The SDA Alternatives Program: Comparison of In Vitro Data With Draize Test Data

Nine in vitro candidate test systems for estimating eye irritancy have been evaluated as potential replacements for the Draize test. They are a chorioallantoic membrane assay and a modification of it, a corneal plasminogen activator assay, the SIRC cytotoxicity assay, a uridine uptake assay, a cell protein accumulation assay, a Neutral Red assay, a chromium release assay and a Tetrahymena motility assay. The eye irritancy potentials of a number of cleaning products and ingredients as estimated from in vivo data were compared to in vitro results. For each test method, comparative data for a minimum of 11 and a maximum of 23 test materials have been obtained in Phases 1 and 2 of this study. The alkalinity of the test materials ranged from 0 to 2 meq HCl/g, encompassing the range for most cleaning products. The future possibility of utilizing alkalinity data and the results of an in vitro test method for classifying the irritancy of materials is suggested. Defining such an algorithm, one that would classify a material as an irritant or non-irritant, and the error associated with a classification decision based on this approach, remains to be done. Data on reproducibility of the in vitro test methods were obtained. Relative standard errors of the estimates reported for each method ranged from 14 to 33 percent.

SDA Fragrance Subcommittee Report: Industry Surveys Fragrance Sensttization Test Data

The Fragrance Raw Material Subcommittee of the Soap and Detergent Association (SDA) was formed in early I977 to review information on the human skin sensitization potential of some fragrance ingredients important to the soap and detergent industry. The committee included representatives of member companies and fragrance suppliers. A summmary of this work
and overall conclusions are provided here.

Surfactants: A survey of short-term genotoxicity testing

The available results for tests on over 200 surfactants in nine short-term genotoxicity assay systems were reviewed. These tests included the Salmonella/microsome mutation assay, bacterial DNA repair tests, mitotic recombination in Saccharomyces cerevisiae, the mouse lymphoma cell-mutation assay, unscheduled DNA synthesis and sister chromatid exchange assays in mammalian cells, mammalian chromosome damage tests in vitro and in vivo, the dominant lethal test in rodents, and mammalian cell-transformation tests. The collected data cover all four major classes of surfactants: anionic, cationic, nonionic and amphoteric. The results of these genotoxicity tests were overwhelmingly negative. Although there were occasional positive results in bacterial or cell-transformation systems, the testing performed to date indicates that surfactants have negligible potential to cause genetic damage. The available data also indicate that none of the assays were incompatible with testing surfactants for genotoxicity.

Eugenol and clove leaf oil: A survey of consumer patch-test sensitization

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 × 10^-2 and 9 × 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).

Isoeugenol: A survey of consumer patch-test sensitization

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-or-equal, slanted0.8% 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.