Systemic toxicity is not to be taken lightly
To protect patients from potential toxicological risks, e.g. from the use of medical devices, the toxicological assessment of a test article normally starts with in vitro cytotoxicity tests. Because of the large variation in test articles and test substances, several test strategies are available. We support you to select the most appropriate one through our long-time experience and expertise.
For some therapies, investigating the potential for phototoxicity in cell cultures is compulsory and we are happy to provide these assays for you along with the required absorption spectrum.
In addition, we’re offering different in vivo studies to assess acute toxicity (via oral, dermal or parenteral administration). Tests for acute toxicity are indispensable for an adequate risk assessment of articles or substances and they’re also required by regulatory authorities as part of standard test packages. In this regard the studies are justified ethically to ensure protection of man, animals, nature and the environment.
In each study the smallest-possible number of animals are used to reach the required test results.
The design of the acute oral and dermal toxicity tests according to OECD 420 and OECD 402, respectively (the so-called fixed dose method), reduces both the number of animals used in comparison to “traditional” methods and introduces a clear refinement: in the main experiment only moderately toxic doses are administered and criteria for interruption of the experiment as well as its endpoints are clearly defined.
Our test methods
|XTT test||ISO 10993-5 / ISO 7405|
|MTT test||ISO 10993-5 / ISO 7405|
|Neutral red uptake (NRU)||ISO 10993-5 / ISO 7405|
|Agar overlay assay||ISO 10993-5 / ISO 7405|
|Elution Test||USP 87|
|In vitro 3T3 NRU Phototoxicity Test||OECD 432|
|Acute Oral Toxicity Testing in Rodents, fixed dose method||OECD 420|
|Acute Dermal Toxicity Testing in Rodents, fixed dose method||OECD 402|
|Acute Systemic Toxicity Testing in Rodents||ISO 10993 – 11|