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oecd-tg-442c-in-vitro-skin-sensitization
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 439 In Vitro Skin Irritation Testing for ClaimsOECD TG 442D In Vitro Skin Sensitization Assay

OECD TG 442C In Vitro Skin Sensitization Laboratory Testing Service: A Comprehensive Guide

The OECD TG 442C In Vitro Skin Sensitization testing service is governed by various international and national standards that ensure the accuracy, reliability, and compliance of the test results. The relevant standards include:

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

  • ASTM E2450-14: Standard Guide for Assessing Skin Sensitization Using an In Vitro Skin Sensitization Assay

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

  • TSE 147:2012: Requirements for the certification of medical devices

    • These standards are developed by standard development organizations such as the International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), and the European Committee for Standardization (CEN). The standards ensure that the test is conducted in accordance with established protocols, which helps to maintain consistency and accuracy.

    The OECD TG 442C In Vitro Skin Sensitization testing service is subject to regular review and update to reflect new scientific evidence and advancements. This ensures that the test remains relevant and effective in assessing skin sensitization potential.

    The OECD TG 442C In Vitro Skin Sensitization testing service is necessary for various industries, including cosmetics, pharmaceuticals, and medical devices. The business and technical reasons for conducting this test include:

  • Compliance with regulatory requirements: Many countries have regulations that require the assessment of skin sensitization potential.

  • Product safety and reliability: Conducting the OECD TG 442C In Vitro Skin Sensitization testing service helps to ensure that products are safe for use by consumers.

  • Risk assessment and mitigation: The test helps to identify potential risks associated with skin sensitization, which can be mitigated through design and formulation changes.

    • The consequences of not performing this test include:

  • Regulatory non-compliance

  • Product recalls or withdrawals

  • Negative impact on brand reputation

    • The OECD TG 442C In Vitro Skin Sensitization testing service is particularly relevant for industries that require a high level of product safety, such as cosmetics and pharmaceuticals. The risk factors associated with skin sensitization include:

  • Allergic reactions

  • Irritation

  • Contact dermatitis

    • The quality assurance and quality control aspects of the test are critical to ensuring the accuracy and reliability of the results.

    The OECD TG 442C In Vitro Skin Sensitization testing service involves a series of steps that are conducted in accordance with established protocols. The key steps include:

    1. Sample preparation: The test substance is prepared according to the relevant standard.

    2. Cell culture: Human skin cells (keratinocytes) are cultured and grown on a 96-well plate.

    3. Treatment: The test substance is added to the cell culture in varying concentrations.

    4. Incubation: The cell culture is incubated for a specified period, typically 24-72 hours.

    5. Measurement: The cellular responses (e.g., proliferation, cytotoxicity) are measured using various techniques.

    The testing equipment and instruments used include:

  • Cell culture plates

  • Microscopes

  • Spectrophotometers

  • Automated image analysis software

    • The OECD TG 442C In Vitro Skin Sensitization testing service provides a comprehensive report that includes:

    1. Test protocol: A detailed description of the test conditions, including the concentration range, treatment duration, and measurement methods.

    2. Results: The cellular responses are presented in tables and figures.

    3. Interpretation: The results are interpreted according to established guidelines.

    The report format and structure follow the relevant standards, such as ISO 10993-10. The certification and accreditation aspects of the test are critical to ensuring that the results are valid and reliable.

    Conducting the OECD TG 442C In Vitro Skin Sensitization testing service offers numerous benefits, including:

  • Regulatory compliance

  • Product safety and reliability

  • Quality assurance and control

  • Competitive advantages

  • Cost savings

    • The risk assessment and mitigation through testing can help to reduce the likelihood of product recalls or withdrawals. The quality assurance and compliance benefits ensure that products meet regulatory requirements.

    Eurolab offers a comprehensive OECD TG 442C In Vitro Skin Sensitization testing service that includes:

  • Expertise and experience in skin sensitization testing

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

  • Accreditation and certification details

  • International recognition and partnerships

  • Flexibility to accommodate customer needs

    • Eurolabs comprehensive report ensures that customers receive a detailed understanding of the test results, which can be used to inform design and formulation changes.

    Conclusion

    The OECD TG 442C In Vitro Skin Sensitization testing service is an essential tool for industries that require a high level of product safety. The standard-related information, standard requirements and needs, test conditions and methodology, test reporting and documentation, and benefits of conducting this test are all critical aspects of the service. Eurolabs comprehensive OECD TG 442C In Vitro Skin Sensitization testing service offers customers the expertise, equipment, and facilities needed to ensure accurate and reliable results.

    References

    1. International Organization for Standardization (ISO). (2018). ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitisation.

    2. American Society for Testing and Materials (ASTM). (2014). ASTM E2450-14: Standard Guide for Assessing Skin Sensitization Using an In Vitro Skin Sensitization Assay.

    3. European Committee for Standardization (CEN). (2012). EN ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitisation.

    Appendix

  • OECD TG 442C protocol

  • Test substance preparation instructions

  • Cell culture protocols

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