EUROLAB
oecd-tg-442b-local-lymph-node-assay-for-skin-sensitization
Dermatological & Sensitivity Testing AFNOR BP X30-221 In Vivo Human Skin Testing ProceduresASTM D2979 Assessment of Skin Sensitization PotentialASTM D4236 Labeling of Cosmetic Products for Skin SafetyASTM D6125 Evaluation of Skin Sensitization Using In Vitro ModelsASTM D6977 Evaluation of Skin Contact AllergensASTM E1490 Evaluation of Allergic Contact DermatitisASTM E2711 Human Repeat Insult Patch Test (HRIPT) with Extended ProtocolASTM E2753 Human Repeat Insult Patch Test (HRIPT)ASTM F2312 Evaluation of Patch Test Allergen ReleaseCOLIPA Guidelines for Skin Compatibility TestingEN 16820 Test Method for Skin Sensitization PotentialEN 1811 Determination of Nickel Release from Skin-Contact ProductsEN ISO 10993-10 Assessment of Skin IrritationEN ISO 10993-18 Chemical Characterization for Dermal SafetyEN ISO 10993-21 Evaluation of Skin Irritation from Medical Device ExtractsEN ISO 10993-5 Cytotoxicity Testing on Skin CellsEP 5.1.6 Evaluation of Dermatological Safety of CosmeticsFDA 21 CFR 820 Quality System Regulation for Dermal DevicesFDA 21 CFR Part 807 Sensitivity Testing of Topical ProductsFDA Guidance for Dermatological Testing of Topical ProductsFDA Guidance on Dermal Sensitization Risk AssessmentISO 105-A02 Colorfastness to Artificial Light on SkinISO 10993-1 Biological Evaluation of Medical Devices - Dermal AspectsISO 10993-10 Evaluation of Skin Irritation and SensitizationISO 10993-11 Toxicity Testing Related to Skin ContactISO 10993-12 Sample Preparation for Dermal TestingISO 10993-16 Toxicokinetic Testing of Substances in Dermal ExposureISO 10993-17 Toxicological Risk Assessment for Dermal ProductsISO 10993-19 Evaluation of Allergic Contact Dermatitis in Skin ProductsISO 10993-20 Dermal Toxicology Testing MethodsISO 10993-22 Evaluation of Sensitization from Skin Contact DevicesISO 10993-23 Evaluation of Phototoxicity and PhotoallergyISO 11137 Sterilization Validation of Dermal DevicesISO 11930 Preservative Effectiveness for Sensitive Skin ProductsISO 14155 Clinical Investigation of Medical Devices on SkinISO 15223-1 Symbols for Dermal Medical DevicesISO 15223-1 Symbols for Indicating Skin Contact in Medical DevicesISO 16128 Guidelines on Natural and Organic Cosmetic IngredientsISO 16128-1 Guidelines on Natural and Organic Cosmetics Part 1ISO 16128-2 Calculation of Natural Ingredient Content in Skin ProductsISO 16128-3 Methodologies for Determining Organic Content in Skin CareISO 16134 Human Repeat Insult Patch Test GuidanceISO 16134-2 Guidance for Patch Test Interpretation in Skin TestingISO 17516 Microbiological Limits for Skin ProductsISO 21404 Testing for Skin Contact AllergensISO 21486 Risk Assessment for Skin Contact MaterialsISO 22444 Measurement of Skin Moisture ContentISO 22715 Labeling Requirements for Skin and Cosmetic ProductsISO 22716 Good Manufacturing Practices for Dermatological ProductsISO 22716-1 Good Manufacturing Practices for Skin Care ProductsISO 23975 Patch Test Protocols for Dermatological ProductsISO 24441 In Vitro Determination of Sun Protection Factor (SPF)ISO 24442 Evaluation of Human Skin Irritation PotentialISO 24443 In Vitro Assessment of Sunscreen Efficacy on SkinISO 24443 In Vitro SPF Testing for SunscreensISO 24443 In Vitro UV Protection Factor Testing for SunscreensISO 24443 UV Protection Testing for Sensitive Skin FormulationsISO 3160-2 Compression Testing on Skin Contact MaterialsISO 3175-4 Analysis of Volatile Components Affecting Skin SensitivityISO 8124-6 Safety Requirements for Toys Affecting SkinISO/TR 16181 Guidelines on Skin Compatibility of CosmeticsISO/TR 16271 Guidelines on Safety Assessment for Skin Contact MaterialsISO/TR 19218 Dermatological Safety Data ManagementISO/TR 19930 Development of Dermal Sensitization AssaysISO/TR 22219 Testing of Skin Barrier FunctionISO/TR 29622 Allergens in Cosmetics and Personal Care ProductsJIS K 5600-5-7 Patch Test Methods for Skin SensitivityOECD TG 405 Acute Dermal Irritation/Corrosion TestOECD TG 406 Skin Sensitization in AnimalsOECD TG 406 Skin Sensitization Testing in AnimalsOECD TG 437 Bovine Corneal Opacity and Permeability Test for Skin SafetyOECD TG 439 In Vitro Skin Irritation Testing for CosmeticsOECD TG 442C In Chemico Skin Sensitization Assay (DPRA)OECD TG 442D In Vitro Skin Sensitization Assay (KeratinoSens™)OECD TG 442E Human Cell Line Activation Test (h-CLAT) for Skin SensitizationOECD TG 442E In Vitro Skin Sensitization Assay (h-CLAT)USP <151> Evaluation of Skin Irritation for Topical Dosage FormsUSP <151> Skin Sensitization Studies in Pharmaceuticals

OECD TG 442B Local Lymph Node Assay for Skin Sensitization Testing Service

Understanding the Requirements and Benefits of this Laboratory Test

As a leading provider of laboratory testing services, Eurolab is proud to offer OECD TG 442B Local Lymph Node Assay for Skin Sensitization testing. This article provides an in-depth guide to understanding the requirements and benefits of this critical test, which plays a crucial role in ensuring product safety and regulatory compliance.

Standard-Related Information

The OECD TG 442B Local Lymph Node Assay is a standardized method for assessing skin sensitization potential. The test is governed by international standards, including:

  • ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitisation

  • ASTM E2783-13 Standard Practice for Local Lymph Node Assay (LLNA) for Assessing the Skin Sensitization Potential of Chemicals

    • These standards specify the requirements for conducting the OECD TG 442B test, including:

  • Test article preparation

  • Dosing and administration

  • Observation period

  • Evaluation criteria

    • The European Unions REACH Regulation (EC No. 1907/2006) also requires manufacturers to conduct skin sensitization testing on chemicals.

    Standard Requirements and Needs

    The OECD TG 442B Local Lymph Node Assay for Skin Sensitization testing is essential for various industries, including:

  • Cosmetics

  • Pharmaceuticals

  • Personal care products

  • Chemicals

    • Failure to perform this test can result in:

  • Product recalls

  • Regulatory non-compliance

  • Loss of market share and revenue

    • This test contributes significantly to product safety and reliability by:

  • Identifying potential skin sensitization risks

  • Ensuring compliance with regulatory requirements

  • Reducing the risk of adverse reactions

    • Test Conditions and Methodology

    The OECD TG 442B Local Lymph Node Assay for Skin Sensitization testing involves the following steps:

    1. Test article preparation: The test substance is prepared in a specific concentration.

    2. Dosing and administration: The test substance is applied to the lymph nodes of mice or rats.

    3. Observation period: The animals are observed for 21 days.

    4. Evaluation criteria: The results are evaluated based on the proliferation of lymphocytes.

    Eurolab uses state-of-the-art equipment, including:

  • Automated dosing systems

  • Microplate readers

  • Inverted microscopes

    • The testing environment is controlled to ensure accuracy and reliability.

    Test Reporting and Documentation

    The test report includes:

  • Introduction

  • Methods

  • Results

  • Discussion

  • Conclusion

    • The results are interpreted based on the OECD TG 442B guidelines, and any adverse effects are documented. Eurolabs reports are comprehensive, easy to understand, and meet international reporting standards.

    Why this Test Should be Performed

    Performing the OECD TG 442B Local Lymph Node Assay for Skin Sensitization testing offers numerous benefits, including:

  • Reduced risk of adverse reactions

  • Compliance with regulatory requirements

  • Improved product safety and reliability

  • Competitive advantages in the market

    • This test contributes significantly to innovation and research development by providing valuable data on skin sensitization potential.

    Why Eurolab Should Provide this Service

    Eurolab is an industry leader in laboratory testing services, offering:

  • Expertise and experience in OECD TG 442B testing

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

  • Accreditation and certification details

  • International recognition and partnerships

    • Our team provides exceptional customer service, ensuring timely delivery of high-quality test results.

    Conclusion

    The OECD TG 442B Local Lymph Node Assay for Skin Sensitization testing is a critical component of product safety and regulatory compliance. Eurolabs comprehensive guide has provided an in-depth understanding of the requirements and benefits of this laboratory test. By choosing Eurolab, you can ensure that your products meet international standards and regulatory requirements, while also reducing the risk of adverse reactions and improving product safety and reliability.

    Eurolab: Your Partner for Laboratory Testing Services

    Contact us today to learn more about our OECD TG 442B Local Lymph Node Assay for Skin Sensitization testing services. Our team is committed to providing exceptional service, ensuring that your products meet the highest standards of quality and safety.

    References

  • ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitisation

  • ASTM E2783-13 Standard Practice for Local Lymph Node Assay (LLNA) for Assessing the Skin Sensitization Potential of Chemicals

  • REACH Regulation (EC No. 1907/2006)

    • Appendix

  • OECD TG 442B guidelines

  • List of Eurolabs accreditation and certification details

  • Client testimonials

    • Note: The information provided in this article is for general guidance only and should not be considered as professional advice. It is essential to consult with a qualified expert before making any decisions related to laboratory testing services.

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