Explore InnoSer’s GLP OECD toxicology study capabilities, from study planning and dose selection to GLP execution for chemical safety programmes.

Bringing your chemical substance to the market requires a robust understanding of its potential hazards to human health and the environment, providing the safety information needed to identify and manage potential risks. Under the EU REACH framework, which aims to protect human health and the environment while supporting the free circulation of substances within the internal market, manufacturers and importers are responsible for generating and providing the safety information needed to demonstrate how their substances can be used safely.  

Your chemical has reached the point where additional safety data are needed to move its regulatory assessment forward. Where your existing data and non-animal approaches, including (Q)SAR, read-across, weight-of-evidence, and available in vitro methods, cannot adequately address a remaining data safety gap, an in vivo OECD toxicity study may still be required for certain complex health endpoints.  

This is where InnoSer’s GLP study team comes in, supporting sponsors with OECD GLP toxicology studies for chemical testing, from dose selection and study planning to definitive study execution and reporting.

Our GLP infrastructure includes:  

• GLP-certified toxicology capabilities since 2004, in full compliance with the international OECD guidelines 

• Two GxP archives, full audit trail, with client audit rights 

• GLP-certified histopathology platform with assessments performed by a board-certified veterinary histopathologist  

With over 20 years of experience serving the chemical industry alongside the pharma and biotech industries, our dedicated GLP toxicology team based in Gronau, Germany (previously known as Vivo Science; read more about the acquisition performed in August 2026 here), frequently performs in vivo GLP toxicity testing of new chemicals in accordance with OECD guidelines, most commonly focusing on:  

• Acute toxicity studies (e.g., OECD TG 420, OECD TG 423, OECD TG 425)  

• Repeated-dose systemic toxicity studies (e.g., OECD TG 407, OECD TG 408, OECD TG 409, OECD TG 452) 

• Developmental and reproductive toxicity (DART) studies (e.g., OECD TG 414, OECD TG 421, OECD TG 422, OECD TG 443)  

• Chronic toxicity and carcinogenicity studies (e.g., OECD TG 451, OECD TG 452, OECD TG 453) 

This represents a selection of OECD GLP toxicology capabilities at InnoSer. Additional study designs under OECD guidelines can be supported depending on your testing requirements.  For detailed information on individual test methods, study objectives, and testing procedures, consult the OECD Guidelines for the Testing of Chemicals.

Our team has experience working with a variety of test items, including well-defined chemicals as well as more complex substances and mixtures. 

For chemical companies outsourcing in vivo GLP toxicology studies, selecting a CRO with proximity, quick study timelines, and direct access to an experienced study team can make the route from study request to final report considerably more straightforward. 

At InnoSer, we work as a specialist European preclinical CRO with chemical-industry sponsors across the DACH region and beyond, providing operational partnership for defined OECD GLP toxicity studies and ensuring you obtain high-quality safety data on your chemicals under the GLP framework.

At InnoSer, we are a specialist European preclinical CRO supporting chemical-industry sponsors across the DACH region and beyond, with OECD GLP toxicology studies, providing operational partnership for defined toxicity studies and high-quality safety data under the GLP framework.

Through our GLP-certified site in Gronau, Germany, formerly vivo Science, sponsors continue to work directly with the established scientific and technical team, with the site’s GLP-certified offering retained within the InnoSer group.  

In this article, we show what working with InnoSer looks like in practice, from evaluating the dose information available for your chemical and determining whether dose-range finding is needed to executing and reporting the definitive OECD GLP toxicity study. 

From study request to definitive GLP study: selecting appropriate dose levels for your OECD GLP toxicology study  

Once the required OECD study has been defined, one of the first practical questions our study team considers is whether sufficient information is already available to select appropriately graduated dose levels (low, intermediate, and high) of the substance in order to reach a NOAEL (no-observed-adverse effect level).  

Where the available substance safety data do not provide a sufficient basis for selecting dose levels for the definitive study, a dose-range-finding study can be performed.  

Depending on the available information and study requirements, this may use a: 

• Conventional parallel-group dose-range finding design; 

• Dose-escalation studies; 

• Or an extended range-finding design incorporating additional endpoints such as toxicokinetics 

Our previous study experience illustrates how this can work in practice across different types of chemical toxicology programmes. 

For repeated-dose toxicity, our study director highlights how this has been applied:  

Similarly, dose selection is particularly relevant when progressing into reproductive and developmental toxicity studies. Drawing on our experience with speciality chemicals, our Study Director notes:  

Ultimately, the route into the definitive GLP study depends on what is already known about your chemical.

Our team evaluates the available dose information and, where needed, uses preliminary range-finding to support appropriate dose selection before the main OECD study begins. 

From OECD GLP toxicology study execution to final report: generating chemical safety data for your regulatory programme

Once your OECD study requirements and dose levels have been established, our study team takes your chemical into the definitive GLP study. From protocol finalisation through study conduct, Quality Assurance and reporting, we maintain the quality and traceability of your study data while keeping you informed of progress and relevant findings throughout the programme. The result is a documented GLP study with reliable, traceable chemical safety data for its intended regulatory use. 

When you work with InnoSer, you can expect: 

• Study request and quotation: Once you send us your required OECD Test Guideline together with the available information on your chemical and study requirements, our team reviews the request and prepares a study quotation, including the proposed scope and available study-start timing. 

• Following quote acceptance – study planning and protocol: Our team translates your requested OECD Test Guideline into the study protocol, incorporating the defined dose levels and relevant study-specific and statistical considerations. The study then progresses through the applicable GLP and Quality Assurance processes before initiation.  

• During study execution: You remain in contact with the study team through project updates, with relevant emerging findings discussed when appropriate and deviations documented and managed within the GLP framework. Direct communication with the scientific team throughout the study gives you visibility into study progress and allows practical questions to be addressed as they arise. 

• At study completion: The study findings are consolidated into the final GLP-compliant study report, accompanied by the applicable Quality Assurance statement. Study records and raw data are retained according to GLP archiving requirements. OECD GLP explicitly encompasses study reporting as well as storage and retention of records and materials. Where required, our team can also support the transfer of study data into IUCLID for subsequent use in the sponsor’s regulatory dossier. 

Generating the chemical safety data you need from your OECD GLP toxicity studies

Depending on the test substance, intended use, and applicable OECD Test Guideline, the substance may be administered via dietary inclusion, drinking water, oral gavage, or dermal application. The selected route should reflect realistic human exposure wherever possible. 

Throughout the in-life phase, our study teams monitor the animals for a range of endpoints that help build a comprehensive picture of the substance’s toxicological profile, including: 

Clinical signs 

• Body weight development 

• Food and water consumption 

• Behavioural observations 

• Ophthalmic examinations 

• Neurological assessments 

At study completion, additional investigations may include: 

• Gross necropsy 

• Organ weight evaluation 

• Haematology 

• Clinical chemistry 

• Histopathological examination 

InnoSer’s scientists integrate these findings to characterise the toxicological profile of your chemical, including potential adverse effects, target organs and dose-response relationships. 

Where applicable, the study establishes a NOAEL, providing a point of departure for the sponsor’s subsequent chemical safety assessment and the derivation of exposure limits such as Derived No-Effect Levels (DNELs). 

Our commitment to the 3Rs and animal welfare in chemical safety testing for OECD GLP toxicology studies

Where an in vivo OECD study is required, our responsibility extends beyond generating reliable GLP data to using laboratory animals only where scientifically and regulatorily necessary, and designing studies according to the 3Rs principles of Replacement, Reduction and Refinement.  

At InnoSer, this means replacing animal studies with non-animal alternatives wherever possible, reducing animal use while maintaining scientifically robust study designs, and refining experimental procedures to minimise their impact on animal welfare.  

In practice, for GLP toxicology programmes, this can include considering whether existing data are sufficient before additional in vivo work is initiated and whether study design generates the required information efficiently without unnecessary animal use. Throughout the study, animal welfare remains a consideration across the animals’ care and study procedures, with protocols designed to minimise unnecessary pain or distress.