3D Reconstructed Human Skin Micronucleus assay (RSMN)

Topic: Genotoxicity/Mutagenicity

Test Method Number:
TM2020-04 (EU)
Short Name of TM:
RSMN
Year received:
2020
Responsible Organisation:
General Comments:
Under evaluation

Method Description

The RS MN Assay is an in vitro genotoxicity assay, which transfers the known micronucleus test in a three-dimensional reconstructed human skin (3D RHS) model. The assay addresses the potential of test items to cause genotoxicity in the form of chromosomal damage (clastogenicity and aneugenicity). The method uses the EpiDermâ„¢ Skin Model (MatTek, Ashland, USA) which is cultured from normal human epidermal keratinocytes derived from neo-natal foreskin tissue on specifically prepared tissue culture inserts. As such, the method is aimed to predict the potential of substances that are primarily associated with dermal exposure to cause DNA damage.

Track Approval Status

  •  
    Submission
  •  
    Validation
  •  
    Peer-review
  •  
    Recommendation
  •  
    Regulatory acceptance/Standards
Step
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Recommendation
Regulatory acceptance/Standards