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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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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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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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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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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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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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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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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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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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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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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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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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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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