LANOLIN ALLERGY? 151 tients--an incidence of 1.1% in this select population. Warshaw (11) in a report continuing this study added three more lanolin-sensitive pa- tients discovered at the New York Skin and Cancer Unit plus seven other patients from private practice. Hjorth (12) in Denmark described 21 lanolin-sensitive patients out of 25,000 allergy patients examined over a twenty year period or, in this select population of allergy cases, an incidence of lanolin sensitivity of less than 0.1%. It must be stressed that in this situation, as in the case of Sulzberger's patients, he was dealing not with normal healthy indi- viduals but rather with individuals with predisposition to sensitivity. Truter (13) in reporting on one case of dermal reaction to lanolin held that, from the dermatological literature, it was apparent that cutaneous hypersensitiv/ty to lanolin is "extremely uncommon." In 1955 Baer et al. (14) claimed to have observed 28 lanolin-sensitive patients out of 637 tested. Then in 1962 Calnan (15) reported 11 cases. A recent report by Wereide (16) in Oslo merits consideration because of the unusual test procedure used and the broad conclusions reached. He tested 270 eczema patients with anhydrous lanolin, Eucerin* (7 per cent lanolin alcoholst in soft paraffin) and mixtures of the two. In each test 5% of salicylic acid was added. He reported two reactions to the lanolin and three to Eucerin but 15 to the mixture of the two he con- cluded that lanolin sensitivity was common in eczema patients. It is well recognized that single materials may be innocuous by themselves but toxic in combination. However, one can't help but suspect the possi- bility Wereide observed some other kind of primary irritation due to the rigor of the test or a possible synergistic phenomenon rather than a true lanolin sensitivity. Carney (17) reported that in fifteen years he had seen only one proved case of lanolin sensitivity. Klauder and Ellis (18) reported five cases in private practice. Orentreich (19) in treating a series of some 154 der- matological cases with the oil soluble liquid fraction of lanolin and prepara- tions made from it found no instances of intolerance. He did report one case discovered in routine patch testing at the Hair Clinic in N. Y. (20). Masters (21), in discussing cosmetic allergies, felt that lanolin and its derivatives are not primary irritants and that allergic manifestations to their use are small. In the regulations issued following the color addi- tive legislation which were published in 1963, lanolin is included in the * Beiersdorf & Co. A. G. t Superhartolan-Croda, Ltd.

152 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS list of "safe" diluents for cosmetic use. The report of the European Committee on Chronic Toxicity Hazards (Eurotox) (22) lists lanolin as completely acceptable in the category of vehides and solvents. It should be pointed out that this review of the literature of reported instances of lanolin sensitivity yields a total of about 100 odd cases-- reported over a period of 30 years and from several countries. In spite of all these data lanolin continues to be suspect in some quarters and with some dermatologists. PRETESTING OF COSMETICS AND INGREDIENTS Under these circumstances it seems unnecessary that the cosmetic manufacturer should be greatly concerned with the problem of cutaneous reaction to lanolin because the reported instances of such reactions are so infinitesimally low. However, no reputable manufacturer of cosmet- ics and toiletries would want to place on the market a product that was unsafe for use. With the exception of 1960 legislation requiring the pretesting of the class of cosmetics defined as color additives, Federal legislation does not require the pretesting of cosmetics for safety. The law as it stands provides for the seizure of dangerous cosmetics, but only after the Government has proved they are dangerous. As pointed out by Miller (23), the Food & Drug Administration has urged that, just as in the case of new drugs and color additives, there be a requirement for pretesting all cosmetics. The Harris Bill now pending before Congress would require such pretesting. Levenstein, Draize et al. (24-26) describe several of the animal tests currently in use to screen cosmetics and ingredients for possible toxicity and irritation. Levenstein feels there is enough correlation between animal pretesting and human use experience to warrant such tests. Rieger and Battista (27) point out that it is not always possible to cor- relate between animals and human tests but urge that both be used. The following are basic screening tests considered to be a reasonable mini- mum for most topically used ingredients. Primary Derreal Irritation Primary irritation, or a skin reaction following a single contact with a substance, is usually determined by patch testing the material on both the intact and abraded skin of rabbits. A more realistic approach is the use of human subjects where possible. In the instance of lanolin and the oil soluble liquid fraction of lanolin,* Shelanski (28) reported that * Lantrol© Maimstrom Chemical Corp.