods, August 26, 2005,Berlin, Germany
Practical Training Workshop on In Vitro Eye Irritation Methods
Co-sponsored by:
Institute for In Vitro Sciences, IIVS (Gaithersburg, USA),
Beiersdorf AG (Hamburg, Germany),
BfR-ZEBET (Berlin, Germany).
SCOPE: The Workshop aims at practical training in most frequently used in vitro methods for
prediction of eye irritation potential. Primar...
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EPIOCULAR™ HUMAN CELL CONSTRUCT: TISSUE VIABILITY AND HISTOLOGICAL CHANGES FOLLOWING EXPOSURE TO SURFACTANTS
Published: August 21st, 2005 | Category: IIVS Publications
Source: Presented at the 5th World Congress on Alternatives and Animal Use in the Life Sciences, Berlin, Germany, August 21-26, 2005
The ability of the EpiOcularTM construct to predict the eye irritation potential of surfactants has been the
subject of a formal validation program. EpiOcularTM correlates a test article's potential for ocular irritation
with the time it takes to reduce tissue viability by 50% (ET(sub>50) as measured by MTT. This study ...
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OPTIMIZATION OF AN IN VITRO LONG TERM CORNEAL CULTURE ASSAY
Published: August 21st, 2005 | Category: IIVS Publications
Source: Presented at the 5th World Congress on Alternatives and Animal Use in the Life Sciences, Berlin, Germany, August 21-26, 2005
The long-term culture of corneas has been proposed as an in vitro model to evaluate potential eye irritation and post-treatment recovery following chemical exposures. Porcine eyes were btained within 24 hours of sacrifice and disinfected prior to excising corneas. Corneas were filled with an agar/gelatin gel in M199
medium to support the corneas, ...
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PERFORMANCE STANDARDS FOR IN VITRO STUDIES
Published: August 21st, 2005 | Category: IIVS Publications
Source: Presented at the 5th World Congress on Alternatives and Animal Use in the Life Sciences, Berlin, Germany, August 21-26, 2005
In vitro test systems offer the potential for high consistency and resulting high predictive capacity. This promise comes from the ability to control many of the independent variables that can lead to the variability of responses in vivo. Furthermore, most of the in vitro tests currently employed, have undergone some level of formal validation or a...
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Applying Good Laboratory Practices (GLPs) to In Vitro Studies: One Laboratory's Perspective
Published: August 21st, 2005 | Category: IIVS Publications
Source: Presented at the 5th World Congress on Alternatives and Animal Use in the Life Sciences, Berlin, Germany, August 21-26, 2005
The steady increase in industry use and regulatory acceptance of in vitro test methods has resulted in an increased need to apply Good Laboratory Practice (GLP) regulations to these systems. The original GLP regulations, developed to address the conduct of animal studies, are concerned with many special conditions that apply to animal housing and c...
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SC JOHNSON’S CONSUMER PRODUCT HAZARD EVALUATION PROGRAM USING ALTERNATIVE ASSAYS
Published: August 20th, 2005 | Category: IIVS Publications
SC Johnson is a global consumer products company that manufactures a variety of household products that must be evaluated for human health hazards. For over 10 years, SC Johnson has conducted the necessary research to spearhead efforts to reduce the use of animals in the hazard assessment process. We routinely use alternative approaches such as the...
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IIVS Newsletter August 2005
Published: August 15th, 2005 | Category: IIVS Publications
Source: Institute for In Vitro Science, Volume 4; Issue 1
IIVS news on 1) In vitro eye irritation testing of antimicrobial products and the EPA, 2) ECVAM eye irritation expert meeting, 3) ICCVAM project on severe eye irritation, 5)World Congress on Alternatives & Animal Use in the Life Sciences Practical Training Workshop on In Vitro eye Irritation Methods and more!...
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OPTIMIZATION OF AN IN VITRO LONG TERM CORNEAL CULTURE ASSAY
Published: March 6th, 2005 | Category: IIVS Publications
Source: Presented at the 44th Annual Meeting of the Society of Toxicology, New Orleans, Louisiana, March 6-10, 2005
The long-term culture of corneas has been proposed as an in vitro model to evaluate potential eye irritation and post-treatment recovery following chemical exposures. Techniques used were modifications of those of Foreman, DM (1996), Xu, KP (2004) and Boulton, M (2003). Porcine eyes were obtained from Sioux-Preme within 24 hours of sacrifice. The e...
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EPIOCULAR™ HUMAN CELL CONSTRUCT: TISSUE VIABILITY AND HISTOLOGICAL CHANGES FOLLOWING EXPOSURE TO SURFACTANTS
Published: March 6th, 2005 | Category: IIVS Publications
Source: Presented at the 44th Annual Meeting of the Society of Toxicology, New Orleans, Louisiana, March 6-10, 2005
The ability of the EpiOcular™ construct to predict the eye irritation potential of surfactants and surfactant-based formulations has been the subject of a formal validation program. EpiOcular™ correlates a test article's potential for ocular irritation with the time it takes to reduce tissue viability by 50% (ET50) as measured by the tis...
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The Bovine Corneal Opacity and Permeability Assay: Observations on Assay Performance
Published: November 19th, 2004 | Category: IIVS Publications
In our 6 years of performing the bovine corneal opacity and permeability (BCOP) assay, a wide variety of chemicals or product classes have been evaluated. These include surfactants and surfactant-based formulations, industrial cleaners, air care products, pharmaceutical in-termediates, organic solvents, and others. Fur-thermore, the application of ...
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MANAGING TOXIC SYNERGISM IN HYPOCHLORITE-CONTAINING CLEANERS USING THE BOVINE CORNEAL OPACITY AND PERMEABILITY (BCOP) ASSAY, Part II
Published: March 12th, 2004 | Category: IIVS Publications
Consumers continue to seek products that will both clean and combat mold and mildew stains on various surfaces in the home. Such products are commonly formulated as alkaline hypochlorite and surfactant-containing aqueous solutions and usually have
significant ocular irritation potential. Previous studies have shown the applicability of the BCOP As...
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Information on current regulatory acceptance status of in vitro methods available on ICCVAM web-site
Published: March 1st, 2004 | Category: IIVS Publications
Source: Presented at the Society of Toxicology Annual Meeting, Baltimore, MD, 2004
The BCOP assay can be used to predict relative eye irritation potential of surfactant-based personal care formulations relative to a corporate benchmark. (Toxicologist, March 2001). The Human Eye Sting test is typically used to evaluate product claims of no tears/no stinging for children's bath products. A preliminary investigation was conducted to...
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EVALUATING THE OCULAR IRRITATION POTENTIAL OF 54 TEST ARTICLES USING THE EPIOCULAR(TM) HUMAN TISSUE CONSTRUCT MODEL (OCL-200)
Published: March 9th, 2003 | Category: IIVS Publications
Source: Presented at the Annual Meeting of the Society of Toxicology, 2003
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, tw...
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EXPLORATORY IN VITRO EYE IRRITATION STUDY OF MARKETED ALKALINE DRY LAUNDRY DETERGENT BY BCOP ASSAY AND PH/ALKALINE (RA) PARAMETERS
Published: March 1st, 2003 | Category: IIVS Publications
Source: Presented at the Annual Meeting of the Society of Toxicology, 2003.
An exploratory in vitro eye irritation study of 11 currently marketed alkaline dry laundry (ADL) detergents was conducted to investigate the correlation between an in vitro biological endpoint and pH/reserve alkalinity (RA) ranges of ADL detergents. Marketed products can be considered "safe benchmarks", since they are produced by indu...
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Ocular Safety: A Silent (In Vitro) Success Story
Published: January 1st, 2002 | Category: IIVS Publications
Source: ATLA, 30, suppliment 2, 69-74, 2002
— Ocular irritation testing has been one of the animal test methods most criticised by animal welfare advocates. Additional criticism has arisen from within the scientific community, based on the variability of the animal test results and the questionable relevance of the extremely high dose levels employed. As a result, the Draize eye irritat...
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Prediction of ocular irritancy of prototype shampoo formulations by the isolated rabbit eye (IRE) test and bovine corneal opacity and permeability (BCOP) assay.
Published: January 1st, 2001 | Category: IIVS Publications
Source: Reprinted from Toxicology In Vitro, Vol. 15, p. 95-103, 2001, with permission from elsevier Science. (ScienceDirectTM http://www. sciencedirect.com)
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Assessment of the Cytosensor Microphysiometer Assay in the COLIPA In Vitro Eye Irritation Validation Study.
Published: January 1st, 1999 | Category: IIVS Publications
Source: Reprinted from Toxicology In Vitro, Vol. 13, pp. 313-323, 1999, with permission from Elsevier Science. (ScienceDirectTM http://www.sciencedirect.com)
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13th Meeting of the Scientific Group on Methodologies for the Safety Evaluation of Chemical (SGOMSEC): Validation and Acute Testing
Published: April 1st, 1998 | Category: IIVS Publications
Source: Environmen Health Perspect 106 (suppl 2):419-425 (1998)
Scientific principles demand that before newly developed alternative methods for safety testing are fully embraced by the regulatory community, they reliably and reproducibly predict the designated toxic end point. The process used to determine reliability and reproducibility is termed validation, and it generally culminates with a highly controlle...
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In Vitro Alternatives for Ocular Irritation
Published: April 1st, 1998 | Category: IIVS Publications
Source: Environ Health Perspec 106 (suppl 2):485-492 (1998)
The necessity of using animals to test whether new chemicals and products are eye irritants has been questioned with increasing frequency and fervor over the last 20 years. During this time many new nonanimal methods have been proposed as reliable alternatives to the traditional rabbit (Draize) test. To date, however, none of these nonanimal (in...
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Validation of Alternative Methods for Toxicity Testing v2
Published: January 1st, 1997 | Category: IIVS Publications
Source: Comments Toxicology, 1997, Vol. 6, No. I, pp. 37-51
The purpose of this paper is to review a practical process that can be used to assess the validity of alternative methods for in vivo safety tests. The important role of a clearly stated prediction model, which defines how to use the results from an alternative method to predict an in vivo toxicity endpoint, has been discussed. Computer simulations...
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Current Approaches to the In Vitro Prediction of Ocular Irritation
Published: January 1st, 1997 | Category: IIVS Publications
Source: Comments Toxicology 1997. Vol. 6, No. 1, pp. 71-85
The eye is a very intricate organ that is susceptible to injury because of its exposure to the external environment. It is therefore important that manufacturers of chemicals and con-sumer products assess the eye safety of their products. In the past, eye safety has been assessed through the use of in vivo tests. More recently, there has been a con...
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A Summary Report of the COLIPA International Validation Study on Alternatives to the Draize Rabbit Eye Test
Published: January 1st, 1997 | Category: IIVS Publications
Source: Reprinted from Toxicology In Vitro, Vol. 11, pp. 141-179, 1997, with permission from Elsevier Science. (SciencedirectTM http://www.sciencedirect.com)
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Development and Validation of Non-animal Tests and Testing Stragegies: the Identification of a Coordinated Response to the Challenge and Opportunity Presented by the Sixth Amendment to the Cosmetic Directive
Published: January 19th, 1995 | Category: IIVS Publications
Source: ATLA 23, 398-409
This is a report of the seventh of a series of workshops organised by the European Center for the Validation of Alterntive Methods (ECVAM). This particular workshop was a joint initiative of ECVAM and the Cosnumer Policy Servie (CPS). ...
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Evaluation of the Human Epidermal Keratinocyte Neutral Red Uptake Assay Using the First 10 MEIC Test Materials
Published: January 1st, 1992 | Category: IIVS Publications
Source: Reprinted from Toxicology In Vitro, vol. 6, No. 4, pp.367-371, 1992, with permision from Elsevier Science. (ScienceDirectTM http://www.scicencedirect.com)
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