Non-testing methods

Using in silico predictions and read-across to obtain regulatory compliance and agility in research and development

In silico prediction models are alternatives to traditional laboratory testing of chemicals and are accepted by many regulatory bodies worldwide. They offer a lower cost price as they replace expensive and resource-demanding testing in compliance with the 3Rs (replacement, reduction and refinement) for laboratory animals.

In silico testing may also be the way forward when small quantities such as impurities cannot be isolated in sufficient quantities for in vitro or in vivo testing.

At DHI, we can help you to reduce cost by using prediction models accepted by authorities for documenting product safety. We strive to offer flexible and pragmatic solutions to enable your company compliance. Depending on your needs we tailor a service to fit the purpose.

Brian S Nielsen

Tel.: +45 4516 9140
bsn@remove-this.dhigroup.remove-this.com

Our expertise

Our toxicological experts cover all aspects of the prediction of risks related to human health or environment, whether it is for documentation to authorities or for design or development of products.

Our experience covers predictions of:

human toxicity (genotoxicity, skin sensitization, reproduction toxicity and endocrine disruption)
ecotoxicity and environmental fate including degradation products
genotoxicity of pharmaceutical impurities in compliance with ICH M7

In addition, we are highly accomplished in

Grouping of substances and read-across
Screening of alternative substances
Substitution of CMR and endocrine disrupting substances
Profiling of metabolites
Prediction and calculation of substance migration for polymeric materials

Non-testing methods can be applied in many fields. See below for a detailed description of our services.

Tools

We use a number of regulatorily accepted in silico tools for predictions, including the OECD QSAR ToolBox, QSAR Vega, ToxTree, Danish QSAR database, EpiSuite, and the programme CheMigrator® developed by DHI.

To fulfil the ICH M7 requirements for assessing genotoxicity with expert rule-based and statistically-based systems we use the Lhasa limited integrated ICH M7 solution.

How we may help you

With the application of in silico prediction models we can offer you a multitude of solutions that will make your processes much more agile:

Strategic advice on using predictions and read-across for global regulatory compliance
Safety assessment of chemicals and metabolic fate
Read-across templates according to specific regulation, e.g. Read-Across Assessment Framework (RAAF) under ECHA
Drinking water quality criteria based on toxicological endpoints and QSAR predictions
Modelling of environmental impact from chemical leakage in the water environment
Modelling the environmental fate of chemicals and pharmaceuticals (APIs, impurities, metabolites)
Courses and training in using alternatives to laboratory testing

Non-testing methods can be applied in many fields. See below for a detailed description of our services.

Chemicals and Biocides

Assessment of toxicity to humans and the environment
Profiling of metabolites
Prediction of migration of chemical substances across polymers

More about our services in chemicals regulations or biocides and biocidal products

Pharmaceuticals

Prediction of toxicity to humans and the environment
Prediction of genotoxic impurities in compliance with the ICH M7 guideline
Classification of impurities in drug substances and drug products (ICH Q3A-Q3D guideline)
Prediction of migration of chemical substances across single or multi-layered polymers

Medical devices and in vitro diagnostics

Prediction of toxicity in relation to critical substances or material changes
Prediction of threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
Prediction of genotoxicity in compliance with the ICH M7 guideline
Prediction of migration of chemical substances across single or multi-layered polymers
Modelling of migration of extractables and leachables

More about our medical device services

Food, food contact materials and packaging materials

Prediction of toxicity to humans and environment
Prediction of migration of chemical substances across single or multi-layered polymers

More about food safety and food contact materials