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ISO 10993-10 2002
​Skin Irritation

The Basic Study design requirements
This test is found in the main body of the document.   
The rabbit is the preferred model.

When the test material is to be tested directly, the sample preparation is performed according to  an associated annex.  If the potential for irritation is suspected, start with one initial pre-screening animal.  If there is not a well defined reaction in the first animal, 2 more animals for direct or 2 more animals per extract are subsequently dosed.


Three, 2 kg or greater rabbits of either sex from a single strain are used.  Shaving of the fur is performed 4 to 24 hours before dosing. Depilatories are permitted if used by trained personnel and the process is validated in the laboratory.  Based upon the clinical use of the test material, there is the possibility of repeated exposure up to 21 days.

The test materials is delivered as a dose of 0.5 ml or 0.5 grams, moistened if necessary.  The test material is applied to both sides of each animal.  The test material is applied for a 4 hour exposure.  Any residual material is removed.

Observations (scoring) is made one hour and at 24, 48, and 72 hours post-removal.  Scoring may be made out to 14 days if necessary based on the results observed.  The skin is graded on a 5 point scale ranging from no(0), very slight(1), well-defined(2), moderate(3), to severe(4) for both erythema and edema.  Only the 24, 48, and 72 hour scores are used for overall calculation.

How to calculate the score is explained as an overall mean score from all animals, all scoring observations and both scoring categories.


The final scoring determination is an irritation grade called the Primary Irritation Index which has scoring ranges including negligible, slight, moderate and severe with corresponding numerical scores from 0.0 to 8.0 with 8.0 being the maximum possible score for a single time point at any given site.  Therefore the calculation of the primary irritation index is the overall mean score for all sites of all animals.
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  • Home
  • Suppliers
    • Contract Laboratories >
      • Toxikon
      • Nelson Labs
      • Eurofins
    • Material Suppliers
    • Contract Manufacturers
    • Consultants >
      • Intrinsic Medical Group
  • Library
    • Which Endpoints Should I Consider?
    • Test Method Summaries
    • White Papers, Articles and Presentations >
      • FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires
      • FDA Recognized Consensus Standards Update
      • The Ten Steps of a Biological Evaluation whtin a Risk Management Process
      • Post-Approval Biocompatibility
      • The Failed Cytotoxicity Test
      • Biocompatibility Deficiency Letters Part 2
      • ISO 18562-1 (2017) Biocompatibility Evaluation of Breathing Gas Pathways
      • In-Vivo Thrombogenicity 101
      • Technical Considerations for Additive Manufactured (3D Printed) Devices
      • How to Pick a Biocompatibility CRO
      • Mitigating Risk in Biocompatibility
      • Biocompatibility Deficiency Letters
      • The First Steps in Biocompatibility
  • Contact
    • About
  • Search