For:
- Nanomaterials
- Advanced Materials
- Chemical Substances and Preparations (REACH)
- Cosmetic Ingredients
Includes:
- Acute and Subacute Studies
- Effect of a single dose on a particular animal species.
- Duration: From several days to after a single dose.
- Parameters in acute studies: Mortality, Clinical pathology, Gross necropsy, Weight change, Signs of toxicity.
- Parameters in sub-acute studies: Mortality, Weight change, Signs of toxicity, Clinical pathology, Pathology and histopathology
- Subchronic & Chronic Studies
- Establishing a “no observable effect level” (NOEL) and characterization of dose-response relationships following repeated doses.
- Identification and determination of specific organs affected after repeated administration.
- Prediction of a reasonable and appropriate dosing for chronic exposure studies. In case of chronic studies evaluation of the cumulative toxicity of chemicals and assessing a carcinogenic potential.
- Duration: From 28 days, through 90 days up to 6 / 12 / 24 months.
- Parameters: Mortality, Weight change, Signs of toxicity, Clinical pathology, Pathology and histopathology.
- Reproductive & Development Studies
- Reproductive studies in vivo determines a potential adverse effects of a test item on fertility and reproductive performance / sexual function in adult males and females and as well as developmental toxicity in the offspring (UNECE).
- Development (teratology) studies in vitro and in vivo pertains to adverse toxic effects to the developing embryo or foetus, resp. adverse effects induced during pregnancy.
- Duration: Varies depending upon end point.
- Parameters: According to OECD and ECVAM Guidelines