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Accurate exposure information for cosmetic products and ingredients is needed in order to conduct safety assessments. Essential information includes both the amount of cosmetic product applied, and the frequency of use. To obtain current data, a study to assess consumer use practices was undertaken. The study included three widely used cosmetic product types: lipstick, body lotion, and face cream. Three hundred and sixty women, ages 19-65 years, who regularly use the products of interest, were recruited at ten different geographical locations within the US. The number of recruits was chosen to ensure a minimum of 300 completes per product type. Subjects were provided with prototype test products, and kept diaries and recorded detailed daily usage information over a two week period. Products were weighed at the start and completion of the study in order to determine the total amount of product used. Statistical analysis of the data was conducted to derive summary distribution of use patterns. The mean and median usage per application, respectively, for the three products was: face cream, 1.22 g and 0.84 g; lipstick, 10 mg and 5 mg; and body lotion, 4.42 g and 3.45 g. The mean and median usage per day for the three products was: face cream, 2.05 g and 1.53 g; lipstick, 24 mg and 13 mg; and body lotion, 8.70 g and 7.63 g. The mean number of applications per day for face cream and lipstick was 1.77 and 2.35, respectively. For body lotion, the mean number of applications per day was dependent on body area, and was 2.12, 1.52, 1.11, 0.95, 0.43, 0.26, and 0.40 for hands, arms, legs, feet, neck and throat, back, and other body areas, respectively. The effect of product preference on use practices was also investigated. This study provides current cosmetic exposure information for commonly used products which will be useful for risk assessment purposes.

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The potential for cinnamic aldehyde, an important fragrance and flavour ingredient, to induce or to elicit delayed contact hypersensitivity reactions in man was evaluated by analysing patch-test data. Results of studies involving a total of 4117 patch tests on various consumer products and fragrance blends containing cinnamic aldehyde and on the material itself were collected from fragrance and formulator companies. The data indicate that cinnamic aldehyde contained in consumer products and fragrance blends at concentrations up to 6 X 10(-1)%, and patch-tested at concentrations up to 8 X 10(-3)%, has no detectable potential to induce hypersensitivity. Cinnamic aldehyde when tested alone induced a dose-related hypersensitivity response. According to published reports, cinnamic aldehyde elicited positive delayed hypersensitivity responses in dermatitic patients. However, results of the current survey show that when cinnamic aldehyde was tested alone or as part of a mixture in subjects in the general population, no pre-existing hypersensitivity reactions to the fragrance material were observed in any of the 4117 patch tests which constituted the survey. Cinnamic aldehyde at the concentrations contained in consumer products and fragrances, has a very low potential to induce hypersensitivity ('induced' reactions) or to elicit sensitization reactions ('elicited' reactions) in the general population.

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The potential of isoeugenol, an important fragrance and flavour ingredient, to induce delayed contact hypersensitivity or to elicit pre-existing sensitization reactions in man was evaluated by analysing patch-test data from dermatitic and non-dermatitic subjects. Results from a total of 6512 patch tests (involving approximately 5850 subjects) on isoeugenol alone and on various consumer products and fragrance blends containing isoeugenol, were collected from fragrance and formulator companies. Hypersensitivity induced by isoeugenol was concentration dependent. All but two of the reactions occurring in this survey were at exposure concentrations greater than or equal to 0.8% isoeugenol. No induced reactions occurred in the 1004 patch tests reported at isoeugenol concentrations between 0.03 and 0.5%. One induced reaction in 32 patch tests was attributable to isoeugenol at a concentration of 0.02% while another induced reaction in 23 patch tests conducted at the same concentration was resolved to an isoeugenol-eugenol mixture. One elicited reaction at an isoeugenol concentration of 0.04% occurred in the 6512 patch tests reported in this survey. This single elicitation was resolved to an isoeugenol-eugenol mixture, but the specific causative agent was not identified. The results of this survey indicate that isoeugenol has a very low potential for either eliciting pre-existing sensitization reactions ('elicited' reactions) or inducing hypersensitivity ('induced' reactions) in subjects exposed to consumer products containing this ingredient.

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The potential of eugenol and of clove leaf oil, which contains a high concentration of eugenol, to induce delayed skin hypersensitivity or to elicit reactions due to pre-existing skin sensitization in man was evaluated by analysing patch-test data. Results from a total of 11,632 patch tests on eugenol itself, on various consumer products containing eugenol and/or clove leaf oil, and on fragrance blends containing eugenol and/or clove leaf oil were collected from fragrance and formulation companies. One instance of induced hypersensitivity and one instance of pre-existing sensitization were observed at eugenol patch-test concentrations of 5 X 10(-2) and 9 X 10(-2)% respectively. In both cases, subsequent patch testing showed skin responses to mixtures of eugenol and isoeugenol, but no further attempt was made to define the causative agent. The survey indicates that, at the concentrations present in consumer products, eugenol alone or as part of clove leaf oil has a very low potential either to elicit pre-existing sensitization ('elicited' reactions) or to induce hypersensitivity ('induced' reactions).

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The potential of benzyl salicylate, an important fragrance and flavour ingredient, to induce hypersensitivity or to elicit reactions to pre-existing hypersensitivity in the general population was evaluated by analysing patch-test data. Results obtained from fragrance and formulator companies for a total of 10,538 patch tests on benzyl salicylate alone, on a variety of household and personal care consumer products and on fragrance blends containing benzyl salicylate were analysed as part of this survey. No induced or elicited responses directly attributable to benzyl salicylate were observed in the 35 patch tests on benzyl salicylate alone, or in the 10,503 patch tests on consumer products or fragrance blends containing benzyl salicylate. The highest concentration of benzyl salicylate tested in the consumer-product tests was 2 X 10(-1)%, and benzyl salicylate alone was tested at 10% in ethanol. This study indicates that benzyl salicylate has a very low potential to induce hypersensitivity ('induced' reactions) or to elicit reactions presumably attributable to pre-existing sensitization ('elicited' reactions) and thus supports the safe use of benzyl salicylate in consumer products and fragrance blends.

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A recent study reported that regular use of commercial mouthwashes produced a significant incidence of oral reactions, including epithelial peeling, inflammation, ulceration and geographic tongue-like lesions. In view of the widespread use of these preparations, without apparent deleterious effects, an investigation of two commercial preparations (Scope, Listerine) and an experimental mouthwash containing cetyl pyridinium chloride was undertaken to assess the possible irritant effects on the oral soft tissue under stringent test conditions. A double blind design was used and soft tissue effects were measured over a two week period. Rinses were used full strength, 20 cc 3 times daily. Examinations were conducted by an oral pathologist at the start and conclusion of the test period, and a record was made of the occurrence of erythema, hyperemia/prominent vasculature, inflammation, petechia, keratosis, tongue coating, and ulceration. These observations did not reveal any soft tissue conditions beyond those which would be expected in the normal population.

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