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astm-e2711-human-repeat-insult-patch-test-hript-with-extended-protocol
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 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 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

ASTM E2711 Human Repeat Insult Patch Test (HRIPT) with Extended Protocol: A Comprehensive Guide

Standard-Related Information

The ASTM E2711 Human Repeat Insult Patch Test (HRIPT) with Extended Protocol is a laboratory testing service that evaluates the skin irritation potential of materials, products, or formulations. This test is governed by various international and national standards, including:

  • ASTM E2711: Standard Practice for Human Repeat Insult Patch Test (HRIPT)

  • ISO 19043: Standard for in-vitro tests to assess the skin irritation potential

  • EN ISO 19043: European standard for in-vitro tests to assess the skin irritation potential

  • TSE 2001: Turkish standard for in-vitro tests to assess the skin irritation potential

    • These standards ensure that the testing is conducted according to rigorous guidelines, providing reliable and reproducible results.

    The development of standards is a collaborative effort between organizations such as ASTM (American Society for Testing and Materials), ISO (International Organization for Standardization), and EN (European Committee for Standardization). These organizations work together to establish common requirements for testing and evaluation procedures. The standards are reviewed and updated regularly to reflect new research findings, technological advancements, and industry needs.

    Standard Requirements and Needs

    The ASTM E2711 Human Repeat Insult Patch Test (HRIPT) with Extended Protocol is required by various industries, including:

  • Cosmetics: To ensure the safety of skin care products

  • Pharmaceuticals: To evaluate the potential for skin irritation due to topical formulations

  • Personal Care Products: To assess the risk of skin irritation from product use

    • The testing provides several benefits, including:

  • Quality assurance and compliance: Ensures that products meet regulatory requirements and industry standards

  • Risk assessment and mitigation: Identifies potential skin irritation hazards, allowing for corrective action to minimize risks

  • Competitive advantage: Demonstrates a commitment to safety and quality, enhancing market positioning and customer trust

  • Cost savings: Reduces the likelihood of costly recalls or product failures due to skin irritation

    • Test Conditions and Methodology

    The ASTM E2711 Human Repeat Insult Patch Test (HRIPT) with Extended Protocol involves several steps:

    1. Subject selection: Volunteers are selected based on specific criteria, such as age, sex, and medical history.

    2. Patch preparation: Patches containing the test material or control substance are prepared for application.

    3. Application: The patches are applied to the subjects skin according to a predetermined schedule.

    4. Observation and evaluation: Skin reactions are observed and evaluated over several days.

    5. Data analysis: Results are analyzed using statistical methods, considering factors such as reaction intensity and frequency.

    The testing is conducted in a controlled environment with precise temperature (23C 2C), humidity (50 10), and pressure conditions.

    Test Reporting and Documentation

    The test report includes:

  • Introduction: Describes the purpose of the study and the test material or formulation.

  • Materials and methods: Details the testing procedures, equipment used, and subject selection criteria.

  • Results: Presents the skin irritation data, including reaction intensity and frequency.

  • Discussion: Interprets the results in relation to the potential for skin irritation.

    • The report also includes certification and accreditation information, ensuring that the test has been conducted by a qualified laboratory.

    Why This Test Should Be Performed

    The benefits of conducting the ASTM E2711 Human Repeat Insult Patch Test (HRIPT) with Extended Protocol include:

  • Risk assessment and mitigation: Identifies potential skin irritation hazards, allowing for corrective action to minimize risks.

  • Quality assurance and compliance: Ensures that products meet regulatory requirements and industry standards.

  • Competitive advantage: Demonstrates a commitment to safety and quality, enhancing market positioning and customer trust.

  • Cost savings: Reduces the likelihood of costly recalls or product failures due to skin irritation.

    • Why Eurolab Should Provide This Service

    Eurolabs expertise in conducting the ASTM E2711 Human Repeat Insult Patch Test (HRIPT) with Extended Protocol includes:

  • State-of-the-art equipment and facilities: Ensures precise control over testing conditions.

  • Qualified and certified personnel: Provides assurance that the test is conducted by experienced professionals.

  • Accreditation and certification details: Demonstrates compliance with international and national standards.

  • Quality management systems and procedures: Guarantees a high level of quality in all aspects of the testing process.

    • Conclusion

    The ASTM E2711 Human Repeat Insult Patch Test (HRIPT) with Extended Protocol is an essential laboratory testing service for industries that require evaluation of skin irritation potential. This comprehensive guide provides a detailed understanding of the standard, its requirements and needs, test conditions and methodology, and reporting and documentation procedures. Eurolabs expertise in conducting this test ensures reliable and reproducible results, providing assurance that products meet regulatory requirements and industry standards.

    Appendix

    The following appendices provide additional information on:

  • ASTM E2711 Standard Practice: Detailed description of the testing procedure.

  • ISO 19043 Standard for in-vitro tests: Description of the international standard for in-vitro tests to assess skin irritation potential.

  • EN ISO 19043 European standard for in-vitro tests: Description of the European standard for in-vitro tests to assess skin irritation potential.

    • These appendices are intended as a reference for those interested in further information on the testing procedure and standards.

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