SUN CARE 69 Table 3, Part 1: Score value
0 = no reaction ± = light reaction + = distinct reaction ++ = severe reaction +++ = very severe n.t. = no treatment
Score value 0 1 2 3 5
symptoms in the clinical study, in contrast to 12-2, which had a very high incidence rate of 5 out of 6 subjects. The differences in the two formulas lay solely in the different UV filter combination. Formula 12-1 contained highly stable organic, oil-soluble or particulate UV filters, whereas formula 12-2 also contained non- stabilised BMDBM and water-soluble PBSA. Non-stabilised BMDBM is known to undergo photoreactions under UV radiation leading to intermediate radical species;3 water-soluble PBSA converts into organic semi-stable free radicals under UV radiation.4 In the current study, A. aestivalis was
triggered using a formulation containing high levels of UV-inducible peroxides and organic free radicals. For example, the free radicals were generated via photo-unstable organic UV filters. Similarly high levels of peroxides and lipid radicals can also be generated using other components of skin care formulations, such as perfumes, emulsifiers, and oils. These components are thought to
induce A. aestivalis and trigger photo and chemo-toxic reactions when exposed to higher levels of UV radiation in sensitive subjects.5
However, the presence of pure
components is not responsible for a high radical power: for example, the terpene components of a perfume (e.g. linalool geraniol, citronellol, limonene, among others) and pure natural oils (almond oil, sunflower oil, avocado oil, among others) will not induce radicals under UV irradiation, nor will they trigger adverse skin reactions. In all cases, to the best of our knowledge, the hydroperoxide-adducts present in the terpenes or the initial rancidity in the oils were responsible for the high RP values.
Conclusion Sunscreen formulations using non- photostable filter systems may have a high potential of UV-inducible peroxide radicals, expressed by a high RP value. Clinical data presented here indicate a clear correlation between the level of UV-inducible free radicals and the amount of A. aestivalis triggered in sensitive individuals. The RP value seems to be a suitable predictive tool for creating sunscreen formulations with a low potential for producing UV-inducible peroxide radicals. As a sound formulation strategy, avoiding any
November 2018
Table 3: Evaluation of the adverse skin reaction of treated subjects where 24 is the sum of the highest possible skin reaction (score value 4 x 6 subjects)
Test product Observation time
UV14-132-12-1 Day 1 before irradiation Day 1 after irradiation Day 2 before irradiation Day 2 after irradiation Day 3 before irradiation Day 3 after irradiation Day 4 before irradiation Day 4 after irradiation Day 5 before irradiation Day 5 after irradiation
UV14-132-12-2 Day 1 before irradiation Day 1 after irradiation Day 2 before irradiation Day 2 after irradiation Day 3 before irradiation Day 3 after irradiation
P1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
±
Day 4 before irradiation ± Day 4 after irradiation
+
Day 5 before irradiation + n.t. Day 5 after irradiation
Negative control
Day 1 before irradiation Day 1 after irradiation
Day 2 before irradiation Day 2 after irradiation Day 3 before irradiation Day 3 after irradiation Day 4 before irradiation Day 4 after irradiation Day 5 before irradiation Day 5 after irradiation
Positive control Day 1 before irradiation Day 1 after irradiation Day 2 before irradiation Day 2 after irradiation
+ 0 0
0 0 0 0 0 0 0 0 0
± 0
±
Day 3 before irradiation + n.t. Day 3 after irradiation
+
Day 4 before irradiation + n.t. Day 4 after irradiation
+
Day 5 before irradiation + n.t. Day 5 after irradiation
+
raw materials with UV-inducible peroxide radical potential and/or adding effective antioxidants to reduce the amount of free radicals can be recommended.
P2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
0 0
0 0 0 0 0 0 0 0 0 0 0 0 0
± ± ±
+ n.t. +
P3 0 0 0 0 0 0 0 0 0 0 0 0 0
± ± ±
++ n.t. ++
++ n.t. ++
0 0
0 0 0 0 0 0 0 0 0 0
± ±
+ n.t. +
+ n.t. +
+ n.t. +
2015; 141: 8-12. PC
First published in SOFW Journal, March 2016 References 1. Andersch Björkman Y, Hagvall L, Siwmark C, Niklasson B, Karlberg AT, Bråred Christensson J. Air-oxidized linalool elicits eczema in allergic patients - a repeated open application test study. Contact Dermatitis. 2014; 70(3):129-38.
2. Herrling T, Seifert M, Sandig G, Jung K. The Radical Power RP of Products. SOFW-Journal
3. Schwack W, Rudolph T. Photochemistry of dibenzoylmethane UVA filters. Part I. J. Photochem. Photobiol. B 1995; 28: 229-234.
4. Bastien N, Millau JF, Rouabhia M, Davies JRH, Drouin R. The Sunscreen Agent 2- Phenylbenzimidazole-5-Sulfonic Acid Photosensitizes the Formation of Oxidized Guanines In Cellulo after UV-A or UV-B Exposure. Journal of Investigative Dermatology 2010; 130: 2463–2471.
5. Fotiades J1, Soter NA, Lim HW. Results of evaluation of 203 patients for photosensitivity in a 7.3-year period. J Am Acad Dermatol. (1995) 33, 597-602.
PERSONAL CARE EUROPE
P4 0 0 0 0 0 0 0 0 0 0 0 0 0 0
± ± ± ± ± ±
0 0
0 0 0 0 0 0 0 0 0 0 0 0
± ± ± +
+ n.t. +
P5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
±
+ n.t. +
0 0
0 0 0 0 0 0 0 0 0 0 0 0
± ± ± +
+ n.t. +
P6 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
±
+ n.t. +
+ n.t. +
0 0
0 0 0 0 0 0 0 0 0 0 0 0
± +
+ n.t +
+ n.t. +
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