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ISO 10993-10 2010
Guinea Pig Maximization test
AKA MAGNUSSON-KLIGMAN

The Basic Study design requirements
The  method is found in the main body of the document.

It is also known as the Magnusson-Kligman Test


If the test article is to be tested directly, the preparation is to be according to an associated annex.  A note has been inserted discussing a specific method for extracting polymers.

Healthy albino guinea pigs of either sex from a single strain between 300 and 500 grams should be used. Females shall  be nulliparous and not pregnant.

The number of animals used should be a minimum of 10 test animals for a powder, liquid or each extraction vehicle.  A minimum of 5 control animals for a powder,  liquid or for each extraction vehicle.  Additional animals may be required for preliminary tests.

The fur should be clipped prior to treatment.

Dosages
    0.1 ml per site for intradermal injections.
    Saturated filter paper or gauze under an occlusive dressing for topical applications.

Preliminary tests:
  • Not required for undiluted extracts using typical solvents.
  • Used for the purpose of establishing concentrations in main test.
  • Pretreat the animals with Freund’s Complete Adjuvant (FCA).
  • 3 topical preliminary animals receive a range of dose concentrations.
The highest concentration that does not cause extensive destruction of the skin when injected intradermally shall be used for the intradermal induction phase of the main test. The highest concentration that causes slight erythema, but does not affect the animal when applied topically, shall be used for the topical induction phase of the main study. The highest concentration that causes no erythema when applied topically shall be sued for the topical challenge phase of the main study.

Main test:
Three Phases

Intradermal Induction Phase:
  • 3 pairs of 0.1 ml injection.
  • First pair is a 1 to 1 mixture of FCA and the vehicle or carrier.
  • The second pair is the concentration of the test article determined to not cause extensive skin destruction in the intradermal preliminary test or the extraction vehicle alone in the case of the control animals.
  • The third pair is a 1 to 1 mixture of what was injected in the second pair with FCA.

Topical Induction Phase:
If there was no irritation observed in the topical preliminary test, apply 10% sodium dodecyl sulfate (SDS) in petrolatum 24 (+/-2) hours before topical application of the test article or extract (see below).  Perform the same procedure to the control animals.  Freshly prepared extracts should be used.  If the extracts are stored for greater than 24 hours the stability needs to be verified.  Apply the highest concentration that caused slight erythema but didn’t affect the animals in the preliminary topical test to filter paper over the shoulder blades topically and secure with occlusive dressing 7 (+/-1) days after the intradermal induction phase.  The dose should be removed after 48 hours.  Control animals receive the the vehicle or carrier.

Challenge Phase:
Apply the highest concentration that caused no erythema in the topical preliminary test to the flanks of both the test and the control animals 14 (+/- 1) days after the completion of the topical induction phase.  The dose should be applied for 24 (+/- 2) hours via patches as in the topical induction phase under an occlusive dressing.

Observe the dosed sites of all animals 24 (+/- 2) and 48 (+/- 2) hours after the removal of the patches.  Grading is 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.  Grades in test animals greater than the grades observed in the control animals indicate sensitization.  Questionable results may warrant a rechallenge 1 to 2 weeks later following the same procedures although a new FCA treated control group would be necessary.
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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