Skin Problems

de Groot AC, Frosch PJ. Adverse reactions to fragrances.
A clinical review. Contact Dermatitis. 1997 Feb;36(2):57-86.

"Depending on the degree of sensitivity, the severity of dermatitis may range from mild to severe with dissemination and even erythroderma. Airborne or "connubial" contact dermatitis should always be suspected. "

Schafer T, Bohler E, Ruhdorfer S, Weigl L, Wessner D, Filipiak B, Wichmann HE, Ring J. Epidemiology of contact allergy in adults. Allergy. 2001 Dec;56(12):1192-6.

BACKGROUND: We aimed to determine the prevalence of contact sensitization in the general population and to investigate associations with important sociodemographic and medical characteristics. METHODS: Within a population-based nested, case-control study in Germany, we performed patch tests with 25 standard allergens in 1141 adults (50.4% female, age median 50 years).

Additional information was obtained by a dermatologic examination, a standardized interview, and blood analysis. RESULTS: At least one positive reaction was exhibited by 40.0% of the subjects, with reactions most frequently observed to fragrance mix (15.9%), nickel (13.1%), thimerosal (4.7%), and balsam of Peru (3.8%). Women were sensitized more often than men (50.2% vs

29.9%, OR 2.36, CI 1.84-3.03), and this was also significant for fragrance mix, nickel, turpentine, cobalt chloride, and thimerosal. Contact sensitization was more frequent in subjects who reported adverse skin reactions (53.8% vs. 32.6%; OR 2.41, CI 1.85-3.14), and this was particularly true for sensitization to nickel (45.5% vs 8.8%, OR 8.64, CI 5.67-13.17) and fragrance mix (29.0% vs 14.0%, OR 2.51, CI 1.60-3.91) and the corresponding intolerance of fashion jewelry and fragrances. Contact sensitization decreased with increasing degree of occupational training (unskilled 45.9%, apprenticeship 40.1%, technical college 40.4%, and school of engineering 12.5%; P=0.023; trend test P=0.042). Significant associations of contact sensitization and presence of allergen-specific IgE antibodies, atopic eczema, or psoriasis were not observed. Frequency estimates for the general adult population based on these findings were 28.0% for overall contact sensitization and 11.4% for fragrance mix, 9.9% for nickel, and 3.2% for thimerosal. CONCLUSIONS: It is concluded that contact allergy is influenced by sociodemographic parameters and plays an important role in the general population.

Stehlin D. Cosmetic Safety: More Complex Than at First Blush U. S. Food and Drug Administration: FDA Consumer: November 1991; revised May 1995
http://www.cfsan.fda.gov/~dms/cos-safe.html

According to a study of cosmetic reactions conducted by the North American Contact Dermatitis Group,preservatives are the second most common cause of allergic and irritant reactions to cosmetics. Fragrances are number one. Although the study is more than 10 years old, the results can still be considered valid today, says Harold R. Minus, M.D., an associate professor of dermatology at Howard University Hospital. (For more information on this study, see "Cosmetic Allergies" in the November 1986 FDA Consumer.)

Rastogi SC, Johansen JD, Menne T, Frosch P, Bruze M, Andersen KE, Lepoittevin JP, Wakelin S, White IR. Contents of fragrance allergens in children's cosmetics and cosmetic-toys. Contact Dermatitis. 1999 Aug;41(2):84-8.

Fragrances are one of the major causes of allergic contact dermatitis from use of cosmetics. The aim of the current study was to assess the possible exposure of infants and children to fragrance allergens from cosmetic products and "toy-cosmetics". 25 children's cosmetics or toy-cosmetic products were analysed by gas chromatography - mass spectrometry. Target substances were the fragrance allergens from the fragrance mix and 14 other fragrance substances, most of which have been described as contact allergens. The fragrance mix ingredients were either not present in children's shampoos/shower gels and cream/lotions, or they were present in fairly low concentrations. In hydro-alcoholic products, such as eau de parfum, eau de toilette, several ingredients of the fragrance mix were found: geraniol was present in 7/7 products, hydroxycitronellal in 6/7 and isoeugenol in 2/7 products. Isoeugenol was present in a maximum concentration of 0.07%. In one cosmetic-toy, cinnamic alcohol was present at 3.7% which exceeds the current industry guideline for safe products by a factor of 5. In all types of products other fragrance allergens were frequently found. In conclusion, children are already exposed at an early age to well-known allergens, sometimes at concentrations which are considered to be unsafe. As contact allergy usually persists for life, manufacturers of children's cosmetics should be aware of their special responsibility and apply the highest possible safety standards.

There is considerable documentation that the primary testing for fragrance safety by the industry focuses on skin. The following is an excerpt from the section entitled:
RIFM Activities in the Safety Assessment of the Dermal Effects of Fragrance Materials (pg 183 ) by R,A.Ford, Fragrances: Beneficial and Adverse Effects; pg 185. Springer-Verlag 1998 Edited by P J Frosch, JD Johansen, IR White

In the early days of RIFM, these experts focused on the obvious target organ, the skin. As such, they designed a program to assure the existence of a basic battery of tests on all fragrance ingredients in common use in other than trivial quantities. This battery consisted of at least skin irritation and sensitization testing and, as a screen for systemic toxicity, oral and dermal limit tests (generally at 5 g/kg) or LD50 tests. To round out the

basic battery, where the chemical nature of the ingredient indicated, phototoxicity and photosensitization tests were conducted. Over the years RIFM has subjected about 1300 substances to this battery resulting in recommendations by the International Fragrance Association (IFRA) for the restriction of use level, prohibition of use or use only with certain specifications of approximately 70 fragrance ingredients (see the chapter by F. Grundschober, this volume).

In keeping with the purpose of RIFM, the results of our testing along with other available data were published in the peer reviewed journal, Food and Chemical Tox:icology, where we have published approximately 1200 monographs on fragrance ingredients. We fully recognize that many of these monographs are very badly out of date and we are currently designing a program to view and update all of these along with reviewing and evaluating the additional approximately 1400 materials on the European Fragrance inventory. This formidable job will take several years to complete and will be directed by a priority scheme based on the principles mentioned by E.A. Pfitzer ( see his chapter, this volume).

In the late 1970s the RIFM experts recognized the growing evidence that materials applied to the skin may be absorbed and available systemically. RIFM then expanded its program to include research and testing for dermal absorption and possible systemic effects on selected fragrance ingredients chosen by priority determined by consideration of structure, exposure and available data either from the literature or from the test programs of member companies. Some of the results of this expanded program are discussed in more detail by Pfitzer (this volume).

The RIFM has evaluated approximately 1300 materials and plans on evaluating an additional 1400 that are on the European Fragrance inventory. These two listings do not include all the materials used as many newer proprietary materials are not included in either listing. There are approximately 3000 materials in use by the fragrance industry.