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Survey: "Acute Systemic Toxicity Testing – Exploring Waiving Opportunities"

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Oct 27, 2014
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With a view to reducing the need for animal testing in the assessment of acute systemic toxicity. Deadline: 30 Nov 2014

The European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) is responsible for coordinating and promoting the development and use of alternatives to procedures based on vertebrate animals, for example in the areas of basic and applied research and regulatory safety testing (1).

Accordingly, EURL ECVAM launched a survey entitled "Acute Systemic Toxicity Testing – Exploring Waiving Opportunities". It is addressed to experts in the field of toxicity testing and its aim is to explore whether and how it is possible to deduce acute systemic toxic effects from repeated dose studies, with a view to reducing the need for animal testing in the assessment of acute systemic toxicity.

The assessment of acute systemic toxicity is an important component in the safety evaluation of substances and represents a standard  information requirement within several pieces of EU legislation. This includes the Regulation on Classification, Labelling and Packaging (CLP) of substances and mixtures (2), the Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (3), the Biocidal Products Regulation (BPR) (4), the Plant Protection Products regulation (PPP) (5) and the Cosmetic Products Regulation (6).


Who should fill in this questionnaire?

This questionnaire is addressed to experts in the area of toxicity testing from authorities, academia, industry and other NGO's that are involved in the toxicological assessment of substances in the EU (either by carrying out the tests themselves or by analysing the data).  This survey builds on previous surveys carried out on this topic in the pharmaceutical sector (7) and other industrial sectors (8).

For more information and to fill in the survey, please go to this interactive questionnaire
Deadline: 30 November 2014


Background and study purpose

Currently, only in vivo tests are accepted by regulatory bodies to determine the acute systemic toxicity of substances administered by the oral, dermal or inhalational route. However, under REACH regulations it is possible to propose alternative, non-testing methods instead of in vivo tests, provided that adequate documentation and coverage of the standard parameters and observations are included in the dossier submitted for evaluation. The in vivo tests have been criticised both on scientific and ethical grounds and there is a real need to develop and validate alternative methods and assessment approaches that satisfy the regulatory requirements for acute systemic toxicity testing. This can be approached in a number of ways, one of which is to explore waiving opportunities in current testing protocols.

The upcoming deadline for REACH registrations for substances imported or manufactured between 10 - 100 tpy (Annex VIII) in 2018 may provide a potential scenario where waiving opportunities can be applied to increase testing efficiency and use less animals. Under Annex VIII repeated-dose 28 day studies are required in addition to acute systemic toxicity studies. In this survey we want to explore whether it is possible and feasible to deduce classification and labelling information (or acute LD50 values) from repeated dose studies.

 

How will the results be used?

The results from this questionnaire will feed into JRC projects that aim to explore non-testing methods and waiving opportunities for acute systemic toxicity testing. The information is provided in confidence. Individual responses will not be released. The aggregated data will be published in a JRC report on waiving opportunities for acute systemic toxicity testing. Respondents will be informed about the final results.

 

(1) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes. See also EURL ECVAM's mandate.
(2) European Commission (2008). Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. Official Journal of the European Union L353.
(3) European Commission (2008). Council regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to regulation (EC) no. 1907/2006 of the European Parliament and of the Council on the registration, evaluation, authorisation and restriction of chemicals (REACH). Official Journal of the European Union L142:1–739.
(4) European Union (2012). Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products. Official Journal of the European Union L 167, 1-116.
(5) European Commission (2009). Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. Official Journal of the European Union L309, 1-47.EC N° 1107/2009.
(6) European Commission (2009b). Regulation (EC) No 1223/2009 of the European Parliament and the Council of 30 November 2009 on cosmetic products. Official Journal of the European Union L342, 59-209.
(7) Robinson, S., Delongeas, J.-L-., Donald, E. et al., (2007) A European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development. Regul Toxicol Pharmacol 50, 345-352.
(8) Seidle, T., Robinson, S., Holmes, T. et al., (2010) Cross-sector review of drivers and available 3Rs approaches for acute systemic toxicity testing. Toxicol Sci 116(2), 382-396.