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Volume 14 Issue 2

IIVS signs MOU with China FDA to Promote Non-Animal Testing Methods in China 

 

IIVS recently signed a Memorandum of Understanding (MOU) with the National Institute for Food and Drug Control (NIFDC), a subordinate agency of the China Food and Drug Administration (CFDA). According to the memorandum, the two organizations will work collaboratively on a number of projects focused on cosmetic safety testing designed to promote in vitro (non-animal) technologies in China.

 

The MOU was signed by Dr. Wang Youchun, Deputy Director General of the NIFDC, and Erin Hill, Co-founder and Vice President of IIVS. "The NIFDC has a great responsibility to introduce in vitro techniques to a large number of regulators within China" states Ms. Hill. "IIVS is honored to assist them in achieving this goal. Our expertise in validation projects will also be helpful as new in vitro methods are developed within China."  Read the complete press release here on the IIVS website.

SCIENCE
The Reconstructed Skin Micronucleus Assay          

     

Why do we need a new genetox assay? A number of non-animal test methods exist for genotoxicity testing and, in fact, several were among the first in vitro assays standardized for regulatory approval. These methods, e.g. the Ames assay, Mouse Lymphoma Assay, and in vitro Micronucleus test, are well characterized and understood, have been included in many publications, and are used by regulatory agencies throughout the world. They are often the first step in the genotoxicity testing of cosmetic ingredients. However, these tests are very sensitive and are known to often provide "false," or misleading, positive results. Since this high false positive rate is well known, if initial tests show the material is potentially genotoxic, many companies perform further investigations using animal-based genotoxicity assays which are less likely to produce false positive results.

 

However, the EU's 7th Amendment to the Cosmetics Directive, effective as of March 2009, prohibits the use of in vivo genotoxicity assays to assess the safety of cosmetic ingredients. Thus many ingredients that are safe might be unavailable for use in cosmetics because they were deemed "positive" in the first tier in vitro battery and cannot be retested in the less sensitive animal assay. Developing a new in vitro genotoxicity assay that is more predictive of human response and is relevant to cosmetics use became extremely important.

                                                             

This line of investigation led to the development of the Reconstructed Skin Micronucleus Assay (RSMN) by IIVS and the Procter & Gamble Company.  

 

In the RSMN, the test material is dosed onto the topical surface of a three dimensional human skin tissue construct (EpiDermTM, MatTek Corporation, Ashland, MA), similar to the way a human cosmetic user might be exposed through skin application. After treatment and a suitable time for cell recovery, cells are collected by trypsinization of the tissues. By exposing the tissue to cytochalasin B (a cytokinesis blocker) along with the test material, actively dividing basal cells within the EpiDerm tissue can be identified as binucleated cells, i.e. proof that they have undergone a nuclear division. These binucleated cells are evaluated microscopically to identify micronuclei that result from DNA damage. This protocol is similar to a previously used rodent skin micronucleus method (Nishikawa et al. 2005 Mutat. Res. 588: 58-63).  

 

IIVS is participating - along with partners which have included the Procter & Gamble Company, BioReliance, and L'Oreal - in a prevalidation of the assay sponsored by Cosmetics Europe. Previously the assay had been shown to have good intra- and inter-laboratory reproducibility. Current efforts focus on evaluation of a broad range of chemicals, e.g. expanding the database to include substances which require metabolic activation. Twenty eight chemicals have been tested thus far and data review is currently underway.  

  

Because the assay has shown initial promise, IIVS has worked with scientists from the FDA/OFVM/CFSAN/OARSA/DT to provide them with technical training. Scientists from the Center for Food Safety and Applied Nutrition (FDA CFSAN)* visited IIVS for several days to receive hands-on training on our protocol for the method. The FDA scientists have since been able to set-up their own laboratory (based on our specifications), and worked our protocol into an internal SOP for the method. Their early work has also been promising indicating that they were able to successfully transfer the method into their laboratory.  

*FDA does not endorse or recommend the RSMN assay and notes that the assay is being used for research purposes in one of their laboratories.

  

If you are interested in learning more about the micronucleus assay, please join us for our upcoming webinar by following the link above. The webinar is free to attend, but registration is required.

 

EDUCATION
International Training Program Presented in Vietnam
 
IIVS Study Director Nathan Wilt Demonstrating the BCOP Assay
N.Wilt demonstrates the BCOP assay at the MOH laboratory in Vietnam. 

While many countries have implemented in vitro methods to determine the safety of cosmetic and personal care products, some still rely heavily on animal testing. Recently some of these countries have shown an interest in moving toward more predictive and relevant in vitro test methods. There is a particular interest in adopting those methods that have been evaluated and deemed acceptable by the Organization for Economic Cooperation and Development (OECD). Often, laboratories and government regulators require training in the science behind in vitro methods, and help in understanding how to interpret the data from these new systems. Recognizing this need, IIVS works with a variety of collaborators to help fund its training programs aimed at assisting these countries in the adoption of in vitro methods.


Recently, IIVS scientists traveled to Ho Chi Minh City, Vietnam to visit the Ministry of Health (MOH). IIVS Study Directors, Allison Hilberer and Nathan Wilt, met with with the Directors and employees of MOH for introductory lectures and hands-on training on the Bovine Corneal Opacity and Permeability (BCOP) assay, an in vitro method to assess eye irritation. The laboratory and lecture work also included discussion of specific case studies that will provide practical knowledge for the MOH group to use during their post-market testing of a number of different product types.

This was the first experience that many of the participants had with the BCOP assay. The group, largely from the pharmacology department, showed good laboratory techniques and were eager to begin implementing the method on their own. The trip was funded by Cruelty Free International (CFI). Attending on behalf of CFI was Nick Palmer, who also gave a presentation on the use of non-animal testing. A critical piece of equipment for the assay was generously donated by BASF. IIVS will continue to provide support to the Vietnam MOH group as they begin to utilize the BCOP assay in their laboratory.
        
OUTREACH
IIVS Provides Training During the Second Annual Guangzhou Alternatives Conference 

 

IIVS Study Director Observes Trainees During Performance of the BCOP Assay
A. Hilberer supervises cornea isolation during the Guangzhou Alternatives Conference. 

The 5 day conference, organized by Dr. Shujun Cheng of the Guangdong Inspection and Quarantine Bureau (GCIQ), provided lectures on in vitro techniques to over 90 participants from industry and the Chinese regulatory community. An essential component of the meeting was to provide hands-on training in a variety of methods for roughly 20 attendees. IIVS scientists, funded by a grant from the Humane Society International, The Humane Society of the United States and the Human Toxicology Project Consortium, provided training on the BCOP and 3T3 Photoxicity Assay. Scientists from the CIQ provided training on the CAMVA assay and L'Oreal introduced skin irritation testing with their 3D tissue construct.  

 

Dr. Zhang presents non-animal test methods for ocular irritation testing to scientists in Japan and Taiwan. 

Following the training in China, IIVS Senior Scientist, Dr. Quanshun Zhang, traveled with Humane Society International (HSI) representatives to address law makers in Japan and Taiwan. The goal of these meetings was to give policy makers a global perspective on the legislative, scientific and corporate efforts regarding the use and acceptance of non-animal testing methods.

 

 
Recent Publications
The Role of the Study Director in Nonclinical Studies

IIVS' Gertrude-Emilia Costin and Hans Raabe recently co-authored the chapter "In Vitro Toxicology Models" in the book The Role of the Study Director in Nonclinical Studies: Pharmaceuticals, Chemicals, Medical Devices, and Pesticides edited by William J. Brock, Barbara Mounho, and Lijie Fu and published by Wiley. More information about the book can be found on the Wiley publishing website.





Handbook of Toxicology

Hans Raabe served as co-author with industry consultant Dr. John Harbell for a chapter in the third edition  of the Handbook of Toxicology titled "In Vitro Methods for the Prediction of Ocular and Dermal Toxicity" edited by Michael J. Derelanko and Carol S. Auletta and published by CRC Press. More information about this book can be found on the CRC website
Upcoming Events
July 24-25, 2014 
Zurich, Switzerland

July 31, 2014 
IIVS Webinar

August 24-28, 2014 
Prague, Czech Republic

August 31, 2014 
St. Petersburg Russia

September 3-5, 2014 
Bethesda, Maryland, USA

September 5, 2014 
Newcastle University, UK

September 7-10, 2014 
Edinburgh, UK

September 22, 2014 
Athens, Greece

September 25-26, 2014 
Washington, D.C., USA

September 29-30, 2014 
Durham, North Carolina, USA 


News
Dr. Holger Behrsing Joins IIVS

IIVS is pleased to announce the addition of Dr. Holger Behrsing as Principal Scientist. Dr. Behrsing will largely be responsible for developing and optimizing in vitro methods for the new inhalation toxicology program at IIVS. IIVS is expanding its expertise to meet the growing needs of the chemical, consumer and household products industries, for industrial hygiene support, and anticipated tobacco product regulatory requirements for inhalation and respiratory toxicology. In addition to developing laboratory programs, Dr. Behrsing will liaise with stakeholder groups to coordinate technical workshops and symposia to explore the use of in vitro methods for inhalation toxicology purposes.

 
Dr. Behrsing completed his doctoral degree in Pharmacology and Toxicology at the University of California, Davis and subsequently accepted a post-doctoral appointment at SRI International where he developed ex vivo liver and lung slice technologies. Dr. Behrsing joined SAIC-Frederick (now Leidos Biomedical) to lead the Predictive Toxicology Laboratory where he facilitated transfer of the slice technology to the NCI and developed a range of in vitro models to test chemotherapeutic agents. Dr. Behrsing has expertise establishing and working with a variety of cell lines, primary cells, and tissues including those of human origin.  We look forward to Dr. Behrsing's contributions in applying novel endpoint methods to complement our considerable cell and tissue culture platforms.  

 

 

IIVS Vice President H. Raabe Elected President of the SOT IVAM  
    

The In Vitro and Alternative Methods Specialty Section (IVAM) of the Soceity of Toxicology (SOT) promotes the reduction and humane use of animals in toxicology research by encouraging of the development and validation of effective in vitro and alternative methods and models.

 

To this end, its objectives are: to encourage widespread use of in vitro and alternative methods to reduce, refine and replace animal testing in toxicology; increase effectiveness of in vitro and alternative methods through emphasis on predictability and validation; inform and encourage the growth of in vitro and alternative methods through programs and educational activities on current and new developments; and serve as a resource to the Society of Toxicology and its members pertaining to all aspects of in vitro and alternative methods.

 

Further details may be found on the IVAM website.  

August 24-28, 2014
Prague, Czech Republic

Join IIVS staff at our booth, view our recent research and activities in the poster sessions, and participate in a demonstration of in vitro methods at WC9.
Visit our Upcoming Meetings page for more details.

     

Would you like to learn more about in vitro skin sensitization assays? Send us an email at
 +1 301 947 6523 
 
 
Dr. Emilia Costin of IIVS will present "A New Non-animal Based, Hazard Identification Strategy for Ocular Irritation of Anti-microbial Cleaning Products". For more information on testing strategies for cleaning products, please contact Dr. Costin at ecostin@iivs.org.

 

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Online Forum:

Skincare Ingredients 2014   
 
IIVS President Dr. Rodger Curren gave a presentation on the regulatory status of animal testing on cosmetics in China during this online event. The presentation was followed by a live Question and Answer session. If you missed the free conference, please contact us for the latest information on alternative methods in China.


 
Nominations are Open for the 2014 LUSH Prize

 The LUSH prize supports animal-free testing by awarding prizes totaling 250,000 annually. Nominations are now open and entries are invited in the categories of science, lobbying, training and public awareness in alternatives to animal use. Prizes are also available for young scientists. Please consider nominating IIVS or another worthy group in one of these categories. The closing date for nominations is Friday, July 25th.  
Visit the LUSH Prize website for more information. 

September 3-5, 2014
Bethesda, MD


The National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the Physicians Committee for Responsible Medicine (PCRM) will cosponsor a scientific workshop on "Adverse Outcome Pathways: From Research to Regulation." The workshop proposes to explore and discuss how interaction and collaboration among stakeholders can be initiated and maintained so that scientific progress in adverse outcome pathway (AOP) concepts may improve regulatory assessment of chemical toxicity. The Society of Toxicology endorses this workshop.
Please visit the website for registration information.  
  

Hepatic metabolic clearance plays a key role in the transformation and the elimination of chemicals from the human body. Recently, various in vitro methods for human hepatic metabolic clearance/stability have been developed. Through this survey EURL ECVAM hopes to identify in vitro human hepatic metabolic clearance/stability methods, which can contribute to the development of harmonized standards and associated international toxicokinetic test guidelines. Keep an eye on the EURL ECVAM website
for the results of this survey.  

ASCCT Banner

American Society for Cellular and

Computational Toxicology

 

Save the Date!

3rd Annual ASCCT Meeting

November 12, 2014

Lister Hill Auditorium

NIH Campus,  

Bethesda, MD 


Where Chemistry and Biology Meet: AOPs as a Framework for Advancing Toxicology

Plenary Lecturer:
Robert Kavlock, US EPA

Registration available soon at the

 

 

  Next Webinar: 

 

July 24, 2014

11:00 US ET

 

Threshold of Toxicological Concern - an Approach for Safety Assessment and its Applicability to Cosmetics-related Chemicals

 

presented by:  

Dr. Chihae Yang

Altimira, LLC and

Molecular Networks 

 

In cooperation with the COSMOS project we will also offer this webinar to the general public. Registration is not required. Visit the ASCCT website for information on how to access the webinar.


www.ascctox.org