ABSTRACTS 219 Inhibitory effect of aminoefaderma (collagen linoleate) on the acanthosis-inducing activity of castor oil and petrolatum (heavy mineral oil) Prof. Giorgio Rialdi, One Dag Hammerskjold Plaza, New York, NY 10017. The protective effect of aminoefaderma (collagen linoleate) on skin alterations induced by prolonged application of castor oil and heavy mineral oil was studied in Swiss albino mice. Mouse skin was selected on the basis of its great similarity to human skin two irritants were chosen because they pro- voke skin alterations of comparable entity to those caused by normal exposure of skin to various environmental skin-offensive agents. For sixty con- secutive days castor oil and heavy mineral oil were applied daily to a depilated section of skin over an area of about 4 cm 2. The histologic tests made at the end of the treatment showed that castor oil provokes acanthosis, destroys the base layer, and brings about slight skin infiltration. Pronounced acanthosis, considerable thickening of the mal- phagian layer with disassociation of the tonofibrils and discheratosic aspects were present on the skin of the mice treated with heavy mineral oil. These skin-offensive effects caused by castor oil and heavy mineral oil were either of very little signifi- cance or completely absent on the mice given applications of the two irritants during the morning and followed after eight hours by local applications of aminoefaderma. Formulating mild surfactant systems with counter irritants Robert J. Verdicchio, Johnson & Johnson Baby Products, Grandview Rd., Skillman, NJ 08558. The ocular irritation profiles of several selected anionic, zwitterionic ampholytic and nonionic sur- factants are reviewed. Ethoxylated nonionic surfac- rants demonstrate excellent ocular irritation reduc- tion in mixed binary and ternary surfactant systems. Similar reductions in irritation effects of aggressive surfactants are demonstrated for a newer class of novel bis-quaternary ammonium compounds. Otherwise aggressive, potentially irritating surfac- tants, when combined in selected ratios, exhibit synergistic ocular irritation reduction. This effect is illustrated by the combination of a zwitterionic sultaine with an alkyl ether sulfate. Skin irritation produced by detergent mixtures is substantially mitigated by novel rosin-modified sorbitan esters. APPLICATIONS OF TOXICOLOGY Toxicity testing of cosmetic ingredient and formulation--a collaborative approach for chemist and toxicologist Bradford H. Arthur, Greenfield Laboratories, P.O. Box 708, Greenfield, IN 46140. The review process for examining current data available for cosmetic ingredients and the applica- bility of this data will be discussed. Also included in the discussion will be the review process of ingredients and intermediates and how their toxic- ity affects bench chemists. Why the cosmetic chemist should understand toxicological test results Anne Wolven, A.M. Wolven, Inc., 6560 Sentry Hill Trail N.E., Atlanta, GA 30328. The paper will address the need for safety data on individual ingredients and the finished product, the appropriateness of toxicological studies and their meaning as related to human exposure, and the chemist serving as an expert witness. Good clinical practices in cosmetic safety and claims substantiation testing J. James Pearce, Jr., Hill Top Research, Inc., P.O. Box 42501, Cincinnati, OH 45242. "Good Clinical Practices" is a title given to several regulations, promulgated or about to be promul- gated by the FDA, defining the investigative pro- cess for FDA-regulated studies employing human subjects. Although "GCP's" apply only to studies of regulated compounds, many of the practices are good common sense and should be routinely included in nonregulated cosmetic studies. Bench chemist awareness: factors which affect toxicity Michael A. Gallo, Ph.D., Griggstown Rd., Belle Mead, NJ 08502. The classes of compounds, biological structures, distribution, and physiological mechanisms in- volved in the up-take and excretion of cosmetic chemicals will be discussed in detail. Attention will also be paid to kinetic models relevant to the question of dermo-toxicity. Classic toxicity studies used in the evaluation of cosmetic chemicals and skin care products will be illustrated. ADVANCES IN MICROBIOLOGY AND PRESERVATION An independent laboratory's approach to evaluation of preservative systems Gayle Mulberry, James R. Agin, and Ward L. Billhimer, Hill Top Research, P.O. Box 42501, Cincinnati, OtI 45242. The independent laboratory may serve a broad range of industries, each with unique but related

220 .JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS needs. These range from the needs of the chemical company that is involved in the development of new antimicrobial compounds to those of the small firm concerned with the manufacture of a pre- moistened wipe, hand lotion, or other product. An independent laboratory plays a vital role in the evaluation of preservative systems, both in the developmental and the finished product stages. Evaluations of the antimicrobial system can be made through a relatively simple zone of inhibition tests and minimum inhibitory concentration (MIC) evaluations. MIC studies can be modified to evalu- ate ingredient compatibility or to predict effective concentration endpoints through computer- assisted data evaluation. Similar screening methods can also be used to evaluate the cidal activities of antimicrobial systems. The evaluation of the effi- cacy of the preservative systems in finished prod- ucts can be conducted through standard proce- dures (USP, TFA, ASTM methods) or through special rapid methodologies. A discussion of the various factors which the independent laboratory should consider when assisting the client in the design or selection of a suitable testing program will be presented. Effect of some cosmetic pigments on the bac- tericidal activities of preservatives Tetsuo Sakamoto, Mitsuo Yanagi and Takeo Mit- sui, Shiseido Laboratories, 100 Tokeneke Rd., Dar- ien, CT 06820. The effect of eight cosmetic pigments on the bactericidal activities of p-hydroxybenzoic acid esters was investigated by a viable cell count method. Most of the materials tested interfered with the antibacterial action of all of the four preservatives. The inactivating agents were found to be ultramarine, talc, titanium dioxide (R), tita- nium dioxide (A), red oxide of iron, and yellow oxide of iron, in descending order. In general, the bactericidal activities of methyl p-hydroxybenzoic acid was inactivated the greatest, while butyl p- hydroxybenzoic acid was affected the least. The mechanism of these inactive actions was also inves- tigated. The signal of phenolic proton of inacti- vated methyl p-hydroxybenzoic acid had disap- peared, according to H-NMR analysis. It is likely that phenolic proton of methyl p-hydroxybenzoic acid was replaced by some metals from the coexis- tent pigments, which is considered to be in inacti- vating action, and that the addition of EDTA prevented the inactivating action. Rapid detection of microbes in cosmetics Stephen j. Bellis, Noxell Corporation, P.O. Box 1799, Baltimore, MD 21203. A rapid radiometric (24-28 hours) method using a Bactec 301 has been developed for detecting low level (10•-10 2) microbial contamination in cosmet- ics. A series of parallel experiments comparing the conventional 48-72 hour method with the radio- metric method was performed. Anhydrous and hydrous cosmetic products were innoculated with E. coli, P. aeruginosa, S. aureus, B. subtilis and C. albicans. The ability to detect these contaminants using conventional (Modified Letheen Broth and Agar, MacConkey, Vogel-Johnson Agars) method versus the radiometric system using a Bactec 301, AA broth, CN broth and BH broth vials was compared. The results indicate that the Bactec system can reliably detect low level contamination within 24-48 hours. The advantages of the Bactec system are its ability to rapidly detect microbial growth and its ease of operation. Some disadvan- tages are its initial cost and limited shelf life of media. A standardized method of comparison for preservative system selection Stephen B. Miller, Noxell Corporation, P.O. Box 1799, Baltimore, MD 21203. With at least 122 different compounds classified as preservatives, the task of choosing a preservative system seems formidable. In actuality, this vast number is reduced to between 20-30 more com- monly used cosmetic preservatives. Recently, sup- pliers have introduced a number of newer alterna- tive compounds to add to this number. Traditional- ly, preservative system selection is based on elemen- tal considerations of the total formulation itself. These considerations include an evaluation of phys- ico-chemical factors, raw ingredients, packaging components, and the preservatives themselves. A comparative evaluation of a number of possible alternative systems can be performed using stan- dard challenge methodology. The method requires: (1) selection of a standard for comparison, (2) selection of appropriate challenge organisms, and (3) a strict numerical comparison of recovery num- bers. Results can provide a basis for the selection of possible preservative systems and beneficial infor- mation about compounding with different preser- vatives in established and development products. The responsibility of manufacturing opera- tions in the production of microbiologically acceptable cosmetics Susan E. Simpson and John Yablonsky, Avon Products, Inc., Division St., Suffern, NY 10901. High quality, microbiologically acceptable cosmet- ics are the result of a combination of the following factors: 1) raw ingredient control, 2) quality water systems, 3) equipment cleaning, sanitation, and design, 4) good manufacturing practices, 5) product