Categorical evaluation of the ocular irritancy of cosmetic and consumer products by human ocular instillation procedures

Yang Gao; Bruce E. Kanengiser

324 35 1t1 C - 0 3 111- .. • .! .J'C7,5 e -= g -� 2 (/) .. a, • 1.5 Iii e :i 1 • II) 0 o.5 45 H 4 t j 3.5 .J .t:: et 3 g � 2.5 (/) &l £ 8 1.5 ... 0 1 0.5 35 GI 30 • a, ...I C rs 25 oS (/) (/) 20 tJ .5 ,SI GI s:. 0 ·? e ,s g & ii: 10 I! 'o JOURNAL OF COSMETIC SCIENCE A Baseline 30" B Baseline 30' C Baseline 30' 5' 15' Time of Evaluation 15' Time of Evaluation 5' 15' Time of Evaluation 60' 60' 60' + Liquid makeup +Shampoo +Babywash * Eye makeup remover +Mascara + Powder eye shadow +Facial cleanser 120' 24h 120' 24h 120' 24h Figure 5. Average score levels of ocular irritation at post-instillation evaluation intervals. staining than the remaining product types, in which mascara exhibited the lowest correlation between subjective response and objective irritation. Epithelial defects of the ocular surface were observed at later post-instillation evaluations, compared to the subjective responses and objective irritation, in which facial cleanser, shampoo, baby

ASSESSMENT OF OCULAR IRRITANCY 325 Table III Correlation Coefficient (r value) of Fluorescein Staining Between Categories Liquid Baby Eye makeup Powder eye Facial makeup Shampoo wash remover Mascara shadow cleanser Liquid makeup 1.00 Shampoo 0.92 1.00 Baby wash 0.91 0.95 1.00 Eye makeup remover 0.94 0.88 0.82 1.00 Mascara 0.85 0.88 0.77 0.97 1.00 Powder eye shadow 0.88 0.92 0.99 0.77 0.71 1.00 Facial cleanser 0.92 0.95 0.98 0.79 0.71 0.98 1.00 wash, and powder eye shadow elicited the most similar fluorescein staining patterns at post-instillation intervals. Human ocular instillation is an effective and safe in vivo methodology for the assessment of cosmetic irritancy. Ocular irritation elicited by the evaluated test materials varied markedly by product category, with respect to the type (subjective reports, inflamma tion, and fluorescein staining), duration, and ocular tissue involvement, demonstrating that these factors are important considerations for the prediction of the ocular irritancy of a test material. ACKNOWLEDGMENT The authors acknowledge Julie R. Meyers for her valuable assistance in writing this paper. REFERENCES (1) N. E. McCain, R. R. Binetti, S. D. Gettings, and B. C. Jones, Assessment of ocular irritation ranges of market-leading cosmetic and personal-care products using an in vitro tissue, Toxicologist, 66 (1-S), 243 (2002). (2) P. A. Jones, E. Budynsky, K. J. Cooper, D. Decker, H. A. Griffiths, and J. H. Fentem, Comparative evaluation of five in vitro tests for assessing the eye irritation potential of hair-care products, Altern. Lab. Anirn., 29, 669-692 (2001). (3) Y. Gao and B. E. Kanengiser, Observation of ocular irritation in human subject, IOVS, 41, 5257 (2000). (4) J. D. Burdick, Y. Gao, B. E. Kanengiser, J. C. Merrill, and J. W. Harbell, Comparative assessment of two eye area cosmetic formulations through evaluation of alternative eye irritation methods relative to endpoints measured in a human clinical sub-acute study design, Society of Toxicology 2003 Annual Meeting. (5) J. H. Draize, G. Woodward, and H. 0. Calvery, Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes,]. Pharrnacol. Exper. Therapeutics, 78, 458-463 (1944). (6) J. S. Friedenwald, W. D. Hughes, and H. Hermann, Acid-base tolerance of the cornea, Arch. Ophthal rnol., 31, 279-283 (1994). (7) U.S. EPA, Primary eye irritation study in pesticide assessment guidelines, subdivision F hazard evaluation: Human and domestic animals, EPA Guidelines 1982, 51, 81-84 (1982). (8) U.S. EPA, Toxic substance control act test guidelines, part 798: Health effect testing guidelines. Subpart B-General toxicity testing, Fed. Reg. 1985, 50, 39398.

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50 45 CIJ "i 40 .J 35 � 30 ,! 25 � a, � 20 CD a, 15 CD � 10 5 0 Liquid makeup ASSESSMENT OF OCULAR IRRITANCY 323 Shampoo Baby wash Eye makeup remover Mascara Po'A{:ler eye Facial cleanser shadow Figure 4. The distribution of weighted scores of area and density of fluorescein staining patterns. jective reports of irritation and objective ophthalmic scores, as well as fluorescein stain ing patterns, were observed during the post-instillation examinations. The average subjective irritation scores for all product types peaked at 30 seconds post-instillation and decreased markedly at the 5 minute examination, with the exception of powder eye shadow, which decreased at 15 minutes post-instillation (Figure SA). Objective oph thalmic irritation was observed in various patterns (Figure SB). Objective irritations decreased at the 5 minute examination for liquid makeup, mascara, eye makeup remover, and powder eye shadow, and at the 60 minute examination for shampoo and baby wash. However, objective irritation for facial cleanser persisted at 120 minutes following ocular instillation. The average weighted scores (Figure SC) of fluorescein ophthalmic staining of ocular tissues revealed that superficial punctate staining peaked at 15 min utes post-instillation for shampoo, baby wash, eye makeup remover, mascara, and pow der eye shadow, and at 60 minutes post-instillation for liquid makeup and facial cleanser. Most ocular irritation resolved after 24 hours. The statistical analysis of weighted scores for fluorescein staining at post-instillation examination intervals dem onstrated a very good correlation (r 0.95) between facial cleanser, shampoo, or powder eye shadow and baby wash, and a fair correlation (r 0.75) between powder eye shadow or facial cleanser and mascara (Table III). CONCLUSIONS Based on the comparison analysis of the limited data in each product category, this study has demonstrated that subjective irritation reports, objective ocular irritation, and fluo rescein staining patterns attenuated rapidly during the two-hour study period for all categories except facial cleanser. Mascara and powder eye shadow elicited more subjective ocular discomfort shampoo and baby wash exhibited higher objective ocular irritation scores and shampoo, baby wash, and powder eye shadow elicited greater ocular tissue

324 35 1t1 C - 0 3 111- .. • .! .J'C7,5 e -= g -� 2 (/) .. a, • 1.5 Iii e :i 1 • II) 0 o.5 45 H 4 t j 3.5 .J .t:: et 3 g � 2.5 (/) &l £ 8 1.5 ... 0 1 0.5 35 GI 30 • a, ...I C rs 25 oS (/) (/) 20 tJ .5 ,SI GI s:. 0 ·? e ,s g & ii: 10 I! 'o JOURNAL OF COSMETIC SCIENCE A Baseline 30" B Baseline 30' C Baseline 30' 5' 15' Time of Evaluation 15' Time of Evaluation 5' 15' Time of Evaluation 60' 60' 60' + Liquid makeup +Shampoo +Babywash * Eye makeup remover +Mascara + Powder eye shadow +Facial cleanser 120' 24h 120' 24h 120' 24h Figure 5. Average score levels of ocular irritation at post-instillation evaluation intervals. staining than the remaining product types, in which mascara exhibited the lowest correlation between subjective response and objective irritation. Epithelial defects of the ocular surface were observed at later post-instillation evaluations, compared to the subjective responses and objective irritation, in which facial cleanser, shampoo, baby

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322 JOURNAL OF COSMETIC SCIENCE cleanser, with scores of 3.025 ± 0.12, 2.783 ± 0.141, 1.8 ± 0.25, 3.4 ± 0.11, and 2.34 ± 0.25, respectively (Figure 3). DISTRIBUTION OF FLUORESCEIN STAINING The maximum area and density scores at each examining timepoint for the fluorescein staining patterns of each ocular tissue were multiplied and totaled for all examination intervals. Scores from each evaluated tissue were weighted, based on a modification of the Draize method (5,6) for assessing ocular irritancy potential, and totaled to determine an overall fluorescein staining score for all eyes by the following equation: Total weighted score = (palpebral + bulbar) x 2 + cornea x 5 + caruncle x 1. The distributions of the average weighted score (Figure 4) for liquid makeup, shampoo, baby wash, eye makeup remover, mascara, powder eye shadow and facial cleanser were 11.4 ± 1.34, 31.03 ± 1.52, 39.19 ± 2.70, 9.6 ± 0.91, 39.92 ± 3.45 and 9.55 ± 1.98, respectively. The scores for shampoo, baby wash, and powder eye shadow were statistically signifi cantly higher than those of the others (p 0.05). POST-INSTILLATION EVALUATION INTERVALS The Draize method and the modified Draize methods, such as the FHSA method, the OECD method, and the FIFRA/TSCA method (7 ,8), established the stipulated intervals for observing irritation, which were limited to 1, 24, 48, and 72 hours after adminis tration of the test material in animals. Human eyes are highly sensitive to cosmetic products and respond frequently and quickly to test material exposure. Therefore oph thalmic evaluations were performed at the following time intervals: 30 seconds, 5 minutes, 15 minutes, 60 minutes, 120 minutes, and 24 hours post-instillation. Sub- 4.5 4 3.5 (I) : 3 � 2.5 "' 2 a, 1.5 0.5 0 Liquid makeup Sha"l)OO Baby wash Eye makeup remowr Mascara PO'Ader eye Facial cleanser shadow Figure 3. Average maximum levels of objective irritation.

50 45 CIJ "i 40 .J 35 � 30 ,! 25 � a, � 20 CD a, 15 CD � 10 5 0 Liquid makeup ASSESSMENT OF OCULAR IRRITANCY 323 Shampoo Baby wash Eye makeup remover Mascara Po'A{:ler eye Facial cleanser shadow Figure 4. The distribution of weighted scores of area and density of fluorescein staining patterns. jective reports of irritation and objective ophthalmic scores, as well as fluorescein stain ing patterns, were observed during the post-instillation examinations. The average subjective irritation scores for all product types peaked at 30 seconds post-instillation and decreased markedly at the 5 minute examination, with the exception of powder eye shadow, which decreased at 15 minutes post-instillation (Figure SA). Objective oph thalmic irritation was observed in various patterns (Figure SB). Objective irritations decreased at the 5 minute examination for liquid makeup, mascara, eye makeup remover, and powder eye shadow, and at the 60 minute examination for shampoo and baby wash. However, objective irritation for facial cleanser persisted at 120 minutes following ocular instillation. The average weighted scores (Figure SC) of fluorescein ophthalmic staining of ocular tissues revealed that superficial punctate staining peaked at 15 min utes post-instillation for shampoo, baby wash, eye makeup remover, mascara, and pow der eye shadow, and at 60 minutes post-instillation for liquid makeup and facial cleanser. Most ocular irritation resolved after 24 hours. The statistical analysis of weighted scores for fluorescein staining at post-instillation examination intervals dem onstrated a very good correlation (r 0.95) between facial cleanser, shampoo, or powder eye shadow and baby wash, and a fair correlation (r 0.75) between powder eye shadow or facial cleanser and mascara (Table III). CONCLUSIONS Based on the comparison analysis of the limited data in each product category, this study has demonstrated that subjective irritation reports, objective ocular irritation, and fluo rescein staining patterns attenuated rapidly during the two-hour study period for all categories except facial cleanser. Mascara and powder eye shadow elicited more subjective ocular discomfort shampoo and baby wash exhibited higher objective ocular irritation scores and shampoo, baby wash, and powder eye shadow elicited greater ocular tissue

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J. Cosmet. Sci.J 55, 327-341 Quly/August 2004) Evaluation for collagen products for cosmetic application YONG PENG, VERONICA GLATTAUER, JEROME A. WERKMEISTER, and JOHN A. M. RAMSHA W CSIR0 Molecular Science} 343 Royal Parade, Parkville, Victoria 3052, Australia. Accepted for publication January 15, 2004. Synopsis Collagen is an important component for cosmetic formulation, where it is an effective natural humectant with high substantivity. Commercial collagen preparations have a wide range of properties. In the present study, various techniques have been used to examine three distinct commercial collagens that illustrate the range of properties that are available. The usefulness of the various techniques for assessing collagen quality and batch-to-batch variation is discussed. The results indicate that there are several simple, cheap, and effective methods, such as gel electrophoresis, that provide excellent information on collagen quality. The appropriate selection of tests allows informed decisions on the choice of which collagen preparation to use to provide the desired functionality and shelf life of a formulation. INTRODUCTION Collagen has become a valuable and well used component in cosmetic formulation, where it provides significant benefits. In particular, it is an effective natural humectant (1,2) as a result of the extensive, ordered hydration network that surrounds the molecule (3), in combination with its high substantivity to the skin surface. A wide variety of collagen preparations is now available that are suitable for cosmetic formulations. These preparations vary considerably in their composition and properties. Quality testing to allow informed decisions on the choice of which collagen preparation to use is therefore important so as to ensure that the preparation provides the desired functionality. Testing should also be capable of monitoring potential batch-to-batch variations that could also affect product performance. Also, it should indicate whether the collagen is in its native, triple-helical form or is present in its denatured form, gelatine. Native collagen is characterized by a triple-helical structure, in which three extended left-handed polyproline II-like helical chains are supercoiled into a right-handed triple helix, linked through interchain hydrogen bonds (4,5). The triple-helical conformation requires a distinctive amino acid sequence, in particular glycine as every third residue, Address all correspondence to John A. M. Ramshaw. 327

328 JOURNAL OF COSMETIC SCIENCE to accommodate the close packing of the three chains. The extended conformation of the individual polyproline II-like chains in the triple helix is stabilized by the high level of occurrence of the amino acids praline and 4-hydroxyproline (Hyp). Hyp, which is post-translationally modified from praline, confers a greater stability than praline in the Y position (6) and is a characteristic amino acid marker of collagen. In tissue, the collagen molecules are crosslinked to form an extended network that provides the tissue with strength and durability. These crosslinks are specific and use short, non-triple helical peptides, the telopeptides, at the ends of the triple-helical domain of each collagen molecule (7). Bovine collagen has been a common source for cosmetic applications. However, more recently, collagens from other species of origin have also become commercially available. Collagens from alternative species may provide a benefit in that potential zoonoses, particularly transmissible spongiform encephalopathies, are less likely from sources such as chicken and fish. However, collagens from various species may differ in their prop erties. For example, they may have different thermal stabilities (8), which could affect formulation or the shelf life of products. In the present study we have examined the suitability of a range of tests, using a selection of commercially available collagen samples. These samples illustrate a selection from the range of materials available and allow commentary on the information that each test provides. Some tests, those found in water analysis standards (9), for example, are readily available from many analytical laboratories, whereas other tests, which may be critical for providing discrimination between samples, may require the involvement of more spe cialized laboratories. MATERIALS AND METHODS COLLAGEN SAMPLES Commercial collagen samples suitable for cosmetic application were obtained from the following sources: Collasol® was from Croda Chemicals Ltd (Humberside, UK). CLR Collagen® was from Chemisches Laboratorium Dr. Kurt Richter Gmbh (Berlin, Ger many). AteloHelogen® was a gift from the manufacturer (Meddicoll, North Ryde, Australia). Soluble collagen samples were also prepared in our laboratory from fresh, minced dermis (bovine, porcine, and chicken, obtained from local abattoirs) by pepsin digestion using 1 mg/ml pepsin in 100 mM acetic acid adjusted to pH 2.5 with HCl (10). Soluble collagen from diced fish skin (Blue Grenadier (Macruronus sp.) and Nile perch (Tilapia sp.) obtained from a local supplier) was extracted using 0.1 mg/ml pepsin in 100 mM acetic acid adjusted to pH 2.5 with HCl. All collagens were purified by differential NaCl fractionation at pH 2.5 and then at pH 7.4 (11). Separation of type I and III collagens was by rapid ammonium sulfate fractionation (11). METHODS Solution analysis. Analyses for ash, arsenic, and heavy metals (as lead) were performed by a certified external analytical laboratory (MGT Environmental Consulting Pty. Ltd., Oakleigh, Australia) following standard procedures (9). pH was determined using a

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