EUROLAB
iso-24442-evaluation-of-human-skin-irritation-potential
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 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 24442 Evaluation of Human Skin Irritation Potential Testing Services by Eurolab

The ISO 24442 standard is a widely recognized and adopted international standard for evaluating the human skin irritation potential of substances. This standard provides a framework for assessing the potential of chemicals to cause skin irritation, which is essential for ensuring product safety and compliance with regulatory requirements.

Legal and Regulatory Framework

The legal and regulatory framework surrounding this testing service is governed by various international and national standards. Some of the key regulations include:

  • EU Cosmetics Regulation (EC) No 1223/2009: Requires cosmetics to be safe for human use, including assessment of skin irritation potential.
  • European Chemicals Agency (ECHA) REACH Regulation (EC) No 1907/2006: Requires chemical manufacturers to provide information on the potential risks associated with their products, including skin irritation potential.
  • OECD Test Guidelines (TG): Provide a framework for assessing the skin irritation potential of substances.
  • International and National Standards

    The following standards apply to this specific laboratory test:

  • ISO 24442: Provides a standardized method for evaluating the human skin irritation potential of substances.
  • ASTM E2053-08: Provides an alternative method for evaluating skin irritation potential.
  • EN ISO 24442: Specifies the requirements for testing in the European market.
  • Standard Development Organizations

    Standard development organizations (SDOs) play a crucial role in developing and maintaining standards. Some key SDOs include:

  • International Organization for Standardization (ISO): Develops and publishes international standards.
  • American Society for Testing and Materials (ASTM): Develops and publishes ASTM standards.
  • European Committee for Standardization (CEN): Develops and publishes European standards.
  • Evolution of Standards

    Standards evolve over time to reflect changes in technology, science, and regulatory requirements. The following factors contribute to the evolution of standards:

  • Advances in technology: Improved testing methods and equipment enable more accurate and reliable results.
  • Scientific research: New findings and discoveries inform the development of new or revised standards.
  • Regulatory updates: Changes in laws and regulations require corresponding updates to standards.
  • Standard Numbers and Scope

    The following are some key standard numbers and their scope:

    Standard Number Title

    --- ---

    ISO 24442 Evaluation of human skin irritation potential: In vitro method

    ASTM E2053-08 Standard test method for evaluating the dermal penetration of chemical substances using in vivo and in vitro methods

    EN ISO 24442 European standard for evaluating the human skin irritation potential of substances

    Standard Compliance Requirements

    Different industries have varying compliance requirements. Some key industries that require this testing include:

  • Cosmetics: Must comply with EU Cosmetics Regulation (EC) No 1223/2009.
  • Chemicals: Must comply with REACH Regulation (EC) No 1907/2006.
  • Pharmaceuticals: Must comply with international regulations, such as ICH Q2(R1).
  • Standard-Related Information

    The following is a summary of key standard-related information:

    Standard Title Scope

    --- --- ---

    ISO 24442 Evaluation of human skin irritation potential: In vitro method Provides a standardized method for evaluating the human skin irritation potential of substances.

    ASTM E2053-08 Standard test method for evaluating the dermal penetration of chemical substances using in vivo and in vitro methods Provides an alternative method for evaluating skin irritation potential.

    EN ISO 24442 European standard for evaluating the human skin irritation potential of substances Specifies the requirements for testing in the European market.

    The ISO 24442 Evaluation of Human Skin Irritation Potential testing service is necessary to ensure product safety and compliance with regulatory requirements.

    Business and Technical Reasons

    Conducting this test provides several benefits, including:

  • Product safety: Ensures that products do not cause skin irritation.
  • Compliance with regulations: Meets international and national standards for assessing skin irritation potential.
  • Risk assessment: Helps manufacturers to identify potential risks associated with their products.
  • Consequences of Not Performing This Test

    Not performing this test can result in:

  • Non-compliance with regulations: Manufacturers may face fines or penalties for non-compliance.
  • Product recalls: Products that cause skin irritation may be recalled, resulting in financial losses and reputational damage.
  • Loss of customer trust: Failure to ensure product safety can lead to a loss of customer confidence.
  • Industries and Sectors

    The following industries require this testing:

  • Cosmetics: Must comply with EU Cosmetics Regulation (EC) No 1223/2009.
  • Chemicals: Must comply with REACH Regulation (EC) No 1907/2006.
  • Pharmaceuticals: Must comply with international regulations, such as ICH Q2(R1).
  • Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

    Standard Title Scope

    --- --- ---

    ISO 24442 Evaluation of human skin irritation potential: In vitro method Provides a standardized method for evaluating the human skin irritation potential of substances.

    ASTM E2053-08 Standard test method for evaluating the dermal penetration of chemical substances using in vivo and in vitro methods Provides an alternative method for evaluating skin irritation potential.

    EN ISO 24442 European standard for evaluating the human skin irritation potential of substances Specifies the requirements for testing in the European market.

    Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

  • Product safety: Ensures that products do not cause skin irritation.
  • Compliance with regulations: Meets international and national standards for assessing skin irritation potential.
  • Risk assessment: Helps manufacturers to identify potential risks associated with their products.
  • Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

    Standard Title Scope

    --- --- ---

    ISO 24442 Evaluation of human skin irritation potential: In vitro method Provides a standardized method for evaluating the human skin irritation potential of substances.

    ASTM E2053-08 Standard test method for evaluating the dermal penetration of chemical substances using in vivo and in vitro methods Provides an alternative method for evaluating skin irritation potential.

    EN ISO 24442 European standard for evaluating the human skin irritation potential of substances Specifies the requirements for testing in the European market.

    Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

  • Product safety: Ensures that products do not cause skin irritation.
  • Compliance with regulations: Meets international and national standards for assessing skin irritation potential.
  • Risk assessment: Helps manufacturers to identify potential risks associated with their products.
  • Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

    Standard Title Scope

    --- --- ---

    ISO 24442 Evaluation of human skin irritation potential: In vitro method Provides a standardized method for evaluating the human skin irritation potential of substances.

    ASTM E2053-08 Standard test method for evaluating the dermal penetration of chemical substances using in vivo and in vitro methods Provides an alternative method for evaluating skin irritation potential.

    EN ISO 24442 European standard for evaluating the human skin irritation potential of substances Specifies the requirements for testing in the European market.

    Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

  • Product safety: Ensures that products do not cause skin irritation.
  • Compliance with regulations: Meets international and national standards for assessing skin irritation potential.
  • Risk assessment: Helps manufacturers to identify potential risks associated with their products.
  • Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

    Standard Title Scope

    --- --- ---

    ISO 24442 Evaluation of human skin irritation potential: In vitro method Provides a standardized method for evaluating the human skin irritation potential of substances.

    ASTM E2053-08 Standard test method for evaluating the dermal penetration of chemical substances using in vivo and in vitro methods Provides an alternative method for evaluating skin irritation potential.

    EN ISO 24442 European standard for evaluating the human skin irritation potential of substances Specifies the requirements for testing in the European market.

    Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

  • Product safety: Ensures that products do not cause skin irritation.
  • Compliance with regulations: Meets international and national standards for assessing skin irritation potential.
  • Risk assessment: Helps manufacturers to identify potential risks associated with their products.
  • Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

    Standard Title Scope

    --- --- ---

    ISO 24442 Evaluation of human skin irritation potential: In vitro method Provides a standardized method for evaluating the human skin irritation potential of substances.

    ASTM E2053-08 Standard test method for evaluating the dermal penetration of chemical substances using in vivo and in vitro methods Provides an alternative method for evaluating skin irritation potential.

    EN ISO 24442 European standard for evaluating the human skin irritation potential of substances Specifies the requirements for testing in the European market.

    Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

  • Product safety: Ensures that products do not cause skin irritation.
  • Compliance with regulations: Meets international and national standards for assessing skin irritation potential.
  • Risk assessment: Helps manufacturers to identify potential risks associated with their products.
  • Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

    Standard Title Scope

    --- --- ---

    ISO 24442 Evaluation of human skin irritation potential: In vitro method Provides a standardized method for evaluating the human skin irritation potential of substances.

    ASTM E2053-08 Standard test method for evaluating the dermal penetration of chemical substances using in vivo and in vitro methods Provides an alternative method for evaluating skin irritation potential.

    EN ISO 24442 European standard for evaluating the human skin irritation potential of substances Specifies the requirements for testing in the European market.

    Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

  • Product safety: Ensures that products do not cause skin irritation.
  • Compliance with regulations: Meets international and national standards for assessing skin irritation potential.
  • Risk assessment: Helps manufacturers to identify potential risks associated with their products.
  • Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

    Standard Title Scope

    --- --- ---

    ISO 24442 Evaluation of human skin irritation potential: In vitro method Provides a standardized method for evaluating the human skin irritation potential of substances.

    ASTM E2053-08 Standard test method for evaluating the dermal penetration of chemical substances using in vivo and in vitro methods Provides an alternative method for evaluating skin irritation potential.

    EN ISO 24442 European standard for evaluating the human skin irritation potential of substances Specifies the requirements for testing in the European market.

    Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

  • Product safety: Ensures that products do not cause skin irritation.
  • Compliance with regulations: Meets international and national standards for assessing skin irritation potential.
  • Risk assessment: Helps manufacturers to identify potential risks associated with their products.
  • Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

    Standard Title Scope

    --- --- ---

    ISO 24442 Evaluation of human skin irritation potential: In vitro method Provides a standardized method for evaluating the human skin irritation potential of substances.

    ASTM E2053-08 Standard test method for evaluating the dermal penetration of chemical substances using in vivo and in vitro methods Provides an alternative method for evaluating skin irritation potential.

    EN ISO 24442 European standard for evaluating the human skin irritation potential of substances Specifies the requirements for testing in the European market.

    Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

  • Product safety: Ensures that products do not cause skin irritation.
  • Compliance with regulations: Meets international and national standards for assessing skin irritation potential.
  • Risk assessment: Helps manufacturers to identify potential risks associated with their products.
  • Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

    Standard Title Scope

    --- --- ---

    ISO 24442 Evaluation of human skin irritation potential: In vitro method Provides a standardized method for evaluating the human skin irritation potential of substances.

    ASTM E2053-08 Standard test method for evaluating the dermal penetration of chemical substances using in vivo and in vitro methods Provides an alternative method for evaluating skin irritation potential.

    EN ISO 24442 European standard for evaluating the human skin irritation potential of substances Specifies the requirements for testing in the European market.

    Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

  • Product safety: Ensures that products do not cause skin irritation.
  • Compliance with regulations: Meets international and national standards for assessing skin irritation potential.
  • Risk assessment: Helps manufacturers to identify potential risks associated with their products.
  • Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

    Standard Title Scope

    --- --- ---

    ISO 24442 Evaluation of human skin irritation potential: In vitro method Provides a standardized method for evaluating the human skin irritation potential of substances.

    ASTM E2053-08 Standard test method for evaluating the dermal penetration of chemical substances using in vivo and in vitro methods Provides an alternative method for evaluating skin irritation potential.

    EN ISO 24442 European standard for evaluating the human skin irritation potential of substances Specifies the requirements for testing in the European market.

    Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

  • Product safety: Ensures that products do not cause skin irritation.
  • Compliance with regulations: Meets international and national standards for assessing skin irritation potential.
  • Risk assessment: Helps manufacturers to identify potential risks associated with their products.
  • Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

    Standard Title Scope

    --- --- ---

    ISO 24442 Evaluation of human skin irritation potential: In vitro method Provides a standardized method for evaluating the human skin irritation potential of substances.

    ASTM E2053-08 Standard test method for evaluating the dermal penetration of chemical substances using in vivo and in vitro methods Provides an alternative method for evaluating skin irritation potential.

    EN ISO 24442 European standard for evaluating the human skin irritation potential of substances Specifies the requirements for testing in the European market.

    Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

  • Product safety: Ensures that products do not cause skin irritation.
  • Compliance with regulations: Meets international and national standards for assessing skin irritation potential.
  • Risk assessment: Helps manufacturers to identify potential risks associated with their products.
  • Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

    Standard Title Scope

    --- --- ---

    ISO 24442 Evaluation of human skin irritation potential: In vitro method Provides a standardized method for evaluating the human skin irritation potential of substances.

    ASTM E2053-08 Standard test method for evaluating the dermal penetration of chemical substances using in vivo and in vitro methods Provides an alternative method for evaluating skin irritation potential.

    EN ISO 24442 European standard for evaluating the human skin irritation potential of substances Specifies the requirements for testing in the European market.

    Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

  • Product safety: Ensures that products do not cause skin irritation.
  • Compliance with regulations: Meets international and national standards for assessing skin irritation potential.
  • Risk assessment: Helps manufacturers to identify potential risks associated with their products.
  • Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

    Standard Title Scope

    --- --- ---

    ISO 24442 Evaluation of human skin irritation potential: In vitro method Provides a standardized method for evaluating the human skin irritation potential of substances.

    ASTM E2053-08 Standard test method for evaluating the dermal penetration of chemical substances using in vivo and in vitro methods Provides an alternative method for evaluating skin irritation potential.

    EN ISO 24442 European standard for evaluating the human skin irritation potential of substances Specifies the requirements for testing in the European market.

    Standard Requirements and Needs

    The following is a summary of key standard requirements and needs:

  • Product safety: Ensures that products do not cause skin irritation.
  • Compliance with regulations: Meets international and national standards for assessing skin irritation potential.
  • Risk assessment: Helps manufacturers to identify potential risks associated with their products.
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