Mérieux NutriSciences laboratories perform toxicological tests to evaluate the potential health risks of MSD and biocides. A wide range of toxicological tests is performed in accordance with Good Laboratory Practices (GLPs) and all global quality and safety standards.

Safety studies aim at evaluating the potential risks to human health and the environment arising from the use of a biocide. These studies are essential to meet regulatory requirements and to protect consumers and operators.

Human Toxicology

Skin Irritation

• In vitro skin irritation (OECD 439). The method is based on a reconstructed human epidermal tissue (RHE) model to evaluate the irritant potential of a substance. The test measures cell viability by MTT colorimetric assay. The reduction in cell viability, according to criteria established by the guideline, indicates that the tested substance is irritating to the skin.

Skin corrosion

• In vitro skin corrosion (OECD 431). The method allows the corrosive potential of chemicals to be assessed on the skin using reconstructed human epidermal tissue (RHE) models. The method measures cytotoxicity by reducing cell viability and allows the identification of corrosive substances without the use of animal testing.

Eye Irritation

• Eye irritation epiOcular™ EIT test (OECD 492). This method uses a reconstructed ocular tissue (RhCE) model to identify the irritant potential of chemicals and finished products to the eye, based on cell viability and tissue damage.
• Eye irritation STE test (OECD 491). The test measures the ocular irritating potential of a substance by assessing cell permeability and viability in a mammalian corneal cell line (SIRC cells), classifying the risk of irritation.

Skin Sensitisation

• epiCS™. Based on a reconstructed human epidermal tissue model (RHE), it evaluates the sensitizing potential of a substance by observing specific markers of cellular activation and inflammatory response.
• Human-cell line activation – h-CLAT (OECD 442E). It uses human cell lines to evaluate the sensitizing potential by measuring the expression of specific surface markers (CD86 and CD54), representative of monocyte activation.
• Human-cell line activation – U-SENS (OECD 442E). Method based on human cell lines to determine the sensitizing potential of a substance by analyzing the secretion of a specific surface marker, i.e. CD86.

Cytotoxicity

• In vitro cytotoxicity. The method evaluates the toxicity of a substance after exposure to monolayer cells. The effect is measured by determining cell viability using a colorimetric assay.

Genotoxicity

• Ames test (OECD 471). The method evaluates the mutagenic potential of a substance through the exposure of genetically modified bacterial strains, analyzing the mutation frequency.
• MLA (OECD 490). In vitro method that measures the ability of a substance to induce gene mutations in mammalian cell lines, through the detection of changes in the thymidine kinase gene.
• Micronucleus test (OECD 487). In vitro method that evaluates the clastogenic and aneugenic potential of a substance by measuring the formation of micronuclei in cell lines, representative of damage to DNA or to the mitotic spindle.

Environmental safety

Evaluation of biodegradability and persistence of the product:

• Aerobic ultimate biodegradability (ISO 14593 / OECD 301). This method evaluates the biodegradability of a chemical substance under aerobic conditions, measuring the release of carbon dioxide as an indicator of the biological degradation process. The substance is incubated in a test system that simulates aquatic environments, observing the percentage of degradation with respect to a standard acceptance criterion.
• Aerobic ultimate biodegradability (ISO 11734). The method evaluates the anaerobic biodegradability of organic substances in environmental conditions that simulate the absence of oxygen. It measures the production of biogas (e.g. methane) as an index of the degradation process, using an anaerobic reactor with specific microorganisms.

Safety studies ensure the balance between the efficacy of the product and the protection of public health and the environment.