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iso-16134-human-repeat-insult-patch-test-guidance
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 16134-2 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

Comprehensive Guide to ISO 16134 Human Repeat Insult Patch Test Guidance Laboratory Testing Service

The ISO 16134 standard provides guidance for the human repeat insult patch test (HRIPT) used in the evaluation of skin irritation potential of chemicals. This standard is part of a suite of international standards developed by the International Organization for Standardization (ISO), which aims to facilitate trade, promote innovation, and ensure public safety.

Legal and Regulatory Framework

The HRIPT is regulated by various national and international laws, including:

  • European Unions Cosmetics Regulation (EC) No. 1223/2009

  • United States Food and Drug Administrations (FDA) Good Laboratory Practice (GLP) regulations

  • International Organization for Standardization (ISO) standards, such as ISO 16134

    • International and National Standards

    The following international and national standards apply to the HRIPT:

  • ISO 16134:2012 Human repeat insult patch test (HRIPT)

  • EN 1499:2006 Skin irritation/corrosion testing of subfractions from complex mixtures

  • ASTM E2220-15 Standard Guide for Conducting Repeat Insult Patch Tests

    • Standard Development Organizations

    The development and maintenance of standards, including ISO 16134, are the responsibility of standard development organizations (SDOs) such as:

  • International Organization for Standardization (ISO)

  • European Committee for Standardization (CEN)

  • American Society for Testing and Materials (ASTM)

    • Standard Evolution and Updates

    Standards evolve and get updated to reflect new scientific knowledge, technological advancements, or regulatory changes. The HRIPT standard has undergone several revisions since its initial publication in 2012.

    Standard Numbers and Scope

    The following standard numbers and scope apply to the HRIPT:

  • ISO 16134:2012 Human repeat insult patch test (HRIPT) - Test method for skin irritation potential

  • EN 1499:2006 Skin irritation/corrosion testing of subfractions from complex mixtures

    • Standard Compliance Requirements

    Compliance with relevant standards is mandatory for industries such as:

  • Cosmetics and personal care products

  • Pharmaceuticals and biotechnology

  • Chemical manufacturing and processing

    • Failure to comply with standard requirements can result in product recalls, fines, or even criminal prosecution.

    The HRIPT is a crucial test for assessing the skin irritation potential of chemicals. This test is essential for:

    Why this Test is Needed

  • Business and Technical Reasons: Conducting HRIPT testing ensures that products meet regulatory requirements, reducing the risk of product failures or recalls.

  • Consequences of Not Performing this Test

    • Product failure or recall

    Regulatory non-compliance

    Negative impact on customer trust and loyalty

    Industries and Sectors Requiring this Testing

  • Cosmetics and personal care products

  • Pharmaceuticals and biotechnology

  • Chemical manufacturing and processing

    • Risk Factors and Safety Implications

    The HRIPT is essential for identifying potential skin irritation risks associated with chemicals. Failure to conduct this test can lead to severe consequences, including:

  • Skin irritation or allergic reactions in consumers

  • Product recalls and damage to brand reputation

  • Regulatory non-compliance and fines

    • Quality Assurance and Quality Control Aspects

    Conducting the HRIPT requires a robust quality assurance and control (QA/QC) system to ensure:

  • Accurate test results

  • Reliable data interpretation

  • Compliance with standard requirements

    • The HRIPT contributes significantly to product safety and reliability by identifying potential skin irritation risks.

    Competitive Advantages of Having this Testing Performed

    Conducting the HRIPT can provide significant competitive advantages, including:

  • Improved product safety and quality

  • Enhanced customer trust and loyalty

  • Regulatory compliance and reduced risk

    • The cost-benefit analysis of performing the HRIPT is favorable, considering the potential costs associated with non-compliance or product recalls.

    The HRIPT involves a series of steps to assess skin irritation potential. This section provides an in-depth explanation of:

  • Testing Equipment and Instruments: Patch testers, measuring instruments, and other equipment used during the test.

  • Testing Environment Requirements: Temperature, humidity, pressure, and other environmental conditions necessary for accurate testing.

  • Sample Preparation Procedures: Preparation of test samples, including skin irritation potential assessments.

  • Testing Parameters and Conditions: Application times, concentrations, and exposure durations required for accurate results.

    • The HRIPT involves measuring and analyzing the effects of chemicals on human skin using a patch test. This test requires:

  • Calibration and validation procedures to ensure accuracy and reliability

  • Quality control measures during testing to prevent errors or contamination

    • Data Collection and Recording Procedures

    Accurate data collection and recording are essential for reliable results. The HRIPT involves documenting:

  • Test parameters, such as application times, concentrations, and exposure durations

  • Measured effects on human skin, including irritation scores or reactions

  • Statistical analysis of test results to identify trends or patterns

    • Test Results Interpretation

    Interpreting the results of the HRIPT requires expertise in:

  • Skin irritation assessment and scoring systems

  • Data analysis and statistical interpretation

  • Regulatory compliance and standard requirements

    • A thorough understanding of the HRIPT is essential for accurate data interpretation and reliable results.

    Conclusion

    The ISO 16134 standard provides guidance for the human repeat insult patch test (HRIPT), which is a crucial assessment tool for evaluating skin irritation potential. This comprehensive guide has provided an in-depth explanation of the standard, its application, and requirements.

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