Annex B. RPA analysis of the cost of testing and (Q)SARs based on data from the European Chemicals Agency’s Registration Database
The European Chemicals Agency (ECHA) has undertaken analyses of new substances and existing substances registered under the REACH Regulation in the European Union to determine the extent to which the following have been used to fulfil information requirements for each (eco)toxicological endpoint:
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new experimental studies
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old experimental studies
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proposals for new experimental studies
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read-across
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(Quantitative) Structure-Activity Relationship [(Q)SAR]
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weight of evidence.
Data for the period up to March 2016 on the number of new and existing substances completing their data requirements via each of the above routes is described in the report entitled The Use of Alternatives to Testing on Animals for the REACH Regulation (ECHA, 2017).
Table B.1 provides a breakdown of the costs by endpoint. It also provides data on the average costs of new experimental studies drawn from the Risk & Policy Analysts Limited (RPA)’s in-house database of testing costs and the number of animals required to undertake tests.
These data have been used to derive estimates of the statistical average costs of new experimental studies and costs avoided owing to (Q)SARs via the OECD (Q)SAR Toolbox. These are provided in Table B.2.
For new industrial chemicals, costs are based on actual numbers of tests and (Q)SARs undertaken for new industrial chemicals registered in the EU and the average costs of experimental studies (as in Table B.1). In terms of costs avoided owing to (Q)SARs, it has been assumed that in the absence of a valid (Q)SAR or read-across, a new experimental study would be undertaken for all endpoints except the most expensive ones, namely repeated dose toxicity – all routes, carcinogenicity, toxicity to reproduction and developmental toxicity. For these endpoints it has been assumed that new experimental studies would only be carried out in 10% of cases where no (Q)SAR was available.
REACH requires different levels of information for substances manufactured or imported at different tonnages. As such, the level of information required for a given endpoint will differ from one tonnage to the next. Data from the European Chemical Agency’s Registration Database (available at https://echa.europa.eu/information-on-chemicals/registered-substances) have been analysed to identify the number of substances requiring different levels (and costs) of individual tests (where they are required). These have been used to develop a statistical cost of new experimental studies and cost avoided by using (Q)SARs/read-across (employing the same assumptions above on the most expensive test endpoints in the absence of (Q)SARs/read-across).
References
ECHA (2017), The Use of Alternatives to Testing on Animals for the REACH Regulation, Third report under Article 117(3) of the REACH Regulation, European Chemicals Agency, Helsinki, https://www.echa.europa.eu/documents/10162/13639/alternatives_test_animals_2017_en.pdf/075c690d-054c-693a-c921-f8cd8acbe9c3.
Van der Jagt, K. et al. (2004), “Alternative approaches can reduce the use of test animals under REACH”, Addendum to the report “Assessment of additional testing needs under REACH: Effects of (Q)SARS, risk based testing and voluntary industry initiatives”, European Communities, Italy, http://publications.jrc.ec.europa.eu/repository/bitstream/JRC29111/EUR%2021405%20EN.pdf.