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oecd-tg-406-skin-sensitization-testing-in-animals
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 405 Acute Dermal Irritation/Corrosion TestOECD TG 406 Skin Sensitization 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

OECD TG 406 Skin Sensitization Testing in Animals Laboratory Testing Service Provided by Eurolab

The OECD TG 406 Skin Sensitization Testing in Animals is a widely accepted standard for evaluating the potential of substances to cause skin sensitization. This testing service is essential for industries that handle or produce chemicals, cosmetics, and pharmaceuticals, as it ensures product safety and compliance with regulatory requirements.

Legislative Framework

The OECD TG 406 Skin Sensitization Testing in Animals 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)

  • ASTM F2412-11 (Standard Test Methods for Evaluation of Human Eye Irritation from Chemicals to Rabbits Eyes from a Single Application)

  • EN 717-1:2004 (Determination of formaldehyde release from wood-based panels -- Part 1: Formaldehyde, free formaldehyde and total aldehyde content)

  • TSE LRB 004:2013 (Biocidal products -- Particular requirements for evaluation of skin sensitization)

    • International and National Standards

    The OECD TG 406 Skin Sensitization Testing in Animals is subject to international standards set by the Organization for Economic Co-operation and Development (OECD). National standards, such as those mentioned above, also apply.

    Standard Development Organizations

    The development and maintenance of standards are handled by various organizations, including:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • These organizations work together to ensure consistency and compatibility between international and national standards.

    Evolution and Updates

    Standards evolve over time as new scientific knowledge becomes available. This process involves the development of new test methods, modifications to existing tests, and updates to standard requirements.

    Standard Numbers and Scope

    Some relevant standard numbers and their scope are:

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

  • ASTM F2412-11: Standard Test Methods for Evaluation of Human Eye Irritation from Chemicals to Rabbits Eyes from a Single Application

  • EN 717-1:2004: Determination of formaldehyde release from wood-based panels -- Part 1: Formaldehyde, free formaldehyde and total aldehyde content

    • Standard Compliance Requirements

    Compliance with standards is essential for industries handling chemicals, cosmetics, and pharmaceuticals. Failure to comply can result in product recalls, regulatory fines, or even company closure.

    Industries Requiring OECD TG 406 Skin Sensitization Testing in Animals

    The following industries require this testing service:

  • Chemical manufacturers

  • Cosmetic producers

  • Pharmaceutical companies

  • Medical device manufacturers

    • These industries must ensure product safety and compliance with regulatory requirements, making the OECD TG 406 Skin Sensitization Testing in Animals an essential tool.

    Risk Factors and Safety Implications

    Skin sensitization can have serious consequences for human health. The OECD TG 406 Skin Sensitization Testing in Animals helps identify potential risks, allowing industries to take preventive measures.

    Quality Assurance and Quality Control Aspects

    Eurolabs quality management system (QMS) ensures the highest standards of testing accuracy and reliability. Our personnel are qualified and certified to perform this testing service.

    Contribution to Product Safety and Reliability

    The OECD TG 406 Skin Sensitization Testing in Animals is essential for ensuring product safety and reliability. By identifying potential risks, industries can take corrective action, reducing the likelihood of adverse reactions or regulatory non-compliance.

    Competitive Advantages

    Performing the OECD TG 406 Skin Sensitization Testing in Animals demonstrates an industrys commitment to product safety and compliance with regulatory requirements. This can provide a competitive advantage and improve market positioning.

    Cost-Benefit Analysis

    The cost of performing the OECD TG 406 Skin Sensitization Testing in Animals is outweighed by the benefits of ensuring product safety, regulatory compliance, and customer confidence.

    Business and Technical Reasons for Conducting OECD TG 406 Skin Sensitization Testing in Animals

    This testing service is required for various business and technical reasons:

  • To ensure product safety

  • To comply with regulatory requirements

  • To reduce the risk of adverse reactions or regulatory non-compliance

  • To maintain customer confidence

  • To demonstrate an industrys commitment to quality and safety

    • Consequences of Not Performing OECD TG 406 Skin Sensitization Testing in Animals

    Failure to perform this testing service can result in:

  • Regulatory fines or penalties

  • Product recalls

  • Loss of customer confidence

  • Damage to brand reputation

    • The following industries require this testing service:

  • Personal care products manufacturers

  • Food and beverages manufacturers

  • Textile manufacturers

  • Paints and coatings manufacturers

    • These industries must ensure product safety and compliance with regulatory requirements, making the OECD TG 406 Skin Sensitization Testing in Animals an essential tool.

    Quality Assurance and Quality Control Aspects

    Eurolabs quality management system (QMS) ensures the highest standards of testing accuracy and reliability. Our personnel are qualified and certified to perform this testing service.

    Contribution to Product Safety and Reliability

    The OECD TG 406 Skin Sensitization Testing in Animals is essential for ensuring product safety and reliability. By identifying potential risks, industries can take corrective action, reducing the likelihood of adverse reactions or regulatory non-compliance.

    Competitive Advantages

    Performing the OECD TG 406 Skin Sensitization Testing in Animals demonstrates an industrys commitment to product safety and compliance with regulatory requirements. This can provide a competitive advantage and improve market positioning.

    Cost-Benefit Analysis

    The cost of performing the OECD TG 406 Skin Sensitization Testing in Animals is outweighed by the benefits of ensuring product safety, regulatory compliance, and customer confidence.

    The following industries require this testing service:

  • Biocides manufacturers

  • Medical device manufacturers

  • Pharmaceutical companies

  • Cosmetic producers

    • These industries must ensure product safety and compliance with regulatory requirements, making the OECD TG 406 Skin Sensitization Testing in Animals an essential tool.

    Risk Factors and Safety Implications

    Skin sensitization can have serious consequences for human health. The OECD TG 406 Skin Sensitization Testing in Animals helps identify potential risks, allowing industries to take preventive measures.

    Quality Assurance and Quality Control Aspects

    Eurolabs quality management system (QMS) ensures the highest standards of testing accuracy and reliability. Our personnel are qualified and certified to perform this testing service.

    Contribution to Product Safety and Reliability

    The OECD TG 406 Skin Sensitization Testing in Animals is essential for ensuring product safety and reliability. By identifying potential risks, industries can take corrective action, reducing the likelihood of adverse reactions or regulatory non-compliance.

    Competitive Advantages

    Performing the OECD TG 406 Skin Sensitization Testing in Animals demonstrates an industrys commitment to product safety and compliance with regulatory requirements. This can provide a competitive advantage and improve market positioning.

    Cost-Benefit Analysis

    The cost of performing the OECD TG 406 Skin Sensitization Testing in Animals is outweighed by the benefits of ensuring product safety, regulatory compliance, and customer confidence.

    Business and Technical Reasons for Conducting OECD TG 406 Skin Sensitization Testing in Animals

    This testing service is required for various business and technical reasons:

  • To ensure product safety

  • To comply with regulatory requirements

  • To reduce the risk of adverse reactions or regulatory non-compliance

  • To maintain customer confidence

  • To demonstrate an industrys commitment to quality and safety

    • Consequences of Not Performing OECD TG 406 Skin Sensitization Testing in Animals

    Failure to perform this testing service can result in:

  • Regulatory fines or penalties

  • Product recalls

  • Loss of customer confidence

  • Damage to brand reputation

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

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