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Epiderm Skin Corrosion Test - OECD TG 431, a Method to evaluate the safe Handling, Packing and Transport of Chemicals



Overview

Epiderm belongs to the group of reconstructed human epidermis models. This model mirrors similarity to native human tissue comprising lipid composition, biochemical markers, and morphology. The model is suited for tests of phototoxicity, corrosivity, and irritancy.

Test protocols are available and validated by institutions and are based on validation studies. Important are suitable indications for transport experiments of drugs and xenobiotics across the skin.

Skin corrosion test evaluates the corrosion power of chemicals, such as drugs, cosmetics, industrial chemicals, biocides, and mixtures of chemicals.
The test must be compliant with OECD TG 431.

Skin corrosion is irreversible related to damage and loss of cell viability of the skin following the application of a test substance. Skin corrosion is classified in Category 1, representing dermal tissue destruction as visible necrosis in at least one animal. The subcategory 1A is defined as exposure < 3 minutes with observation below 1 hour. Subcategory 1B reflects exposures of less than 1 hour and observations below one to four days, while subcategory 1C is based on less than 4 hours and 14 days, respectively.

The EpiDerm Skin corrosion test is performed using human cell-based three-dimensional highly differentiated keratinocyte cultures. A chemical's potential to induce skin corrosion is an essential consideration in establishing procedures for the safe handling, packing, and transport of chemicals.

The EpiDerm Skin Corrosion Test can reliably discriminate chemicals corrosive to the skin from non-corrosive chemicals. It can classify skin corrosion hazards by GHS, the globally harmonized system developed in 2003.

What does Epiderm mean?


As mentioned before,
Epiderm is known as Reconstructed Human Epidermis (RHE). It is a ready-to-use, highly differentiated 3D tissue model consisting of normal, human-derived epidermal keratinocytes (NHEK) cultured on specially prepared tissue culture inserts.

EpiDerm showcases the required human epidermal tissue structure and cellular morphology with optimized uniformity and reproducibility. The corresponding 3D structure comprises organized and proliferative basal cells, spinous and granular layers, and cornified epidermal layers, characterized by mitotically and metabolically activity.

Epiderm Tissue and Epiderm System


Mattek Corporation has developed the Epiderm tissue, which Primacyt and its partner FICAM can provide based on GLP or non-GLP testing procedures.

MatTek Corporation’s patented EpiDerm™ system is leading in vitro testing technology for dermal toxicologists and formulation scientists. With multiple ECVAM validations and OECD accepted test guidelines, EpiDerm™ is a proven in vitro model system for chemical, pharmaceutical, and skincare product testing. It is produced under GMP conditions, proving excellent in vitro – in vivo correlation.

The required tissue culture Insert employs the air-liquid interface (ALI). The model is capable of evaluating topically applied compounds, chemicals, cosmetic/personal care product ingredients, and final formulations. MatTek’s straightforward protocols, in combination with more than 20 years of expertise. EpiDerm can be considered as the gold standard for a broad range of highly predictive in vitro applications.

Applications for Epiderm Skin Corrosion

This skin corrosion test is a stand-alone in vitro alternative to animal skin corrosion testing. The viability of tissue is determined by the MTT Assay, a colorimetric assay for assessing cell metabolic activity. NAD(P)H-dependent cellular oxidoreductase enzymes may, under defined conditions, reflect the number of viable cells present. The MTT Assay determines tissue viability.

General evaluation of skin corrosion potential…
of chemicals (drugs, cosmetics, industrial chemicals, biocides) and mixtures of chemicals. Application areas include, but are not limited to:
• Human skin models.
• Classification of corrosive materials.
• Determination of hazard potentials
• In vitro membrane barrier test for skin corrosion.
• Resolution of cross-resistance between unrelated and related drugs
• Measurement of Sensitivity of novel drugs
• Measurement of drug sensitivity ex vivo for the prediction of clinical results.
• Drug screening and testing of cell lines or patient samples.

The In vitro skin corrosion test in more detail

  • The skin corrosion test complies with OECD TG 431 using EpiDerm (TM) tissue by MatTek Corporation.
  • According to the needs of our users, GLP and non-GLP testing services are provided.
  • Our test is based upon loss of cell viability of the skin, following the application of a test substance for 3 and 60 minutes - other intervals on request.
  • The core feature of the skin corrosion test is the human cell-based three-dimensional highly differentiated keratinocyte cultures from MatTek Corporation (EpiDerm (TM).
Overview

Epiderm belongs to the group of reconstructed human epidermis models. This model mirrors similarity to native human tissue comprising lipid composition, biochemical markers, and morphology. The model is suited for tests of phototoxicity, corrosivity, and irritancy.

Test protocols are available and validated by institutions and are based on validation studies. Important are suitable indications for transport experiments of drugs and xenobiotics across the skin.

Skin corrosion test evaluates the corrosion power of chemicals, such as drugs, cosmetics, industrial chemicals, biocides, and mixtures of chemicals.
The test must be compliant with OECD TG 431.

Skin corrosion is irreversible related to damage and loss of cell viability of the skin following the application of a test substance. Skin corrosion is classified in Category 1, representing dermal tissue destruction as visible necrosis in at least one animal. The subcategory 1A is defined as exposure < 3 minutes with observation below 1 hour. Subcategory 1B reflects exposures of less than 1 hour and observations below one to four days, while subcategory 1C is based on less than 4 hours and 14 days, respectively.

The EpiDerm Skin corrosion test is performed using human cell-based three-dimensional highly differentiated keratinocyte cultures. A chemical's potential to induce skin corrosion is an essential consideration in establishing procedures for the safe handling, packing, and transport of chemicals.

The EpiDerm Skin Corrosion Test can reliably discriminate chemicals corrosive to the skin from non-corrosive chemicals. It can classify skin corrosion hazards by GHS, the globally harmonized system developed in 2003.


What does Epiderm mean?


As mentioned before,
Epiderm is known as Reconstructed Human Epidermis (RHE). It is a ready-to-use, highly differentiated 3D tissue model consisting of normal, human-derived epidermal keratinocytes (NHEK) cultured on specially prepared tissue culture inserts.

EpiDerm showcases the required human epidermal tissue structure and cellular morphology with optimized uniformity and reproducibility. The corresponding 3D structure comprises organized and proliferative basal cells, spinous and granular layers, and cornified epidermal layers, characterized by mitotically and metabolically activity.

Epiderm Tissue and Epiderm System


Mattek Corporation has developed the Epiderm tissue, which Primacyt and its partner FICAM can provide based on GLP or non-GLP testing procedures.

MatTek Corporation’s patented EpiDerm™ system is leading in vitro testing technology for dermal toxicologists and formulation scientists. With multiple ECVAM validations and OECD accepted test guidelines, EpiDerm™ is a proven in vitro model system for chemical, pharmaceutical, and skincare product testing. It is produced under GMP conditions, proving excellent in vitro – in vivo correlation.

The required tissue culture Insert employs the air-liquid interface (ALI). The model is capable of evaluating topically applied compounds, chemicals, cosmetic/personal care product ingredients, and final formulations. MatTek’s straightforward protocols, in combination with more than 20 years of expertise. EpiDerm can be considered as the gold standard for a broad range of highly predictive in vitro applications.


Applications for Epiderm Skin Corrosion

This skin corrosion test is a stand-alone in vitro alternative to animal skin corrosion testing. The viability of tissue is determined by the MTT Assay, a colorimetric assay for assessing cell metabolic activity. NAD(P)H-dependent cellular oxidoreductase enzymes may, under defined conditions, reflect the number of viable cells present. The MTT Assay determines tissue viability.

General evaluation of skin corrosion potential…
of chemicals (drugs, cosmetics, industrial chemicals, biocides) and mixtures of chemicals. Application areas include, but are not limited to:
• Human skin models.
• Classification of corrosive materials.
• Determination of hazard potentials
• In vitro membrane barrier test for skin corrosion.
• Resolution of cross-resistance between unrelated and related drugs
• Measurement of Sensitivity of novel drugs
• Measurement of drug sensitivity ex vivo for the prediction of clinical results.
• Drug screening and testing of cell lines or patient samples.

The In vitro skin corrosion test in more detail

  • The skin corrosion test complies with OECD TG 431 using EpiDerm (TM) tissue by MatTek Corporation.
  • According to the needs of our users, GLP and non-GLP testing services are provided.
  • Our test is based upon loss of cell viability of the skin, following the application of a test substance for 3 and 60 minutes - other intervals on request.
  • The core feature of the skin corrosion test is the human cell-based three-dimensional highly differentiated keratinocyte cultures from MatTek Corporation (EpiDerm (TM).


You have arrived at this page, because you are searching for human skin models, OECD guideline 431 for the corrosion test Your focus area is directed to the reconstructed human epidermis, Rhe, testing of chemicals, validation study, corrosive chemical substances, and mixtures. Your technical interests are probably in the fields of cell viability, skin irritation, skinethic rhe, rhe test methods, and more.