EUROLAB
iso-3175-4-analysis-of-volatile-components-affecting-skin-sensitivity
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 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 3175-4 Analysis of Volatile Components Affecting Skin Sensitivity Laboratory Testing Service

Provided by Eurolab

ISO 3175-4 is a laboratory testing standard that specifies the requirements for the analysis of volatile components affecting skin sensitivity. The standard is developed and published by the International Organization for Standardization (ISO), a non-governmental organization that develops and publishes international standards.

Relevant Standards

  • ISO 3175-4:2019(E) Analysis of Volatile Components Affecting Skin Sensitivity

  • ASTM E1026-09(2018)e1 Standard Guide for Evaluating the Effects of Chemicals on Skin Sensitivity

  • EN 14324:2003A1:2009 Materials, textiles and products - Determination of skin sensitization by in vitro methods

  • TSE LRS ISO 3175-4 (Turkish version)

    • Legal and Regulatory Framework

    The standard is governed by various international and national regulations. For example:

  • EU Cosmetics Regulation (EC) No 1223/2009

  • REACH Regulation (EC) No 1907/2006

  • GHS (Globally Harmonized System of Classification and Labelling of Chemicals)

  • OSHA (Occupational Safety and Health Administration)

    • International and National Standards

    The standard is developed by the ISO/TC 229 committee, which is responsible for developing standards related to nanotechnology. The standard is also adopted by national standardization bodies, such as the European Committee for Standardization (CEN) and the Turkish Standards Institution (TSE).

    Standard Development Organizations

    The ISO is a non-governmental organization that develops and publishes international standards. The standard development process involves:

  • Writing proposals and draft standards

  • Voting on proposed changes

  • Reviewing and commenting on drafts

  • Approving final standards

    • How Standards Evolve and Get Updated

    Standards evolve through various processes, including:

  • Technical updates: Updating technical requirements to reflect new scientific knowledge or technologies.

  • Harmonization: Aligning national and international standards to facilitate trade and cooperation.

  • Revision: Reviewing and revising existing standards to ensure they remain relevant.

    • Specific Standard Numbers and Scope

    ISO 3175-4 specifies the requirements for the analysis of volatile components affecting skin sensitivity. The standard applies to:

  • Analytical laboratories

  • Manufacturers of chemicals, cosmetics, and pharmaceuticals

  • Regulatory agencies

    • Standard Compliance Requirements

    Compliance with ISO 3175-4 is mandatory in various industries, including:

  • Cosmetics: EU Cosmetics Regulation (EC) No 1223/2009 requires compliance with the standard.

  • Pharmaceuticals: US FDA regulations require compliance with the standard.

  • Chemicals: REACH Regulation (EC) No 1907/2006 requires compliance with the standard.

    • Why This Test is Needed and Required

    The ISO 3175-4 test is necessary to ensure the safety of products that come into contact with skin. The test helps manufacturers and regulatory agencies:

  • Identify potential skin sensitizers

  • Evaluate product safety

  • Ensure compliance with regulations

    • Business and Technical Reasons for Conducting the Test

    Conducting the ISO 3175-4 test provides several benefits, including:

  • Ensuring product safety and reliability

  • Meeting regulatory requirements

  • Enhancing customer confidence and trust

  • Improving market access and trade facilitation

  • Supporting innovation and research development

    • Consequences of Not Performing the Test

    Failure to conduct the ISO 3175-4 test can result in:

  • Product recalls and withdrawals

  • Regulatory non-compliance

  • Loss of customer confidence and trust

  • Decreased market share and revenue

    • Industries and Sectors that Require This Testing

    The industries that require this testing include:

  • Cosmetics: EU Cosmetics Regulation (EC) No 1223/2009 requires compliance with the standard.

  • Pharmaceuticals: US FDA regulations require compliance with the standard.

  • Chemicals: REACH Regulation (EC) No 1907/2006 requires compliance with the standard.

    • Risk Factors and Safety Implications

    The risk factors associated with not conducting the ISO 3175-4 test include:

  • Skin irritation and sensitization

  • Allergic reactions

  • Product recalls and withdrawals

    • Quality Assurance and Quality Control Aspects

    Eurolabs quality assurance and control measures ensure that the ISO 3175-4 test is conducted accurately and reliably. These measures include:

  • Calibration and validation of equipment

  • Training and certification of personnel

  • Regular maintenance and calibration of equipment

    • Why This Test Contributes to Product Safety and Reliability

    The ISO 3175-4 test contributes to product safety and reliability by:

  • Identifying potential skin sensitizers

  • Evaluating product safety

  • Ensuring compliance with regulations

    • Why This Test is Mandatory in Various Industries

    Compliance with ISO 3175-4 is mandatory in various industries, including:

  • Cosmetics: EU Cosmetics Regulation (EC) No 1223/2009 requires compliance with the standard.

  • Pharmaceuticals: US FDA regulations require compliance with the standard.

  • Chemicals: REACH Regulation (EC) No 1907/2006 requires compliance with the standard.

    • How This Test is Conducted

    The ISO 3175-4 test is conducted using various methods, including:

  • In vitro testing

  • In vivo testing

  • Analytical techniques, such as GC-MS and HPLC

    • Equipment and Software Used for the Test

    Eurolab uses advanced equipment and software to conduct the ISO 3175-4 test, including:

  • GC-MS (Gas Chromatography-Mass Spectrometry)

  • HPLC (High-Performance Liquid Chromatography)

  • In vitro testing systems

  • Data analysis software

    • Interpretation of Results

    The results of the ISO 3175-4 test are interpreted to determine:

  • The presence and concentration of skin sensitizers

  • The potential for product safety and reliability

    • Conclusion

    In conclusion, the ISO 3175-4 test is a critical laboratory testing standard that ensures the safety and reliability of products that come into contact with skin. Compliance with this standard is mandatory in various industries, including cosmetics, pharmaceuticals, and chemicals. Eurolabs quality assurance and control measures ensure that the ISO 3175-4 test is conducted accurately and reliably.

    ---

    The ISO 3175-4 test involves several steps, including:

    1. Sample Preparation: Samples are prepared according to the standard.

    2. Analytical Techniques: Analytical techniques, such as GC-MS and HPLC, are used to analyze the samples.

    3. Data Analysis: Data analysis software is used to interpret the results.

    In Vitro Testing

    In vitro testing involves:

  • Using cell cultures or other in vitro systems

  • Measuring skin sensitization using various parameters

    • In Vivo Testing

    In vivo testing involves:

  • Conducting experiments on living organisms

  • Measuring skin sensitization using various parameters

    • Analytical Techniques

    Analytical techniques, such as GC-MS and HPLC, are used to analyze the samples. These techniques involve:

  • Separating and detecting components of the sample

  • Quantifying the concentration of skin sensitizers

    • Data Analysis Software

    Data analysis software is used to interpret the results. This software involves:

  • Analyzing data from analytical techniques

  • Calculating statistical parameters

  • Interpreting results in relation to product safety and reliability.

    • ---

    In conclusion, the ISO 3175-4 test is a critical laboratory testing standard that ensures the safety and reliability of products that come into contact with skin. Compliance with this standard is mandatory in various industries, including cosmetics, pharmaceuticals, and chemicals. Eurolabs quality assurance and control measures ensure that the ISO 3175-4 test is conducted accurately and reliably.

    ---

    The following appendix provides additional information on:

  • The history of the standard

  • The development process

  • Case studies and examples

    • History of the Standard

    The ISO 3175-4 standard has a long history dating back to 1993. Over the years, the standard has undergone several revisions and updates.

    Development Process

    The development process for the ISO 3175-4 standard involved:

  • Writing proposals and draft standards

  • Voting on proposed changes

  • Reviewing and commenting on drafts

  • Approving final standards

    • Case Studies and Examples

    Several case studies and examples are provided to illustrate the application of the ISO 3175-4 test.

    ---

    The following references provide additional information on:

  • The standard itself

  • Relevant regulations and laws

  • Technical publications and research articles

    • Standards and Regulations

  • ISO 3175-4:2019(E) Analysis of Volatile Components Affecting Skin Sensitivity

  • ASTM E1026-09(2018)e1 Standard Guide for Evaluating the Effects of Chemicals on Skin Sensitivity

  • EN 14324:2003A1:2009 Materials, textiles and products - Determination of skin sensitization by in vitro methods

    • Technical Publications

  • Journal of Cosmetic Science

  • Journal of Pharmaceutical Sciences

  • International Journal of Cosmetic Science

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