Skin Irritation Testing Lab in India | Medical Devices Testing

Skin Irritation Testing Lab in India




The in-vitro skin irritation test is a laboratory test that helps in determining whether a product has the potential to cause skin irritation when used by the consumer. Some products have the potential to irritate the skin by passing through the outer layer of the skin and into the layers beneath, inflicting harmful and damaging effects on the cells. This, in turn, triggers an acute immunological reaction in the area of touch with the substance, which is often characterized by redness, itching, or pain. 

What is in-vitro skin irritation testing?

Skin irritation is an important component of the biological safety evaluation of products and medical devices. The skin irritation test performed by an accredited lab is an in-vitro test that is used to discover compounds, chemicals, and mixtures that can cause moderate skin irritation.

In vivo models have traditionally been used to test products and medical device irritation. Alternative approaches for measuring skin irritation risk in vitro have been developed in an effort to decrease the necessity for in vivo testing using animals. 

In-Vitro Skin Irritation Testing Regulation 

ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials about their potential to produce irritation and skin sensitization.

ISO 10993 includes:

  • pretest considerations for irritation, including in vitro methods for dermal exposure;
  • details of in vivo (irritation and sensitization) test procedures;
  • key factors for the interpretation of the results.

What is the use of in-vitro skin irritation tests?

The in-vitro skin Irritation test evaluates skin irritation using three-dimensional skin models. Since several in vivo studies for cosmetic components have now been restricted for usage in many places, this in vitro model is an excellent replacement for animal research. We use the EpiDerm kit, which is a proven in vitro model system for chemical, pharmaceutical, and skincare product testing. 

The in-vitro skin irritation test model will help you figure out if a chemical or substance in your product can penetrate the skin’s outer layer and cause cytotoxicity in the cells beneath it. If the effect is mild or undetectable, the skin model releases a quantifiable amount of inflammatory mediators, which can be employed to improve the test’s sensitivity. The model can test liquids as well as solids. 

Sigma Test and Research Centre is an accredited and certified laboratory that offers in-vitro skin irritation testing services!

Why choose Sigma Test and Research Centre? 

For more than a decade, Sigma Test and Research Centre, which is accredited by the NABL and the FSSAI, has provided testing facilities for industrial products all around the world. We pay close attention to proper health, safety, quality, and environmental requirements while making such purchases, with the latter being the ultimate goal.

Sigma Test and Research Centre use state-of-the-art facilities, knowledgeable and experienced faculty, and a comprehensive digitized data management system. We provide exceptional testing services for a wide range of testing services to ensure complete safety and regulatory compliance with our testing, inspection, and certification services. 

We provide in-vitro skin irritation testing services to assess any product and its constituent materials with regard to their potential to cause and produce skin irritation and sensitization and check its compliance with ISO 10993 standard.

Sigma Test and Research Centre uses MatTek’s patented EpiDerm system which is a leading in-vitro testing technology. EpiDerm is an established in-vitro model system for chemical, pharmaceutical, and skincare product testing, with numerous ECVAM validations and OECD-recognized test protocols. 

If you’re seeking an in-vitro skin irritation testing lab to assist you, feel free to reach out to us.

Fill out the inquiry form or call us right now at +91 – 95 60 222 333 to get in touch. After learning more about your testing requirements, we’ll be happy to assist you with our in-vitro skin irritation testing services.



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