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OECD Guideline For Testing Of Chemicals: Skin Sensitization - Local Lymph Node Assay (LLNA).pdf

oecd-tg429-2010.pdf
Preview of OECD Guideline for Testing of Chemicals: Skin Sensitization - Local Lymph Node Assay (LLNA)
🔗 Source: ntp.niehs.nih.gov
📊 Size: 291 KB
👤 Author: OECD
⬇️ Downloads: 27

Summary

Key Points:

Purpose: LLNA provides an alternative to guinea pig tests (TG 406) for identifying potential skin sensitizers, offering reduced animal use and refined pain/distress.
 Assay Principle: Measures lymph node cell proliferation induced by test substances, correlating with allergen potency and dose. A Stimulation Index (SI) ≥3 indicates potential skin sensitization.
Animal Species: Young adult female CBA/Ca or CBA/J mice are the preferred species. Other strains and males can be used if sufficient data demonstrate minimal strain/gender differences.
 Housing & Feeding: Mice should be group-housed under standardized conditions.
Limitations: LLNA may yield false negatives for certain metals and skin irritants, and positive results are more likely with pesticide formulations. Test substance properties can also impact accuracy.
 Advantages Over TG 406: Reduces animal pain/distress, avoids adjuvants, and doesn't require eliciting dermal hypersensitivity reactions.
Performance Standards (PS): Annex 1 details criteria for evaluating the validation status of modified LLNA test methods.

Application:

The LLNA is suitable for testing any chemical substance unless specific properties could interfere with its accuracy. It should be considered when:

There's a regulatory need to confirm a negative prediction of skin sensitizing potential.
* Dose-response information is needed, such as for UN Globally Harmonized System classification.

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Description

The OECD Guideline (2010) updates the Local Lymph Node Assay (LLNA; TG 429), a test for mouse skin sensitization, based on validation studies and new scientific evidence. This periodic revision considers regulatory needs, animal welfare, and scientific progress.

Technical Information

  • File Format: PDF
  • File Size: 291 KB
  • Pages: 20
  • Language: EN
  • Author: OECD
  • Total Downloads: 27
  • Last Updated: 1 month ago

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OECD guideOECD tutorialGuideline guideGuideline tutorialTesting guideTesting tutorialChemicals: guideChemicals: tutorialSkin guideSkin tutorialSensitization guideSensitization tutorialLocal guideLocal tutorialLymph guideLymph tutorialNode guideNode tutorialAssay guideAssay tutorial(LLNA) guide(LLNA) tutorial

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