[OTDev] The Use of Alternatives to Testing on Animals for the REACH Regulation 2011
Asish Mohapatra amohapa at gmail.comFri Aug 19 19:20:16 CEST 2011
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http://www.euconf.eu/reach/en/registration/index.html There is a REACH conference on Sept 23rd 2011. This will be an opportunity for the Opentox to share more information on various initiatives. Sincerely, Asish On Fri, Aug 19, 2011 at 10:38 AM, Vedrin Jeliazkov < vedrin.jeliazkov at gmail.com> wrote: > Hi folks, > > An interesting report on the use of alternatives to testing on animals > for the REACH regulation has been published by ECHA on July 29th, > 2011. It can be downloaded from: > > http://echa.europa.eu/doc/117reports/alternatives_test_animals_2011_en.pdf > > Here are some important quotes and some further comments (prefixed > with VJ: and enclosed in square brackets): > > -- p. 14: "There are many research projects ongoing within and beyond > the EU that focus on replacement, reduction or refinement of animal > testing. Important examples within the EU are research initiatives > that have been launched in recent last years. These include the > development and optimisation of reproductive toxicology (Re-Pro-Tect; > 2004-2009), acute toxicity (A-Cute-Tox; 2004-2009), skin and > respiratory sensitisation (sens-it-iv; 2005-2010), carcinogenicity > (Carcinogenomics; 2006-2011), chronic toxicity (Predict-iv; 2008-2013) > and repeated dose toxicity (COLIPA-DG RTD Joint Research Initiative; > 2009). In the future, these research projects may deliver in the > future (sic) new approaches to combine different tests in the most > optimal way (testing strategies) for these endpoints. For more > details, please visit the ECVAM website." [VJ: note that neither > OpenTox, nor Cadaster are mentioned here; looks like we need to do > more to increase our visibility on ECHA's radar screen; I think that > this issue could be addressed best by the project coordinators in > cooperation with the scientific project officers] > > -- p. 15: "It has to be noted that the results of research projects > and new or refined methods based on those results can be used for > regulatory purposes once they are validated and adopted. In the area > of alternative methods to animal testing, such validations are > conducted according to internationally agreed principles. In Europe, > ECVAM is the responsible body for the validation of these methods, and > more internationally, the OECD plays a role. This process is rather > time consuming and may take years for a specific method to be > internationally validated and accepted for regulatory purposes." [VJ: > note that validation has a substantially different meaning in machine > learning and regulatory context (I intentionally avoid the discussion > here whether this is sound or not...); OpenTox addresses quite well > the validation in the machine learning sense, however AFAIK we haven't > done much yet on the ECVAM/OECD front -- again, this could be best > tackled by the project coordinator in cooperation with the scientific > project officer and authorised representatives of ECVAM/OECD. Last but > not least, ECHA acknowledges here that the "process is rather time > consuming and may take years for a specific method to be > internationally validated and accepted for regulatory purposes". This > should answer any concerns or criticisms regarding whether OpenTox > models have been validated and accepted for regulatory purposes -- in > the light of ECHA's standpoint on this, such validation is clearly > beyond the timeframe of the project and the competences/authority of > the project partners] > > -- p. 16: "The OECD QSAR Toolbox is an important tool for supporting > and enabling category building. ECHA actively contributes to the > further development of this Toolbox. This freely available software is > useful to group chemicals and apply read-across techniques for > assessing the (eco)toxicity hazards of chemical substances under > REACH." [VJ: would be nice to see ECHA endorse the OpenTox framework > at least to the same level as the OECD QSAR Toolbox, but I might be > asking for too much...again something that is probably achievable by > some joint efforts of the project coordinator and the scientific > officer] > > -- p. 16: "ECHA is collaborating with the JRC Computational Toxicology > Group in its mission to promote the availability for regulatory use of > valid computer-based methods, for example, QSARs, used for assessing > the intrinsic properties of chemical substances. More information, > including structured and peer-reviewed documentation of (Q)SAR models > and free access to JRC QSAR Model Database is available from the JRC > website." [VJ: would be nice to submit and see published some of the > relevant OpenTox models in the QMRF inventory, hosted by JRC and > available at http://qsardb.jrc.it/qmrf/] > > -- p. 16: "There are a number of promotion platforms and organisations > which actively contribute to the promotion and/or development of > alternative methods, e.g. the European Partnership for Alternative > Approaches to Animal Testing (EPAA), European Consensus-Platform for > Alternatives (ECOPA), and many others. The International Council on > Animal Protection in OECD Programmes, ICAPO is an international > organisation that develops guidelines and programmes for the testing > of chemicals. ICAPO is currently working with the Working Group of > National Co-ordinators of the Test Guideline Program, Task Forces on > Endocrine Disruptor Testing and and Existing Chemicals, including > (Q)SAR, and in the Validation Management Groups for Non-Animal testing > and for Mammalian testing. For the up-to-date progress in the > development of alternatives to animal testing the reader is referred > to the above listed organisations and their websites, which provide > useful information." [VJ: Might be a good idea to work on increasing > awarness of OpenTox results within those (and similar) organizations] > > -- p. 26: [VJ: Distribution of data sources for Acute Toxicity; read > accros 21.4%, QSAR 0.1% of the ESRs] > > -- p. 27: [VJ: Distribution of data sources for Skin irritation in > vitro; read across 11.9%, QSAR 0.0% of the ESRs] > > -- p. 28: [VJ: Distribution of data sources for Skin irritation in > vivo; read across 21.3%, QSAR 0.1% of the ESRs] > > -- p. 29: [VJ: Distribution of data sources for Eye irritation in > vitro; read across 7%, QSAR 0% of the ESRs] > > -- p. 30: [VJ: Distribution of data sources for Eye irritation in > vivo; read across 20.9%, QSAR 0% of the ESRs] > > -- p. 31: [VJ: Distribution of data sources for Skin sensitisation in > vivo; read across 20.8%, QSAR 0.5% of the ESRs] > > -- p. 33: [VJ: Distribution of data sources for Repeated Dose toxicity > (all routes and all durations); read across 28.1%, QSAR 0.1% of the > ESRs] > > -- p. 35: [VJ: Distribution of data sources for Genetic toxicity in > vitro; read across 22%, QSAR reported as 0% of the ESRs, but obviously > a typo/rounding error, since in fact 5 ESRs were based on QSARs > according to the same table] > > -- p. 36: [VJ: Distribution of data sources for Genetic toxicity in > vivo; read across 24.8%, QSAR 0% of the ESRs] > > -- p. 38: [VJ: Distribution of data sources for Toxicity to > reproduction; read across 23.8%, QSAR 0.1% of the ESRs] > > -- p. 39: [VJ: Distribution of data sources for Developmental > toxicity; read across 29.7%, QSAR 0.2% of the ESRs] > > -- p. 40: [VJ: Distribution of data sources for Carcinogenicity; read > across 27.9%, QSAR 0.2% of the ESRs] > > -- p. 42 : [VJ: Distribution of data sources for Bioaccumulation in > fish; read across 24.7%, QSAR 3.1% of the ESRs] > > -- p. 43: [VJ: Distribution of data sources for Toxicity to fish; read > across 20.2%, QSAR 2.1% of the ESRs] > > -- p. 44: [VJ: Distribution of data sources for Long term toxicity to > fish; read across 21.2%, QSAR 4.3% of the ESRs] > > -- p. 45: [VJ: Distribution of data sources for Long term toxicity to > birds; read across 6.4%, QSAR reported as 0% of the ESRs, but > obviously a typo/rounding error, since in fact 1 ESR was based on > QSARs according to the same table] > > -- p. 54: "When interpreting the findings of the ESR analysis, it > should be noted that in principle there may be deficiencies discovered > in the compliance check dossier evaluation work that result in further > animal studies being requested if the quality of either the > experimental data or the justifications for the adaptations in the > dossiers is discovered to be inadequate. This was found for > read-across approaches as well as for the options to omit the study. > These two approaches are identified in the current report as the main > options used by the registrants for higher tier tests if they did not > use experimental data or submitted a testing proposal." [VJ: looks > like read across is more likely to *delay* experimental tests through > administrative ping-pong plays, rather than completely avoid animal > testing in most of the cases] > > As you can see from the above statistics, QSARs are rarely used (if at > all) in endpoint study records. One reason for this might be that > published/validated models are usually trained on public data, while > in most cases companies have models trained on proprietary data that > capture somehow better the specifics of the chemicals they're dealing > with. It might be economically more advantageous to apply read-across > as a first step and consider other alternative methods or experiments > only if/when required by ECHA. It is also worth mentioning that the > OECD QSAR toolbox provides relatively good support for read-across. In > this context it is important to keep in mind that the low usage of > QSARs for REACH can hardly be attributed as a failure of a single > project like OpenTox, but is rather a much more generic issue which > has probably some scientific, regulatory, economic and cultural > aspects. > > Kind regards, > Vedrin > _______________________________________________ > Development mailing list > Development at opentox.org > http://www.opentox.org/mailman/listinfo/development >
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