EXPERIENCES IN SAFETY TESTING OF COSMETICS TABLE II--DRAxZE RABBIT EYE TESTS 165 15% Active Com- mercial Wetting Agent Time After Lab. II, Lab. III, Instillation, 3 Rabbits 3 Rabbits hr. Unrinsed Unrinsed Undiluted Com- mercial Shampoo Lab. II, Lab. III, 10 Rabbits 3 Rabbits Unrinsed Unrinsed Cornea score, (opacity X 1 8.3 area) X 5 2 11.7 4 11.7 6 11.7 24 16.7 48 15.0 72 15.0 96 11.7 168 6.7 Iris score, (value X 5) 1 0 2 0 4 1.7 6 3.3 24 3.3 48 3.3 72 1.7 96 1.7 168 1.7 Conjunctiva score, (red- 1 12.7 ness+ chemosis + 2 13.3 discharge) X 2 4 13.3 6 13.3 24 12.7 48 11.3 72 8.7 96 7.7 168 4.7 0 0 0 0 ß . ß . . . •)'' 0 0 0 0 , . . . . . ß . . 6.0 2.7 0.7 0 13.5 ... 15.0 ... 15.5 . .. 15.5 16.0 •)' ' 16.5 0 19.5 0 20.0 0 12.0 0 0.5 ... 2.0 ... 2.0 2.s 3.5 0 3.5 1.6 2 0 (P)* 1.6 1.0 (P)* 0 9.6 ... 10.4 ... 12.2 ... 12.2 12.o 12.0 7.7 11.4 7.7 10.4 4.0 7.0 0 * P indicates pannus in at least 2 test animals. Another example is illustrated in Table II, in this case with results obtained from testing one of the most popular commercially available American shampoos. As before, Laboratory III reports this product safe, whereas the results from Laboratory II suggest that the product might be too irritating for distribution. Since this shampoo has been used for many years by millions of consumers, it might be reasonable to conclude that Laboratory II scores the tests too severely or that the test is not repro- ducible. Several years ago a detergent-containing neutralizer allegedly caused eye irritation in some users. The rabbit eye test (Table III), conducted by Laboratory III, indicated that this product was safe for its intended use. Obviously, the rabbit eye test in this particular case was very misleading and led to release of the neutralizer which was believed safe by the manu- facturer on the basis of an accepted animal testing procedure. Subse- quent]y, human eye tests were initiated to identify the agent or agents responsible for the reported cases of irritation. It appears now that the safety of products should not be based exclusively on animal tests. As has

166 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS T^BLV, III--DRAm•, R^BBrr EYF, T•,ST or NV, trTR^•nZV,•--I,aBO•ATO•¾ I11 3 Rabbits ....... 2 4 Time After Second Second Instillation Unrinsed Wash Wash Cornea score, 24 hr. and up to and (opacity X area) including 168 hr. 0 0 0 X5 Iris score, (value 24 hr. and up to and X 5) including 168 hr. 0 0 0 Conjunctiva score, 24 8.3 0 0 (redness q- chem- 48 6.0 0 0 osis q- discharge) 72 2.0 0 0 X 2 96 0.7 0 0 168 0 0 0 been shown above, animal tests can be misleading and should be used only as guides for subsequent human clinical evaluation. The results of two preparations (A and B) subjected to the Draize rabbit eye test are shown in Table IV. Based on these results, both products were adjudged safe and ready for human eye instillation tests. This assump- tion seemed especially valid because of the apparent mildness exhibited by the two products during the Draize test conducted by Laboratory II, the most severe scorer of the three laboratories employed. Nevertheless, an ophthalmologist conducting human eye instillation tests observed reactions indicating greater irritation potential for Product B than for Product A. Product B caused some corneal irritation and rather severe chemosis in human eyes, an effect not noted in the animal tests. TABLE IV--DRAIZE RABBIT EY•. TEST (UNI.INSEO--LABORATORY II) Prep. A, Prep. B, Time hr. 15 Rabbits 23 Rabbits Corneal score, (opacity X 1 0 0.9 area X 5) 2 0.7 0.7 4 1.0 0.4 6 1.0 0.2 24 0 0 48 0 0 72 0 0 96-168 0 0 Iris score, (value X 5) 0-!68 () 0 Conj unctiv:t score (red- I 6.0 6.5 ness q- chemosis q- dis- 2 7.5 8.7 charge) X 5 4 9.7 10.3 6 10.5 10.9 24 5.7 6.4 48 3.7 2.2 72 O.7 1.2 96 O. 1 0.3 168 0 0