In Vitro Vaginal Safety Screening Approach For Bath And Body Wash Products Utilizing Skinethic Human Vaginal Epithelium (HVE) Model Poster Presented at IUTOX Meeting
Published: August 4th, 2010 | Category: Whats New
A common goal of many personal care companies is to assure the safety of their products without animal testing, due to concerns about
ethical and animal welfare issues as well as the relevancy of the animal model to humans. To address these issues, we have developed an in vitro testing program to support the safety evaluation of potential vaginal ...
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The predictive capacity of the 3T3 Neutral Red Uptake assay to identify substances LD with acute oral LD50 50 > kg> 2000 mg/kg poster presented at IUTOX
Published: August 4th, 2010 | Category: Whats New
The purpose of this validation study is to assess the capacity of the 3T3/NRU cytotoxicity assay to give a simple yes or no answer in order to discriminate between toxic/hazardous (LD50 < 2000 mg/kg) and not classified (LD50 >2000 mg/kg) substances....
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The predictive capacity of the 3T3 Neutral Red Uptake assay to identify substances LD with acute oral LD50 50 > kg> 2000 mg/kg
Published: March 8th, 2010 | Category: IIVS Publications
Source: SOT
The purpose of this validation study is to assess the capacity of the 3T3/NRU cytotoxicity assay to give a simple yes/no answer in order to discriminate between toxic/hazardous (LD50 < 2000 mg/kg) and not classified (LD50 >2000 mg/kg) substances. High (87%) prevalence of substances with acute oral LD50 > 2000 mg/kg. Registry of Cytotoxicity showed ...
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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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IN VITRO ASSESSMENT OF PERSONAL CARE PRODUCTS FOR VAGINAL IRRITATION USING 3D TISSUE CONSTRUCTS
Published: March 5th, 2010 | Category: IIVS Publications
Three dimensional (3D) human vaginal-ectocervical tissue constructs may be a relevant in vitro model to rapidly screen for vaginal mucosal irritation potential of raw materials and final formulations. Here we report results from a study with an in vitro vaginal tissue construct (EpiVaginalTM from Mattek Corporation, USA), used to predict irritation...
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Incorporating flow cytometry based automated scoring into the Reconstructed Skin Micronucleus Assay
Published: March 5th, 2010 | Category: IIVS Publications
Starting in March of 2009, in vivo genotoxicity testing for cosmetics sold in the European Union was banned by the 7th Amendment to
the Cosmetics Directive. In vivo tests were used to confirm the results of in vitro tests, which produce a high number of false positives. The Reconstructed Skin Micronucleus Assay (RSMA)
was developed as a possible ...
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INTEGRATED IN VITRO VAGINAL SAFETY SCREENING APPROACH FOR BATH AND BODY WASH PRODUCTS UTILIZING SKINETHIC HUMAN VAGINAL EPITHELIUM (HVE) MODEL
Published: March 5th, 2010 | Category: IIVS Publications
A common goal of many personal care companies is to assure the safety of their products without animal testing, due to concerns
about ethical and animal welfare issues as well as the relevancy of the animal model to humans. To address these issues, we have
developed an in vitro testing program to support the safety evaluation of potential vaginal...
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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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DEVELOPMENT OF A BARRIER-COMPROMISED HUMAN SKIN MODEL FOR IN VITRO PERCUTANEOUS PENETRATION STUDIES
Published: March 5th, 2010 | Category: IIVS Publications
Procedures for preparing barrier-compromised human donor skin for use in in vitro percutaneous penetration studies as a model of damaged or disease-state skin, where a reduced barrier function due to loss or abnormal development of the stratum corneum is characteristic, were developed. Two methods for disrupting the stratum corneum were evaluated, ...
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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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COLIPA validation of the Reconstructed Human Skin Micronucleus Assay (RSMN): A novell micronucleus assay in a 3D human skin model
Published: October 5th, 2009 | Category: IIVS Publications
Current mammalian cell in vitro genotoxicity assays induce a high level of false positive results leading to a large number of costly and time consuming followup in vivo genotoxicity studies. As of March 2009, the 7th Amendment to the EU Cosmetics Directive prohibits the use of in vivo genotoxicity tests in safety assessments for cosmetics, greatly...
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Critical Factors Impacting Interlaboratory Transferrability of the Mouse Embryonic Stem Cell Test
Published: October 5th, 2009 | Category: IIVS Publications
The EST has been formally validated by the European Centre for the Validation of Alternative Methods (ECVAM) as an acceptable in vitro embryotoxicity assay. During the prevalidation trials, the technology was easily transferred between laboratories in the European Union. However, transferring the assay to the Institute for In Vitro Sciences (IIVS) ...
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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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Reference Laboratories Can Make Validation More Efficient
Published: October 5th, 2009 | Category: IIVS Publications
The validation of in vitro methods is a lengthy process encompassing multiple phases. It progresses from initial test development, through test optimization and prevalidation, to a formal validation assessment, and eventually to regulatory acceptance. Each of these phases relies heavily on the outcome of laboratory activities - even the regulatory ...
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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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Poster on IIVS to be Presented this Weekend at Linz Conference
Published: September 18th, 2008 | Category: IIVS Publications
A poster explaining the services provided by IIVS and highlighting how IIVS contributes to the global alternatives testing community will be presented this weekend at the 15th Congress on Alternatives to Animal Testing in Linz, Austria. ...
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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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The Importance Of Supplier Qualification For Vendors Of Materials Used In In Vitro Assays
Published: September 20th, 2007 | Category: IIVS Publications
Source: 6th World Congress on Alternatives and Animal Use in the Life Sciences, Tokyo, Japan 2007
Pre-clinical assays, including in vitro assays, rely heavily on suppliers who provide specific products or services essential to the proper conduct of the study. The overall credibility of the results and subsequent conclusions drawn from the assay are highly dependent on the quality of the supplies used. Variable results for the same assay control...
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Estimating Systemic Toxicity In Vitro Using An Adenosine Triphosphate Cytotoxicity (ATP) Assay In Normal Human Epidermal Keratinocytes
Published: September 20th, 2007 | Category: IIVS Publications
Source: 6th World Congress on Alternatives and Animal Use in the Life Sciences, Tokyo, Japan 2007
Ekwall et al. (ATLA 17:83-100, 1989) have proposed that ˜80% of chemical-induced systemic toxicity is the result of disruption of basic cellular processes common to most cell types in the body, and that systemic toxicity for many chemicals could be estimated in in vitro cultures. Strickland et al (The Toxicologist, Abs#761, 2003) reported on a join...
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Estimating Systemic Toxicity In Vitro Using An Adenosine Triphosphate Cytotoxicity (ATP) Assay In Normal Human Epidermal Keratinocytes
Published: March 25th, 2007 | Category: IIVS Publications
Source: Presented at the Society of Toxicology Annual Meeting, 2007
Ekwall et al. (ATLA 17:83-100, 1989) have proposed that ˜80% of chemical-induced systemic toxicity is the result of disruption of basic cellular processes common to most cell types in the body, and that systemic toxicity for many chemicals could be estimated in in vitro cultures. Accordingly, Strickland et al. (The Toxicologist, Abs#761, 2003) repo...
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Further Development Of A Reconstructed Skin Micronucleus Assay
Published: March 25th, 2007 | Category: IIVS Publications
Source: Presented at the Society of Toxicology Annual Meeting, 2007
We have previously reported initial investigations of a novel micronucleus assay which utilizes a 3-dimensional human skin model EpiDerm™ supplied by MatTek Corporation (Ashland, MA). The advantage of this in vitro system is that it might potentially replace second-tier animal studies (or possibly first-tier non-specific traditional in vitro assays...
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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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The Importance Of Supplier Qualification For Vendors Of Materials Used In In Vitro Assays
Published: August 22nd, 2006 | Category: IIVS Publications
Source: Presented at the Society of Toxicology Annual Meeting, 2006
Pre-clinical assays, including in vitro assays, rely heavily on suppliers who provide specific products or services essential to the proper conduct of the study. The overall credibility of the assay and the results obtained from the assay are highly dependent on the quality of the supplies used. Variable results for the same control material over t...
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Evaluation Of A Novel Micronucleus Assay Using A Human 3-D Skin Model, Epiderm™
Published: August 22nd, 2006 | Category: IIVS Publications
Source: Presented at the Society of Toxicology Annual Meeting, 2006
For many chemicals and products, most notably cosmetics, skin is the highest exposed tissue; however, very few assays are available to directly address potential genotoxicity to this tissue. Although rodent models are being developed to measure micronucleus induction in the skin, European legislation such as the 7th amendment to the Cosmetics Direc...
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Use Of An Adenosine Triphosphate (ATP) Cytotoxicity Assay In Normal Human Epidermal Keratinocytes To Predict Systemic Toxicity In Vitro
Published: August 22nd, 2006 | Category: IIVS Publications
Source: Presented at the Society of Toxicology Annual Meeting, 2006
Ekwall et al (ATLA 17:83-100, 1989) have proposed that ˜80% of chemical-induced systemic toxicity is the result of disruption of basic cellular processes common to most cell types in the body, and that systemic toxicity for many chemicals could be estimated in in vitro cultures. The Multicenter Evaluation of In Vitro Cytotoxicity (MEIC) was establi...
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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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INDUCTION OF A ZONE OF CELL DEATH IN MULTI-WELL PLATES BY REFEEDING
Published: March 1st, 2004 | Category: IIVS Publications
Source: Presented at Society of Toxicology, 2004, Baltimore, MD
Multi-well plates provide an efficient format for cell-based bioassays. As the number of wells increases per plate, the surface area and number of cells per well decreases. Use of the small-well format can present some problems. We have observed cell cultures in 96-well plates where significant populations of cells begin to die shortly after refeed...
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In Vitro Percutaneous Absorption In The MatTek EPI-606X Skin Construct And Human Skin
Published: April 30th, 2003 | Category: IIVS Publications
Source: Presented at the International Investigative Dermatology 2003
The rates of absorption of chemicals in human skin can be modeled in the in vitro percutaneous absorption assay. Moreover, the impact of various vehicles on the permeation rates of chemicals can also be evaluated. Benzoic acid (BA) was prepared in two vehicles (acetone and petrolatum) and was tested in duplicate trials in an engineered human skin c...
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ASSESSMENT OF PROTOCOL VARIABLES IN CYTOTOXICITY ASSAYS UTILIZING BALB/C 3T3 CELLS AND NORMAL HUMAN KERATINOYTES
Published: March 1st, 2003 | Category: IIVS Publications
Source: Presented at the Society of Toxicology Annual Meeting, 2003
The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the European Center for the Evaluation of Alternative Methods (ECVAM) are currently sponsoring a study to determine the usefulness of two in vitro basal cytotoxicity methods [employing BALB/c 3T3 (3T3) cells and normal human keratinocytes (NHK)] for pre...
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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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