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
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