The Latest Issue of the PASPCR Newsletter Now Available Online
Published: August 5th, 2010 | Category: Whats New
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The latest issue of PanAmerican Society for Pigment Cell Research (PASPCR) is now available online. Dr. Gertrude-Emilia Costin, Study Director at IIVS, serves as Editor of the PanAmerican Society for Pigment Cell Research (PASPCR) Newsletter,which is published three times a year and is intended to serve as a regular means of communication for the m...
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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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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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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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The latest issue of the PASPCR newsletter now available online.
Published: December 3rd, 2009 | Category: Non-IIVS Publications
Source: PASPCR website
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The latest issue of PanAmerican Society for Pigment Cell Research (PASPCR) is now available online.
Dr. Gertrude-Emilia Costin, Study Director at IIVS, serves as editor of the PanAmerican Society for Pigment Cell Research (PASPCR) Newsletter which is published three times a year and is intended to serve as a regular means of communication for th...
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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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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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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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Vitamin D Therapy and its Effects on Human Vitiligo
Published: February 27th, 2009 | Category: IIVS Publications
Source: PubMed
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Dr. Gertrude-Emilia Costin, Study Director at IIVS, along with other co-authors has just published a paper titled "New insights on therapy with vitamin D analogs targeting the intracellular pathways that control repigmentation in human vitiligo". The article is available in the February 24th e-publication of the journal Medicinal Research Reviews. ...
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Australian Scientists Develop a 3-Dimensional Tissue Model
Published: August 25th, 2008 | Category: Press Releases
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Scientists at the Australian Institute of Health and Biomedical Innovation (IHBI) in Queensland have created a tissue construct for use in addressing cosmetic and personal care product testing concerns. The model is created using donated surgical off-cuts and was originally developed for use in wound healing studies. Existing tissue models are diff...
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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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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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Institute Update - March 2007 Newsletter
Published: April 20th, 2007 | Category: IIVS Publications
Take a look at our March 2007 newsletter: 3-D Human Skin Models – The Next Generation of Tools for the In Vitro Toxicologist, Society of Toxicology Annual Meeting, SAP Member Highlight - Dr. Marilyn Aardema, SkinInVitro 2007 Meeting, Development of Genotoxicity Assays in 3D Human Skin Models, CELEBRATING
10 YEARS!, POM Wonderful Suppo...
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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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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 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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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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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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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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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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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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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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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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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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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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New Epidermal Model for Dermal Irritancy Testing
Published: January 1st, 1994 | Category: IIVS Publications
Source: Reprinted from Toxicology In Vitro, Vol. 8, No. 5, pp.889-891, 1994, with permission form Elsevier Sciences. (ScienceDirect TM http://www.sciencedirect.com)
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