58 TESTING
formulation is irritating or not. It does not actually describe how irritating that item is. For more sophisticated approaches today, we need to know how irritating that item is, not just whether it is an irritant or not. In order to achieve a more detailed
profile of irritation, more sensitive approaches such as the ET50 method are used. This measures cell damage over a time course rather than just a single time point. As a result, we are able to classify items as severe, moderate, mild or minimal or non-irritant, and to calculate an ET50 value, which is the time taken to reduce the viability of the cells in the model to 50% compared with untreated controls. These values then allow us to place items into a rank order of irritation. But there were still some limitations with this methodology, because it went out to a time of 18 hours and we wanted to look at something even more sensitive. There are several ways that irritation is
measured in vivo, including the dermatologist assessing the skin in real-life conditions or large panels of home use of products. But we wanted to look at patch testing because it is a controllable model, we can apply standard doses for standard times and the assessments are well established and have been since the 1950s or 1960s.
Patch testing uses the principle of maximising the exposure of the product to the skin by occluding it for a period of multiple days, and it can be up to 14, 21 days. The idea is that it is a very sensitive way of identifying ingredients or products which might be even very weakly irritant, but when used regularly by large numbers of people in the population, could lead to significant numbers of people having reactions to products. And of course, that
ET50 120 100
Rank order of irritancy using linear extrapolation and logic equation
80 60 40 20 0 1 Time (h) Figure 3: Irritation potential of surfactant blends (SLES / CAPB). PERSONAL CARE EUROPE February 2020 10 100 ET50 1.82
C > A > 3.85
B 5.59
A= SLES/CAPB blend 1 B = SLES/CAPB blend 2 C = SLES/CAPB blend 3 D = SLES/CAPB blend 4
> D 9.01
14 13 12 11 10 9 8 7 6
2 3 Day Rank order of irritancy Stepanol WA (SLS)®
SLS 70% SLES 70%
Cocamidopropyl Betaine Water
Novel Biosurfactant Figure 2: Using surfactants to determine the correlation with in vivo.
has a potential impact on branding integrity and reputation. So it is a well-established, very sensitive method. Cutest clients tend to choose it where they are looking at critical applications, so baby care products, facial products, personal hygiene products,
determination of surfactant blends
where they want a good safety margin on the likelihood of irritation for their products. Of course, it is used to support claims including ‘dermatologically tested’, ‘suitable for sensitive skin’ or ‘eczema-prone skin’, because we can choose the panel of
Cumulative irritation scores
16 14 9 4 0 0
4 5
* *
SLES 70% *
Cocamidopropyl Betaine
Stepanol WA (SLS) Biosurfactant SLS 70% B Water
Percentage of viability relative to untreated control
Chroma a* value
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