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Phototoxicity

1053

Development of Sensitive In Vitro Protocols for the Biocompatibility Testing of Medical Devices and Pharmaceuticals Intended for Contact with the Eyes: Acute Irritation and Phototoxicity Assessment

This study introduces a novel in vitro methodology that employs the 3-D reconstructed tissue model, EpiOcular, to assess the irritation and phototoxicity potential of medical devices and drugs in contact with the eye. Our study evaluated diverse test materials, including medical devices, ophthalmological solutions and an experimental drug (cemtirestat), for their potential to cause eye […]
956

In Vitro and Clinical Safety Assessment of the Multiple W/O/W Emulsion Based on the Active Ingredients from Rosmarinus officinalis L., Avena sativa L. and Linum usitatissimum L.

The multiple W/O/W emulsion supplemented with the extracts of Rosmarinus officinalis L., Avena sativa L. and Linum usitatissimum L. was prepared in the study, its active compounds were determined by HPLC and its safety was evaluated in vitro by the means of reconstituted human skin model EpiDerm™ for the assessment of its irritation, phototoxicity and […]
955

Skin phototoxicity of cosmetic formulations containing photounstable and photostable UV-filters and vitamin A palmitate

The aim of this study was to evaluate the in vitro skin phototoxicity of cosmetic formulations containing photounstable and photostable UV-filters and vitamin A palmitate, assessed by two in vitro techniques: 3T3 Neutral Red Uptake Phototoxicity Test and Human 3-D Skin Model In Vitro Phototoxicity Test. For this, four different formulations containing vitamin A palmitate […]
953

Use of alternative test methods in a tiered testing approach to address photoirritation potential of fragrance materials

The safety assessment of fragrance materials for photoirritation utilized by The Research Institute for Fragrance Materials has recently been modified and is described in detail. Materials demonstrating significant absorbance in the ultraviolet and visible light (UV/VIS) range (290–700 nm) may present a concern for photoirritation and require further investigation. If there are no photoirritation data […]
926

Retrospective review on in vitro phototoxicity data generated in 3D skin models to support the development of new OECD Test Guideline

Phototoxicity (also photo-irritation), is a light-induced skin reaction that occurs when photoreactive chemicals are activated to produce cytotoxic effects. Phototoxicity testing of chemicals is mostly conducted in vitro, following the methods described in the OECD test guideline (OECD TG 432), using the Balb/c 3T3 mouse fibroblast cell line. The test is highly sensitive, but low […]
897

Evaluation of phototoxicity of tattoo pigments using the 3 T3 neutral red uptake phototoxicity test and a 3D human reconstructed skin model

Phototoxicity due to dermally impregnated compounds exposed to ultraviolet radiation is associated with skin inflammation. The phototoxicity potential of active substances applied to the skin should be evaluated. Pigments are widely used for tattoos, and hypersensitivity reactions, such as photoallergic dermatitis, are possible tattoo related complications. However, the phototoxicity of these chemicals is not well […]
890

Evaluation of Phototoxic and Cytotoxic Potential of TiO2 Nanosheets in a 3D Reconstructed Human Skin Model

Despite a continuous increase in commercial products containing nanoparticles, only few materials are currently used in such large amounts, forms and sizes as titanium dioxide – TiO2. Besides their use in cosmetics, the food industry and biomedicine, TiO2 nanoparticles (NPs) are also used as highly efficient photocatalysts due to their unique ability to convert complex […]
880

Unlocking Mother Nature’s Building Blocks

Just as the foundation of water is hydrogen and oxygen, the foundation of plants and trees are cellulose and lignin. These universal materials act as Mother Nature’s building blocks and have proven critical to botanical viability, enabling growth and protecting against environmental stresses. Historically, scientists have failed to extract cellulose and lignin in the form […]
879

Development of a Model for Assessment of Blue Light Activated Toxicity in EpiGingival™ and EpiGingival™-FT Tissues

Traditional phototoxicity models examine activation of test material by ultraviolet A (UVA) light. In these models, the ability of a test chemical to induce toxicity in cells or tissues after light exposure is compared to non-light exposed tissues. While UV-induced toxicity is of great concern, it is clear that lower energy light in the blue […]
825

The EpiDerm Phototoxicity Test (EpiDerm H3D-PT)

Phototoxicity is defined as a toxic response from a substance applied to the body which is either elicited or increased (apparent at lower dose levels) after exposure to light, or that is induced by skin irradiation after systemic administration of a substance. Identification of the phototoxic potential of topically or systemically applied test chemicals is a […]
795

Total Defense + Repair: A Novel Concept in Solar Protection and Skin Rejuvenation

For more than a century, solar radiation has been known to contribute Significantly to the extrinsic aging of skin. Until recently, this was almost exclusively attributed to the photodamage caused by ultraviolet (UV) light. However, a growing body of evidence now indicates that both infrared (IR) and visible light may also contribute to extrinsic skin aging. Infrared […]
683

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 […]
143

PRESENCE OF HYDROCORTISONE DRAMATICALLY AFFECTS CYTOKINE PRODUCTION FOLLOWING UV IRRADIATION IN 3-DIMENSIONAL SKIN MODEL EPIDERM.

Dating back to work originally done by Rheinwald and Green, hydrocortisone (HC) is commonly used in culture media for epithelial cells, especially keratinocytes. In the culture of EpiDerm™, a highly differentiated, three-dimensional model of the human epidermis, this additive is included in the culture media. However, HC is a glucocorticoid, known for its anti-inflammatory efficacy. […]
224

EVALUATION OF THE USEFULNESS OF 3-D MODELS OF RECONSTITUTED HUMAN SKIN AND EPIDERMIS IN APPLICATIONS OF REGULATORY SKIN TOXICOLOGY: PREVALIDATION, VALIDATION, CATCH-UP VALIDATION, AND REGULATORY ACCEPTANCE.

In 1991 we evaluated a model of full human skin (Skin2, ATS, La Jolla) for phototoxicity testing. The test developed showed promising results as an adjunct to a test performed with Balb/c 3T3 cells. While it detected acute phototoxins correctly, it classified those chemicals negative, that are known photoallergic in humans, but are not phototoxic […]
209

A REPRODUCIBLE SKIN MODEL FOR DERMAL SAFETY AND EFFICACY TESTING.

The utility of any toxicological test system or method critically depends on the short and long term reproducibility of the method. Over the past 6 years, histological observations and quantitative quality control test methods utilizing the MTT assay have established a high level of intra-lot and inter-lot reproducibility for Mattek’s organotypic skin model, EpiDerm™. Interestingly, […]
205

A REPRODUCIBLE, STRUCTURALLY APPROPRIATE SKIN MODEL FOR DERMAL SAFETY AND EFFICACY TESTING.

The ability to determine, in vitro, the safety and efficacy profile for a material contacting the skin critically depends on the skin model’s structure and biochemistry. In addition, to be useful, the model must have a high level of intra-lot and inter-lot reproducibility. For this reason, the structure, biochemical nature, and reproducibility of the organotypic […]
355

LONG TERM REPRODUCIBILITY OF EPIDERM, AN EPIDERMAL MODEL FOR DERMAL TESTING AND RESEARCH.

This technical reference summarizes Mattek’s 10-plus YEAR EpiDerm tissue reproducibility data. Long-term reproducibility is important not only to Mattek Customers, but also to European (ECVAM) and US (ICCVAM) regulators. Regulators constantly stress the need for superior reproducibility of in vitro tissue equivalents, not only during a specific validation program, but also long after the initial […]
558

THE Mattek STORY – HOW THE THREE Rs PRINCIPLES LED TO 3-D TISSUE SUCCESS!

FRAME, the UK-based Fund for the Replacement of Animals in Medical Experiments, asked Mattek to contribute an article to a special edition of ATLA, FRAME’s scientific journal, commemorating FRAME’s 40th anniversary. FRAME asked Mattek to focus the article on the successful development of our in vitro 3-D tissues, produced from normal (non-transformed) human cells, as […]
169

PREVALIDATION OF TESTS FOR PREDICTING SKIN CORROSIVITY AND PHOTOTOXICITY USING AN IN VITRO MODEL OF HUMAN EPIDERMIS.

Tests for prediction of skin corrosivity and dermal phototoxicity using the model EpiDerm™ were evaluated at ZEBET in a prevalidation study funded by the European Centre for the Validation of Alternative Methods (ECVAM). The study comprised an interlaboratory method transfer, a refinement of test protocols and prediction models, and a blind trial involving three laboratories […]
119

UVB IRRADIATION OF AN ORGANOTYPIC SKIN MODEL, EPIDERM™, RESULTS IN SIGNIFICANT RELEASE OF CYTOKINES.

Ultraviolet light, especially UVB (290-320 nm), is believed to be responsible for most of the immediate and long term effects of excessive exposure to sunlight. In many cases, the initial stages of these UV induced changes are the release of cytokines. Although cytokine release from human keratinocytes in monolayer cultures following UV exposure has been […]
193

LACK OF PHOTOTOXICITY OF COSMETIC FORMULATIONS CONTAINING GLYCOLIC ACID IN AN IN VITRO HUMAN SKIN MODEL.

Glycolic acid (GA) is a naturally occurring product found in sugar cane and is a member of a class of chemicals known as alpha-hydroxy acids. GA has been widely used in cosmetic and dermatological formulations for over a decade. These formulations are often used in dermal applications where they may be sub-ject to ultraviolet radiation […]
192

PREVALIDATION OF THE EPIDERM PHOTOTOXICITY TEST (ED-PT).

The EpiDerm™ phototoxicity test was chosen for prevalidation within ECVAM’s tiered prevalidation procedure. In phase 1, ZEBET drafted an SOP and project plan for conducting the study. ZEBET’s task in phase I was to adapt the existing Skin2 methodology to the specific needs of the epidermal model EpiDerm. UVA sensitivity experiments revealed 6J/cm2 as the […]
181

PREVALIDATION OF THE EPIDERM PHOTOTOXCITY TEST.

The EpiDerm™ phototoxicity test was chosen for prevalidation within ECVAM’s tiered prevalidation procedure, since production of the full human in vitro skin model Skin2™ had been ceased in October 1996. ZEBET had developed a test protocol of a Skin2 phototoxicity test and had obtained promising results with a refined version of this test in the […]
172

PROTECTING THE SKIN AGAINST EXOGENOUS NOXES.

The authors have monitored various parameters to evaluate the protection of skin against oxidative damage by antioxidants. Chemoluminescence and liposomal preoxidation determined the efficiency of several antioxidants.
171

EPIDERMAL STRATIFICATION REDUCES THE EFFECTS OF UVB (BUT NOT UVA) ON KERATINOCYTE CYTOKINE PRODUCTION AND CYTOTOXICITY.

Ultraviolet (UV) radiation induced cytokine release from cultured keratinocytes as well as from epidermis in vivo. The purpose of this study was to determine whether differentiation of cultured keratinocytes into stratified epithelium decreases the effects of UVA and UVB radiation on cytokine release. Interleukin-1 IL-1á, IL-1â and tumor necrosis factor (TNF)-á release from human keratinocytes […]
155

DEVELOPMENT OF A NEW IN VITRO TEST FOR DERMAL PHOTOTOXICITY USING A MODEL OF RECONSTITUTED HUMAN EPIDERMIS (EPIDERM).

Results are reported using the human epidermis model (EpiDerm™) in a test protocol that was adopted from the method developed by ZEBET for phototoxicity testing with the model Skin2. In the new phototoxicity test the cytotoxicity of test materials applied topically to EpiDerm™ is determined at five concentrations in the absence and presence of a […]
128

AN IN VITRO METHOD TO EVALUATE THE ANTIOXIDANT EFFICACY OF TOPICAL FORMULATIONS.

We have developed a method of evaluating antioxidant efficacy in vitro using a three dimensional epidermal construct (Mattek EPI-100, Mattek Corpora-tion, Ashland, MA) which contains a well defined stratum corneum with a lipid profile similar to human skin. The EPI-100 allows direct application of test products to the stratum corneum. This method was used to […]
126

A COMPARISON STUDY OF FOUR IN VITRO PHOTOTOXICITY SYSTEMS.

Four in vitro phototoxicity systems were evaluated to determine how closely each method would reproduce the others. Eleven materials were used to evaluate these methods. All eleven materials were run in each system. Phototoxicity was evaluated using the Mattek EPI-100 dermal construct, the Advanced Tissues Sciences’ model 2K1300 dermal construct, and a monolayer of neonatal […]
116

USE OF THE Mattek EPI-100 IN VITRO SYSTEM TO SCREEN ANTIOXIDANT EFFICACY.

In this study, scientists at R. Thomas Stephens & Associates present an in vitro method to evaluate the efficacy of antioxidants and antioxidant formulations. The premise of this research is that exposure of human skin equivalents, specifically the commercially available Mattek EpiDerm EPI-100 skin model, to ultraviolet B (UVB) irradiation stimulates the production of oxygen […]
150

RECONSTITUTED 3-DIMENSIONAL HUMAN SKIN, A NEW IN VITRO MODEL FOR SKIN CARCINOGENESIS STUDY.

EpiDerm (Mattek Co., MA) is a newly developed reconstituted human skin equivalent that exhibits human skin-like morphological and growth characteristics. It has been utilized to evaluate the cytotoxicity and irritant potential of various cosmetic and household products. In this study, we found that EpiDerm can also be used to evaluate the genotoxicity of carcinogenic agents […]
188

THE PROTEASE-ACTIVATED RECEPTOR 2 REGULATES PIGMENTATION VIA KERATINOCYTE-MELANOCYTE INTERACTIONS.

Close association exists between melanocytes, the pigment melanin-producing cells in the body, and their neighboring keratinocytes. Keratinocytes are the pigment recipients and skin pigmentation is the result of this interaction. While the chemical basis of melanin production (melanogenesis) is well documented, the molecular mechanism of melanosome transfer needs to be elucidated. We are now providing […]
173

NEW RESULTS WITH MELANODERM™, AN EPIDERMAL MODEL CONTAINING FUNCTIONAL MELANOCYTES.

We have previously reported on the successful incorporation of normal human melanocytes (NHM) into a highly differentiated, three-dimensional tissue culture model of human epidermis (JID, 104(4), 616, 1995). Melanocytes exhibited dendritic morphology, were localized in the basal cell layer, and converted 1-dopa to melanin. Previously, spontaneous pigmentation of the melanocytes could not be observed using […]
217

EFFECTS OF ANTIOXIDANT INGREDIENTS ON HUMAN SKIN: FROM CELL CULTURE TESTING TO HUMAN CLINICAL TRIALS.

Cosmetic chemists have included Vitamins A, C, and 12 and other similar ingredients into skin care and cosmetic products for many years now. These ingredients and their derivatives were originally incorporated into those products for their effects in improving the appearance and feel of the skin. It has been well documented that Vitamins A and […]
212

IN VITRO TESTING FOR PHOTOTOXIC POTENTIAL USING THE EPIDERM 3-D RECONSTRUCTED SKIN MODEL.

An in vitro photocytotoxicity model using mouse 3T3 fibroblasts (the 3T3 NRU PT) has recently been validated for the detection of the phototoxic potential of test substances. Although the 3T3 NRU PT has been demonstrated to detect the phototoxic potential of both strong and weak phototoxins, irrespective of their aqueous solubility, in cases of low […]
588

PHOTOTOXICITY OF BERGAMOT OIL ASSESSED BY IN VITRO TECHNIQUES IN COMBINATION WITH HUMAN PATCH TESTS.

The aim of this study was to clarify the differences in the phototoxicity of bergamot oil obtained from four different suppliers. Spectral and chemical analyses were performed to identify presence of photoactive compounds in the test samples. The phototoxicity was assessed in vitro by the 3T3 NRU phototoxicity test (PT) and subsequently in a phototoxicity […]
531

ALTERNATIVE METHODS FOR PHOTOTOXICITY TEST USING RECONSTRUCTED HUMAN SKIN MODEL.

This study by researchers at the Korea Food and Drug Administration (KFDA) demonstrated that Mattek’s EpiDerm in vitro human skin tissue equivalent can be used to determine the phototoxic potency of chemicals. Phototoxicity is defined as a skin inflammatory reaction elicited by topical or systemic administration of chemicals and subsequent exposure to light, particu-larly UVA […]
441

COMPARISON OF IN VITRO PHOTOTOXICITY TEST METHODS: 3T3 NRU PT VS. ENHANCED PHOTOTOXICITY SCREENING ASSAY IN RECONSTITUTED SKIN (EPARS).

This study by scientists at MB Research Labs demonstrated that Mattek’s EpiDerm in vitro human tissue equivalent provided more in vivo-like test results for phototoxicity testing than the 3T3 Neutral Red Uptake Phototoxicity Test. Currently, only the 3T3 Neutral Red Uptake Phototoxicity Test (3T3-NRU PT) has been approved as a non-animal phototoxicity test by governmental […]
412

IN VITRO SCREEN FOR PHOTOTOXICITY OPTIMIZED DRUG DEVELOPMENT USING A HIGHLY DIFFERENTIATED SKIN MODEL.

This study by Mattek Corp. scientists demonstrated that Mattek’s EpiDerm human skin tissue equivalent can be used to determine the phototoxicity of systemically administered drugs, significantly improving the drug development process. PURPOSE: Both topically applied and systemically administered medications can induce photosensitivity. Photosensitivity includes both photo-allergic (immunologically mediated) reactions, and phototoxic effects, which occur following […]
372

ECVAM FEASIBILITY STUDY: CAN THE PRE-VALIDATED IN VITRO SKIN MODEL PHOTOTOXICITY ASSAY BE UPGRADED TO QUANTIFY PHOTOTOXIC POTENCY OF TOPICAL PHOTOTOXINS?

This study by scientists at ZEBET (Germany) and the Czech Republic National Institute of Public Health (SZU) demonstrated that Mattek’s EpiDerm in vitro human skin tissue equivalent can be used in place of animals to accurately predict the phototoxicity of topically applied formulations. The determination of phototoxicity of a chemical in the 3T3-NRU-PT test according […]
316

AN ASSESSMENT OF THE PHOTOTOXIC HAZARD OF A PERSONAL PRODUCT INGREDIENT USING IN VITRO ASSAYS.

Where substances are intended for use in personal products applied to the skin an assessment of potential phototoxic hazard is required. This report describes a tiered testing strategy involving in vitro assays used for the phototoxic hazard assessment of a personal product ingredient (Ingredient X). The initial assay was measurement of a UV/visible absorption spectrum […]
306

A TIERED STRATEGY FOR IN VITRO PHOTOTOXICITY TESTING.

Of the materials used to demonstrate the value of the 3-D Skin Assay (in supporting and interpreting 3T3 NRU PT results), all of those predicted phototoxic in the 3T3 NRU PT were confirmed phototoxic in the 3-D Skin Assay, with the exception of one (material coded 10). This material was clearly defined as phototoxic to […]
207

DERMATACS™ IN SITU APOTOSIS DETECTION KIT FOR SKIN CELLS AND TISSUES.

Trevigen announces the release of a new in situ apoptosis detection kit for skin cells and tissues, DermaTACS, and the companion products, EpiDerm™ Control Slides. DermaTACS was developed for the scientist working in skin research seeking distinct identification of cells with fragmented DNA and unprecedented low background interference. DermaTACS is ideal for the novice user […]
197

CHANGES IN CANCER-RELATED GENE EXPRESSION IN AN IN VITRO HUMAN SKIN MODEL FOLLOWING UVB-IRRADIATION.

UV-irradiation causes initiation and promotion of skin cancers, photoaging and immunosuppression. To further our understanding of these processes at the molecular level, we utilized cDNA array technology to examine changes in gene expression in the EpiDerm™ in vitro human skin model following irradiation with UVB (175 ml per cm2). Viability of irradiated EpiDerm tissue, as […]
743

ASSESSMENT OF PHOTOTOXICITY, SKIN IRRITATION, AND SENSITIZATION POTENTIAL OF POLYSTYRENE AND TiO2 NANOPARTICLES.

The human skin equivalent model (HSEM) is well known as an attractive alternative model for evaluation of dermal toxicity. However, only limited data are available on the usefulness of an HSEM for nanotoxicity testing. This study was designed to investigate cutaneous toxicity of polystyrene and TiO2 nanoparticles using cultured keratinocytes, an HSEM, and an animal […]
122

INITIAL CHARACTERIZATION OF AN EPIDERMAL MODEL CONTAINING FUNCTIONAL MELANOCYTES.

A model of the human epidermis, EpiDerm™, cultured from foreskin derived normal human epidermal keratinocytes (NHEK) has been shown to reproduce many of the histological and ultrastructural properties of native epidermis. In an effort to extend the utility and complexity of these cultures, normal human melanocytes (NHM) have recently been incorporated. Both melanocyte free and […]
229

AVOCADO PHYTOSTEROLS DECREASE UVB-INDUCED PRO-INFLAMMATORY MEDIATORS.

Exposure of skin to UVB radiation can cause the production of pro-inflammatory cytokines and prostanoids. Changes in the production of these mediators in the skin can decrease or increase the potentially damaging effects of UVB irradiation. In this series of experiments we investigated the effects of avocado-derived sterols on the production of pro-inflammatory mediators IL-1α, […]
235

EXPRESSION OF PLACENTA GROWTH FACTOR CYCLOOXYGENASE AND THYMUS-AND ACTIVATION-REGULATED CHEMOKINE IN THE EPIDERM IN VITRO HUMAN SKIN EQUIVALENT.

In vitro skin equivalent models are finding increased utility as tools in basic skin research, safety assessment and product development processes. To further utilization for these purposes, we are currently defining a growing list of physiologically significant molecular endpoints to monitor the effects of experimental treatments on EpiDerm™ in vitro human skin tissue. In the […]
164

ULTRAVIOLET B RADIATION UPREGULATES THE PRODUCTION OF MACROPHAGE MIGRATION INHIBITORY FACTOR (MIF) IN HUMAN EPIDERMAL KERATINOCYTES.

Human epidermal cells are capable of secreting various cytokines with immunologic, inflammatory, and proliferative properties. In a previous study, by reverse transcription-polymerase chain reaction and immunohistochemical analysis, we have shown that human epidermal keratinocytes express macrophage migration inhibitory factor and identified its presence in the cytoplasm. In this study, we detected an increased serum macrophage […]
236

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 […]
121

CYTOKINE RESPONSE OF THE EPIDERM SKIN MODEL TO TOPICALLY APPLIED IRRITANTS AND TOXICANTS.

EpiDerm™, Mattek Corporation’s in vitro reproduction of the human epidermis provides a convenient way in which toxicity and irritation potential of chemicals and physical stresses can be assessed. Derived from single strains of human keratinocytes, the model contains layers of cells which have differentiated into easily recognizable component strata of human epidermis. These include basal, […]