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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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International prevalidation studies of the EpiDermTM 3D human reconstructed skin micronucleus (RSMN) assay: Transferability and reproducibility
Published: July 16th, 2010 | Category: IIVS Publications
After a new, comprehensive evaluation of the prior available data, the ECVAM scientific advisory committee
(ESAC) has recently accepted the CytosensorMicrophysiometer as capable of identifying non-irritants for testing limited to
water-soluble surfactants and water-soluble surfactant-containing mixtures. This 25-year development
is remarkable an...
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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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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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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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Further development of the EpiDerm 3D reconstructed human skin micronucleus (RSMN) assay
Published: March 27th, 2009 | Category: IIVS Publications
Source: Mutation Research/Genetic Toxicology and Environmental Mutagenesis
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The upcoming ban on testing of cosmetics in animals by the European Union 7th Amendment to the Cosmetics Directive will require genotoxicity safety assessments of cosmetics ingredients and final formulations to be based primarily on in vitro genotoxicity tests. The current in vitro test battery produces an unacceptably high rate of false positives,...
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Intralaboratory and interlaboratory evaluation of the EpiDermâ„¢ 3D human reconstructed skin micronucleus (RSMN) assay
Published: March 27th, 2009 | Category: IIVS Publications
Source: Mutation Research/Genetic Toxicology and Environmental Mutagenesis
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A novel in vitro human reconstructed skin micronucleus (RSMN) assay has been developed using the EpiDerm™ 3D human skin model [R. D. Curren, G. C. Mun, D. P. Gibson, and M. J. Aardema, Development of a method for assessing micronucleus induction in a 3D human skin model EpiDerm™, Mutat. Res. 607 (2006) 192–204]. The RSMN assay has potential u...
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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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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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New REACH regulation
Published: February 6th, 2007 | Category: Press Releases
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Amendments to the REACH directive were published in the Official Journal of the European Union on December 30, 2006.
Article (1) states:
“This Regulation should ensure a high level of protection of human health and the environment as well as the free movement of substances, on their own, in preparations and in articles, while enhancing co...
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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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IIVS newsletter - July 2006
Published: August 21st, 2006 | Category: IIVS Publications
Source: IIVS
...
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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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REPORT FROM AN IN VITRO DERMAL ABSORPTION ASSAY WORKSHOP
Published: August 21st, 2005 | Category: IIVS Publications
Source: Presented at the 5th World Congress on Alternatives and Animal Use in Life Sciences, Berlin, Germany, August 21-25.
The Institute for In Vitro Sciences (IIVS), Gaithersburg, Maryland, USA, hosted a workshop on in vitro
percutaneous absorption (PA) methods for a small group of international stakeholders in July 2005. The
purpose of the workshop was to provide a forum where stakeholders and method experts could come
together to discuss the various OECD-approved...
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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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Addressing Animal Testing Concerns: A Novel Micronucleus Assay Using The Human 3-D Skin Model, EpiDerm™
Published: August 21st, 2005 | Category: IIVS Publications
Source: Presented at the 5th World Congress on Alternatives & Animal Use in the Life Sciences, Berlin Germany, Aug. 21-26, 2005
To meet the requirements of the EU 7th Amendment to the Cosmetics Directive, manufacturers of cosmetics
products will need to ascertain the safety of ingredients using non-animal methods. Starting in 2009, in vivo
genotoxicity tests for cosmetic ingredients will not be allowed. Skin is one of the target areas of interest for
many cosmetic produc...
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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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Development of a Novel Micronucleus Assay in the Human 3-D Skin Model, EpiDerm™
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 rodent in vivo micronucleus assay is an important part of a tiered testing strategy in genetic toxicology. However, this assay, in general, only provides information about materials available systemically, not at the point of contact, e.g. skin. Although in vivo rodent skin micronucleus assays are being developed, the results will still ...
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A Prevalidation Study on In Vitro Skin Corrosivity Testing
Published: January 1st, 2005 | Category: IIVS Publications
Source: ATLA 23, 219-255
The Report and Recommendation of ECVAM Workshop 6....
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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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DEVELOPMENT OF A MICRONUCLEUS ASSAY IN THE EPIDERMTM HUMAN 3D SKIN MODEL
Published: October 2nd, 2004 | Category: IIVS Publications
Source: Presented at the Environmental Mutagen Society Meeting, October 2-6, 2004, Pittsburgh, PA
To meet the requirements of the EU 7th Amendment to the Cosmetics Directive, manufacturers of cosmetics
products will need to ascertain the safety of ingredients using non-animal methods. Starting in 2009, in vivo
genotoxicity tests for cosmetic ingredients will not be allowed. Skin - because of its generally high exposure - is a
targ...
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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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THE IMPACT OF ETHANOL ON THE IN VITRO SKIN PENETRATION RATES OF CAFFEINE IN ENGINEERED SKIN CONSTRUCTS.
Published: March 1st, 2004 | Category: IIVS Publications
Source: Presented at Society of Toxicology 2004, March, 2003, Baltimore, MD,
The reference material, caffeine (prepared in ethanol), was evaluated in 3 in vitro models to compare the rates of skin
penetration in each of the models. The models were human donor skin, an engineered skin construct (MatTek Corporation,
Model EPI-606X) and slaughterhouse-derived pig skin. The tissues were mounted in flow-through diffusion cells...
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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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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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An investigation of new toxicity test method performance in validation studies: 1. toxicity test methods that have predictive capacity no greater than chance
Published: May 1st, 2002 | Category: IIVS Publications
Source: Human & Experimental Toxicology, 2002; 6: 305-312 (The PDF of this paper is intended for personal academic use only and should not be printed, downloaded or forwarded electronically. Please contact publisher if you require reprints or further usage of this paper: arnoldjournals@hodder.co.uk www.arnoldpublishers.com/journals)
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An approach commonly used to measure new toxicity test method (NTM) performance in validation studies is to divide toxicity results into positive and negative classifications, and then identify true positive (TP), true negative (TN), false positive (FP) and false negative (FN) results. After this step in completed, the contingent probability statis...
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An investigation of new toxicity test method performance in validation studies: 2. Comparison of three measures of toxicity test performance
Published: May 1st, 2002 | Category: IIVS Publications
Source: Human & Experimental Toxicology, 2002; 6: 313-323 (The PDF of this paper is intended for personal academic use only and should not be printed, downloaded or forwarded electronically. Please contact publisher if you require reprints or further usage of this paper: arnoldjournals@hodder.co.uk www.arnoldpublishers.com/journals)
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An area that requires further research is how best to measure test method performance in validation studies and how to set criteria that should be used to judge the adequacy of this performance. The studies reported here were designed to begin an investigation of these questions. Computer simulations were used to generate data sets similar to those...
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An investigation of new toxicity test method performance in validation studies: 3. Sensitivity and specificity are not independent of prevalence or distribution of toxicity
Published: May 1st, 2002 | Category: IIVS Publications
Source: Human & Experimental Toxicology, 2002; 6: 325-335 (The PDF of this paper is intended for personal academic use only and should not be printed, downloaded or forwarded electronically. Please contact publisher if you require reprints or further usage of this paper: arnoldjournals@hodder.co.uk www.arnoldpublishers.com/journals)
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Often, the only measures of toxicity test performance provided in validation studies are the contingent probability statistic (CPS) sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Sensitivity and specificity are generally used in preference to NPV and PPV since NPV and PPV are assumed to vary with cha...
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TOXICITY TESTS USED ONLY AS SCREENS STILL NEED CAREFUL VALIDATION
Published: March 1st, 2002 | Category: IIVS Publications
Source: Annual Meeting of the Society of Toxicology, 2002
New toxicity tests, especially in vitro tests, are often used as screens, i.e. they are used to preliminarily divide a test set of chemicals into positive or negative subsets. One of two strategies can then be applied. Either 1) the negatives can be accepted as correct and the presumed positives evaluated in a second tier
test, or 2) the positives...
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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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A prevalidation study on in vitro tests for acute skin irritation: results and evaluation by the Management Team
Published: January 1st, 2001 | Category: IIVS Publications
Source: Reprinted from Toxicology In Vitro, Vol. 15, pp. 57-93, 2001, with permission from Elsevier Science (ScienceDirect TM http://www.sciencedirect.com)
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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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Is it good enough? Objective assessment of toxicity test method performance in validation studies.
Published: November 30th, 1999 | Category: IIVS Publications
Source: Progress in the Reduction, Refinement, and Replacement of Animal Experimentation, M. Balls, A. -M. van Zeller and M. E. Halder. eds. The Netherlands, Elsevier Science
For several years, a great deal of work has been done to assess the validity of toxicity test methods. This effort has not only provided evaluations of several toxicity tests, but has also permitted researchers to substantially improve the validation process itself. Although approaches to the design and conduct of validation studies are now much cl...
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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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Validation of Alternative Methods for Toxicity Testing
Published: April 1st, 1998 | Category: IIVS Publications
Source: Environmental Health Perspectives 106 (suppl.2), 477-484
Before nonanimal toxicity tests may be officially accepted by regulatory agencies, it is generally agreed that the validity of the new methods must be demonstrated in an independent, scientifically sound validation program. Validation has been defined as the deonstration of the reliability and relevane of a test method for a particular purpose. Thi...
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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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A Practical Process for assessing the validity of alternative methods for toxicity testing
Published: January 1st, 1998 | Category: IIVS Publications
Source: In Dermatotoxicology Methods: The Laboratory Worker's Vade Mecum. F. N. Marzulli and H. I. Maibach., Washington, D.C. , Taylor & Francis:331-375
Please see attached document....
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The ECVAM International Validation Study on In Vitro Tests for Skin corrosivity. 2. Results and Evaluation by the Management Team
Published: January 1st, 1998 | Category: IIVS Publications
Source: Reprinted from Toxicology In Vitro, Vol. 12, pp. 483-524, 1998, with permission from Elsevier Science (ScienceDirect TM http://www.sciencedirect.com)
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The Validation of Toxicological Prediction Models
Published: January 19th, 1997 | Category: IIVS Publications
Source: ATLA 25, 505-516
An alternative method is shown to consist of two parts; The test system itself; and a prediction model for onverting in vitro endpoints into predictions of in vivo toxicity. For the alternative method to be relevant and reliable, it is important that its prediction model component is of high predictive power and is sufficiently robust against sourc...
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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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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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No Prediction Model, No Validation Study
Published: January 1st, 1996 | Category: Non-IIVS Publications
Source: ATLA 24, 139-142
There has recently been increasing interest in the development and validation of alternative methods that could be used in the place of in vivo toxicity tests. The goal is that a toxicologist will be able to test a substance by an alternative method, convert the results into correct predictions of toxic hazard and, ultimately, use the predic...
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The Role of Prevalidation in the Development, Validation and Acceptance of Alternative Methods
Published: January 1st, 1995 | Category: IIVS Publications
Source: ATLA 23, 211-217, 1995
Experience has shown that the outcome of large and expensive validation studies on alternative methods can be compromised if their managers do not insist that optimised test protocols and proof of their performance are submitted ,i>before the start of the formal validation study. One way for the sponsors of validation studies to confirm both th...
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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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