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ECVAM News & Views

ECVAM News & Views ATLA 39, 113, 2011 113 tific and technical aspects of validation studies Meeting of the ECVAM Scientific based on PSs, and ECVAM’s approach to the Advisory Committee (ESAC) peer review of such studies. The ESAC also addressed a request from ECVAM concerning On 22–23 March 2011, the ECVAM Scientific the definition of PSs for two in vitro eye irrita- Advisory Committee (ESAC) met at the Joint tion assays: the Cytosensor Microphysiometer Research Centre in Ispra, Italy. The ESAC dis- and the Fluorescein Leakage test methods. Both cussed how its opinion, adopted in February were validated by ECVAM in 2009, and the draft 2011, on the prevalidation of three protocols of Test Guidelines are on the table of a forthcom- an in vitro cell transformation assay (CTA) ing OECD meeting (April 2011). However, for could be used to support further steps toward the Cytosensor Microphysiometer method, PSs the use of this assay in the assessment of the are an essential pre-condition for adoption of carcinogenic potential of substances. ECVAM is the draft Test Guideline. It was agreed that currently preparing, on the basis of the ESAC’s ECVAM would prepare the PSs, and the ESAC advice, a recommendation on the status of the would then peer review this work. CTA assay. In the meantime, the ESAC opinion In a brief exchange of views concerning the has already been transmitted to the OECD in recent Society of Toxicology conference, the February, in order to support discussions at committee agreed with ECVAM that future key OECD meetings in April, on, inter alia, the developments in toxicology may require alter- potential development of a Test Guideline based native approaches to validation, and expressed on this assay. interest in supporting ECVAM in such develop- The ESAC also started the preparation for the ments. peer review of three validation studies, and Finally, the ESAC was informed about the agreed on setting up dedicated ESAC Working ongoing and planned activities of ECVAM, and Groups charged with supporting the ESAC peer of the other validation bodies with which review. Two of the three studies concern test ECVAM cooperates in the context of the methods for skin sensitisation. These are: 1) an International Cooperation on Alternative ECVAM-coordinated prevalidation study on the Testing Methods (ICATM). The OECD observer Direct Peptide Reactivity Assay (DPRA), and 2) provided the committee with an update on an external prevalidation study on a cell-based developments in the OECD Test Guidelines pro- reactivity assay. The third one concerns an gramme, and the responsible Commission serv- ECVAM-coordinated study on the predictive ices summarised briefly the revised Directive capacity of the 3T3 NRU assay for identifying (2010/63/EU) on the protection of animals used substances that do not require classification as for scientific purposes. It was highlighted that acute oral toxicants under the UN Globally Harmonised System (GHS) and the EU the Directive firmly embeds the Three Rs prin- ciples into European legislation, and that Classification, Labelling and Packaging Regula - tion (EC) 1272/2008. ECVAM has now been legally mandated to act as the European Union Reference Laboratory for One session of the ESAC meeting was dedi- cated to detailed discussions on Performance the validation of alternative methods. Standards (PSs), including the emerging con- The next meeting of the ESAC is planned for cept of PS-based Test Guidelines (PBTGs), scien- 4–5 October 2011. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Alternatives to Laboratory Animals SAGE

ECVAM News & Views

Alternatives to Laboratory Animals , Volume 39 (2): 1 – May 1, 2011
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Publisher
SAGE
Copyright
© 2011 Fund for the Replacement of Animals in Medical Experiments
ISSN
0261-1929
eISSN
2632-3559
DOI
10.1177/026119291103900204
Publisher site
See Article on Publisher Site

Abstract

ATLA 39, 113, 2011 113 tific and technical aspects of validation studies Meeting of the ECVAM Scientific based on PSs, and ECVAM’s approach to the Advisory Committee (ESAC) peer review of such studies. The ESAC also addressed a request from ECVAM concerning On 22–23 March 2011, the ECVAM Scientific the definition of PSs for two in vitro eye irrita- Advisory Committee (ESAC) met at the Joint tion assays: the Cytosensor Microphysiometer Research Centre in Ispra, Italy. The ESAC dis- and the Fluorescein Leakage test methods. Both cussed how its opinion, adopted in February were validated by ECVAM in 2009, and the draft 2011, on the prevalidation of three protocols of Test Guidelines are on the table of a forthcom- an in vitro cell transformation assay (CTA) ing OECD meeting (April 2011). However, for could be used to support further steps toward the Cytosensor Microphysiometer method, PSs the use of this assay in the assessment of the are an essential pre-condition for adoption of carcinogenic potential of substances. ECVAM is the draft Test Guideline. It was agreed that currently preparing, on the basis of the ESAC’s ECVAM would prepare the PSs, and the ESAC advice, a recommendation on the status of the would then peer review this work. CTA assay. In the meantime, the ESAC opinion In a brief exchange of views concerning the has already been transmitted to the OECD in recent Society of Toxicology conference, the February, in order to support discussions at committee agreed with ECVAM that future key OECD meetings in April, on, inter alia, the developments in toxicology may require alter- potential development of a Test Guideline based native approaches to validation, and expressed on this assay. interest in supporting ECVAM in such develop- The ESAC also started the preparation for the ments. peer review of three validation studies, and Finally, the ESAC was informed about the agreed on setting up dedicated ESAC Working ongoing and planned activities of ECVAM, and Groups charged with supporting the ESAC peer of the other validation bodies with which review. Two of the three studies concern test ECVAM cooperates in the context of the methods for skin sensitisation. These are: 1) an International Cooperation on Alternative ECVAM-coordinated prevalidation study on the Testing Methods (ICATM). The OECD observer Direct Peptide Reactivity Assay (DPRA), and 2) provided the committee with an update on an external prevalidation study on a cell-based developments in the OECD Test Guidelines pro- reactivity assay. The third one concerns an gramme, and the responsible Commission serv- ECVAM-coordinated study on the predictive ices summarised briefly the revised Directive capacity of the 3T3 NRU assay for identifying (2010/63/EU) on the protection of animals used substances that do not require classification as for scientific purposes. It was highlighted that acute oral toxicants under the UN Globally Harmonised System (GHS) and the EU the Directive firmly embeds the Three Rs prin- ciples into European legislation, and that Classification, Labelling and Packaging Regula - tion (EC) 1272/2008. ECVAM has now been legally mandated to act as the European Union Reference Laboratory for One session of the ESAC meeting was dedi- cated to detailed discussions on Performance the validation of alternative methods. Standards (PSs), including the emerging con- The next meeting of the ESAC is planned for cept of PS-based Test Guidelines (PBTGs), scien- 4–5 October 2011.

Journal

Alternatives to Laboratory Animals – SAGE

Published: May 1, 2011

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