1、ISBN 3900734275 . COMMISSION INTERNATIONALE DE LCLAIRAGE INTERNATIONAL COMMISSION ON ILLUMINATION INTERNATIONALE BELEUCHTUNGSKOMM ISSION SUNSCREEN TESTING (UV.B) Pub. No. CIE 90 Ist Edition 1991 UDC: 612.014.481-06 Descriptor: Optical radiation effect on humans, experimental techniques 614.898:616.5
2、-001.15 Protection of the skin: Sunburn CIE 90 91 E 9006345 000420b 740 II This Technical Report has been prepared by CIE Technical Committee 6-12 of Division 6 Photobiology and Photochemistry and has been approved by the Council of the Commission Internationale de IEclairage for study and applicati
3、on. The document reports on current knowledge and experience within the specific field of light and lighting described, and is intended to be used by the CIE membership and other interested parties. It should be noted, however, that the status of this document is advisory and not mandatory. The late
4、st CIE Proceedings or CIE NEWS, or publication listings should be consulted regarding possible subsequent amendments. Ce rapport technique a t prpar par le Comit Technique CIE 6-12 de la Division 6 Photobiologie et photochimie et a t approuv par le Conseil de la Commission Internationale de lclairag
5、e, pour tude et application. Le document traite des connaissances courantes et de lexprience dans le domaine spcifique indiqu de la lumire et de lclairage, et il est tabli pour lusage des membres de la CIE et autres groupements intresss. II faut cependant noter que ce document est indicatif et non o
6、bligatoire. Pour connaitre dventuels amendements, consulter les plus rcents comptes rendus, CIE NEWS ou liste des publications de la CIE. Dieser Technische Bericht ist vom CIE-Technischen Komitee 6-1 2 der Division 6 Photobiologie und Photochemie ausgearbeitet und vom Rat der Commission Internationa
7、le de lclairage gebilligt worden. Das Dokument berichtet ber den derzeitigen Stand des Wissens und der Erfahrung in dem behandelten Gebiet von Licht und Beleuchtung; es ist zur Verwendung durch CIE-Mitglieder und durch andere Interessierte bestimmt. Es sollte jedoch beachtet werden, da das Dokument
8、ene Emp- fehlung und keine Vorschrift ist. Die neuesten CIE-Tagungsberichte, das CIE NEWS oder die Publi- kationsliste sollten im Hinblick auf mgliche sptere nderungen zu Rate gezogen werden. Any mention of organisations or products does not imply endorsement by the CIE. Whilst every care has been t
9、aken in the compilation of any lists, up to the time of going to press, these may not be comprehensive. Toute mention dorganisme ou de produit nimplique pas une prfrence de la CIE. Malgr le soin apport la compilation de tous les documents jusqu la mise sous presse, ce travail ne saurait etre exhaust
10、if. Die Erwhnung von Organisationen oder Erzeugnissen bedeutet keine Billigung durch die CIE. Ob- gleich groe Sorgfalt bei der Erstellung von Verzeichnissen bis zum Zeitpunkt der Drucklegung an- gewendet wurde, ist es mglich, da diese nicht vollstndig sind. O CIE 1991 CIE 90 91 I 900b145 0004207 687
11、 The following members of TC6-12 took part in the preparation of this technical report. The Committee comes under CIE Division 6 (Photobiology and Photochemistry): BARTH J CESARINI J P (Chairman) COLE C FORBES D HOLZLE E HONIGSMANN H KIVISAKK E MASCOTTO R E MUTZHAS M PATHAK M POELMAN M C ROELANDTS R
12、 RONCHI L R URBACH F Van der LEUN J C Responsible for the written document Consultants BERGER D GROVES G A IPPEN H LOBEL E LOCK G RIPPERE J L (F.D.A.) Van der VENNE (E.E.C.) WISKEMANN A Federal Republic of Germany France U.S.A. U.S.A. Federal Republic of Germany Austria Sweden Switzerland Federal Re
13、public of Germany U.S.A. France Belgium Italy U.S.A. The Netherlands U.S.A. Australia Federal Republic of Germany Australia Australia U.S.A. Luxembourg Federal Republic of Germany Comit de Liaison des Associations Europennes de lIndustrie, de la Parfumerie, des Produits Cosmtiques et de Toilette (C.
14、O.L.I.P.A.). Belgium The Cosmetic, Toiletry and Flagrance Association (C.T.F.A.) U.S.A. The CIE is grateful for all contributions, discussions, suggestions of specialists and the constant exchange of views representative of industry 1. INTRODUCTION 1.1 Scope 1.2 Background IV CONTENTS 2. SELECTION O
15、F SUBJECTS 3. TEST SITE 3.1 Application of tested sunscreen 3.2 Marking of the test sites 3.3 Use of a standard formulation 4. SOURCES OF IRRADIATION 4.1 Solar spectrum and artificial sources 4.2 Calibration of equipment 4.3 Practical aspects P. 1 1 1 2 5. DETERMINATION OF THE MINIMAL ERYTHEMAL DOSE
16、 (MED) 3 6. NUMBER OF SUBJECTS AND CALCULATION OF THE SPF 3 7. WATER RESISTANCE 4 8. RECOMMENDATIONS FOR LABELLING SUNSCREENS 4 9. CONCLUSIONS AND FUTURE DEVELOPMENTS 5 10. REFERENCES 6 11. APPENDICES 9 11.1 Sunlight spectral distribution and distribution of the spectral emission of a xenon arc with
17、 WG 320 (Schott) 1 mm and 2 mm filters 9 SPF of sunscreens 10 skin phototypes 11 11.2 Comparison of existing methods for evaluation of the 11.3 Estimating the exposure time for MED for different - CIE 90 91 9006145 O004209 45T V SUMMARY Sunscreen Testing (UV-B) The terms of reference of TC6-12 were:
18、 “To provide guide lines for sunscreen testing, offering to the users security and efficacy. Sunscreens are characterized essentially by the protection they offer against UV radiations from the sun and artificial sources. Testing procedures are critical: they depend on the source used. - Discussion
19、on existing methods of testing. Selection of the most suitable methods for both consumers needs and those carrying out the tests“. This report is intended to provide guidance to appropriate qualified scientists, medical personnel, and authorized persons under qualified guidance, to design UV sources
20、, elaborate sunscreen preparations and evaluate their efficacy under proper conditions. RESUME Evaluation du facteur de protection (UV-6) de produits anti-solaires La mission donne au TC 6-12 tait la suivante: “Fournir des orientations et un guide pour tester des produits antisolaires, afin doff rir
21、 A lutilisateur le maximum de scurit et deff icack. Les produits antisolaires sont essentiellement caractrises par la protection quils offrent contre les radiations UV produites par le soleil ou par des sources artificielles. Les procds de testing sont une tape critique qui dpend en grande partie de
22、 la qualit de la source utilise. On discutera les mthodes de tests dj reconnues. On slectionnera la mthode la plus adapte aux besoins des consommateurs et aux impratifs techniques des tests.“ Ce rapport est destin fournir un guide aux scientifiques qualifis, au personnel mdical, et aux personnes aut
23、orises sous une direction qualifie, pour fabriquer des sources UV, laborer des prparations antisolaires et valuer leur efficacit dans des conditions rigoureuses et adaptes. ZUSAMMENFASSUNG UV.B Prfung von Sonnenschutzprodukten TC 6-1 2 hatte die folgenden Aufgaben: “Erstellung von Richtlinien fr die
24、 Prfung von Sonnenschutzprodukten, um den Benutzern maximale Sicherheit und Wirksamkeit zu garantieren. Wesentliches Merkmal der Sonnencchutzprodukte ist der Schutz vor UV-Strahlung der Sonne oder knstlicher Strahlungsquellen. Ein entscheidender Punkt sind die Testverfahren, die von der verwendeten
25、Strahlungsquelle abhngen. Die Errterung bereits existierender Testmethoden. Auswahl der geeignetsten Methoden, sowohl im Hinblick auf die Bedrfnisse der Konsumenten, als auch auf die Erfordernisse fr die Durchfhrung der Tests.“ Dieser Bericht soll als Leitfaden dienen fr Fachleute im Wissenschaftsbe
26、reich, medizinisches Personal und autorisierte Personen unter fachlicher Fhrung, die UV-Quellen gestalten, Sonnenschutzprparate entwickeln und deren Wirksamkeit unter den jeweiligen Bedingungen beurteilen. CIE 90 91 I 9006145 0004210 171 1 i. INTRODUCTION 1.1 Scope The purpose of this CIE Technical
27、Report is to give guidance to appropriately qualified scientific and medical personnel who are responsible for the testing of sunscreen products. The report is concerned only with: a The specification of the characteristics of suitable radiation sources and associated equipments. b The test procedur
28、es to be followed by appropriately qualified personnel to give consistent results within the accuracy limits possible within the current state of knowledge of the subject. c The evaluation of the test result and the calculation necessary to obtain a relative Sun Protection Factor (SPF) for the sunsc
29、reen product being tested. d Suggestions for additional information to be included in the manufacturers instructions on the use of sunscreens. The guidance given does not, in any way, comment or give advice on the ability of the sunscreen products to give quantifiable degrees, or guarantees of prote
30、ction against any form of skin damages which may be attributed to exposure to solar or artificial radiations. Neither does this document absolve those carrying out the test from the responsibility for the safety and well being of the subjects on whom the tests are conducted. 1.2 Background The Techn
31、ical Committee has used the existing standards and proposals l to 51 as a basis for discussions and has also taken into account the recent major reports on short term, intermediate, and long term effects of ultraviolet radiations (UVR) on human skin (6 to 17). A brief comparison of existing methods
32、is shown in Appendix 11.2. It is recognized that skin cancers and particularly, malignant melanomas, are increasing rapidly, that the average annual exposure related to work and leisure, or latitude correlates to skin cancer prevalence, and that an increasing proportion of the population is exposed
33、to sun-light early in life. Furthermore, the recently noticed stratospheric ozone depletion could be a threat for the future and could increase the sun exposure risks. A significant yearly rise in UV irradiance, however, has not yet been recorded. It is known that the damage to skin bytanning, sunbu
34、rn, wrinkling, etc . is the result of UVR injury of the skin and the usefulness of sunscreen products has been recognized (1 8-23). There is also the potential danger of inadequate protection of consumers by incomplete or inadequate applications of sunscreens and the particular need to protect child
35、ren and the elderly (24 to 31). The Technical Committee has also been aware of the tendency of commercial manufacturers to increase the Sun Protection Factor (SPF) to fulfill the increasing demand of the consumer to be protected by “tanning with security“ and has particularly focused its attention i
36、n this Report on higher SPF product testing 132 to 381. The CIE proposes the following method to test for sunscreen products and makes recommendationsfor their classification, advertisement, etc Sunscreen products must also comply with individual country rules concerning authorized chemicals and max
37、imum concentration which are generally applicable to this class of product. The present proposal reflects a consensus of the Technical Committee members and consultants who have been selected from the opinion leaders and experts in the field. The proposals represent the present state of the art in s
38、unscreen product testing. 2 2. SELECTION OF SUBJECTS It is proposed to use a Caucasian (white), untanned population of volunteers of both sexes with skin phototypes I, II, or III, as defined according to FITZPATRICK and coll. 7, 171. - Phototype I : always burns and tans minimally - Phototype II : b
39、urns easily and sometimes tans - Phototype III : burns moderately and tans gradually - Phototype IV: rarely burns, tans profusely Normal volunteers have to be carefully checked to insure that they are free of any sun-related diseases, sunscreen phototoxicity, photo-allergy, or atopy (hypersensitivit
40、y). The inspection of the test site should not reveal nevi, skin blemishes, residual erythema or pigmentation which can interfere with the study. They must be asked not to take systemic or topical medications known to produce modifications in sunlight responses, and particularly, not to take aspirin
41、 or anti-inflammatory drugs during the test. Scratching, washing with soap or similar products or the use of “after sun lotion“ on the test area should be avoided. For high SPF sunscreen testing, phototypes I and II, rather than III or IV, subjects are recommended, since the other phototypes may dev
42、elopa 24 hour-pigmentation from the UV.A which will mask the minimal erythema. A written, fully informed consent, must be obtained from each individual. 3. TEST SITE The site to be tested is the back between the belt line and the shoulder blade, from the lateral axillae to the mid-line. The test pro
43、duct(s) have to be applied over at least 35 cm2 surface, each application area being separated from the next by at least 1 cm. The irradiated site has to be separated by 1 cm at least from the edge of the application surface, and from other irradiated area. Each irradiated surface should be at least
44、 0.4 cm2 in area. These subsites are exposed to increasing UVR light (see section 5). Protected and unprotected test sites should be close and irradiated with the same source. The delineation (application, irradiation and observation) of the test sites should be performed in the same position. 3.1 A
45、pplication of tested sunscreen To insure a standardized method and results, the test product must be carefully distributed on the test site at a concentration of 2 mg/cm2 or 2 rJ/cm2. The sunscreen is spread by a light massage with a finger covered by a fingercot, at least 15 minutes before irradiat
46、ion. 3.2 Marking of the test sites Test sites have to be delineated with special ink or waterproof markers. These marks should remain visible for 24 hours to accurately locate the site of examination. 3.3 Use of a standard formulation The use of a calibration standard, in each test series, is recomm
47、ended. The standard has to be chosen according to the supposed SPF of the tested sunscreens. The purpose of the calibration standard is only to check consistency of results from previous tests by the same laboratory. It is recommended that the calibration be performed on a significant number of subj
48、ects in a series or at least any time a change has been made in any part of the irradiating equipment. CIE 90 93 M 9006345 0004212 T44 9 3 For testing products below SPF 12, the 8% homosalate as recommended by the revised standard of FDA (Food and Drug Administration) or the 2.7% cinnamate recommend
49、ed by the DIN Norm (See 1 1.2), should be considered. For testing products SPF 12 and higher, a standard of at least SPF 10 should be used: this preparation should contain UV filters and/or sunblockers in a suitable base. 4. SOURCES OF IRRADIATION 4. I Solar spectrum and artificial sources Filtered xenon arc sources (e.g. with 1 to 2 mm SCHOTT WG 320 filter or equivalent) will reasonably match the solar UV spectrum in the mid-latitude during 10 a.m.4 p.m. focal sta
