Beagle locked behind a fence.
Photo: Csaba Nagy, Pixabay.

The ECEAE (European Coalition for the End of Animal Experiments) argues⁽³⁾ that the initiative stands in stark contrast to the global scientific and ethical movement that advocates reducing animal testing and replacing these practices with modern, animal-free methods (NAM).

In particular, there are widespread efforts to end the use of animals such as dogs and primates in scientific research as quickly as possible. What is the current situation?

Claim: Happy ending for happy lab beagles?
The Swiss organization Doctors for Animal Welfare in Medicine compared some of the key statements of the EARA campaign with reality and concluded that an assessment of whether laboratory dogs are doing well or not can only be made if “unannounced” observations are carried out by outside parties. For example, in 2019, unbearable images were published from the German testing facility LPT in Hamburg-Neugraben showing beagles lying in their own blood and feces after tests for the Swiss company Inthera. The animals were not cared for but left to fend for themselves. The company has since been liquidated. Poor conditions were also found in Italy: the animal testing company Aptuit in Verona carries out animal experiments on behalf of pharmaceutical companies. Inspections revealed that dogs were kept in windowless, tiled rooms and suffered severe physical and psychological impairments. There are other cases like this, and the situation is no better in the US.

Claims of subsequent rehoming are also rare in reality, as most dogs are euthanized after the experiments are completed. In other cases, they are said to be unsocialized, which makes rehoming difficult.⁽²⁾

Experiments on dogs in research and development of drugs for human and animal diseases
According to ALURES ⁴⁾ (a database of the European Union that collects information on animal experiments), 14,368 experiments on dogs were carried out in 27 European member states, including Norway, in 2022.

In basic research, 1,304 dogs were used, for example, to study multisystemic diseases, the immune system, the urogenital tract, the reproductive system, the musculoskeletal system, and the gastrointestinal system in humans. In translational and applied research, 70% of the 4,933 dogs were used to study animal diseases and just under 5% of the animals were used for animal nutrition issues. The remaining 25% of the animals were used to study human diseases. In routine production, i.e., for antibody production, 891 dogs were used. For regulatory purposes, 7,061 dogs were used, with 5,130 dogs suffering in toxicity, safety, and pharmacological tests, over 50% of them in long-term studies (repeated administration or repeated dose) with repeated administration. This is to determine the “maximum tolerated dose,” which helps to determine the size of doses for human studies.⁽⁵⁾ In quality control, 511 dogs. 1,070 dogs were used for training, further education, and continuing education.

The article on the EARA website states: Dogs are used in biomedical research because they have certain similarities to humans—for example, in genetics, anatomy, and physiology—that are not found in almost any other animal.⁽⁵⁾ Duchenne muscular dystrophy is cited as an example—a genetic disorder in which the protein dystrophin, which is important for the heart and skeletal muscles, is missing. It occurs not only in humans but also in golden retrievers, e.g.⁽⁶⁾ Human heart problems are also often studied in cardiovascular studies on dogs because of the similarity in heart connection and size to humans.⁽⁵⁾

In the ICH (International Council for Harmonisation) guidelines for safety testing, dogs are often not explicitly mentioned as the second non-rodent species, but are rarely excluded as the second non-rodent species.

Biotechnologically produced drugs: Dog study may be misleading
The biological activity and species and/or tissue specificity of many biotechnologically produced drugs often preclude standard toxicity testing in commonly used species (e.g., rats and dogs). Therefore, for biotechnologically produced drugs, Prog safety assessments with “relevant” animal species should be provided. Toxicity studies in non-relevant species could be misleading and are therefore not recommended. A relevant species is “a species in which the test material is pharmacologically active due to the expression of the receptor or an epitope (in the case of monoclonal antibodies).” If no relevant species exists, the use of relevant transgenic animals expressing the human receptor or the use of homologous proteins should be considered.⁽⁷⁾

Cardiac toxicity studies and immunotoxicity studies including studies in dogs
ICH Guideline S 7 B, dogs are also considered in the non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human drugs in electrophysiological studies in addition to monkeys, pigs, rabbits, ferrets, and guinea pigs.⁽⁸⁾

The ICH Guideline S 8 directly mentions dogs in immunotoxicity studies for human drugs. A subordinate clause states that, in order to minimize variability in spleen weight in dogs and monkeys, it is recommended that the animals be thoroughly bled during necropsy.⁽⁹⁾

Guidelines S1B(R1) (Guidelines for the Testing of Substances for the Detection of Tumour Development), S9 (Guidelines for the Testing of Anticancer Agents), and S4 (Guidelines for Long-Term Studies) mention rodents such as mice and rats, but not dogs as a non-rodent species.^{(10, 11, 12)}

The second species in toxicity testing according to the European Chemicals Directive (REACH)
Repeated dose studies cover a wide range of toxicological studies lasting from 28 days of systemic toxicity to 2-year tumor development studies in a number of animal species. Systemic toxicity is assessed in rats and mice, and in some areas also in dogs.⁽¹³⁾

The non-rodent species commonly used in 90-day studies in chemical testing is the dog, often the beagle. At least 8 animals (four female and four male) should be used per dose level. (3 doses and 2 controls) = 5 x 8 = 40. If intermediate killings are planned, the number should be increased by the number of animals to be killed before the end of the study.⁽¹⁴⁾ Dogs are not really excluded from chronic studies (two years), but it is argued that a long-term study on dogs does not provide more information than a subchronic 90-day study.^{(15, 16)}

Plant protection products: 90-day study on dogs
Subchronic toxicity studies are usually studies involving repeated administration over a period of 13 weeks (90 days). The main purpose of subchronic testing is to identify any target organs and to establish dose values for chronic exposure studies. Repeated dose studies are generally conducted on at least two species, one rodent species (usually rats) and one non-rodent species (usually dogs), if the active substances are conventional and not microbial.^{(17, 1)}

While EARA acknowledges that dogs are often used for repeated dose testing to determine the maximum tolerated dose, the ECEAE clarifies that this is primarily due to regulatory requirements and not for scientific reasons, as dogs are not well suited for reliably predicting human toxicity due to species differences. An analysis of animal and human studies of more than 2,000 drugs has shown that the absence of toxic effects in dogs has virtually no predictive value for the absence of adverse effects in humans.⁽²⁾

Groundbreaking new animal-free methods
Regardless of the species differences, which cannot be ignored and which make the transferability of animal test results to humans questionable, especially in human medicine, the international trend is moving steadily toward animal-free methods.

These include in vitro, in chemico, and computer-assisted (in silico) methods, which, alone or in combination with other methods, contribute to improved substance safety assessment. In addition, there are analyses of quantitative structure-activity relationships (QSAR), high-throughput screening bioassays, so-called omics applications, microphysiological systems, machine learning models, and artificial intelligence.^{(18, 19)}

This is also recognized by European researchers, industry, and regulatory authorities, who are therefore working on ways to end testing on dogs, e.g., in chemical testing.

Toxicity testing: The second test species in drug and chemical testing is being put to the test
With regard to regulatory requirements, European stakeholders recommended clear milestones for reducing a certain percentage of animal testing within a specific timeframe in a roundtable consultation on the EU roadmap for the phase-out of animal testing in chemical testing. This should include the abolition of testing on a second animal species.⁽²⁰⁾

Regulatory authorities such as the European Medicines Agency are also addressing the issue: The European Medicines Agency's 3R Working Group has published its three-year plan for 2025–2027. Among other things, the plan is for the 3R Working Group to work with relevant international stakeholders to find ways to implement the use of only one animal species in regulatory safety studies instead of two.⁽²¹⁾

Projects in Europe and internationally
In the August 2022 issue of the EFSA-Journal, scientists from the European Food Safety Authority point out the weaknesses of animal testing due to low throughput, excessive resource requirements, limited understanding of the mechanisms behind the observed toxicity, and ethical reasons.⁽²²⁾ The dog was originally chosen as the second test species mainly because it was already widespread in the US in the 1950s and was available as a common laboratory breed.

* The European Partnership for Alternatives to Animal Testing (EPAA),⁽²³⁾ a consortium of industry and regulatory authorities, has launched a project to develop a cross-sectoral recommendation for the Commission's roadmap for the phasing out of vertebrate testing by eliminating the second test species for subchronic toxicity. This means that the elimination of dog testing could be examined first and, if appropriate, extended to the second species, rabbits, in the area of developmental toxicity.

* The Innovative Medicines Initiative (IMI), an EU-US public-private partnership promoting health research and innovation, is working with the London-based scientific organization NC3Rs to develop a virtual second species to replace testing on dogs. Using modern computer-based and mathematical modeling approaches, a series of virtual dog tissues and organs will be developed that can be used to model toxicological endpoints.⁽²⁴⁾

* The US Health and Environmental Sciences Institute (HESI), a non-profit institution, is working with other organizations to end dog studies in the safety assessment of agrochemicals. The aim is to develop a scientifically sound framework for eliminating 90-day dog studies.⁽²⁵⁾

Sources/literature:
⁽¹⁾ European Animal Research Association (EARA) (2025). Why are dogs used in biomedical research? https://www.eara.eu/why-dogs-are-used-in-research?mc_cid=a55fadb54f&mc_eid=f2a2553ea3
⁽²⁾ Ärztinnen und Ärzte für Tierschutz in der Medizin (2025). Hundeversuche.https://www.aerztefuertierschutz.ch/themen/hundeversuche
⁽³⁾ The European Coalition to End Animal Experiments (2025). https://www.eceae.org/?view=article&id=1669:eceae-refutes-campaign-of-animal-research-lobby-organisation-regarding-the-use-of-dogs-in-biomedical-research&catid=73
⁽⁴⁾ European Commission (2025). ALIRES - Animaluse Reporting System - EU Statistics Database on the Use of Animals for Scientific Purposes under Directive 2010/63/EU. https://webgate.ec.europa.eu/envdataportal/content/alures/section2_number-of-uses.html
⁽⁵⁾ https://www.eara.eu/why-dogs-are-used-in-research?mc_cid=a55fadb54f&mc_eid=6756585450
⁽⁶⁾ Generatio - Center for Animal Genetics (2025). https://generatio.de/ratgeber/lexikon/grmd-hund
⁽⁷⁾ International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) (2011). Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1). https://www.ich.org/page/safety-guidelines
⁽⁸⁾ International Conference on Harmonisation of Technical Requikrements for Registration of Pharmaceuticals for Human Use (ICH) (2005). The Non-Clinical Evaluation of the potential for Delayed Ventricular Repolarization (QT interval Prolongation) by Human Pharmaceuticals. S7B. https://www.ich.org/page/safety-guidelines
⁽⁹⁾ International Conference on Harmonisation of Technical Requikrements for Registration of Pharmaceuticals for Human Use (ICH) (2005). Immunotoxicity Studies for Human Pharmaceuticals. S8. https://www.ich.org/page/safety-guidelines
⁽¹⁰⁾ European Medicines Agency (2010) CPMP/SWP/1042/99 Rev 1 Corr*, 18 March 2010.
⁽¹¹⁾ International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) (1995).  Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals S1A. https://www.ich.org/page/safety-guidelines
⁽¹²⁾ International Conference on Harmonisation of Technical Requikrements for Registration of Pharmaceuticals for Human Use (ICH) (1998). Duration of Chronic Toxicity Testing in Animals (Rodent  and Non Rodent Toxicity Testing). S4. https://www.ich.org/page/safety-guidelines
⁽¹³⁾ European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) (2021). Guidance on Dose Selection. Technical Report No. 138. ISSN-2079-1526-138 (online)
⁽¹⁴⁾ OECD TG 409 (1998). Repeated Dose 90-day Oral Toxicity Study in Non-Rodents. https://www.oecd.org/en/publications/test-no-409-repeated-dose-90-day-oral-toxicity-study-in-non-rodents_9789264070721-en.html
⁽¹⁵⁾ OECD (2009), Draft Guidance Document on the Design and Conduct of Chronic Toxicity and Carcinogenicity Studies, Series on Testing and Assessment No. 116, available on the OECD public website for Test Guidelines: www.oecd.org/env/testguidelines.
⁽¹⁶⁾ OECD (2018). Test No. 453: Combined Chronic Toxicity/Carcinogenicity Studies. https://www.oecd.org/en/publications/test-no-453-combined-chronic-toxicity-carcinogenicity-studies_9789264071223-en.html
⁽¹⁷⁾ Organisation for Economic Co-operation and Development (OECD) (2002). OECD Environment, Health and Safety Publications Series on Testing and Assessment No. 32 and Series on Pesticides No. 10. Guidance Notes for Analysis and Evaluation of Repeat-Dose Toxicity Studies. 
⁽¹⁸⁾ Sewell F, Alexander-White C, Brescia S, Currie RA, Roberts R, Roper C, Vickers C, Westmoreland C, Kimber I. New approach methodologies (NAMs): identifying and overcoming hurdles to accelerated adoption. Toxicol Res (Camb). 2024 Mar 25;13(2):tfae044. doi: 10.1093/toxres/tfae044. PMID: 38533179; PMCID: PMC10964841.
⁽¹⁹⁾ Schmeisser S, Miccoli A, von Bergen M, Berggren E, Braeuning A, Busch W, Desaintes C, Gourmelon A, Grafström R, Harrill J, Hartung T, Herzler M, Kass GEN, Kleinstreuer N, Leist M, Luijten M, Marx-Stoelting P, Poetz O, van Ravenzwaay B, Roggeband R, Rogiers V, Roth A, Sanders P, Thomas RS, Marie Vinggaard A, Vinken M, van de Water B, Luch A, Tralau T. New approach methodologies in human regulatory toxicology - Not if, but how and when! Environ Int. 2023 Aug;178:108082. doi: 10.1016/j.envint.2023.108082. Epub 2023 Jul 4. PMID: 37422975; PMCID: PMC10858683.
⁽²⁰⁾ Walder L, Pallocca G, Bastos LF, Beekhuijzen M, Busquet F, Constantino H, Corvaro M, Courtot L, Escher B, Fernandez R, Gougeon E, Hansell L, Herzler M, Holden L, Hornek-Gausterer R, Irizar A, Kandarova H, Kern P, Kolle S, Lacasse K, Lee I, Macmillan DS, Maxwell G, Moriarty O, Nadzialek S, Pochat J, Reid K, Revel M, Ritskes-Hoitinga M, Sobanski T, Stoddart G, Underhill D, Veillette M, Vriend J, Westmoreland C, Baines J. EU roadmap for phasing out animal testing for chemical safety assessments: Recommendations from a multi-stakeholder roundtable. ALTEX. 2025 Mar 26. doi: 10.14573/altex.2503241. Epub ahead of print. PMID: 40266612.
⁽²¹⁾ European Medicines Agency, 3Rs Working Party. (2025). Consolidated 3-year rolling work plan for the Non-clinical domain 2025-2027. https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/3rs-working-party
⁽²²⁾ Panzarea M, Terron A, Coja T, Pelkonen O. Editorial: Relevance of dog studies for the derivation of health-based guidance values for plant protection products approval. EFSA J. 2022 Sep 22;20(9):e200923. doi: 10.2903/j.efsa.2022.e200923. PMID: 36188063; PMCID: PMC9495302.
⁽²³⁾ European Commission (2025). European Partnership for Alternative Approaches to Animal Testing. https://single-market-economy.ec.europa.eu/sectors/chemicals/european-partnership-alternative-approaches-animal-testing_en
⁽²⁴⁾ NC3Rs Innovation Platform - Exploiting 3Rs Technologies (2025). Challenge 40: Virtual Second Species. https://nc3rs.org.uk/crackit/virtual-second-species
⁽²⁵⁾ HESI Global (2025). Working Groups. Waiving Dog Studies in Agrochemical Safety Evaluations. https://hesiglobal.org/pbpk-models/