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oecd-tg-405-acute-dermal-irritationcorrosion-test
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 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 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

Comprehensive Guide to OECD TG 405 Acute Dermal Irritation/Corrosion Test Laboratory Testing Service Provided by Eurolab

The OECD TG 405 Acute Dermal Irritation/Corrosion Test is a standardized laboratory test used to evaluate the potential skin irritation and corrosion of substances. This test is governed by various international and national standards, including:

  • ISO 10993-10:2010 (Biological evaluation of medical devices Part 10: Tests for irritation and sensitization in humans)

  • EN 717-1:1995 (Determination of formaldehyde release from wood-based panels Part 1: Formaldehyde emission by the desiccator method)

  • TSE ISO 10993-10:2016 (Biological evaluation of medical devices Part 10: Tests for irritation and sensitization in humans)

  • ASTM E2787-13 (Standard Guide for Assessing the Irritation Potential of Materials)

    • These standards provide a framework for conducting the test, ensuring consistency and accuracy across different laboratories. The OECD TG 405 Acute Dermal Irritation/Corrosion Test is also subject to regulatory requirements, such as those outlined in the EUs Cosmetics Regulation (EC) No 1223/2009.

    Standard Development Organizations

    The development of standards for the OECD TG 405 Acute Dermal Irritation/Corrosion Test is a collaborative effort between international organizations, including:

  • International Organization for Standardization (ISO)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • These organizations work together to develop and update standards, ensuring they remain relevant and effective.

    International and National Standards

    The OECD TG 405 Acute Dermal Irritation/Corrosion Test is covered by several international and national standards. Some of the key standards include:

    Standard Number Title

    --- ---

    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and sensitization in humans

    EN 717-1:1995 Determination of formaldehyde release from wood-based panels Part 1: Formaldehyde emission by the desiccator method

    TSE ISO 10993-10:2016 Biological evaluation of medical devices Part 10: Tests for irritation and sensitization in humans

    ASTM E2787-13 Standard Guide for Assessing the Irritation Potential of Materials

    These standards outline the requirements for conducting the test, including sample preparation, testing conditions, and data analysis.

    Standard Compliance Requirements

    Compliance with these standards is essential for ensuring the accuracy and reliability of the OECD TG 405 Acute Dermal Irritation/Corrosion Test results. Eurolabs laboratory testing service ensures that all testing is conducted in accordance with relevant international and national standards.

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    The OECD TG 405 Acute Dermal Irritation/Corrosion Test is a critical component of product safety and regulatory compliance. This test provides essential information on the potential skin irritation and corrosion of substances, enabling manufacturers to make informed decisions about product formulation and labeling.

    Business and Technical Reasons for Conducting the Test

    The OECD TG 405 Acute Dermal Irritation/Corrosion Test is required by various industries, including:

  • Cosmetics

  • Personal care products

  • Pharmaceuticals

  • Medical devices

  • Chemicals

    • This test helps manufacturers ensure compliance with regulatory requirements, such as those outlined in the EUs Cosmetics Regulation (EC) No 1223/2009.

    Consequences of Not Performing the Test

    Failure to conduct the OECD TG 405 Acute Dermal Irritation/Corrosion Test can result in:

  • Regulatory non-compliance

  • Product recalls and withdrawals

  • Financial penalties and reputational damage

  • Customer complaints and loss of trust

    • ---

    The OECD TG 405 Acute Dermal Irritation/Corrosion Test is conducted using a standardized protocol, ensuring consistency and accuracy across different laboratories. The test involves the following steps:

    1. Sample Preparation: The substance to be tested is prepared according to the relevant standard.

    2. Testing Conditions: The test is conducted in a controlled environment, with specified temperature (23C 2C) and humidity (50 10) conditions.

    3. Test Parameters: The test parameters are monitored using specialized equipment, including:

    pH meter

    Temperature control unit

    Humidity control unit

    4. Measurement and Analysis Methods: The test results are analyzed using standardized methods, including:

    Visual assessment of skin irritation

    Histopathological examination

    ---

    The OECD TG 405 Acute Dermal Irritation/Corrosion Test report includes:

    1. Introduction: Overview of the test method and purpose.

    2. Materials and Methods: Description of the substance, sample preparation, testing conditions, and equipment used.

    3. Results: Presentation of the test results, including visual assessment of skin irritation and histopathological examination.

    4. Discussion: Interpretation of the test results and conclusions drawn.

    Eurolabs laboratory testing service provides detailed reporting and documentation to ensure transparency and accuracy in the test results.

    ---

    Conclusion

    The OECD TG 405 Acute Dermal Irritation/Corrosion Test is a critical component of product safety and regulatory compliance. Eurolabs laboratory testing service ensures that all testing is conducted in accordance with relevant international and national standards, providing accurate and reliable results for manufacturers to make informed decisions about product formulation and labeling.

    Appendix

  • ISO 10993-10:2010 (Biological evaluation of medical devices Part 10: Tests for irritation and sensitization in humans)

  • EN 717-1:1995 (Determination of formaldehyde release from wood-based panels Part 1: Formaldehyde emission by the desiccator method)

  • TSE ISO 10993-10:2016 (Biological evaluation of medical devices Part 10: Tests for irritation and sensitization in humans)

  • ASTM E2787-13 (Standard Guide for Assessing the Irritation Potential of Materials)

    • ---

    Eurolabs Laboratory Testing Service

    Eurolab provides a comprehensive laboratory testing service, including:

  • OECD TG 405 Acute Dermal Irritation/Corrosion Test

  • Other standardized tests and analyses

    • Our experienced team ensures that all testing is conducted in accordance with relevant international and national standards, providing accurate and reliable results for manufacturers to make informed decisions about product formulation and labeling.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

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