skin discs & dermatomed skin

PRIMACYT offers dermatomed and full thickness skin discs from human donors. These ex vivo skin explants serve as valuable model systems and tools for drug discovery, safety evaluation of chemicals, pesticides and cosmetic active ingredients. The human skin discs are used for applications like

• Characterisation of topically applied pharmaceuticals (OECD TG 428)
• Safety assessment of biocides, agrochemicals (EU 528/2012)
• Safety evaluation of cosmetic ingredients
• Classification of substance based medical devices (EU 2017/745)

PRIMACYT provides researchers with fresh and cryopreserved human ex vivo skin explants for cosmetics and chemical testing. Applications include but are not limited to skin penetration assays, dermal absorption, percutaneous absorption studies using Franz diffusion cell systems according to OECD guideline 428. 

For research use only. Not intended for human or animal diagnostic or therapeutic use. Cryopreserved tissues will be shipped on dry ice.

All donors are serologically tested for HAV, HBV, HCV and HIV 1+2.

Ethical Compliance:
Human tissue donations are obtained with the inform consent from donors who undergo cosmetic surgery. The tissue is removed during surgical operations and would otherwise be discarded as biological waste.

Alternatives to Animal Testing

The ex vivo human skin discs (full thickness or dermatomed) are an important and excellent alternative to animal testing with regard to efficacy and safety of chemicals (agrochemicals, biocides, cosmetics, and pharmaceuticals). They are in line with multiple guidelines including, but not limited to the 3R directive to replace, reduce and refine the use of animals in efficacy and safety testing, and the EU initiative to prohibit the marketing of cosmetic products or its ingredients tested on animals.

P. Shah, J. Elkins, S.-Y. Lam, and J. P. Skelly: Determination of in vitro drug release from hydrocortisone creams. Int. J. Pharmaceutics, 1989, 53:53-59, DOI:10.1016/0378-5173(8I9)90361-X

S.-F. Ng, J. J. Rouse, F. D. Sanderson, V. Meidan, and G. M. Eccleston: Validation of a Static Franz Diffusion Cell System for In Vitro Permeation Studies. AAPS PharmSciTech, 2010, 11:1432-1441, DOI: 10.1208/s12249-010-9522-9

OECD GUIDELINE FOR THE TESTING OF CHEMICALS Skin Absorption: in vitro Method (OECD TG 428).

EFSA Guidance Dermal Absorption

EU Regulation No. 528/2012 Biocides

EU Regulation No. 2017/745 Medical devices

All skin samples are collected under strict ethical restrictions and with the informed consent of the donor. All donors are tested for HVA, HVB, HVC and HIV. The average age of the donor is around 40 years. The skin samples are prepared under high quality standards. The time from surgery to lab is less that 4 hours. The tissues are processed to meet customers’ specifications. Fresh full thickness skin tissue can be delivered within 24 – 48 hours after surgical removal to researchers and clients within Europe. Ex vivo human skin discs are available either fresh or frozen.

Specimen criteria include:

• Age
• Gender
• Body Mass Index
• Ethnicity
• Full thickness, with adipose removed
• Dermatomed (Thickness from 200 µm – 1200 µm)
• Disc diameter 18-25 mm (other sizes please inquire)
• Transepidermal waterloss (TEWL, g/m²*h)

Ex vivo skin explants are obtained from different body parts, including abdomen, breast, thighs and arm.

Skin tissues are visually inspected to meet specific requirements for stretch marks, moles, scars, tattoos other factors affecting the integrity of the sample. Photos of skin samples are provided in the accompanying analysis certificates.

This info refers to the product data below:

• To print lot information, please select the print icon at the end of the lists below. For research use only. 
• Not intended for human or animal diagnostic or therapeutic use.

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This info refers to the product data below:

Download MSDS