- Animal welfare
refers to studies as per Article 5(b)(iii) of Directive 2010/63/EU.
- Animals born at an authorised breeder in the Union
refers to animals born at breeders authorised and registered under Article 20 of Directive 2010/63/EU.
- Animals born in the rest of Europe
includes, amongst others, animals born in Switzerland, Turkey, Russia and Israel, and groups together all animals, irrespective of whether they have been bred in registered breeding establishments or other establishments, and includes, amongst others, animals that have been captured in the wild.
- Basic research
refers to studies of a fundamental nature including physiology;
- Developmental toxicity
includes also developmental neurotoxicity studies.
- Diagnosis of Diseases
includes, amongst others, animals used in direct diagnosis of diseases such as rabies, botulism, but excluding those covered under regulatory use.
- F0
refers to animals that are captured from the wild.
- F1
refers to animals that are born in captivity to one, or two parents, that were captured from the wild.
- Genetically altered with a harmful phenotype
refers to
- Genetically altered without a harmful phenotype
refers to
- Kinetics
refers to pharmacokinetics, toxicokinetics and residue depletion.
- Neurotoxicity
includes, amongst others, acute delayed effects (for example, delayed neurotoxicity of organophosphorus substances following acute exposure) and repeated dose studies for the purposes of neurotoxicity, but excludes developmental neurotoxicity.
- Non-regulatory Toxicology and Ecotoxicology
refers to discovery toxicology and investigations to prepare for the regulatory submission and method development.
- Not genetically altered
refers to all animals that have not been genetically altered, including also genetically normal parent animals used for the creation of a new genetically altered animal line/strain.
- Other lethal methods
refers to those methods that categorise substances in a class, that is to say, methods involving assignment of a range in which LD50 would fall, such as fixed dose methods and acute toxic class methods.
- Repeated dose toxicity
includes also immunotoxicological studies.
- Reproductive toxicity
includes, amongst others, extended one-generation reproductive toxicity studies, also when including cohorts for developmental neuro- and immunotoxicity.
- Routine production
includes animals used in the manufacturing process of products such as antibodies and blood based products, for example, animals used in the manufacturing of serum-based medicinal products shall be included within this category.
- Safety testing in the food and feed area
includes also testing of drinking water (including target animal safety testing).