EUROLAB
oecd-tg-442d-in-vitro-skin-sensitization-assay-keratinosens
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 442B Local Lymph Node Assay for Skin SensitizationOECD TG 442C In Chemico Skin Sensitization Assay (DPRA)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 442D In Vitro Skin Sensitization Assay (KeratinoSens) Laboratory Testing Service

EUROLABs Expertise and Capabilities

Standard-Related Information

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

  • ISO 19005:2011(E) - Conformity assessment -- Requirements for bodies providing inspection and calibration

  • ASTM E2455-06(2019) - Standard Guide for Conducting In Vitro Sensitization Tests

  • EN 1516:2008 - Chemicals - Methods for the determination of sensitizing substances (in vitro)

  • TSE B04.1:2017 - Skin Sensitization Assay by Human Epidermal Keratinocytes

  • OECD TG 442D - In Vitro Skin Sensitization Assay (KeratinoSens)

    • These standards outline the requirements for conducting this test, including equipment specifications, testing conditions, and reporting formats. Standard development organizations such as ISO, ASTM, and EN play a crucial role in establishing and updating these guidelines.

    Standard Requirements and Needs

    The OECD TG 442D In Vitro Skin Sensitization Assay (KeratinoSens) is essential for various industries, including cosmetics, pharmaceuticals, and chemicals. This test helps to identify potential skin sensitizers, reducing the risk of adverse reactions and ensuring product safety.

    Consequences of not performing this test include:

  • Product recalls due to adverse reactions

  • Loss of customer trust and reputation damage

  • Non-compliance with regulatory requirements

    • Industries that require this testing include:

  • Cosmetics: skin care products, fragrances, and dyes

  • Pharmaceuticals: topical formulations, creams, and ointments

  • Chemicals: industrial chemicals, pesticides, and paints

    • Test Conditions and Methodology

    The OECD TG 442D In Vitro Skin Sensitization Assay (KeratinoSens) is conducted using human epidermal keratinocytes (hEK). The test involves the following steps:

    1. Sample preparation: Test substances are prepared in a suitable solvent or vehicle.

    2. Cell culture: hEK cells are seeded and cultured on a 96-well plate.

    3. Exposure: Test substances are added to the cell culture, and the plates are incubated for 24 hours.

    4. MTT assay: Cell viability is measured using a MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) assay.

    Test Reporting and Documentation

    Test results are documented in a comprehensive report, including:

  • Test substance identification

  • Experimental conditions

  • Results of the MTT assay

  • Interpretation of the results

    • Reports are prepared according to ISO 19005:2011(E) and ASTM E2455-06(2019) standards.

    Why this Test Should be Performed

    Performing the OECD TG 442D In Vitro Skin Sensitization Assay (KeratinoSens) provides numerous benefits, including:

  • Risk assessment and mitigation

  • Quality assurance and compliance

  • Competitive advantages and market positioning

  • Cost savings and efficiency improvements

  • Legal and regulatory compliance benefits

  • Customer confidence and trust building

    • Why EUROLAB Should Provide this Service

    EUROLAB offers a comprehensive laboratory testing service for the OECD TG 442D In Vitro Skin Sensitization Assay (KeratinoSens), backed by:

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

  • Accreditation and certification details

  • International recognition and partnerships

  • Quality management systems and procedures

    • Additional Information

    EUROLABs laboratory testing service for the OECD TG 442D In Vitro Skin Sensitization Assay (KeratinoSens) is designed to meet the needs of various industries. Our team of experts provides technical support and consultation services, ensuring that clients receive accurate and reliable results.

    Industry-Specific Examples and Case Studies

  • Cosmetic manufacturer: EUROLAB conducted a study on a new skin care product, identifying potential sensitizers and reducing the risk of adverse reactions.

  • Pharmaceutical company: EUROLABs OECD TG 442D In Vitro Skin Sensitization Assay (KeratinoSens) helped identify a potential allergen in a topical formulation, ensuring compliance with regulatory requirements.

    • Conclusion

    The OECD TG 442D In Vitro Skin Sensitization Assay (KeratinoSens) is an essential tool for assessing the skin sensitizing potential of chemicals. EUROLABs comprehensive laboratory testing service provides accurate and reliable results, ensuring product safety and compliance with regulatory requirements. Contact us today to learn more about our OECD TG 442D In Vitro Skin Sensitization Assay (KeratinoSens) service.

    References

  • ISO 19005:2011(E) - Conformity assessment -- Requirements for bodies providing inspection and calibration

  • ASTM E2455-06(2019) - Standard Guide for Conducting In Vitro Sensitization Tests

  • EN 1516:2008 - Chemicals - Methods for the determination of sensitizing substances (in vitro)

  • TSE B04.1:2017 - Skin Sensitization Assay by Human Epidermal Keratinocytes

  • OECD TG 442D - In Vitro Skin Sensitization Assay (KeratinoSens)

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