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astm-d6977-evaluation-of-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 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 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 D6977 Evaluation of Skin Contact Allergens Laboratory Testing Service

Provided by Eurolab: A Comprehensive Guide

ASTM D6977 is a widely accepted standard for the evaluation of skin contact allergens in the cosmetic and personal care industries. This standard, developed by ASTM International, provides guidelines for testing the potential skin irritation caused by substances that come into contact with human skin.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ASTM D6977 testing is governed by various national and international standards, including:

  • ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

  • EN 14641: Cosmetics - Safety assessment - Skin irritancy and skin sensitizer tests

  • TSE (Turkish Standards Institution) TS EN 14641

    • These standards require manufacturers to test their products for potential skin irritation and sensitization before they can be sold in the market.

    International and National Standards

    ASTM D6977 testing is governed by international and national standards, which are constantly evolving to reflect new scientific knowledge and technological advancements. Some of the key standard development organizations include:

  • ASTM International (formerly known as American Society for Testing and Materials)

  • ISO (International Organization for Standardization)

  • EN (European Committee for Standardization)

    • Standard Compliance Requirements

    Manufacturers must comply with relevant standards, including ASTM D6977, to ensure that their products meet regulatory requirements. Failure to comply can result in product recalls, reputational damage, and even legal action.

    Business and Technical Reasons for Conducting ASTM D6977 Testing

    Conducting ASTM D6977 testing provides several business and technical benefits, including:

  • Ensuring compliance with regulatory requirements

  • Protecting consumers from potential skin irritation and sensitization

  • Enhancing product safety and reliability

  • Demonstrating a commitment to quality and customer satisfaction

    • Consequences of Not Performing ASTM D6977 Testing

    Failure to conduct ASTM D6977 testing can result in:

  • Regulatory non-compliance

  • Product recalls

  • Reputational damage

  • Loss of consumer trust and confidence

    • Industries and Sectors that Require This Testing

    ASTM D6977 testing is required for various industries, including:

  • Cosmetic and personal care

  • Pharmaceutical

  • Medical device manufacturing

  • Chemical industry

    • Risk Factors and Safety Implications

    Skin contact allergens can cause a range of adverse effects, including skin irritation, sensitization, and even anaphylaxis. Manufacturers must take steps to mitigate these risks through rigorous testing and quality control measures.

    Quality Assurance and Quality Control Aspects

    ASTM D6977 testing is subject to strict quality assurance and quality control (QA/QC) requirements, which include:

  • Validation of test methods

  • Calibration of equipment

  • Use of certified reference materials

    • Contributions to Product Safety and Reliability

    Conducting ASTM D6977 testing contributes significantly to product safety and reliability by:

  • Identifying potential skin irritation and sensitization risks

  • Ensuring compliance with regulatory requirements

  • Enhancing consumer trust and confidence

    • Competitive Advantages of Having This Testing Performed

    Manufacturers that conduct ASTM D6977 testing can benefit from:

  • Enhanced reputation and brand image

  • Improved product safety and reliability

  • Compliance with regulatory requirements

  • Competitive advantages in the market

    • Cost-Benefit Analysis of Performing This Test

    The cost-benefit analysis of conducting ASTM D6977 testing reveals significant benefits, including:

  • Reduced regulatory risks

  • Improved product safety and reliability

  • Enhanced reputation and brand image

  • Competitive advantages in the market

    • ASTM D6977 testing involves a series of rigorous steps, including:

    1. Sample Preparation: Preparing test samples according to the standard requirements.

    2. Testing Equipment and Instruments: Using specialized equipment, such as skin irritation chambers and spectrophotometers.

    3. Testing Environment Requirements: Maintaining precise temperature, humidity, and pressure conditions.

    4. Measurement and Analysis Methods: Conducting measurements using standardized methods, including spectrophotometry and chromatography.

    Detailed Step-by-Step Explanation of the Test

    1. Sample Preparation: Preparing test samples according to standard requirements.

    2. Equipment Calibration: Calibrating testing equipment to ensure accuracy.

    3. Testing Conditions: Maintaining precise temperature, humidity, and pressure conditions.

    4. Measurement and Analysis: Conducting measurements using standardized methods.

    ASTM D6977 test results are documented and reported in a comprehensive manner, including:

  • Test Report Format: Standardized report format for test results.

  • Interpretation of Test Results: Detailed interpretation of test results.

  • Certification and Accreditation Aspects: Details on certification and accreditation aspects.

    • Electronic Reporting Systems

    ASTM D6977 testing is supported by electronic reporting systems, which facilitate:

  • Rapid data collection

  • Streamlined reporting process

  • Improved accuracy

    • Conclusion

    In conclusion, ASTM D6977 testing is a critical aspect of ensuring product safety and reliability in the cosmetic and personal care industries. By understanding the standard-related information, conducting rigorous testing, and following strict QA/QC requirements, manufacturers can enhance their reputation and brand image while protecting consumers from potential skin irritation and sensitization risks.

    Appendix

  • ASTM D6977 Standard

  • ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

  • EN 14641: Cosmetics - Safety assessment - Skin irritancy and skin sensitizer tests

    • References

    1. ASTM International. (2020). Standard Test Method for Evaluating the Potential of Cosmetic Ingredients or Products to Cause Skin Irritation or Sensitization.

    2. ISO 10993-10:2015 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.

    3. EN 14641:2009 Cosmetics - Safety assessment - Skin irritancy and skin sensitizer tests.

    Please note that the references provided are subject to change, and it is recommended to consult the latest versions of the standards and guidelines.

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