OECD TG 442E Human Cell Line Activation Test (h-CLAT) for Skin Sensitization

OECD TG 442E Human Cell Line Activation Test (h-CLAT) for Skin Sensitization: Laboratory Testing Services Provided by Eurolab

Standard-Related Information

The OECD TG 442E Human Cell Line Activation Test (h-CLAT) for Skin Sensitization is a laboratory testing service governed by the Organisation for Economic Co-operation and Developments (OECD) Test Guideline No. 442E. This guideline provides a standardized method for assessing the skin sensitizing potential of chemicals.

International and National Standards

Standard Development Organizations

The OECD, ISO, ASTM, and TSE are leading standard development organizations responsible for creating and maintaining standards related to skin sensitization testing.

Legal and Regulatory Framework

The OECD TG 442E is recognized by regulatory authorities worldwide, including the European Unions REACH regulation (EC) No. 1907/2006 and the US FDAs Guidance on Testing of Skin Sensitizing Substances.

Standard Compliance Requirements

Compliance with OECD TG 442E is mandatory for industries that develop or market chemicals, cosmetics, or pharmaceuticals. Non-compliance can result in regulatory penalties, product recalls, or even business closure.

Standard Requirements and Needs

The OECD TG 442E Human Cell Line Activation Test (h-CLAT) is a critical testing service required to assess the skin sensitizing potential of chemicals. This test provides a reliable and efficient method for identifying potential skin irritants and allergens.

Business and Technical Reasons for Conducting OECD TG 442E

Conducting OECD TG 442E h-CLAT is essential for ensuring product safety, preventing regulatory non-compliance, and maintaining consumer trust. This test helps industries:

Risk Factors and Safety Implications

Skin sensitization can lead to severe health consequences, including allergic contact dermatitis, phototoxicity, and even anaphylaxis. Conducting OECD TG 442E h-CLAT helps mitigate these risks by identifying potential skin sensitizers early on.

Test Conditions and Methodology

The OECD TG 442E h-CLAT involves a step-by-step process:

1. Sample preparation

2. Cell culture and seeding

3. Incubation and stimulation

4. Measurement of activation markers

5. Data analysis and interpretation

Eurolabs state-of-the-art equipment and facilities ensure accurate and reliable test results.

Test Reporting and Documentation

Test results are documented in a comprehensive report, including:

Reports are submitted to clients within 30 days of test completion.

Why This Test Should Be Performed

Conducting OECD TG 442E h-CLAT provides numerous benefits, including:

Why Eurolab Should Provide This Service

Eurolabs expertise and experience in skin sensitization testing make us an ideal partner for this service. Our state-of-the-art equipment, qualified personnel, and accreditation ensure accurate and reliable results.

Additional Requirements

To further enhance customer satisfaction, Eurolab offers:

We believe that our expertise, facilities, and quality management systems make us the ideal partner for OECD TG 442E h-CLAT testing.

Eurolabs Capabilities and Advantages

Our team of experts is dedicated to providing accurate and reliable test results. We pride ourselves on:

Customer Testimonials

We were impressed by Eurolabs professionalism and expertise in skin sensitization testing. - Client Name

Eurolabs results helped us identify potential skin sensitizers, saving us from costly recalls and regulatory penalties. - Client Name

Conclusion

The OECD TG 442E Human Cell Line Activation Test (h-CLAT) for Skin Sensitization is a critical laboratory testing service that ensures product safety, prevents regulatory non-compliance, and maintains consumer trust. Eurolabs expertise, facilities, and quality management systems make us the ideal partner for this service.