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oecd-tg-442d-in-vitro-skin-sensitization-assay
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 442C In Vitro Skin Sensitization

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

The OECD TG 442D In Vitro Skin Sensitization Assay is a standardized laboratory test for assessing the skin sensitizing potential of chemicals. This test is governed by several international and national standards, including:

  • ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
  • ASTM E2455-17 Standard Guide for Assessing Skin Sensitization Potential in Chemicals
  • EN 1510:2012 In vitro skin corrositity test (modified with the use of cell culture media)
  • TSE (Turkish Standards Institution) TS EN ISO 10993-10
  • These standards provide a framework for the testing and evaluation of chemicals to determine their potential to cause skin sensitization. The OECD TG 442D In Vitro Skin Sensitization Assay is designed to assess the ability of a chemical to induce an immune response in human cells, which can lead to skin irritation or other adverse effects.

    The legal and regulatory framework surrounding this testing service is governed by various national and international regulations, including:

  • REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulation
  • CLP (Classification, Labelling and Packaging) regulation
  • GHS (Globally Harmonized System of Classification and Labelling of Chemicals)
  • These regulations require manufacturers to test their chemicals for skin sensitization potential before marketing them.

    The OECD TG 442D In Vitro Skin Sensitization Assay is a necessary testing service for various industries, including:

  • Cosmetics and personal care products
  • Pharmaceuticals
  • Chemical manufacturing
  • Biotechnology
  • This test is required to ensure the safety and efficacy of these products. The consequences of not performing this test can be severe, including:

  • Product recalls
  • Financial losses due to regulatory non-compliance
  • Damage to brand reputation
  • Potential harm to consumers
  • The industries that require this testing service must comply with various standards and regulations, which can be complex and time-consuming.

    The OECD TG 442D In Vitro Skin Sensitization Assay is conducted using a combination of cell culture and biochemistry techniques. The test involves the following steps:

    1. Cell preparation: Human keratinocytes are isolated from skin samples and cultured in vitro.

    2. Test chemical treatment: The test chemical is added to the cell culture medium, and the cells are exposed for 24 hours.

    3. Measurement of cytokine release: The level of cytokines released by the cells is measured using ELISA (Enzyme-Linked Immunosorbent Assay).

    4. Data analysis: The data is analyzed using statistical methods to determine the test chemicals skin sensitization potential.

    The testing equipment and instruments used include:

  • Cell culture incubators
  • Microscopes
  • ELISA reader
  • Spectrophotometer
  • The testing environment requirements are as follows:

  • Temperature: 37C 2C
  • Humidity: 60 10
  • Pressure: 1013 mbar 5 mbar
  • The test report includes the following information:

  • Test chemical name and concentration
  • Cell culture conditions
  • Measurement of cytokine release
  • Data analysis and results
  • Conclusion and recommendations
  • The report is structured according to various international standards, including ISO 17025:2018.

    The OECD TG 442D In Vitro Skin Sensitization Assay provides numerous benefits and advantages, including:

  • Reduced risk of skin sensitization
  • Improved product safety and efficacy
  • Compliance with regulatory requirements
  • Increased customer confidence and trust
  • Enhanced brand reputation
  • Competitive advantages in the market
  • Cost savings through reduced testing times and costs
  • Eurolabs expertise and experience in this field make us an ideal partner for your skin sensitization testing needs. Our state-of-the-art equipment, qualified personnel, and accreditation details ensure that our results are accurate and reliable.

    Our international recognition and partnerships demonstrate our commitment to providing high-quality services globally. Our quality management systems and procedures guarantee that all testing is performed according to the highest standards.

    We offer competitive pricing and value proposition, as well as technical support and consultation services to ensure your complete satisfaction.

    Additional Requirements

    The OECD TG 442D In Vitro Skin Sensitization Assay is a complex testing service that requires expertise in cell culture and biochemistry. Eurolabs team of professionals has the necessary qualifications and experience to perform this test with accuracy and reliability.

    We comply with various international standards, including ISO 17025:2018, and our testing services are performed according to a strict quality control protocol.

    Conclusion

    The OECD TG 442D In Vitro Skin Sensitization Assay is an essential testing service for various industries. Eurolabs expertise and experience in this field make us the ideal partner for your skin sensitization testing needs. Our state-of-the-art equipment, qualified personnel, and accreditation details ensure that our results are accurate and reliable.

    Contact us today to learn more about our OECD TG 442D In Vitro Skin Sensitization Assay services and how we can help you ensure product safety and efficacy.

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