Toxicology studies of medicinal products and feed additives in laboratory animals
Toxicology studies define the safety margins of a veterinary medicinal product or feed additive: at which doses and under which regimen adverse effects appear. The results form part of the preclinical section of the registration dossier and are mandatory for state registration in Russia and the EAEU.
Types of toxicology studies
- Acute toxicity: determination of the median lethal dose (LD50), hazard class and the picture of acute poisoning after a single administration.
- Subchronic toxicity: assessment of the effect of repeated administration over several weeks on clinical, haematological and biochemical parameters.
- Chronic toxicity: long-term administration to reveal delayed effects and target organs of toxicity.
- Local irritation: reaction of the skin, mucous membranes and tissues at the injection site.
- Specific toxicity: mutagenicity, reproductive toxicity, embryotoxicity, allergenic and immunotoxic effects, carcinogenicity, depending on the requirements for the specific product type.
What is assessed
- Clinical condition and behaviour of the animals, feed and water intake, body weight dynamics.
- Haematological and biochemical blood parameters.
- Organ weights, gross and histological changes.
- Reversibility of the changes after the product is withdrawn.
How we work
- Review of the product composition and intended use, and selection of the required scope of studies based on registration requirements.
- Development of the study plan: species and number of laboratory animals, doses, duration, parameters to be monitored.
- Conduct of the experiment with daily clinical observation, blood sampling and pathomorphological examination.
- Statistical analysis and preparation of the report for the registration dossier.
What the client receives
- A study plan with justification of the design, doses and selected models.
- A toxicology study report with raw data, statistical analysis and conclusions.
- Advice on interpreting the results and using them in the registration dossier.
Timing and cost
An acute toxicity study takes several weeks; subchronic and chronic studies take several months or more. The cost is calculated individually and depends on the set of studies, the number of groups and animals, the duration of administration and the scope of pathomorphological examination.
Why choose us
- Experience: more than 20 years of work with veterinary medicinal products and feed additives and over 10,000 completed studies.
- In-house laboratory: 170 units of analytical and test equipment, including chromatography–mass spectrometry.
- Full cycle: studies, laboratory analysis and registration dossier preparation in one company, with no time lost passing data between contractors.
- Transparency: an agreed plan and timeline, with interim results as the work progresses.
How to order
To get a quote and agree on the study design, contact Neurometrix specialists by phone at +7 903 613-00-79 or send a request to info@neirometrix.ru. We prepare a commercial proposal within two business days.
Frequently asked questions
Which toxicology studies are needed to register a veterinary product?
It depends on the product type: new active substances require studies of general and specific toxicity, while for generic products the scope may be reduced using literature data and data on the reference product. We define the required list at the start based on the product composition and EAEU requirements.
Are toxicology studies needed for a feed additive?
Yes, registering a feed additive requires proof that it is harmless. The scope depends on the composition and purpose of the additive: for well-studied components, acute toxicity and literature data are sufficient, while new substances require a wider set of tests.
How many animals does a study require?
The number depends on the type of study and the methodological guidelines; usually several test groups and a control group are formed. We calculate the minimum sufficient number so that the results are statistically reliable and comply with the principles of humane treatment of animals.
Can results obtained in another laboratory be used?
Yes, if the studies were carried out using recognised methods and documented according to the requirements for the registration dossier. We audit the existing reports and identify which data need to be supplemented.