OECD 492 – Eye irritation testing

In vitro testing allows products to be tested for tolerability and efficacy before or instead of testing on a human subject. Tests on human subjects are unsuitable or even unable to address many issues or questions. Such testing is often associated with health or safety risks for the test subjects, hence, it is banned on ethical grounds or impossible in practice. This is why here at Dermatest we also use primary skin cells and 3D models of the skin when looking at complex issues.

Same testing method – new seal design

In a dynamic market, it is important to stay ahead. That’s why we are introducing our innovative “Consumer Line” seals. Through claims and corresponding visual elements, they provide direct information about what has been tested – for your customers, this means instant clarity.
Get in touch with our experts about the possibilities of the new seal.

Benefits of In vitro testing

  • using physical, histological and biochemical techniques, specific claims can be made regarding the effects of a product on biological processes in human skin.
  • 3D models of the skin, grown from primary human cells, adequately reflect the natural properties of native human skin including all tyical skin layers as well as expression of characteristic markers.
  • comprehensive quantitative and qualitative assessment of various parameters is available
  • aspects which cannot be tested on human subjects, such as irritation tests, wound healing studiesinflammation or penetration/permeation can still be investigated
  • techniques can be adapted to the individual product and matter at hand, so that almost every aspect of tolerability and safety can be addressed
  • testing can often be done rapidly, as no human subjects are involved in the study

How we test OECD TG 492

For this test, 3D reconstructed human ocular models are exposed to the test material for 30 minutes (liquids) or 6 hours (solids). After exposure models are rinsed and post-soaked for 25 minutes. The viability of the models is subsequently assessed using the MTT test (colorimetric assay). If the remaining viability is > 60%, the test material is non-irritant.

Note: OECD/OCDR TG No. 492 adopted the following classification in 2019: If the viability of the tissue treated with the test article is > 60.0% relative to negative control-treated tissue viability, the test article does not require classification and labelling (No Category) and no further testing is required. If the viability of the tissue treated with the test article is ≤ 60.0% relative to negative control-treated tissue viability, then no prediction can be made for the test article and further testing is required.

3D model of the skin

In order to provide you with the best possible testing methods for your product, our in vitro work is done using Phenion® skin models from Henkel® as well as EpiDermTM models from MatTek. The models are composed entirely of human skin cells (keratinocytes and fibroblasts). The design is modelled on human skin which it resembles in both anatomical and physiological properties. It consists of a fully differentiated epidermis and underlying dermis, containing connective tissue made from natural collagen synthesized by human fibroblasts. These highly specific human skin tissue models can be used to broaden our basic cosmetic research and assess the safety of raw materials and products. The investigations and tests which we perform on these models are as close as possible to native human skin and you get meaningful, marketable results.

Your route to the seal of approval in 4 steps

After receiving your request, we check whether the desired test is possible with your product type.

You decide with us on one of the possible studies and send us the required sample quantities. We then start with the actual study preparation and order the cells/models.

We will conduct the planned study in our laboratory as previously agreed.

Provided your product passes our review stage successfully once the study is complete, we then send you the study report and authorisation to use the appropriate Dermatest® seal. Besides the German version, we would be delighted to provide you with the Dermatest® seal to support sales in the national language of your sales markets as appropriate.

Ask us now about the OECD 492 seal

We will get back to you promptly

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You can find details about what personal data we store and who has access to it in our data protection policy.

I consent to my personal data being stored and processed in line with the data protection policy and I consent my personal data being processed by Dermatest GmbH in order to answer my contact or information request.

I can withdraw my consent at any time with immediate effect.*

Companies who trust our seal

Natural Elements

Natsana GmbH

Nature Love

Natsana GmbH

Pampers

Procter & Gamble

Dead Sea Mud Mask

Haus Schaeben GmbH & Co. KG

GLYNT PURE Shampoo

Hans Conzen Kosmetik GmbH

Hej Organic Sensitive Cleansing Gel

HEJ ORGANIC GmbH

FAQ

The start and duration of an application test is strongly dependent on the study design and availability of appropriate skin models. Usually it takes 3-4 weeks after product arrival to conduct the study and finalize the expert opinion.

Unlike in vivo studies in vitro only needs a very small amount of a product (5 ml or 5 g) or substance. The amount of product for application ranges between 1- 100 µl or 1 – 50 mg  depending on the study design. Frequency of use should be taken into account. We do not need a retention samples or spare samples.

Besides the product samples, the qualitative INCI names or composition of the test product is needed for all testing. As an order confirmation, we need the study protocol to be returned to us, signed (digital format is sufficient).

We offer various tests design which can always be adapted by the customer to suit the preferred test design or needs.

No. In addition to cosmetic products, we also test consumer goods, medical devices and biocides for skin tolerability according to currently valid OECD testing guidelines or DIN EN ISO protocols.

Our team is at your disposal

Dr. Janina Tiemann

Head of In-Vitro Analysis

Schnellkontakt

Rufen Sie uns unter 0251 481637-0 an oder senden Sie eine Nachricht. Wir melden uns umgehend bei Ihnen.

1+1?*

You can find details about what personal data we store and who has access to it in our data protection policy.

I consent to my personal data being stored and processed in line with the data protection policy and I consent my personal data being processed by Dermatest GmbH in order to answer my contact or information request.

I can withdraw my consent at any time with immediate effect.*

Quick request

Call us on 0251 481637-0 or send an email. We will get back to you straight away.
1+1?*

You can find details about what personal data we store and who has access to it in our data protection policy.

I consent to my personal data being stored and processed in line with the data protection policy and I consent my personal data being processed by Dermatest GmbH in order to answer my contact or information request.

I can withdraw my consent at any time with immediate effect.*