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EU adoption of alternative method is too slow

The EU REACH Committee last week approved a further six new test methods for use for safety testing of chemicals. The new methods will appear in EU Test Method Regulation in what will be the 5th ‘adaptation to technical progress’.

One of the methods to be approved is the Extended One Generation Reproductive Toxicity Study (EOGRTS) which is seen by many to be a replacement for the two generation reproductive toxicity test that uses a minimum of 2200 animals, usually rats[1]. The EOGRTS is still an animal test but uses fewer animals because, if not ‘extended’, only one generation is bred. Estimates of the saving in animals vary as different strains of rat produce different numbers of pups, but our estimate is that a minimum of 960 animals would be used in an EOGRTS, saving 40% of animals[2].

The method has taken years to be accepted because EU member states disagree over whether it can, and should, replace the two generation test. Several scientific reviews have shown that there is no ‘added value’ to producing a second generation of animals[3]. If a substance is harmful then effects are almost always seen in the first generation. The BUAV has been disappointed to see some countries fail to trust the strong scientific evidence.

The BUAV is pleased to see potential savings of hundreds of animals but is frustrated that the decision is that the REACH legal text also has to be revised before these animal savings can be realised. Already it is nearly eight years since the reduced animal method test was first published[4], so hundreds of thousands of animals will have been needlessly used whilst regulators have deliberated.

We are also disappointed since this update appears to have comparatively fast tracked a new animal test (transgenic rodent somatic and germ cell gene mutation assay or TGR) that uses Big BlueÒ and MutaäMouse genetically modified rats or mice and actually uses more animals than the existing animal test.[5]

We are also disappointed that this update also includes three other new animal tests and one in vitro (non animal) test, none of which are specifically required under the REACH legislation.

A number of in vitro tests that are relevant for REACH and would reduce animal numbers are waiting for EU approval. These include:

·         Revised ex vivo eye irritation tests (BCOP TM.47and ICE TM.48) that now allow avoidance of the rabbit test to detect non irritants (revised by OECD 26 July 2013)

·         Revised in vitro skin corrosion methods (TG 430 and TG 431)that now allow sub classification of corrosive substances (revised by OECD 26 July 2013)

Testing strategies for these animal tests also need to be revised or produced in line with OECD guidance and annexes to these test methods to help show companies on how to use these tests to totally avoid animal testing in these cases.

We disagree with the Commission’s process of waiting for OECD approval before accepting in Europe as this slows acceptance down and confuses industry as to the point at which they should use the new methods (OECD approval or Test Methods Regulation?). For example, the new in vitro methods that can replace skin sensitisation tests in mice are going through the OECD process now rather than through the EU.

Even after OECD publication of new or revised test methods, the bureaucratic process of putting them in the Test Methods Regulation has typically taken at least 18 months; an unnecessary hurdle to the replacement of animal testing. Worryingly, the process seems to be slowing down even further; the last published amendment was a full two years after OECD adoption[6]. And, the 4th Adaptation to Technical Progress, voted in favour on 6th September 2013, has not yet been officially published and includes revisions of animal tests that use fewer animals that were approved by the OECD in 2009![7]

The Commission announced a ‘revised streamlined procedure’ in 2009 to fast track alternative method but this does not seem to be being followed. The Commission simply must do more to prioritise the approval of non-animal methods that are able to replace animal tests.

[1] Our estimate based on the instructions within the OECD guideline 416.

[2] Our estimate based on the instructions with the OECD guideline 443.

[3] Janer, G. et al. A retrospective analysis of the two-generation study: What is the added value of the second generation? Reproductive Toxicology 24 (2007) 97–102. And Reuter U. et al. Evaluation of OECD screening tests 421 (reproduction/developmental toxicity screening test) and 422 (combined repeated dose toxicity study with the reproduction/developmental toxicity screening test). Regulat Toxicol Pharmacol 2003;38:17–26. And Myers DP. Et al. An analysis of the results from two-generation reproduction toxicity studies to assess the value of the second (F1) generation for the detection of adverse treatment-related effects on reproductive performance. Reprod Toxicol 2008, 26: 47-50.

[4] Cooper RL. Et al. A tiered approach to life stages testing for agricultural chemical safety assessment. Crit Rev Toxicol 2006;36:69–98.

[5] The TGR uses a minimum of 25 animals and was adopted by the OECD firstly in 28 July 2011 (revised in 26 July 2013), it is preferred by regulators in place of the UDS test which uses 12 animals.

[6] For example, the in vitro mammalian cell micronucleus test, which is an improved in vitro genotoxicity test was approved by the OECD on 23rd July 2010 but was not published in the 3rd ATP Test Methods until 6th July 2012. Similarly, the revision to the local lymph node assay for skin sensitisation that uses fewer mice was published by the OECD on 23rd July 2010 but was not published in the 3rd ATP Test Methods until 6th July 2012.

[7] Revised B.2. ACUTE INHALATION TOXICITY  to use fewer animals (replacement of LC50 with Cxt method) and new B.52. ACUTE INHALATION TOXICITY - ACUTE TOXIC CLASS METHOD (replacement of LC50 with acute toxic class method), revised  and created by the OECD in 8th September 2009


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