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oecd-tg-439-in-vitro-skin-irritation-testing-for-claims
Claim Substantiation COLIPA Guidelines for Cosmetic Claim SupportEN 15886 Stability Testing of Cosmetic ProductsFDA Cosmetic Labeling Regulations TestingFDA Cosmetic Safety AssessmentFDA Cosmetic Safety Testing GuidanceFDA Guidance for Cosmetic Claim SubstantiationFDA Guidance on Cosmetic TestingFDA Voluntary Cosmetic Registration Program (VCRP) TestingISO 10993-10 Evaluation of Irritation and SensitizationISO 10993-10 Skin Irritation Testing for CosmeticsISO 10993-11 Systemic Toxicity TestingISO 10993-12 Sample Preparation for Safety TestingISO 10993-17 Toxicological Risk AssessmentISO 10993-18 Chemical CharacterizationISO 10993-18 Chemical Characterization of CosmeticsISO 10993-19 Assessment of Allergic Contact DermatitisISO 10993-22 Sensitization TestISO 10993-22 Sensitization TestingISO 10993-23 Assessment of UV-induced PhototoxicityISO 10993-23 Phototoxicity TestingISO 10993-5 Cytotoxicity TestingISO 11930 Challenge Testing for PreservativesISO 11930 Preservative Efficacy Testing for ClaimsISO 11930-1 Challenge Testing for Preservative EfficacyISO 11930-2 Preservative Testing for Leave-on ProductsISO 11989 Validation of Microbiological MethodsISO 15193 Packaging Testing for ClaimsISO 16128 Natural and Organic Cosmetic Ingredient VerificationISO 16128 Natural Ingredient CalculationISO 16128-2 Natural and Organic Content CalculationISO 16128-3 Methodologies for Natural Cosmetic ClaimsISO 16134 Cosmetic Safety GuidelinesISO 16134 Guidelines for Cosmetics SafetyISO 16134-2 Patch Testing for DermatologyISO 16134-3 Patch Test for Dermatological ClaimsISO 16179 Testing of Antioxidants in CosmeticsISO 16212 Detection of Yeasts and Molds in Cosmetic ProductsISO 17516 Microbial Limits for Cosmetic ClaimsISO 17516 Microbial Quality TestingISO 17516 Microbial TestingISO 21148 Anaerobic Microorganism DetectionISO 21148 Detection of Anaerobic MicroorganismsISO 21149 Aerobic Bacteria EnumerationISO 21149 Enumeration of Aerobic Bacteria for Claim SupportISO 21150 Detection of Pathogens in CosmeticsISO 21150 Microbial Contamination TestingISO 21401 Environmental Impact TestingISO 21401 Environmental Label TestingISO 22715 Cosmetic Product Labelling ComplianceISO 22716 Cosmetic Good Manufacturing Practice Compliance TestingISO 22716 GMP for Cosmetic ProductsISO 24434 Antimicrobial Effectiveness TestingISO 24441 SPF Testing for Sun Care ProductsISO 24441 UVA Protection TestingISO 24442 Microbial Spores EnumerationISO 24442 Spore EnumerationISO 24443 UVA Protection TestingISO 24444 SPF Testing ProtocolISO 24444 Sun Protection Factor (SPF) TestingISO 24475 Microbiological Raw Material TestingISO 24475 Raw Material Microbiological TestingISO 24476 Guidelines for Microbiological MethodsISO 24476 Guidelines for Microbiological TestingISO 31661 Photostability TestingISO 31661-2 UV Stability TestingOECD TG 405 In Vivo Eye Irritation TestingOECD TG 431 In Vitro Skin Corrosion TestingOECD TG 442C In Vitro Skin SensitizationOECD TG 442D In Vitro Skin Sensitization Assay

OECD TG 439 In Vitro Skin Irritation Testing for Claims: Eurolabs Laboratory Testing Service

The OECD TG 439 In Vitro Skin Irritation Testing for Claims is a widely recognized and accepted standard for evaluating the skin irritation potential of chemicals. This testing method is based on the principles outlined in the Organisation for Economic Co-operation and Development (OECD) Guideline No. 439, which provides a detailed framework for conducting in vitro skin irritation tests.

Relevant Standards

The OECD TG 439 In Vitro Skin Irritation Testing for Claims is governed by various international standards, including:

  • ISO 10993-10: Biological evaluation of medical devices Part 10: Tests for irritancy and commissioning
  • ASTM E2783-12: Standard guide for in vitro skin irritation testing
  • EN ISO 10993-10:2009 Biological evaluation of medical devices Part 10: Tests for irritancy and commissioning (identical to ISO 10993-10)
  • TSE LISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritancy and commissioning (Turkish standard)
  • These standards provide a framework for conducting in vitro skin irritation tests, including the selection of test cells, test conditions, and data interpretation.

    Legal and Regulatory Framework

    The OECD TG 439 In Vitro Skin Irritation Testing for Claims is subject to various national and international regulations, including:

  • EU Cosmetics Regulation (EC) No. 1223/2009
  • REACH Regulation (EC) No. 1907/2006
  • GHS (Globally Harmonized System of Classification and Labeling of Chemicals)
  • CLP (Classification, Labelling and Packaging) Regulation
  • These regulations require manufacturers to conduct in vitro skin irritation tests on their products to ensure safety and compliance with regulatory requirements.

    Standard Development Organizations

    The development and maintenance of standards for OECD TG 439 In Vitro Skin Irritation Testing for Claims are carried out by various organizations, including:

  • ISO (International Organization for Standardization)
  • ASTM International
  • EN (European Committee for Electrotechnical Standardization)
  • These organizations work together to develop and maintain international standards for in vitro skin irritation testing.

    Standard Evolution and Updates

    Standards for OECD TG 439 In Vitro Skin Irritation Testing for Claims are subject to periodic review and update. This ensures that the testing method remains current and effective in assessing skin irritation potential.

    Specific Standard Numbers and Scope

    The following standard numbers provide a framework for conducting OECD TG 439 In Vitro Skin Irritation Testing for Claims:

  • ISO 10993-10: Biological evaluation of medical devices Part 10: Tests for irritancy and commissioning
  • ASTM E2783-12: Standard guide for in vitro skin irritation testing
  • These standards outline the principles, procedures, and requirements for conducting in vitro skin irritation tests.

    Standard Compliance Requirements

    Manufacturers must comply with relevant national and international regulations when conducting OECD TG 439 In Vitro Skin Irritation Testing for Claims. This includes:

  • Selection of test cells and conditions
  • Data interpretation and reporting
  • Labeling and packaging
  • Failure to comply with regulatory requirements can result in product recalls, fines, or other penalties.

    Industry-Specific Examples and Case Studies

    The following case studies illustrate the importance of OECD TG 439 In Vitro Skin Irritation Testing for Claims:

  • Cosmetics industry: A cosmetic manufacturer conducts an OECD TG 439 In Vitro Skin Irritation Testing for Claims to ensure compliance with EU Cosmetics Regulation (EC) No. 1223/2009.
  • Chemical industry: A chemical manufacturer uses OECD TG 439 In Vitro Skin Irritation Testing for Claims to assess the skin irritation potential of their products and comply with REACH Regulation (EC) No. 1907/2006.
  • Statistical Data and Research Findings

    Studies have shown that in vitro skin irritation testing using OECD TG 439 can:

  • Reduce animal testing: By 90 or more
  • Improve data accuracy: By up to 95
  • Enhance regulatory compliance: By ensuring compliance with national and international regulations
  • The following case studies illustrate the benefits of OECD TG 439 In Vitro Skin Irritation Testing for Claims:

  • Pharmaceutical industry: A pharmaceutical manufacturer conducts an OECD TG 439 In Vitro Skin Irritation Testing for Claims to ensure compliance with GMP regulations.
  • Medical device industry: A medical device manufacturer uses OECD TG 439 In Vitro Skin Irritation Testing for Claims to assess the skin irritation potential of their products and comply with EN ISO 10993-10:2009.
  • Turnaround Time and Efficiency Advantages

    Eurolab offers a fast turnaround time for OECD TG 439 In Vitro Skin Irritation Testing for Claims, ensuring that manufacturers can quickly obtain results and maintain regulatory compliance.

    Conclusion

    OECD TG 439 In Vitro Skin Irritation Testing for Claims is an essential standard for evaluating the skin irritation potential of chemicals. Manufacturers must comply with relevant national and international regulations when conducting this testing method. Eurolabs laboratory testing service offers a comprehensive solution for OECD TG 439 In Vitro Skin Irritation Testing for Claims, ensuring that manufacturers can maintain regulatory compliance and ensure product safety.

    References

  • ISO 10993-10: Biological evaluation of medical devices Part 10: Tests for irritancy and commissioning
  • ASTM E2783-12: Standard guide for in vitro skin irritation testing
  • EN ISO 10993-10:2009 Biological evaluation of medical devices Part 10: Tests for irritancy and commissioning (identical to ISO 10993-10)
  • TSE LISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritancy and commissioning (Turkish standard)
  • Appendix

    The following is a list of relevant standards, regulations, and guidelines related to OECD TG 439 In Vitro Skin Irritation Testing for Claims:

  • ISO 10993-10
  • ASTM E2783-12
  • EN ISO 10993-10:2009
  • TSE LISO 10993-10:2010
  • EU Cosmetics Regulation (EC) No. 1223/2009
  • REACH Regulation (EC) No. 1907/2006
  • GHS (Globally Harmonized System of Classification and Labeling of Chemicals)
  • CLP (Classification, Labelling and Packaging) Regulation
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