In Vitro Irritation Testing Lab
By: Dana Mladin, SENIOR TECHNICAL CONSULTANT
Dell Tech operates an ISO 17025 Accredited lab. We offer testing for hazard classification, claim substantiation and performance, eco label certification and more.
Today we are reviewing the in vitro testing performed at Dell Tech, specifically for eye and skin irritation.
Visit our lab testing services page to learn about our full scope of lab services.
The In Vitro Irritation Tests We Offer
Corrositex®
Dell Tech is the leading Corrositex® accredited testing lab in the country. Corrositex (OECD 435) is an accepted test method by GHS – the Globally Harmonized System of Classification and Labelling of Chemicals put out by the United Nations. Additionally, it is accepted by OSHA 2021 and WHMIS 2015. For quality purposes, Corrositex samples are always tested along side a negative and positive control sample.
When it comes to regulatory acceptance for transportation, Corrositex test results can be used as proof of classification with TDG (Canada) and DOT (United States).
For consumer product labelling, Corrositex can verify compliance for:
- Consumer Chemical and Container Regulations, 2001 (CCCR) for Canada
- 16 CFR 1500 for United States
For companies located in Canada who want to conduct the Corrositex testing procedure themselves, Dell Tech is the exclusive distributor of the testing kits for the country. Contact us today to arrange your order and receive the test guideline.
To learn more about the benefits of non-animal skin corrosion testing, check out this article.
Ocular Irritection® (OECD 496) – In Vitro Skin Irritation Testing
The Ocular Irritection® assay predicts the irritancy of chemicals on the eye without animal testing. The assay mimics the biochemical phenomena in which an irritant causing the denaturation or disruption of corneal proteins. This is achieved with a membrane disc that allows the test material to be delivered to a reagent solution made up of proteins, glycoproteins, lipids, and low molecular weight ingredients that form a complex macromolecular matrix.
Irritant activity may be seen when an irritant chemical denatures the proteins of the membrane and reagent solution, causing changes in turbidity of the reagent solution. This change is quantified into an “irritancy score” that directly relates to the potential of the test sample to cause human eye irritancy.
Ocular irritancy should be assessed for the purposes of regulatory compliance and proper hazard classification. Eye irritancy assessment is also beneficial for the purposes of product development and marketing information. Consider In vitro ocular irritation testing for products that are intended for consumer use on human skin that may come into contact with the eye, or intended for direct ocular use. For quality purposes, the In vitro ocular irritation testing always includes a positive control and negative control.
Irritection® Dermal (OECD 496) – In Vitro Skin Irritation Testing
Irritection® Dermal is used to assess the skin irritation potential of chemical products. In vitro skin irritation testing evaluates dermal irritation (skin irritancy) or skin irritant potential without the use of animal or human skin. Potential irritant chemicals are tested at low concentration and high concentration.
Dermal irritation occurs with change to the structure of keratin, collagen, and other proteins in skin. In vitro skin irritation testing mimics this protein change phenomenon using a synthetic membrane of keratin and collagen, and a reagent solution of protein. Irritant activity may be seen when an irritant chemical denatures the proteins of the membrane and reagent solution, causing the release of dye. Skin irritation potential is quantified by measuring the changes in the optical density of the reagent solution (i.e. change caused by how much dye is released into the solution as a result of protein denaturation).
Skin irritancy should be assessed for the purposes of regulatory compliance and proper hazard classification. Skin irritancy assessment is also beneficial for the purposes of product development and marketing information. Consider In vitro skin irritation testing for products that are intended for consumer use on human skin, or have the potential to come into contact with skin. For quality purposes, the In vitro skin irritation testing always includes a positive control and negative control.
The Types of Products We Test
Products we test for skin corrosion:
- Surfactants and concentrated detergents
- Degreasers
- Toilet Bowl Cleaners
- Automotive additives
- Pool chemicals
- Insecticides and Fungicides
- pH adjustors for medical industry
- Metal Polishes
Products we test for eye irritation:
- Detergents and cleaners
- Degreasers
- Cosmetics
- Industrial Chemicals
- Pesticides and Herbicides
- Medication or medication constituents
- Solvents
- Polishes
Products we test for skin irritation:
- Detergents and cleaners
- Degreasers
- Cosmetics
- Industrial Chemicals
- Pesticides and Herbicides
- Medication or medication constituents
- Solvents
- Polishes
Frequently Asked Questions About In Vitro Testing
What is in vitro irritation testing?
In vitro irritation testing is a scientific approach used to evaluate the potential irritant properties of substances without subjecting humans or animals to direct exposure. The term “in vitro” means “in glass;” these tests are conducted in controlled laboratory settings using cells, tissues, or organ-like structures rather than living organisms. The primary objective of in vitro irritation testing is to assess how a particular substance will interact with living tissues. This includes eye and skin irritation potential, inflammation or other damage.
In vitro irritation testing methods vary, but they often involve culturing human or animal cells, or employing tissue or organ models that closely mimic the target tissue’s physiology. Researchers expose these systems to the substance being tested and measure various endpoints, such as cell viability, inflammatory responses, or changes in cellular structures.
How does in vitro irritation testing differ from in vivo testing?
In vitro irritation testing differs from in vivo testing in that it is conducted in a controlled laboratory environment using cell cultures, tissue models, or organ-like structures, while in vivo testing involves live animals or human subjects. In vitro tests aim to simulate the interaction between substances and living tissues at the cellular or tissue level, providing insights into potential irritant properties. In contrast, in vivo testing assesses these effects in whole organisms, providing a more comprehensive but ethically and logistically complex evaluation.
What are the advantages of using in vitro methods for irritation testing?
By using in vitro models, researchers can screen and prioritize substances for further testing or safety assessment, and potentially reduce or replace the need for animal testing, addressing ethical and regulatory concerns.
Using in vitro methods for irritation testing offers several advantages over traditional in vivo (animal-based) testing, reflecting a commitment to ethical, scientific, and regulatory considerations. Firstly, in vitro methods are more humane as they eliminate the need for animal testing, aligning with ethical concerns regarding the use of animals in research.
In addition to ethical considerations, in vitro methods provide results more rapidly, allowing for quicker decision-making in product development and safety assessment. These methods are also more cost-effective, reducing the overall expense associated with toxicity testing compared to in vivo studies. Furthermore, in vitro tests often offer a higher level of standardization and reproducibility, minimizing variability in results and increasing the reliability of data.
In vitro testing is also more adaptable, allowing researchers to assess specific endpoints related to irritation, such as cellular toxicity, inflammation, and tissue damage, with greater precision. This adaptability enhances the ability to tailor tests to address specific concerns related to different types of irritants.
Overall, the advantages of in vitro methods for irritation testing include ethical considerations, faster results, cost-effectiveness, standardization, reproducibility, and adaptability, making them a preferred choice in the field of toxicology and safety assessment.
Why is in vitro irritation testing important?
In vitro testing for irritation potential is important because it provides an alternative to animal testing, which is banned in over 40 countries. In 2023, Canada is finally catching up with proposed changes to the Food and Drugs Act to stop animal testing on consumer products, including cosmetics.
In vitro skin irritation testing and ocular irritation testing removes the need for animal experimentation, addressing ethical concerns associated with animal testing. This aligns with a growing global emphasis on reducing and eventually eliminating animal use in scientific research.
What are the limitations of in vitro irritation testing?
The testing is suitable for products with a pH value between 4 and 9 reducing the number of the products that can be tested. For example, products with a weak acid or base high content, like citric acid, lactic acid, ammonia, etc. are not suitable for this testing.
What types of substances are typically tested for irritation potential?
A wide range of substances can be tested for irritation potential, including chemicals, cosmetics, pharmaceuticals, cleaning products, pesticides, and various consumer goods. These tests aim to ensure the safety of products that come into contact with the skin, eyes, or mucous membranes, helping to assess and minimize potential harm to humans.
Can in vitro irritation testing be used to evaluate ocular irritation?
Yes. Dell Tech performs Ocular Irritection® (OECD 496) to evaluate ocular irritation potential. Contact our team today to learn more about this test method or request a quote.
Can in vitro irritation testing be used for assessing the safety of medical devices?
Yes, however Dell Tech does not test medical devices in our laboratory. Our Canadian regulatory experts do conduct evaluation of medical devices for the purpose of regulatory classification; medical device label development & review; Medical Device Establishment License Applications to Health Canada for Class I and Class II; and Medical Device License Applications to Health Canada for Class I and Class II. Learn more about Dell Tech’s services for medical devices on our medical device regulations page.
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