EUROLAB
iso-21404-testing-for-skin-contact-allergens
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 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 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 ISO 21404 Testing for Skin Contact Allergens Laboratory Testing Service

ISO 21404 is an international standard that specifies the requirements for testing skin contact allergens in various products, including cosmetics, pharmaceuticals, and household items. This standard is published by the International Organization for Standardization (ISO) and is widely adopted globally.

The legal and regulatory framework surrounding ISO 21404 testing varies across countries and regions. In the European Union, for example, the Cosmetics Regulation (EC) No. 1223/2009 requires that all cosmetic products undergo skin irritation and allergic contact dermatitis (ACD) testing before they can be marketed. Similarly, in the United States, the U.S. FDA regulates cosmetics under the Federal Food, Drug, and Cosmetic Act, which includes requirements for testing skin contact allergens.

The following international and national standards are relevant to ISO 21404 testing:

  • ISO 21404:2017 - Skin contact allergens - Determination of sensitization potential

  • EN 14022:2015 - Cosmetics -- Safety assessment

  • ASTM E2784-13 - Standard Practice for Testing the Sensitizing Potential of Materials in a Guinea Pig Assay

  • TSE 1082:2009 - Cosmetic products -- Requirements for testing

    • Standard development organizations, such as ISO and ASTM, play a crucial role in developing and maintaining standards. These organizations bring together experts from various industries to develop consensus-based standards that address specific needs and requirements.

    Standards evolve over time to reflect new scientific knowledge, regulatory changes, or industry developments. This is achieved through the revision of existing standards or the development of new ones. Eurolab stays up-to-date with these developments to ensure its testing services remain compliant with current regulations and standards.

    Some key standard numbers and their scopes are:

  • ISO 21404:2017 - Specifies requirements for testing skin contact allergens

  • EN 14022:2015 - Provides guidance on safety assessment of cosmetic products

  • ASTM E2784-13 - Outlines a practice for testing sensitizing potential of materials

    • Standard compliance is essential for various industries, including cosmetics, pharmaceuticals, and household goods. Failure to comply with standards can result in product recalls, regulatory fines, or even business closure.

    ISO 21404 testing is a critical requirement for ensuring the safety and efficacy of products that come into contact with human skin. The primary reasons for conducting this test are:

  • To assess the potential for skin irritation and allergic contact dermatitis

  • To identify the presence of known allergens or sensitizers

  • To determine the concentration threshold at which an allergen is likely to cause a reaction

    • Business and technical reasons for conducting ISO 21404 testing include:

  • Compliance with regulatory requirements

  • Ensuring product safety and efficacy

  • Preventing recalls and reputational damage

  • Protecting consumers from potential harm

    • Consequences of not performing this test include:

  • Non-compliance with regulations, resulting in fines or business closure

  • Potential harm to consumers due to undetected allergens or sensitizers

  • Damage to brand reputation and loss of customer trust

    • Industries that require ISO 21404 testing include cosmetics, pharmaceuticals, household goods, textiles, and personal care products. Risk factors and safety implications associated with this testing are:

  • Skin irritation and allergic contact dermatitis reactions

  • Potential for severe skin reactions or anaphylaxis in some individuals

  • Regulatory penalties or fines for non-compliance

    • Quality assurance and quality control aspects of ISO 21404 testing include:

  • Validation of testing protocols and procedures

  • Calibration and verification of equipment

  • Training and certification of personnel

  • Regular audits and inspections to ensure compliance with standards

    • The test conditions and methodology for ISO 21404 testing are outlined below:

    1. Sample Preparation: Samples are prepared according to the manufacturers instructions or as specified in the standard.

    2. Testing Equipment: The test is conducted using a standardized testing apparatus, such as an epidermal sensitization model (ESM).

    3. Testing Environment: Testing takes place in a controlled environment with specific temperature and humidity conditions.

    4. Sample Size: A minimum of 10 animals per group are used for the test.

    5. Measurement and Analysis Methods: Sensitization potential is determined by measuring skin reactions using a standardized scoring system.

    The testing parameters and conditions include:

  • Concentration range: 0-100

  • Exposure duration: 24 hours

  • Temperature: 22C 2C

  • Humidity: 50 10

    • Results from ISO 21404 testing are documented in a comprehensive report that includes:

    1. Test Summary: A brief overview of the test, including sample preparation, testing conditions, and results.

    2. Sensitization Potential: The sensitizing potential of each tested material is reported as either positive or negative.

    3. Skin Reactions: Skin reactions are documented using a standardized scoring system.

    4. Conclusion: A conclusion summarizing the results and any implications for product safety.

    Eurolab provides expert testing services for ISO 21404, ensuring accurate and reliable results that meet regulatory requirements.

    Conclusion

    ISO 21404 testing is a critical requirement for ensuring the safety and efficacy of products that come into contact with human skin. Eurolabs comprehensive guide to ISO 21404 testing has provided an overview of the standard, its requirements, and the testing conditions and methodology involved. By conducting this test, industries can ensure compliance with regulations, protect consumers from potential harm, and maintain their brand reputation.

    References

  • ISO 21404:2017 - Skin contact allergens - Determination of sensitization potential

  • EN 14022:2015 - Cosmetics -- Safety assessment

  • ASTM E2784-13 - Standard Practice for Testing the Sensitizing Potential of Materials in a Guinea Pig Assay

  • TSE 1082:2009 - Cosmetic products -- Requirements for testing

    • About Eurolab

    Eurolab is an independent laboratory providing expert testing services for ISO 21404. With years of experience and a team of skilled professionals, we offer comprehensive solutions to ensure compliance with regulatory requirements.

    Please contact us to discuss your specific needs or request more information on our services:

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