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oecd-tg-431-in-vitro-skin-sensitization-tests
Azo & Formaldehyde Testing ASTM D1331 Formaldehyde Emission Test in TextilesASTM D5035 Identification of Formaldehyde in Textile SamplesASTM D5036 Determination of Formaldehyde by Chromotropic Acid MethodASTM D5037 Formaldehyde Content Analysis Using Colorimetric MethodASTM D5154 Formaldehyde Detection in Textile Finishing AgentsASTM D5190 Formaldehyde Determination in Finished FabricsASTM D5195 Quantitative Formaldehyde Testing in Textile SamplesASTM D5196 Formaldehyde Content Analysis by Chromotropic Acid MethodASTM D5196 Formaldehyde Determination by Chromotropic AcidASTM D5197 Formaldehyde Emission Measurement by Gas ChromatographyASTM D5198 Formaldehyde Release Measurement from FabricsASTM D5237 Formaldehyde Content in Finished Textile ProductsASTM D5792 Formaldehyde Extraction and Quantification MethodsASTM D6195 Formaldehyde Determination Using Spectrophotometric MethodASTM D6340 Analysis of Formaldehyde in Textile MaterialsASTM D6545 Determination of Formaldehyde Concentration in FabricsEN 14362-1 Detection of Azo Colorants in Textiles by Extraction and SpectrophotometryEN 14362-10 Analysis of Restricted Azo Dyes in TextilesEN 14362-11 Identification of Aromatic Amines by GC-MSEN 14362-12 Testing for Banned Azo Dyes in TextilesEN 14362-13 Identification and Quantification of Aromatic AminesEN 14362-14 Testing for Restricted Azo ColorantsEN 14362-15 Identification of Aromatic Amines by Liquid ChromatographyEN 14362-16 Testing for Carcinogenic Aromatic AminesEN 14362-2 Identification of Aromatic Amines by Chromatographic TechniquesEN 14362-3 Determination of Carcinogenic Aromatic Amines from Azo ColorantsEN 14362-4 Analysis of Textile Extracts for Azo Dye ResiduesEN 14362-5 Aromatic Amines Quantification by GC-MSEN 14362-6 Testing for Restricted Azo Dyes in Textile ProductsEN 14362-7 Identification of Aromatic Amines by High-Performance Liquid ChromatographyEN 14362-8 Testing for Aromatic Amines in Textile FibersEN 14362-9 Quantitative Analysis of Carcinogenic AminesISO 14184-1 Determination of Formaldehyde in Textiles – Part 1: Free and Hydrolyzed FormaldehydeISO 14184-2 Determination of Formaldehyde Using HPLCISO 14184-3 Formaldehyde Determination by Derivatization and SpectrophotometryISO 14184-4 Formaldehyde Testing Using Spectrophotometric TechniquesISO 14184-5 Determination of Formaldehyde Content Using ChromatographyISO 14184-6 Measurement of Formaldehyde Emission from Textile ProductsISO 14184-7 Determination of Formaldehyde in Textiles Using SpectroscopyISO 14184-8 Formaldehyde Emission Testing in Textile ProductsISO 17234 Azo Dye Release in Dyed and Printed TextilesISO 17234 Determination of Azo Dyes Released from TextilesISO 17234 Extraction and Analysis of Azo Colorants by HPLCISO 17234 Extraction and Quantification of Azo Dyes in Dyed FabricsISO 17234 Extraction of Azo Dyes from Textile MaterialsISO 17234 Quantitative Azo Dye Analysis by LC-MSISO 17234 Quantitative Determination of Azo Dyes by LC-MS/MSISO 17234-2 Extraction of Azo Dyes Using Liquid ChromatographyOECD 406 Skin Sensitization Study for Azo CompoundsOECD 407 Repeated Dose Dermal Toxicity TestOECD 410 Acute Dermal Toxicity Testing of Textile ChemicalsOECD 412 Subchronic Dermal Toxicity StudyOECD 428 Skin Absorption Testing of Formaldehyde in TextilesOECD 429 Assessment of Skin Sensitization by FormaldehydeOECD 429 In Vivo Skin Sensitization TestingOECD 429 Skin Sensitization Assessment for Azo DyesOECD 429 Skin Sensitization Testing Protocols for FormaldehydeOECD 429 Skin Sensitization Tests for Textile FormaldehydeOECD 429 Testing of Formaldehyde in Textile Products for Skin SensitizationOECD TG 405 Acute Dermal Irritation/Corrosion TestingOECD TG 420 Acute Dermal Toxicity Testing for Textile ChemicalsOECD TG 428 Skin Absorption: Azo Dye Penetration TestingOECD TG 429 Skin Sensitization Testing for Formaldehyde

OECD TG 431 In Vitro Skin Sensitization Tests Laboratory Testing Service: A Comprehensive Guide

Standard-Related Information

The OECD TG 431 In Vitro Skin Sensitization Tests is a laboratory testing service that evaluates the skin sensitizing potential of substances using in vitro methods. This test is governed by various international and national standards, which are developed and maintained by organizations such as the International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), and the European Committee for Electrotechnical Standardization (CENELEC).

The legal and regulatory framework surrounding this testing service is based on the principles of safety and protection of human health and the environment. The OECD TG 431 In Vitro Skin Sensitization Tests is a requirement for various industries, including cosmetics, pharmaceuticals, and chemicals, as it helps to identify potential skin sensitizers and prevent adverse reactions.

The international standards that apply to this specific laboratory test include:

  • ISO/TS 25238:2016 (In vitro skin irritation testing)

  • OECD TG 431 (Skin Sensitization: In Vitro Methods)

  • CEN/TR 17369:2015 (Guidance on the use of alternative methods for assessing skin irritation and sensitization)

    • The national standards that apply to this specific laboratory test include:

  • EU Regulation No. 1223/2009 (Cosmetics Regulation)

  • EU Directive 2011/62/EU (Classification, Labelling and Packaging of substances and mixtures)

  • US FDA Guidance for Industry: Nonclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

    • The standard development organizations that play a significant role in developing and maintaining these standards include:

  • ISO

  • ASTM

  • CENELEC

  • OECD

    • Standards evolve and get updated as new technologies and methods become available. For example, the OECD TG 431 In Vitro Skin Sensitization Tests has been updated to reflect the latest developments in in vitro testing methods.

    The standard numbers and their scope are as follows:

  • ISO/TS 25238:2016: In vitro skin irritation testing

    • Scope: This standard provides guidelines for conducting in vitro skin irritation tests using human cell lines.

  • OECD TG 431: Skin Sensitization: In Vitro Methods

    • Scope: This guideline describes the principles and procedures for conducting in vitro skin sensitization tests.

    The industries that require this testing include:

  • Cosmetics

  • Pharmaceuticals

  • Chemicals

  • Personal care products

    • The standard compliance requirements for different industries are as follows:

  • EU Regulation No. 1223/2009 (Cosmetics Regulation): Requires the use of in vitro methods for assessing skin irritation and sensitization.

  • EU Directive 2011/62/EU (Classification, Labelling and Packaging of substances and mixtures): Requires the use of in vitro methods for assessing skin sensitization.

    • Standard Requirements and Needs

    The OECD TG 431 In Vitro Skin Sensitization Tests is a requirement for various industries as it helps to identify potential skin sensitizers and prevent adverse reactions. The business and technical reasons for conducting this test include:

  • To ensure the safety of consumers and workers

  • To comply with regulatory requirements

  • To reduce the risk of adverse reactions

  • To improve product safety and reliability

    • The consequences of not performing this test include:

  • Adverse reactions to products

  • Regulatory non-compliance

  • Damage to reputation and brand image

    • Test Conditions and Methodology

    The OECD TG 431 In Vitro Skin Sensitization Tests is conducted using in vitro methods, which involve the use of human cell lines. The testing equipment and instruments used include:

  • Microplate readers

  • Cell culture incubators

  • Spectrophotometers

    • The testing environment requirements include:

  • Temperature: 37C 1C

  • Humidity: 90 5

  • Pressure: Atmospheric pressure

    • The sample preparation procedures involve:

  • Dispensing the test substance onto the cell culture plate

  • Incubating the cells for 24 hours

  • Measuring the cellular response using a microplate reader

    • The testing parameters and conditions include:

  • Concentration range: 0.01-100

  • Exposure time: 1 hour

  • Cell viability: 80 10

    • The measurement and analysis methods involve:

  • Cell viability assays (e.g., MTT assay)

  • Cytokine release assays (e.g., ELISA)

    • Test Reporting and Documentation

    The test results are documented and reported in a comprehensive report that includes:

  • Test summary

  • Results

  • Discussion of findings

  • Recommendations

    • The report format and structure include:

  • Introduction

  • Materials and methods

  • Results

  • Discussion

  • Conclusion

  • References

    • The interpretation of test results involves:

  • Evaluating the cellular response to the test substance

  • Determining the concentration range that elicits a positive response

  • Comparing the results with the reference substances

    • Why This Test is Important

    The OECD TG 431 In Vitro Skin Sensitization Tests is an important tool for identifying potential skin sensitizers and preventing adverse reactions. The benefits of this test include:

  • Improved product safety and reliability

  • Reduced risk of adverse reactions

  • Compliance with regulatory requirements

  • Protection of human health and the environment

    • Conclusion

    The OECD TG 431 In Vitro Skin Sensitization Tests is a laboratory testing service that evaluates the skin sensitizing potential of substances using in vitro methods. This test is governed by various international and national standards, which are developed and maintained by organizations such as ISO, ASTM, and CENELEC. The standard compliance requirements for different industries include EU Regulation No. 1223/2009 (Cosmetics Regulation) and EU Directive 2011/62/EU (Classification, Labelling and Packaging of substances and mixtures).

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