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oecd-tg-437-bovine-corneal-opacity-and-permeability-test-for-skin-safety
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 406 Skin Sensitization Testing in AnimalsOECD 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 437 Bovine Corneal Opacity and Permeability Test for Skin Safety: Eurolabs Laboratory Testing Service

The OECD TG 437 Bovine Corneal Opacity and Permeability Test for Skin Safety is a standardized laboratory test used to evaluate the skin safety of various substances. This test is governed by international standards, including ISO, ASTM, EN, TSE, and others.

International Standards

  • ISO 10993-9:2010: Biological evaluation of medical devices - Part 9: Test for in vitro cytotoxicity

  • ASTM F1904-09: Standard Guide for In Vitro Cytotoxicity Testing of Materials

  • EN ISO 10993-5:2009: Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

    • Legal and Regulatory Framework

    The OECD TG 437 Bovine Corneal Opacity and Permeability Test for Skin Safety is regulated by various international, national, and regional authorities. These regulations ensure that the test is performed in accordance with established standards and guidelines.

  • EU Biocidal Products Regulation (EU) No 528/2012: Regulates the marketing and use of biocides

  • EU Cosmetics Regulation (EC) No 1223/2009: Regulates the safety assessment of cosmetic products

    • Standard Development Organizations

    Standard development organizations play a crucial role in establishing and maintaining standards for laboratory testing. These organizations include:

  • ISO (International Organization for Standardization): Develops and publishes international standards

  • ASTM International: Develops and publishes standards for various industries, including biocides and cosmetics

    • Why Standards are Important

    Standards ensure that laboratory tests are performed consistently and accurately. They provide a framework for evaluating the safety of substances and help to prevent errors and inconsistencies.

  • Consistency: Standards ensure that test results are comparable across different laboratories

  • Accuracy: Standards guarantee that tests are performed in accordance with established protocols

    • The OECD TG 437 Bovine Corneal Opacity and Permeability Test for Skin Safety is a critical component of the safety assessment process. This test provides valuable information about the skin safety of substances, which is essential for preventing adverse effects on human health.

    Business and Technical Reasons for Conducting the Test

    The OECD TG 437 Bovine Corneal Opacity and Permeability Test for Skin Safety is required by various industries, including cosmetics, pharmaceuticals, and biocides. This test helps to ensure that substances are safe for use on human skin.

  • Cosmetics: The European Cosmetics Regulation (EC) No 1223/2009 requires the safety assessment of cosmetic products

  • Pharmaceuticals: The EU Biocidal Products Regulation (EU) No 528/2012 regulates the marketing and use of biocides

    • Consequences of Not Performing the Test

    Failure to perform the OECD TG 437 Bovine Corneal Opacity and Permeability Test for Skin Safety can result in adverse effects on human health.

  • Adverse Reactions: Untested substances may cause skin irritation, allergic contact dermatitis, or other adverse reactions

  • Regulatory Non-Compliance: Failure to conduct the test may lead to regulatory non-compliance

    • Industries and Sectors that Require this Testing

    The OECD TG 437 Bovine Corneal Opacity and Permeability Test for Skin Safety is required by various industries, including:

  • Cosmetics: Manufacturers of cosmetic products must ensure that their products are safe for use on human skin

  • Pharmaceuticals: Pharmaceutical companies must test the skin safety of their products before marketing

    • Risk Factors and Safety Implications

    The OECD TG 437 Bovine Corneal Opacity and Permeability Test for Skin Safety helps to identify potential risk factors associated with substance exposure.

  • Skin Irritation: The test evaluates the potential for skin irritation and contact dermatitis

  • Allergic Contact Dermatitis: The test assesses the potential for allergic reactions

    • Quality Assurance and Quality Control

    The OECD TG 437 Bovine Corneal Opacity and Permeability Test for Skin Safety is subject to quality assurance and quality control procedures.

  • Calibration and Validation: Instruments are regularly calibrated and validated to ensure accuracy

  • Sampling Procedures: Sampling procedures are followed strictly to ensure representative results

    • The OECD TG 437 Bovine Corneal Opacity and Permeability Test for Skin Safety involves the following steps:

    1. Preparation of the test substance: The test substance is prepared according to established protocols.

    2. Preparation of the bovine cornea: A bovine cornea is prepared for testing by removing any residual tissue.

    3. Measurement of the corneal opacity: The corneal opacity is measured using a calibrated spectrophotometer.

    4. Application of the test substance: The test substance is applied to the cornea according to established protocols.

    Preparation of the Test Substance

    The test substance is prepared according to established protocols, which include:

  • Dilution: The test substance is diluted with a suitable solvent.

  • Filtering: The solution is filtered to remove any particulate matter.

    • Measurement of the Corneal Opacity

    The corneal opacity is measured using a calibrated spectrophotometer. This instrument measures the amount of light that passes through the cornea, which is used to calculate the corneal opacity.

  • Calibration: The spectrophotometer is regularly calibrated to ensure accuracy.

  • Measurement: The corneal opacity is measured after application of the test substance.

    • Application of the Test Substance

    The test substance is applied to the cornea according to established protocols, which include:

  • Dosing: A specific dose of the test substance is applied to the cornea.

  • Incubation: The solution is incubated for a specified period.

    • Why Choose Eurolabs Laboratory Testing Service?

    Eurolabs laboratory testing service provides accurate and reliable results. Our team of experienced technicians and scientists follow established protocols to ensure consistency and accuracy.

  • Accreditation: We are accredited by recognized accrediting bodies, including ISO 17025.

  • Calibration and Validation: Instruments are regularly calibrated and validated to ensure accuracy

    • Conclusion

    The OECD TG 437 Bovine Corneal Opacity and Permeability Test for Skin Safety is a critical component of the safety assessment process. This test provides valuable information about the skin safety of substances, which is essential for preventing adverse effects on human health.

  • Standards: The test is governed by international standards, including ISO 10993-9:2010

  • Regulations: The test is regulated by various international, national, and regional authorities

    • References

    1. OECD TG 437 Bovine Corneal Opacity and Permeability Test for Skin Safety (2016)

    2. European Cosmetics Regulation (EC) No 1223/2009

    3. EU Biocidal Products Regulation (EU) No 528/2012

    4. ISO 10993-9:2010 Biological evaluation of medical devices - Part 9: Test for in vitro cytotoxicity

    5. ASTM F1904-09 Standard Guide for In Vitro Cytotoxicity Testing of Materials

    Contact Us

    For more information about Eurolabs laboratory testing service, please contact us:

  • Phone: 44 (0)20 7183 7700

  • Email: infoeurolab.com(mailto:infoeurolab.com)

  • Website: www.eurolab.com

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

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