volume 31, no. 2 issn 1868-596x altex · volume 31, no. 2 issn 1868-596x 105-240 (2014) ... arise...

AltexVolume 31, No. 2ISSN 1868-596X105-240 (2014)

2/2014

AlterNAtIVeS to ANImAl eXperImeNtAtIoN

Jean Knight and Costanza rovida:Safety evaluations under the proposed US Safe Cosmetics and Personal Care Products Act of 2013: Animal use and cost estimates

Vanessa Ashall and Kate millar:endpoint matrix: a conceptual tool to promote consideration of the multiple dimensions of humane endpoints

CommentsWorkshop reportsCalendar of eventsCornersNews

Food for thought … Katy taylor,

Wolfgang Stengel, Carlotta Casalegno, and David Andrew:

experiences of the ReACH testing proposals system

to reduce animal testing

Food for thought … lena Smirnova, Helena

t. Hogberg, marcel leist, and thomas Hartung:

Developmental neurotoxicity –

Challenges in the 21st century and in vitro opportunities

p. Charukeshi Chandrasekera and John J. pippin:

Of rodents and men: Species-specific glucose

regulation and type 2 diabetes research

Editorial

Altex 31, 2/14U2

Dear readers,

It seems that some developments in the field of alternatives to animal experiments are going in diametrically opposed direc-tions right now. The image on this issue’s cover indicates how the proposed Safe Cosmetics and Personal Care Products Act would greatly increase animal testing for cosmetics ingredients in the US if it is passed, despite the EU finally banning all ani-mal testing on cosmetic ingredients and products last year. In the article this image illustrates, Jean Knight and Costanza Rovida have explored current numbers of animals used for cosmetics testing and different possible scenarios that could arise depending on the interpretation of the bill. A different bill, as reported in the News section, would completely ban ani-mal testing on cosmetic ingredients in the US. If this is passed instead it would likely lead to a worldwide end of animal ex-periments for cosmetic ingredients. In our News we also report that India and the state of São Paulo in Brazil have decided to follow the lead of the EU, Israel, and Norway to ban animal testing for cosmetics.

Another issue in which developments are going in different directions is experiments on primates. In the US two dozen companies, now including Merck & Co., have agreed to stop experiments on chimpanzees following last year’s announce-ment that the NIH will retire 90% of its chimpanzees. No great apes have been used for experimental purposes in the European Union since 1999 and the number of prosimians and non-human primates used for scientific purposes has decreased there as well (see ALTEX 31, 101). However, the German Federal Administra-tive Court has passed its final ruling permitting contentious macaque experiments in Bremen after a long legal battle. The wider implications of the court’s decision have led to the Ger-man Animal Welfare Federation pulling out of all ethics com-mittees and filing a complaint against the German state, as ex-plained by Ruhdel and colleagues in their Comment.

Katy Taylor and colleagues provide Food for Thought … on the experience of the European Coalition to End Animal Experiments (ECEAE) with third party commenting on REACH testing proposals. Although the legislation clearly states that animal experiments are to be performed only as “a last resort” and although it provides the possibility for third parties to identify existing data or alternative methods within a short timeframe, the enormous efforts of ECEAE to prepare such comments have generally been unsuccessful as the Euro-pean Chemicals Agency (ECHA) leaves the decision to the

registrant, although the registrant may choose to retract the testing proposal on the basis of the third party comments. In a Comment, Taylor also reports on a survey on the level of EU member state contribution to alternative methods as demanded by Directive 2010/63/EU, noting that numerous states provide no contribution or are unable or unwilling to provide informa-tion on their efforts.

Just before the DNT4 meeting in May, Lena Smirnova et al. contribute Food for Thought … discussing opportunities and challenges of developmental neurotoxicity testing. The increase in neurodevelopmental disorders may be related to environ-mental chemicals but to date only 150 substances have been tested in the rat assay that is very expensive both in terms of animal lives and money, and only five have been identified as DNToxicants. Therefore, there is a need for high-throughput in vitro strategies. Complementing this article, a Workshop Re-port by Crofton et al. describes efforts to produce a roadmap for developmental neurotoxicity testing for regulatory purposes.

The article by Chandrasekera and Pippin explores the value of diabetes research in rodent models by comparing data on glu-cose regulation in rodents and humans at all levels from gene expression to whole organisms. They conclude that the vast dif-ferences between the species at each level strongly support the development of models based on human cells and tissues.

In their Short Communication, Ashall and Millar introduce us to the concept of “unpredictable endpoints”, i.e., illnesses or accidents that are unrelated to experimental treatment, which they argue should be considered next to scientific and justifiable endpoints in the design of animal experiments to allow one to determine when animals should be taken out of experiments.

Corners and News as well as the Calendar with all 3Rs related events for the next months round off this issue and keep you up to date with new developments.

For your convenience the references for each article now in-clude digital object identifier (DOI) links. These are active links in the online versions of our manuscripts, posted on http://www.altex-edition.org, that lead you straight to the full pdfs of the referenced articles, although you will, of course, still have to pay to view articles from many other journals.

Please note that early registration for the 9th World Congress on Alternatives and Animal Use in the Life Sciences ends on May 31; authors will be notified of acceptance of their abstracts by May 15.

Hoping you enjoy reading this issue of ALTEX,

Sonja von AulockEditor in chief, ALTEX

Humane Science in the 21st Century

Scientifi c Program – draft March 2014I. New technologies Coordinators: Horst Spielmann, FU Berlin, Germany Mardas Daneshian, CAAT Europe, Konstanz, Germany1. Virtual tissue models2. High throughput screening models3. Big data4. Tissue on a chip/Human on a chip5. Novel 3D models6. Bioreactors7. High-content imaging8. Monitoring (telemetry)

II. Predictive Toxicology – Updates, Computational Approaches, Risk Assessment and Advances in Specifi c AssessmentsCoordinators: Nathalie Alépée, L’Oréal, Aulnay-sous-Bois, France Kevin Crofton, US EPA, Research Triangle Park, NC, USA Rodger Curren, IIVS, Gaithersburg, MD, USA Carl Westmoreland, Unilever, Sharnbrook, UK1. Pathway approaches in toxicology (e.g. AOP)2. Systems biology3. Updates on research programs around the world (e.g.

Tox21, ToxCast, EC FP6 & FP7 program, ARCH-Tox…) 4. Exposure5. Topical Toxicity6. Repeated dose toxicity7. Skin sensitization8. Endocrine disruption9. Reproductive and developmental toxicology10. Genotoxicity / Carcinogenicity 11. Inhalation toxicity 12. Ecotoxicology 13. Computational modeling and chem-informatics 14. Risk assessment (e.g. chemicals, drugs, biocides, food,

cosmetics, medical devices, nano-materials, mixtures, biologicals etc.)

15. Discussion session: Model based testing strategies and decision making

III. 3Rs in academia and educationCoordinators: Gilly Griffi n, CCAC, Ottawa, Canada Monika Schaefer-Korting, FU Berlin, Germany1. 3Rs in academic education, training programs and

anticipated needs 2. Funding agencies and funding programs (e.g. Horizon 2020) 3. Innovative teaching and training tools 4. Discussion session: Montreal Declaration IV. Communication, dissemination and data sharingCoordinators: Ursula Sauer, Scientifi c Consultancy Animal Welfare,

Neubiberg, Germany Horst Spielmann, FU Berlin, Germany1. Information requirements on project proposals

(e.g. Directive 2010/63) 2. Scientifi c reporting standards (in vivo and in vitro) 3. Retrospective analysis / non-technical summaries (2010/63) 4. Information systems and databases 5. Intellectual property rights

V. Effi cacy and safety testing of drugs and biologicals Coordinators: Belen Tornesi, AbbVie, North Chicago, IL, USA – IQ

consortium Tobias Schnitzer, Roche Diagnostics GmbH;

Penzberg, Germany – IQ consortium1. Pathway-based assays and screening strategies in drug

development2. Disease models in vivo3. Potency testing of human and veterinary vaccines4. Medical devices and biologicals

VI. Human RelevanceCoordinators: Tuula Heinonen, FICAM, Tampere, Finland Thomas Hartung, CAAT, Baltimore, MD, USA Mardas Daneshian, CAAT Europe, Konstanz,

Germany1. In vitro disease models 2. Use of stem cells in screening 3. Human biomarkers 4. Absorption, distribution, methabolism and excretion 5. Epithelial Biobarriers6. Discussion session: Pros and cons on animal models

VII. Ethics Coordinators: Katy Taylor, BUAV, London, UK Herwig Grimm, Messerli Inst., Vet. Med. U., Vienna,

Austria Roman Kolar, Animal Welfare Academy, Neubiberg,

Germany1. Ethical and normative aspects of human-based approaches2. Ethics of using animals3. Ethical evaluation4. Distress evaluation5. Benefi t evaluation

VIII. Refi nement and welfare Coordinators: Joanne Zurlo, CAAT, Baltimore, MD, USA Thierry Decelle, Sanofi Pasteur, Marcy L‘Etoile,

France – IQ consortium Mark Prescott, NC3Rs, London, UK1. Non-human primates2. Best practice welfare approaches / case studies3. Humane principles in experimental techniques4. Avoidance of severe suffering5. Culture of care6. Transgenics

IX. Global cooperation, regulatory acceptance and standardisation Coordinators: Chantra Eskes, SeCAM, Agno, Switzerland Hajime Kojima, JaCVAM, Tokyo, Japan Maurice Whelan, EURL ECVAM, JRC, Ispra, Italy1. Activity updates from international scientifi c societies2. Animal welfare implementation across the world3. Activity updates from international validation centres4. Novel approaches to validation5. Regulatory acceptance of alternatives6. Breaking down barriers and promoting international

cooperation on 3Rs

X. Free communicationsCoordinators: Horst Spielmann, FU Berlin, Germany Dagmar Jírová, National Institute of Public Health,

Prague, Czech Republic

The abstracts will be published in an international scientifi c journal focused on 3Rs with impact factor.

Keynote SpeakersOpening LectureLadislav MikoDeputy Director-General for the Food Chain in DG Health and Consumers European Commission, Brussels, Belgium

Pavel PocPresident of Animal Welfare IntergroupMember of European Parliament, Brussels, Belgium

CROs (Contract Research Organizations)Nancy GillettCorporate Executive Vice President & Chief Scientifi c Offi cer Charles River Laboratories, Wilmington, MA, USA

Drugs & Chemicals Michel GoldmanExecutive DirectorInnovative Medicines Initiative (IMI), Brussels, Belgium

US Program “Toxicology in the 21st Century” Robert J. Kavlock Deputy Assistant Administrator for Science Offi ce of Research and Development US EPA, Washington DC, USA

Animal Welfare Roman KolarDeputy Director Animal Welfare Academy, Neubiberg, Germany

“Human-on-a-chip”Uwe Marx Founder & Chief Scientifi c Offi cer TissUse GmbH, Berlin, Germany

Czech Republic – Ethics Marek Vácha Head of Department of Ethics Charles University, Prague, Czech Republic

Emerging CountriesHe ZhengmingDirectorNational Institutes for Food and Drug Control (NIFDC), Beijing, China

Congress Co-ChairsDagmar Jírová, Horst Spielmann

ACT MembersHerman Koëter, Acting Chairman, Secretary, Belgium Thomas Hartung, Treasurer, United States of America Michael Balls, United Kingdom Coenraad Hendriksen, Netherlands Andrew Rowan, United States of America Horst Spielmann, Germany CommitteesScientifi c Program CommitteeNathalie Alépée, L‘Oréal, FranceKevin Crofton, US EPA, United States of AmericaMiroslav Červinka, Charles University, Czech Republic

Mardas Daneshian, CAAT Europe, GermanyChantra Eskes, ESTIV, SwitzerlandTuula Heinonen, SSCT & ECOPA, FinlandHelena Kanďárová, SETOX & MatTek, Slovak RepublicHajime Kojima, JaCVAM, JapanRoman Kolar, Animal Welfare Academy, GermanyRobert Landsiedel, BASF, GermanyClive Roper, Charles River Laboratories, United KingdomHarald Schlatter, P&G, GermanyGilbert Schönfelder, ZEBET, GermanyCarl Westmoreland, Unilever, United KingdomMaurice Whelan, EURL ECVAM, JRC, Italy

Local Organizing CommitteeDagmar Jírová, National Institute of Public Health, Czech RepublicMiroslav Červinka, Faculty of Medicine, Charles University, Czech RepublicBarbora Večlová, Freedom for Animals, Czech RepublicLukáš Jebavý, Society for Science on Laboratory Animals, Czech RepublicRostislav Čihák, Center of Ecology, Toxicology and Analytics, VUOS, Czech RepublicHelena Kanďárová, MatTek In Vitro Life Science Laboratories, Slovak RepublicKristina Kejlová, National Institute of Public Health, Czech Republic

Congress SecretariatGUARANT International spol. s r.o.Na Pankráci 17, 140 21 Prague 4, Czech Republic Tel.: +420 284 001 444, fax: +420 284 001 448 E-mail: [email protected] Website: www.wc9prague.org

General InformationCongress VenueHotel Hilton Prague Pobřežní 311/1, 186 00, Prague 8 – Karlín, Czech Republic

Important Dates

Abstract submission deadline 15 April 2014Early Registration deadline 31 May 20149th World Congress on Alternatives & Animal Use in the Life Sciences

24–28 August 2014

RegistrationTo register, please use exclusively our internet registration form at www.wc9prague.org. Registration fees

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Full Participation € 530 € 580 € 635Full Participation-Students / Young Scientists*

€ 380 € 430 € 475

Accompanying Person € 300 € 350 € 390*Students / Young Scientists under 30 are eligible when presenting an offi cial confi rmation of enrolment at a scientifi c institution. The Full Participation includes: Admission to all scientifi c events and exhibition, the Opening and Closing Ceremony, the Get-Together Party on Sunday, the Welcome Reception on Monday, the Gala Dinner on Wednesday, coffee breaks and light lunches.

The registration fee for Accompanying Persons includes:The Opening and Closing Ceremony, the Get-Together Party on Sunday, the Welcome Reception on Monday, the Gala Dinner on Wednesday.

The registration fees do not include accommodation and travel costs.

AccommodationA number of hotel rooms at Hotel Hilton Prague and other nearby hotels has been reserved for the Congress participants.

For the best rates, please use exclusively our internet accommodation form at www.wc9prague.org

Social ProgramSunday, 24 August 2014Get-Together Party at Hotel Hilton Prague (included in the registration fee)Monday, 25 August 2014Welcome Reception at Public Spa (included in the registration fee)Wednesday, 27 August 2014Gala Dinner at Municipal House (included in the registration fee)

For more information on the scientifi c program, abstract submission, registration, hotel reservation and social program please visit our website: www.wc9prague.org.

9th World Congress on Alternatives and Animal Use in the Life Sciences24–28 August 2014 | Prague, Czech Republic | www.wc9prague.org

ACPD2014_inz175x272.indd 1 21.3.14 15:34

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2/2013

AlterNAtIVeS to ANImAl eXperImeNtAtIoNSimonetta Ferruzza, Carlotta

rossi, Yula Sambuy, and maria laura Scarino:Serum-reduced and serum-free media for differentiation of Caco-2 cells

t 4 report: Nina Hasiwa, mardas Daneshian, peter Bruegger, et al.:evidence for the detection

of non-endotoxin pyrogens by the whole

blood monocyte activation testt 4 workshop report:

tzutzuy ramirez, mardas Daneshian, Hennicke Kamp, et al.:Metabolomics in toxicology and preclinical

researchCommentConference report

Symposium reportWorkshop reportCalendar of events

CornersNews

Food for thought … thomas Hartung,

Sebastian Hoffmann, and martin Stephens:

Mechanistic validationFood for thought … martin paparella,

mardas Daneshian,

romana Hornek-Gausterer,

maximilian Kinzl, Ilse mauritz, and Simone mühlegger:

Uncertainty of testing

methods – What do we (want to) know?Si Wang, rené Houtman,

Diana melchers, Jac Aarts, Ad peijnenburg, rinie van Beuningen, Ivonne rietjens,

and toine Bovee:A 155-plex high-throughput

in vitro coregulator binding assay for

(anti-)estrogenicity testing evaluated

with 23 reference compounds

r-altex_2013_2_u1_u1_Titel.indd 1

14.4.2013 11:21:23 Uhr


3/2013

AlterNAtIVeS to ANImAl eXperImeNtAtIoNKarin Dreisig, Camilla taxvig, mia Birkhøj Kjærstad, Christine Nellemann, Ulla Hass, and Anne marie Vinggaard:Predictive value of cell assays for developmental toxicity and embryotoxicity of conazole fungicides

miriam N. Jacobs, Susan C. laws, Kate Willett, pat Schmieder, Jenny odum, and toine F. Bovee:In vitro metabolism and bioavailability tests for endocrine active substances: What is needed next for regulatory purposes?t4 workshop report:louise parks Saldutti, Bruce K. Beyer, William Breslin, et al.:In vitro testicular toxicity models: Opportunities for advancement via biomedical engineering techniques

CommentsWorkshop reporterratumCalendar of eventsCornersNews

Food for thought … thomas Hartung: look back in anger – what clinical studies tell us about preclinical work

Barae Jomaa, Jac m. m. J. G. Aarts, laura H. J. de Haan, Ad A. C. m. peijnenburg, toine F. H. Bovee, Albertinka J. murk, and Ivonne m. C. m. rietjens:In vitro pituitary and thyroid cell proliferation assays and their relevance as alternatives to animal testingSebastian polak:In vitro to human in vivo translation – pharmacokinetics and pharmacodynamics of quinidine

r-altex_2013_3_u1_u1_Titel.indd 1

9.7.2013 16:48:20 Uhr


4/2013


John m. Greally and miriam N. Jacobs:In vitro and in vivo testing methods of epigenomic endpoints for evaluating endocrine disruptors

t4 report:mardas Daneshian, luis m. Botana, marie-Yasmine Dechraoui Bottein, Gemma Buckland, mònica Campàs, Ngaire Dennison, robert W. Dickey, Jorge Diogène, Valérie Fessard, thomas Hartung, Andrew Humpage, marcel leist, Jordi molgó, michael A. Quilliam, Costanza rovida, Benjamin A. Suarez-Isla, Aurelia tubaro, Kristina Wagner, otmar Zoller, and Daniel Dietrich:A roadmap for hazard monitoring and risk assessment of marine biotoxins on the basis of chemical and biological test systems

Calendar of eventsCornersNews

Food for thought … thomas Hartung and

emanuela Corsini: Immunotoxicology:

Challenges in the 21st century and

in vitro opportunities

Stefan Schildknecht, Christiaan Karreman,

Dominik pöltl, liudmila efrémova, Cornelius Kullmann,

Simon Gutbier, Anne Krug, Diana Scholz, Hanne r.

Gerding, and marcel leist: Generation of

genetically-modified human differentiated cells for toxicological tests and

the study of neurodegenerative

diseases

Cameron macKay, michael Davies,

Vicki Summerfield, and Gavin maxwell:

From pathways to people: Applying the adverse

outcome pathway (AOP) for skin sensitization to

risk assessment

altex_2013_4_U1_U1_Titel.indd 1

28.10.2013 12:58:24 Uhr

AltexVolume 31, No. 1

ISSN 1868-596X

1-104 (2014)

1/2014


Cedric Blanc,

madeleine Zufferey, and

pierre Cosson:

Use of in vivo

biotinylated GSt fusion

proteins to select

recombinant antibodies

renata Grzywa,

Agnieszka Łupicka-Słowik,

maciej Walczak, magdalena

Idzi, Kamila Bobrek,

Stephane Boivin, Andrzej

Gaweł, tadeusz Stefaniak,

Józef oleksyszyn, and

marcin Sienczyk:

Highly sensitive

detection of cancer

antigen 15-3 using

novel avian

IgY antibodies

Workshop reports

Symposium reports

Calendar of events

Corners

News

Food for thought …

Joanne Zurlo

and eric Hutchinson:

Refinement

Kristine Kongsbak,

Anne marie Vinggaard,

Niels Hadrup,

and Karine Audouze:

A computational

approach to mechanistic

and predictive

toxicology of pesticides

Andrea Gissi,

Domenico Gadaleta,

matteo Floris, Stefania olla,

Angelo Carotti,

ettore Novellino,

emilio Benfenati, and

orazio Nicolotti:

An alternative

QSAR-based approach

for predicting the

bioconcentration factor

for regulatory purposes

altex_2014_1_U1_U1_Titel.indd 1

13.1.2014 17:37:43 Uhr

volume 31, no. 2 issn 1868-596x altex · volume 31, no. 2 issn 1868-596x 105-240 (2014) ... arise...

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