OECD 208: Terrestrial plant test

The 48-hour acute daphnid immobilisation test according to OECD 22 assesses short-term aquatic toxicity by measuring immobilisation of daphnids, usually Daphnia magna, and using those observations to derive concentration–response values. The primary reported metric is the EC50 at 48 hours, with an optional EC50 at 24 hours calculated from dose–response analysis. The protocol is the following: The test begins with neonates less than 24 hours old exposed for 48 hours to at least five concentrations plus a control, with a minimum of twenty animals per concentration typically arranged in replicate groups (for example, four replicates of five). , Immobilisation is observed and recorded at 24 and 48 hours, and the numbers or proportions immobilised at each concentration and in the control are tabulated for statistical modelling. , Test solutions are prepared by diluting the substance into acceptable test water, avoiding solvents or emulsifiers when possible. Analytical measurements of test substance concentration, dissolved oxygen, and pH are performed at the start and end of the exposure to document conditions. , The biological endpoint is direct observation of loss of swimming activity consistent with immobilisation, EC50 values are derived from dose–response modelling and are normally reported in concentration units such as mg/L.. The report includes the counts or proportions immobilised per concentration and control at each time point, the calculated EC50(s), and supporting water chemistry and analytical concentration data. The method is accepted under REACH for aquatic hazard characterization in registration dossiers submitted to ECHA, where OECD TG 202 is equivalent to EU Method C.2 under Commission Regulation (EC) No. 440/2008. Under the U.S. Toxic Substances Control Act (TSCA), EPA may require daphnid acute toxicity testing to OPPTS 850.1010/OECD 202 for new chemical substances expected to be acutely toxic.

The bacterial reverse mutation (AMES) test is used to evaluate the genotoxic effect of a medical device or its extract when in contact with a bacterial suspension. The test is conducted according to OECD 471 and ISO 10993-3 by exposing a bacterial suspension of Salmonella spp and Escherichia coli to 5 concentrations of the medical device or its pure extracts. The AMES test is a preliminary "screening test" for genotoxicity. A full genotoxicity evaluation usually includes testing the device with two in vitro methods, of which AMES is typically performed first. An additional in vivo method can be used if needed. Measurlabs can support you with the full genotoxicity evaluation. Please contact our experts for a quote.

Determination of acute toxic effects of chemicals on earthworms (Eisenia foetida) according to OECD Test Guideline 207. The guideline comprises two methods used in sequence: Filter paper contact test (optional initial screening): earthworms are exposed to the test substance applied to moist filter paper in sealed glass vials, kept in the dark for 48 hours, with the dose expressed in mg/cm². This test identifies potentially toxic substances and informs concentration selection for the artificial soil test., Artificial soil test: the substance is mixed into a defined artificial soil at a geometric series of at least five concentrations; earthworms are kept for 14 days and observed at 7 and 14 days, with concentrations expressed in mg/kg dry weight.. The test is applicable to water-soluble and insoluble substances, with the application technique adjusted accordingly. Death is assessed by lack of response to gentle mechanical stimulation; behavioral abnormalities and visible pathological lesions are also recorded. The report will include the following: Mortality in controls and reference treatments, analyzed by log-probability plots or probit analysis to derive the LC50 with confidence limits, Highest concentration producing no mortality and lowest causing 100% mortality, Mean live weight and number of live worms per treatment at start and end of exposure, Concentration–effect curve and the statistical method used, For artificial soil tests: initial and final pH and moisture content. In the EU, OECD TG 207 is equivalent to EU Method C.8 (artificial soil test) under Regulation (EC) No. 440/2008, and study data are accepted in REACH registration dossiers submitted to ECHA. ISO 11268-1 is a parallel standard covering the same artificial soil endpoint and is considered interchangeable in most regulatory contexts.

Assessment of the inhibitory effects of chemicals on activated sludge microorganisms by measuring oxygen uptake according to OECD Test Guideline 209 (equivalent to EU Method C.11 under Commission Regulation (EC) No. 440/2008). The test is applicable to water-soluble, poorly soluble, and volatile substances, with appropriate measures taken to maintain exposure concentrations for volatile compounds. Activated sludge from a wastewater treatment plant receiving predominantly domestic sewage is exposed to a geometric series of test substance concentrations together with synthetic sewage feed and dilution water for 3 hours at 20 ± 2°C and pH 7.5 ± 0.2. Oxygen uptake is measured using a dissolved oxygen electrode in a closed measurement cell. Where required, total respiration can be partitioned into: Heterotrophic respiration (carbon oxidation), Nitrification (ammonium oxidation), determined by measuring oxygen uptake with and without N-allylthiourea, a specific nitrification inhibitor. An optional shorter contact time (e.g., 30 minutes) is available for rapidly degrading or volatile compounds. Quality controls include blanks, optional abiotic controls (no inoculum), and a reference substance (typically 3,5-dichlorophenol) to confirm sludge sensitivity. Results are reported as oxygen uptake rates and percentage inhibition relative to controls. Primary endpoints are ECx values (e.g., EC50) and/or NOEC, expressed in mg/L. Results also identify non-inhibitory concentrations suitable for use in subsequent biodegradability testing. The method is accepted in REACH registration dossiers submitted to ECHA, where it fulfills the information requirement for toxicity to microorganisms. The closely related U.S. EPA guideline OPPTS 850.6800 (Modified Activated Sludge, Respiration Inhibition Test for Sparingly Soluble Chemicals) covers a modified version of the same test for poorly soluble substances.

Determination of the effects of a test substance on the growth of freshwater microalgae and cyanobacteria according to OECD Test Guideline 201 (equivalent to EU Method C.3 under Commission Regulation (EC) No. 440/2008 on REACH test methods). In the test, exponentially growing algal or cyanobacterial cultures are exposed in batch vessels to a minimum of five test concentrations, typically with three replicates per concentration, to generate a concentration–response relationship. Tests are run in nutrient-sufficient medium under continuous fluorescent illumination, with pH recorded at the start and end of the exposure. Microscopic checks are performed to verify a normal, healthy inoculum at the outset and note any morphological abnormalities at termination. Growth is quantified over time using a biomass surrogate such as cell number and/or fluorescence, from which average specific growth rate and yield are derived as the primary response variables. Chemical analysis of the test medium is recommended at the start and end of exposure, with additional intermediate sampling where concentration losses are expected; for dissolved concentration measurements, algae can be separated from the medium prior to analysis (e.g. by low-g-force centrifugation). Results are reported as concentration–response curves with ErC50 and NOEC/LOEC values calculated from average specific growth rate and yield, based on initial/nominal concentrations or exposure-based metrics such as geometric means or modelled decline where applicable. pH values and microscopic observations are included in the final report. The OECD 201 method is recognised in regulatory submissions under the EU REACH regulation as part of aquatic hazard characterization, and under the U.S. Toxic Substances Control Act (TSCA), where EPA may require algal toxicity testing to OPPTS 850.5400/OECD 201 for new chemical substances.

The purpose of cleaning validation studies is to show that reusable medical devices can be reprocessed effectively between uses so that patients are not exposed to pathogens. Depending on the device’s intended use and classification, appropriate reprocessing steps may include cleaning, disinfection, and/or sterilization. For cleaning validation more specifically, the testing procedure consists of three steps: Simulated contamination with artificial soils that accurately reflect clinically relevant soils, such as blood and other bodily fluids. , Cleaning (manual and/or automated), carefully following the manufacturer's instructions for parameters such as detergents, cleaning tools, water quality, and temperature. , Inspection, both visually and using quantitative methods relevant to the test soil (e.g., proteins, total organic carbon, or hemoglobin), to assess whether residual contaminants remain on the device.. Successful cleaning validation is often sufficient for non-critical reusable devices, such as blood pressure cuffs, monitors, and clutches. Semi-critical and critical devices will require further disinfection and/or sterilization validation studies, which we can also offer. The displayed example price covers a manual cleaning validation study with 6 reprocessing cycles and cleanability evaluations with visual inspection & protein content measurement. Test protocol formulation and reporting are also included.

Analysis of the specific surface area of porous, solid materials according to the BET (Brunauer–Emmett–Teller) theory. Analysis can be performed with N2 or Kr gases, depending on the expected surface area of the material. BET curve and the specific surface area (in m2/g) are reported. The required sample amount depends on the expected surface area. As a rule of thumb, at least 5 m2 of surface area should be available for measurement. The following gas adsorption devices are used for this measurement: Micromeritics Gemini VII 2390, Micromeritics ASAP 2020, Micromeritics TriStar II 3020, Anton Paar Nova 800.

The substances of very high concern (SVHC) analysis provides comprehensive material screening for SVHC substances as listed in the Registration, Evaluation, and Authorization of Chemical Substances (REACH). The substance list for analysis is updated regularly as new revisions are received from ECHA (twice per year). The maximum allowed concentration of any substance on the SVCH list is 0.1 mass-%. If the product contains more than 0.1% w/w of an SVHC substance, ECHA has to be notified and information on the safe use of the article must be provided to customers upon request. Contact us to request a quote for screening your material for SVHCs. The price of the analysis depends on the sample type.

Rutherford Backscattering Spectrometry (RBS) can be used to measure the composition of solid samples quantitatively at the surface as well as depth profiling. RBS is used for the analysis of heavy elements and can be combined with ToF-ERDA when lighter elements also need to be analyzed. Elements with similar mass can be difficult to differentiate.

ISO 10993-23 is an internationally recognized standard for assessing the irritation potential of medical devices when they come into contact with skin, mucosal membranes, or subcutaneous tissues. Irritation tests performed according to the standard are commonly used to demonstrate compliance with EU MDR and FDA requirements. The appropriate testing approach is chosen based on the body contact site: Skin irritation tests evaluate whether a medical device or material causes localized skin irritation when it comes into direct contact with the skin. Testing can be conducted using in vivo or in vitro methods, depending on the device and the market area. , Intracutaneous reactivity tests apply to medical devices or materials that penetrate the skin or come into contact with deeper tissues. The goal is to determine whether extracts from such devices cause localized inflammatory responses in the dermis or subcutaneous layers.. The device itself is tested with a direct contact method, when possible. Alternatively, polar and non-polar solvents are used to prepare extracts that simulate potential leachables from the device. The displayed example price includes an in vivo direct skin irritation test performed under GLP. For a more accurate quote, do not hesitate to contact us with a description of your device and any additional requirements you may have for testing (e.g., market area, quality systems, in vivo vs. in vitro methods).