Genotoxicity

Assessing nanotoxicity of food-relevant particles: A comparative analysis of cellular responses in cell monolayers versus 3D gut epithelial cultures

Engineered nanoparticles (NPs) are extensively used in the food industry, yet safety concerns remain. The lack of validated methodologies is a bottleneck towards resolving this uncertainty. Hence, the current study aims to compare two cell models by examining the toxicological impacts of two food-relevant NPs (SiO2 and Ag) on intestinal epithelia using monolayer Caco-2 cells and full-thickness […]

Reconstructed human intestinal comet assay, a possible alternative in vitro model for genotoxicity assessment

The aim of the present study was to evaluate the compatibility of reconstructed 3D human small intestinal microtissues to perform the in vitro comet assay. The comet assay is a common follow-up genotoxicity test to confirm or supplement other genotoxicity data. Technically, it can be performed utilizing a range of in vitro and in vivo […]

Development of a micronucleus test using the EpiAirway™ organotypic human airway model

The use of organotypic human tissue models in genotoxicity has increased as an alternative to animal testing. Genotoxicity is generally examined using a battery of in vitro assays such as Ames and micronucleus (MN) tests that cover gene mutations and structural and numerical chromosome aberrations. At the 7th International Workshop on Genotoxicity Testing, working group […]

Proteomic, Metabolomic, and Lipidomic Analyses of Lung Tissue Exposed to Mustard Gas

Sulfur mustard (HD) poses a serious threat due to its relatively simple production process. Exposure to HD in the short-term causes an inflammatory response, while long-term exposure results in DNA and RNA damage. Respiratory tract tissue models were exposed to relatively low concentrations of HD and collected at 3 and 24 h post exposure. Histology, […]

Organotypic 3D primary human nasal tissue model for toxicological studies

The nasal mucosa serves as the first line of defense against inhaled chemicals, drugs, and respiratory infections. Here we developed a novel in vitro primary human cell-based 3D human nasal epithelial tissue (NET) cultured on a cell culture insert with a porous (0.4 μm) membrane bottom at an air-liquid interface (ALI). The NET model was […]

Development of reconstructed intestinal micronucleus cytome (RICyt) assay in 3D human gut model for genotoxicity assessment of orally ingested substances

The micronucleus (MN) assay is widely used as part of a battery of tests applied to evaluate the genotoxic potential of chemicals, including new food additives and novel food ingredients. Micronucleus assays typically utilise homogenous in vitro cell lines which poorly recapitulate the physiology, biochemistry and genomic events in the gut, the site of first […]

Use of the EpiDerm 3D reconstructed skin micronucleus assay for fragrance materials

In order to evaluate the utility of the 3D reconstructed skin micronucleus assay (3DRSMN) to assess clastogenic/aneugenic potential of the fra- grance chemicals, a set of 22 fragrance materials were evaluated in 3DRSMN assay. These materials evaluated were also evaluated in an in vitro as well as in vivo micronucleus assay, conducted as per Organisation […]

Small Molecule IL-36γ Antagonist as a Novel Therapeutic Approach for Plaque Psoriasis

IL-36 cytokines are pro-inflammatory members of the IL-1 family that are upregulated in inflammatory disorders. Specifically, IL-36γ is highly expressed in active psoriatic lesions and can drive pro inflammatory processes in 3D human skin equivalents supporting a role for this target in skin inflammation. Small molecule antagonists of interleukins have been historically challenging to generate. […]

The 3D reconstructed skin micronucleus assay using imaging flow cytometry and deep learning: A proof-of-principle investigation

The reconstructed skin micronucleus (RSMN) assay was developed in 2006, as an in vitro alternative for genotoxicity evaluation of dermally applied chemicals or products. In the years since, significant progress has been made in the optimization of the assay, including publication of a standard protocol and extensive validation. However, the diverse morphology of skin cells […]

Experiments in the EpiDerm 3D Skin In Vitro Model and Minipigs In Vivo Indicate Comparatively Lower In Vivo Skin Sensitivity of Topically Applied Aneugenic Compounds

Risk management of in vitro aneugens for topically applied compounds is not clearly defined because there is no validated methodology to accurately measure compound concentration in proliferating stratum basale keratinocytes of the skin. Here, we experimentally tested several known aneugens in the EpiDerm reconstructed human skin in vitro micronucleus assay and compared the results to […]

Validation of the 3D reconstructed human skin micronucleus (RSMN) assay: an animal-free alternative for following-up positive results from standard in vitro genotoxicity assays

In vitro test batteries have become the standard approach to determine the genotoxic potential of substances of interest across industry sectors. While useful for hazard identification, standard in vitro genotoxicity assays in 2D cell cultures have limited capability to predict in vivo outcomes and may trigger unnecessary follow-up animal studies or the loss of promising […]

The 3D reconstructed skin micronucleus assay: considerations for optimal protocol design

Implementation of the seventh amendment to the EU Cosmetics Directive has driven much research into suitable in vitro alternative assays to support satisfactory risk assessments. One such assay is the reconstructed skin micronucleus (RSMN) assay. First reported in 2006, further development occurred and a standard protocol was published in 2011. To evaluate and optimize the […]

Evaluating the Inflammatory and Genotoxic Effects of Smokeless Tobacco Using a Human Organotypic Model of Oral Epithelium

In addition to the well-known effects of tobacco use on the causation of lung and cardiovascular disease, tobacco use is also implicated as a major cause of oral cavity disease that leads to thousands of deaths per year. Snus, a smokeless tobacco applied to the oral cavity, has been proposed as a less harmful alternative […]

Genetic toxicity assessment of engineered nanoparticles using a 3D in vitro skin model (EpiDerm™)

Background: The rapid production and incorporation of engineered nanomaterials into consumer products alongside research suggesting nanomaterials can cause cell death and DNA damage (genotoxicity) makes in vitro assays desirable for nanosafety screening. However, conflicting outcomes are often observed when in vitro and in vivo study results are compared, suggesting more physiologically representative in vitro models […]

Validation of the In Vitro Reconstructed Skin Micronucleus Assay as a Potential Animal Alternative for Fragrance Materials

The in vitro reconstructed skin micronucleus assay is a skin-based assay which measures the clastogenicity and aneugenicity potential of chemical materials and mixtures. Reconstructed skin models are prepared from primary human cells and are expected to have DNA repair and cell cycle control mechanisms similar to in vivo systems. They are also expected to exhibit a human metabolic capability that is […]

The EpiDerm 3D human reconstructed skin micronucleus (RSMN) assay: Historical control data and proof of principle studies for mechanistic assay adaptations

The in vitro human reconstructed skin micronucleus (RSMN) assay in EpiDerm is a promising novel animal alternative for evaluating genotoxicity of topically applied chemicals. It is particularly useful for assessing cosmetic ingredients that can no longer be tested using in vivo assays. To advance the use of this test especially for regulatory decision-making, we have […]

FORSKOLIN PROTECTS KERATINOCYTES FROM UVB-INDUCED APOPTOSIS AND INCREASES DNA REPAIR INDEPENDENT OF ITS EFFECTS ON MELANOGENESIS.

This study by researchers in the Laboratory of Cell Biology, National Cancer Institute (National Institutes of Health) demonstrated that Mattek’s melanocyte/keratinocyte-containing MelanoDerm in vitro human skin tissue equivalent can be used to investigate the ability of a topically applied compound to prevent UVB-induced DNA damage in keratinocytes independent of melanin production in melanocytes. Melanin pigments […]

UPDATE ON VALIDATION STATUS AND INDUSTRY UTILIZATION OF NORMAL HUMAN 3D (NHU-3D) ANIMAL ALTERNATIVE MODELS.

Progress in in vitro tissue engineering over the last several decades has contributed to a significant decrease in animal use for industrial risk and safety assessment of products and ingredients. Mattek Corporation has a long-standing involvement in development, production and validation of animal alternative in vitro models produced from normal human cells (NHu-3D models). The […]

DERMAL PENETRATION AND METABOLISM OF p-AMINOPHENOL AND p-PHENYLENEDIAMINE: APPLICATION OF THE EPIDERM HUMAN RECONSTRUCTED EPIDERMIS MODEL.

This study by scientists at Procter & Gamble Co. demonstrated that Mattek’s EpiDerm in vitro human skin tissue equivalent showed excellent correlation to in vivo results for skin penetration and metabolism of two hair dye ingredients, further strengthening the evidence for the use of the EpiDerm reconstructed human skin micronucleus assay as a replacement for […]

RECONSTITUTED 3-DIMENSIONAL HUMAN SKIN AS A NOVEL IN VITRO MODEL FOR STUDIES OF CARCINOGENESIS.

EpiDerm (Mattek Co., MA) is a reconstituted human skin equivalent which exhibits morphological and growth characteristics similar to human skin. This model has previously been utilized to evaluate the cytotoxicity and irritant potential of various cosmetic and household products. In this study, we show for the first time that EpiDerm can be used successfully to […]

STUDIES OF BYSTANDER EFFECTS IN ARTIFICIAL HUMAN 3D TISSUE SYSTEMS USING A MICROBEAM IRRADIATION.

According to the target theory of radiation-induced effects (1), a central tenet of radiation biology, DNA damage occurs during or very shortly after irradiation of the nuclei in targeted cells, and the potential for biological consequences can be expressed within one or two cell generations. A range of evidence has now emerged that challenges the […]

THE COLIPA STRATEGY FOR THE DEVELOPMENT OF IN VITRO ALTERNATIVES: GENOTOXICITY.

This report by the COLIPA Genotoxicity Task Force, comprised of researchers from Wella AG, L’Oreal, Procter & Gamble, Henkel, and Unilever, presents details of a concept developed for testing dermally exposed substances, including the use of Mattek’s EpiDerm human skin tissue equivalent, that will be part of a strategy for replacement of animal genotoxicity experiments. […]

CHARACTERIZATION OF THE EPIDERM™ HUMAN 3-D SKIN MODEL FOR GENOTOXICITY TESTING.

This study by scientists at Procter & Gamble, the Institute for In Vitro Sciences (IIVS) and Mattek Corp. demonstrated that a micronucleus assay based on Mattek’s EpiDerm in vitro human skin tissue equivalent shows great promise as a new genotoxicity test for cosmetic products and their ingredients. To meet the requirements of the EU 7th […]

DEVELOPMENT OF A NOVEL MICRONUCLEUS ASSAY USING THE HUMAN 3-D SKIN MODEL, EPIDERM™.

This study by scientists at Procter & Gamble Co. and the Institute for In Vitro Sciences (IIVS) demonstrated that Mattek’s EpiDerm in vitro human skin tissue equivalent is an excellent candidate for use in an in vitro micronucleus assay because micronuclei can be reproducibly induced in EpiDerm, the first step in developing a routine “in […]

DEVELOPMENT OF A MICRONUCLEUS ASSAY IN THE EPIDERM HUMAN 3D SKIN MODEL.

This study by scientists at Procter & Gamble Co. and the Institute for In Vitro Sciences (IIVS) demonstrated that Mattek’s EpiDerm in vitro human skin tissue equivalent is an excellent potential candidate for use in an in vitro micronucleus assay because scientists were able to reliably obtain a reasonably-sized population of binucleated cells. To meet […]

COLIPA VALIDATION OF THE RECONSTRUCTED HUMAN SKIN MICRONUCLEUS ASSAY (RSMN): A NOVEL MICRONUCLEUS ASSAY IN A 3D HUMAN SKIN MODEL.

This COLIPA-funded study by scientists at Procter and Gamble, Henkel AG and Co KGaA, L’Oreal, the Institute for In Vitro Sciences (IIVS), Unilever, Beiersdorf AG, KPSS (Kao Professional Salon Services), GlaxoSmithKline (GSK) and Pierre Fabre demonstrated that Mattek’s EpiDerm in vitro 3-D human skin tissue equivalent, when used as the basis for a human skin […]

ANALYSIS OF IONIZING RADIATION-INDUCED DNA DAMAGE AND REPAIR IN THREE-DIMENSIONAL HUMAN SKIN MODEL SYSTEM.

This study by researchers in the Columbia University College of Physicians and Surgeons Center for Radiological Research demonstrated that Mattek’s EpiDerm in vitro 3-D human skin tissue equivalent and EpiDermFT full-thickness in vitro 3-D human skin tissue equivalent can be used to study the damaging effects to DNA of ionizing radiation exposure. Knowledge of cellular […]

LONG-TERM BIOLOGICAL BYSTANDER EFFECTS OF MICROBEAM IRRADIATION IN 3D HUMAN TISSUE MODELS.

This study by researchers at the National Cancer Institute (NIH), University of Lethbridge (Canada) and Columbia University demonstrated that Mattek’s EpiDermFT and EpiAirway in vitro human tissue equivalents exhibited the “radiation-induced bystander response” thereby overcoming the deficiencies of cultured-cell studies. Irradiated cells can induce genomic instability in unirradiated neighboring cells in vitro. This phenomenon, called […]

THE DEVELOPMENT OF AN IN VITRO SCREENING STRATEGY FOR TOPICALLY APPLIED PRODUCTS.

The objective of this study was the pharmaco-toxicological understanding of the constituents of an authenticated herbal mixture. The mixture was prepared by maceration in ethanol and subsequent dilution to produce a topically applied lotion, for which the intended target conditions are psoriasis and eczema. A three-tiered in vitro screening strategy was adopted for evaluating this […]

FURTHER DEVELOPMENT OF A MICRONUCLEUS ASSAY USING THE HUMAN 3-D SKIN MODEL, EPIDERM™.

COMPARATIVE STUDIES ON THE BIOTRANSFORMATION OF BENZO[A]PYRENE IN HUMAN KERATINOCYTES, IN VITRO SKIN MODELS, AND SKIN EX VIVO: METABOLITE PATTERNS AS INDICATOR FOR THE METABOLIC CAPACITY OF SKIN EQUIVALENTS.

In vitro skin models are increasingly important for toxicological testing strategies to facilitate risk assessment and classification of chemicals. The reliability of these tests depends on the capacity of skin equivalents to metabolize xenobiotics in a similar way as found for human skin. So far, studies aimed at characterizing the metabolic competence of in vitro […]

A TIERED APPROACH TO THE USE OF ALTERNATIVES TO ANIMAL TESTING FOR THE SAFETY ASSESSMENT OF COSMETICS: GENOTOXICITY. A COLIPA ANALYSIS.

For the assessment of genotoxic effects of cosmetic ingredients, a number of well-established and regulatory accepted in vitro assays are in place. A caveat to the use of these assays is their relatively low specificity and high rate of false or misleading positive results. Due to the 7th amendment to the EUCosmetics Directive ban on […]

IMPROVING GENOTOXICITY TESTING: COMET ASSAY WITH 3D SKIN MODELS.

This study by scientists at Henkel, ECVAM, TNO, L’Oreal, COLIPA, Procter and Gamble – Cosmital SA, Unilever, Procter and Gamble US, Beiersdorf, KPSS (Kao Professional Salon Services), GlaxoSmithKline (GSK) and Pierre Fabre demonstrated that Mattek’s EpiDerm in vitro 3-D human skin tissue equivalent can be used in a test system of higher biological relevance compared […]

AUTOMATION AND VALIDATION OF MICRONUCLEUS DETECTION IN THE 3D EPIDERM™ HUMAN RECONSTRUCTED SKIN ASSAY AND CORRELATION WITH 2D DOSE RESPONSES.

Recent restrictions on the testing of cosmetic ingredients in animals have resulted in the need to test the genotoxic potential of chemicals exclusively in vitro prior to licensing. However, as current in vitro tests produce some misleading positive results, sole reliance on such tests could prevent some chemicals with safe or beneficial exposure levels from […]

FURTHER DEVELOPMENT OF THE EPIDERM 3D RECONSTRUCTED HUMAN SKIN MICRONUCLEUS (RSMN) ASSAY.

This study by scientists at Procter & Gamble Co., the Institute for In Vitro Sciences (IIVS), Advanced Testing Laboratory and Mattek Corp. demonstrated that an in vitro human reconstructed skin micronucleus assay (RSMN) based on Mattek’s EpiDerm in vitro human skin tissue equivalent has a higher predictive value than currently available in vitro genotoxicity tests. […]

COLIPA VALIDATION OF THE RECONSTRUCTED HUMAN SKIN MICRONUCLEUS ASSAY (RSMN): FURTHER PRE-VALIDATION STUDIES AND INVESTIGATIONS IN INCREASING TIME EFFICIENCY.

The European Cosmetics Association (COLIPA) has initiated a multi-laboratory project to establish and evaluate more predictive in vitro genotoxicity assays using 3D human tissues as replacements for current mammalian cell in vitro genotoxicity assays, which induce high levels of false positives. The reconstructed skin (RS) model, EpiDermTM, was combined with the micronucleus (MN) and comet […]

INTRALABORATORY AND INTERLABORATORY EVALUATION OF THE EPIDERM 3D HUMAN RECONSTRUCTED SKIN MICRONUCLEUS (RSMN) ASSAY.

This study by scientists at Procter & Gamble Co., the Institute for In Vitro Sciences (IIVS), Advanced Testing Laboratory and Mattek Corp. demonstrated that an in vitro human reconstructed skin micronucleus assay (RSMN) based on Mattek’s EpiDerm in vitro human skin tissue equivalent exhibited the required intra and interlaboratory reproducibility with tissues produced from cells […]

THE USE OF 3D SKIN MODELS IN THE MICRONUCLEUS AND COMET ASSAYS: FURTHER PRE-VALIDATION STUDIES AND INVESTIGATIONS INTO INCREASING THROUGHPUT.

The European Cosmetic Association (COLIPA) has initiated a multi-laboratory project to establish and evaluate more predictive in vitro genotoxicity assays using 3D human tissues as replacements for current mammalian cell in vitro genotoxicity assays, which induce high levels of “false” positives. The reconstructed skin (RS) model, EpiDermTM, was combined with the micronucleus (MN) and Comet […]

GENOTOXICITY TESTING USING THE MICRONUCLEUS ASSAY IN THE EPIDERM™ HUMAN 3D SKIN MODEL.

This study by scientists at Procter & Gamble, the Institute for In Vitro Sciences (IIVS), and Mattek Corp. demonstrated that the Micronucleus Assay that utilizes Mattek’s EpiDerm in vitro human skin tissue equivalent with inherent metabolic activity holds excellent promise to predict genotoxicity while avoiding animal welfare issues. Safety assessment of new products for human […]

THE USE OF HUMAN 3D EPIDERMAL MODELS FOR GENOTOXICITY TESTING: RESULTS WITH THE COMET ASSAY.

EU policy, including REACH and the Cosmetics Directive, implies the urgent need for reliable in vitro strategies with regards to the safety evaluation of chemicals. Currently used in vitro assays are not sufficiently suitable to reliably evaluate substances, for example cosmetic ingredients, for which the skin is the primary route of exposure. Therefore, genotoxicity assays […]

USE OF THE COMET ASSAY TO DETECT GENOTOXIC EFFECTS IN RECONSTITUTED HUMAN SKIN.

This study by scientists at Procter & Gamble and Wella-Cosmital SA demonstrated that Mattek’s EpiDerm in vitro human tissue equivalent may provide an excellent platform for performing comet (genotoxicity) assays of dermally applied cosmetics and their constituents because EpiDerm is produced from primary (non-transformed) human keratinocytes and it possesses a human skin-like barrier function. Current […]

THE RECONSTRUCTED SKIN COMET ASSAY SHOWS GOOD INTRA- AND INTER-LABORATORY REPRODUCIBILITY: RESULTS FROM THREE LABORATORIES.

EU policy marks the need for a broad replacement of animal tests in relation to the 7th Amendment to the Cosmetics Directive. For cosmetics ingredients as well as many chemicals, the skin is the main route of exposure. The currently used standard in vitro genotoxicity assays, if used in a test battery approach, show a […]

IN VITRO GENOTOXICITY TESTING USING THE MICRONUCLEUS ASSAY IN CELL LINES, HUMAN LYMPHOCYTES AND 3D HUMAN SKIN MODELS.

The toxicological relevance of the micronucleus (MN) testis well defined: it is a multi-target genotoxic endpoint,assessing not only clastogenic and aneugenic events butalso some epigenetic effects, which is simple to score,accurate, applicable in different cell types. In addition, it ispredictive for cancer, amenable for automation and allowsgood extrapolation for potential limits of exposure orthresholds and […]

THE RECONSTRUCTED SKIN MICRONUCLEUS ASSAY (RSMN) IN EPIDERM™: DETAILED PROTOCOL AND HARMONIZED SCORING ATLAS.

The European Cosmetic Toiletry and Perfumery Association (COLIPA), along with contributions from the European Centre for the Validation of Alternative Methods (ECVAM), initiated a multi-lab international prevalidation project on the reconstructed skin micronucleus (RSMN) assay in EpiDerm™ for the assessment of the genotoxicity of dermally applied chemicals. The first step of this project was to […]

γ-H2AX FORMATION IN THREE-DIMENSIONAL HUMAN SKIN AND CELL MODELS FOLLOWING INVITRO EXPOSURE TO SULFUR MUSTARD.

Sulfur mustard (2-2’-dichlorodiethyl sulfide, SM) is a cytotoxic chemical warfare agent known for its vesicating properties. SM exposure to human tissue results in DNA damage, eventually leading to cell and tissue death. To elucidate the genotoxic effects of SM, the presence of γ-H2AX foci was determined in several skin models. These included normal human epidermal […]

CHARACTERIZATION OF ENZYME ACTIVITIES OF CYTOCHROME P450 ENZYMES, FLAVIN-DEPENDENT MONOOXYGENASES, N-ACETYLTRANSFERASES AND UDP-GLUCURONYLTRANSFERASES IN HUMAN RECONSTRUCTED EPIDERMIS AND FULL-THICKNESS SKIN MODELS.

With the perspective to use human reconstructed skin models for genotoxicity testing which require metabolic activation of xenobiotics, this study aimed to characterize activities of biotransforming enzymes within two human reconstructed skin models, the epidermis model EpiDerm™ (Mattek) and the Phenion_Full-Thickness skin model Phenion_FT (Henkel). According to existing gene expression profiles, Cytochrome P450 (CYP) enzymes, […]

INVESTIGATION OF THE BIOTRANSFORMING CAPACITY OF HUMAN RECONSTRUCTED SKIN MODELS FOR GENOTOXICITY TESTING.

Skin penetration is a route of xenobiotic uptake in the body, however, less information is available about the fate of the penetrated xenobiotic in regard of metabolic turn over. The presence of xenobiotic metabolizing enzymes in skin has previously been shown by transcriptional expression analysis including CYPs, Flavin-dependent monooxygenases (FMO), Alcohol- (ADH) and Aldehyde-Dehydrogenases (ALDH), […]

METABOLICALLY COMPETENT HUMAN SKIN MODELS: ACTIVATION AND GENOTOXICITY OF BENZO[A]PYRENE.

The polycyclic aromatic hydrocarbon (PAH) benzo[a]pyrene (BP) is metabolized into a complex pattern of BP derivatives, among which the ultimate carcinogen (+)-anti-BP-7,8-diol-9,10- epoxide (BPDE) is formed to certain extents. Skin is frequently in contact with PAHs and data on the metabolic capacity of skin tissue toward these compounds are inconclusive. We compared BP metabolism in […]

EVALUATION OF XENOBIOTIC METABOLISM IN HUMAN RECONSTRUCTED SKIN MODELS FOR GENOTOXICITY TESTING.

Skin penetration and absorption is a major route of xenobiotic uptake. Skin maintains furthermore capacities to transform chemical substances which was previously shown by transcriptional expression analysis of metabolizing enzymes including CYPs, Flavin-dependent monooxygenases (FMO), N- Acetyltransferases (NAT) and UDP-Glucuronyltransferases (UDP-GT) [1-3]. Their catalytic activity in skin tissue however was rarely specified. Human reconstructed skin […]

DNA DOUBLE-STRAND BREAKS FORM IN BYSTANDER CELLS AFTER MICROBEAM IRRADIATION OF THREE-DIMENSIONAL HUMAN TISSUE MODELS.

This study by researchers at the National Cancer Institute (NIH), University of Lethbridge (Canada) and Columbia University demonstrated the ability to use Mattek’s EpiDermFT and EpiAirway in vitro human tissue equivalents as accurate in vitro surrogates to study phenomena known to be deleterious to human health – in this example, the DNA-damaging “bystander effect” of […]

ASSESSMENT OF AIRWAY GENOTOXICITY POTENTIAL USING THE EPIAIRWAY IN VITRO HUMAN AIRWAY MODEL AND THE COMET ASSAY.

Determination of genotoxic potential is an important consideration for safety assessment of chemicals that may be inhaled following exposure to consumer products, occupational chemicals or environmental pollutants.   Commonly used in vitro genotoxicity assays produce a high rate of false positive results, limiting their practical utility for predicting human genotoxicity hazard.  For assessment  of organ-specific genotoxicity […]

GENOTOXICITY TESTING USING THE NORMAL HUMAN CELL BASED 3D EPITHELIAL MODELS.

Safety assessment of new products for human use requires genotoxicity testing to ensure their non-carcinogenicity. Current in vitro genotoxicity assays have low specificity resulting in unacceptably high rates of false positives. Moreover, starting in 2009, in vivo genotoxicity testing was banned by the 7th Amendment to the Cosmetics Directive. Since epithelial tissues have the highest […]

The Cosmetics Europe strategy for animal-free genotoxicity testing: project status up-date

The Cosmetics Europe (formerly COLIPA) Genotoxicity Task Force has driven and funded three projects to help address the high rate of misleading positives in in vitro genotoxicity tests: The completed “False Positives” project optimized current mammalian cell assays and showed that the predictive capacity of the in vitro micronucleus assay was improved dramatically by selecting […]