DraizeJ.H., WoodardG., & CalveryH.O. (1944). Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. Journal of Pharmacology and Experimental Therapeutics82, 377–390.
2.
OECD (2002). OECD Guidelines for the Testing of Chemicals No. 405: Acute Eye Irritation/Corrosion.14 pp. Paris, France: Organisation for Economic Cooperation and Development.
3.
EU (2004). Commission Directive 2004/73/EC of 29 April 2004 adapting to technical progress for the 29th time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Official Journal of the European UnionL152, 1–316.
4.
FisherR.G., PallerB.S., ZietsG.A., GinnG.L., & RachuiS.R. (1995). Predicting in vivo eye irritation potential using a tissue equivalent assay and a bovine corneal opacity and permeability test. In Vitro Toxicology8, 139–147.
5.
ChambersW.A., GreenS., GuptaK.C., HillR.N., HuntleyK., HurleyP.M., LambertL.A., LeeC.C., LeeJ.K., LiuP.T., LowtherD.K., RobertsC.D., SeabaughV.M., SpringerJ.A., & WilcoxN.L. (1993). Scoring for eye irritation tests. Food and Chemical Toxicology31, 111–115.
6.
WilhelmusK.R. (2001). The Draize eye test. Survey of Ophthalmology45, 493–515.
7.
United Nations-Economic Commission for Europe (UN/ECE) (2003). Globally Harmonised System of Classification and Labelling of Chemicals (GHS). Part 3 Health and Environmental Hazards, 107–228. New York, USA, and Geneva, Switzerland: United Nations.
8.
WeilC.S., & ScalaR.A. (1971). Study of intra- and interlaboratory variability in the results of rabbit eye and skin irritation tests. Toxicology and Applied Pharmacology19, 276–360.
9.
LordoR.A., FederP.I., & GettingsS.D. (1999). Comparing and evaluating alternative (in vitro) tests on their ability to predict the Draize maximum average score. Toxicology in Vitro13, 45–72.
10.
OhnoY., KanekoT., InoueT., MorikawaY., YoshidaT., FujiA., MasudaM., OhnoT., HayashiM., MommaJ., UchiyamaT., ChibaK., IkedaN., ImanashiY., & ItakagakiH. (1999). Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (1) Overview of the validation study and Draize scores for the evaluation of the tests. Toxicology in Vitro13, 73–98.
11.
ChristianM.S., & DienerR.M. (1996). Soaps and detergents — alternatives to animal eye irritation tests. Journal of the American College of Toxicology15, 1–44.
12.
FreebergF.E., NixonG.A., ReerP.J., WeaverJ.E., BruceR.D., GriffithJ.F., & SandersL.W. (1986). Human and rabbit eye responses to chemical insult. Fundamental and Applied Toxicology7, 626–634.
13.
MaurerJ.K., ParkerR.D., & JesterJ.V. (2002). Extent of initial corneal injury as the mechanistic basis for ocular irritation: key findings and recommendations for the development of alternative assays. Regulatory Toxicology and Pharmacology36, 106–117.
14.
BallsM., BothamP.A., BrunerL.H., & SpielmannH. (1995). The EC/HO international validation study on alternatives to the Draize eye irritation test. Toxicology in Vitro9, 871–929.
15.
BrantomP.G., BrunerL.H., ChamberlainM., DesilvaO., DupuisJ., EarlL.K., LovellD.P., PapeW.J.W., UttleyM., BagleyD.M., BakerF.W., BrachterM., CourtellemontP., DeclercqL., FreemanS., SteilingW., WalkerA.P., CarrG.J., DamiN., ThomasG., HarbellJ., JonesP.A., PfannenbeckerU., SoutheeJ.A., TchengM., ArgembeauxH., CastelliD., ClothierR., EsdaileD.J., ItigakiH., JungK., KasaiY., KojimaH., KristenU., LarnicolM., LewisR.W., MarenusK., MorenoO., PetersonA., RasmussenE.S., RoblesC., & SternM. (1997). A summary report of the COLIPA international validation study on alternatives to the Draize rabbit eye irritation test. Toxicology in Vitro11, 141–179.
16.
SpielmannH., KalweitS., LiebschM., WirnserbergerT., GernerI., Bertram-NeisE., KrauserK., KreilingR., MiltenburgerH.G., PapeW., & SteilingW. (1993). Validation study of alternatives to the Draize eye irritation test in Germany: cytotoxicity testing and HET-CAM test with 136 industrial chemicals. Toxicology in Vitro7, 505–510.
17.
SpielmannH., LiebschM., KalweitS., MoldenhauerF., WirnsbergerT., HolzhuetterH.G., SchneiderB., GlaserS., GernerI., PapeW.J.W., KreilingR., KrauserK., MiltenburgerH.G., SteilingW., LuepkeN.P., MuellerN., KreuzerH., MuermannP., SpenglerJ., Betram-NeisE., SiegemundB., & WiebelF.J. (1996). Results of a validation study in Germany on two in vitro alternatives to the Draize eye irritation test, the HET-CAM test and the 3T3 NRU cytotoxicity test. ATLA24, 741–858.
18.
GettingsS.D., TealJ.J., BagleyD.M., DemetruliasJ.L., DiPasqualeL.C., HintzeK.L., RozenM.G., WeiseS.L., ChudkowskiM., MarenusK.D., PapeW.J.W., RoddyM., SchnetzingerR., SilberP.M., GlazaS.M., & KurtzP.J. (1991). The CTFA evaluation of alternatives program: an evaluation of in vitro alternatives to the Draize primary eye irritation test (phase I) hydro-alcoholic formulations; (part 2) data analysis and biological significance. In Vitro Toxicology4, 247–288.
19.
GettingsS.D., BagleyD.M., ChudlowskiM., DemetruliasJ.L., DipasqualeL.C., GalliC.L., GayR., HintzeK.L., JanusJ., MarenusK.D., MuscatielloM.J., PapeW.J.W., RenskersK.J., RoddyM.T., & SchnetzingerR. (1992). Development of potential alternatives to the Draize eye test. The CTFA evaluation of alternatives program (Phase II). Review of materials and methods. ATLA20, 164–171.
20.
GettingsS.D., DipasqualeL.C., BagleyD.M., CastertonP.L., ChudkowskiM., & CurrenR.D. (1994). The CTFA evaluation of alternatives program: an evaluation of in vitro alternatives to the Draize primary eye irritation test. (Phase II), oil/water emulsions. Food and Chemical Toxicology32, 943–976.
21.
GettingsS.D., LordoR.A., HintzeK.L., BagleyD.M., CastertonP.L., ChudkowskiM., CurrenR.D., DemetruliasJ.L., DiPasqualeL.C., EarlL.K., FederP.I., GalliC.L., GlazaS.M., GordonV.C., JanusJ., KurtzP.J., MarenusK.D., MoralJ., PapeW.J.W., RenskersK.J., RheinsL.A., RoddyM.T., RozenM.G., TedeschiJ.P., & ZyrackiJ. (1996). The CTFA evaluation of alternatives program: an evaluation of in vitro alternatives to the Draize primary eye irritation test. (phase III) Surfactant-based formulations. Food and Chemical Toxicology34, 79–117.
22.
BradlawJ., GuptaK., GreenS., HillR., & WilcoxN. (1997). Practical application of non–whole animal alternatives: summary IRAG workshop on eye irritation. Food and Chemical Toxicology35, 175–178.
23.
BallsM., BergN., BrunerL.H., CurrenR., deSilvaO., EarlL.K., EsdaileD.J., FentemJ.H., LiebschM., OhnoY., PrinsenM.K., SpielmannH., & WorthA.P. (1999). Eye irritation testing: the way forward. The report and recommendations of ECVAM workshop 34. ATLA27, 53–77.
24.
WorthA.P., & BallsM., eds (2002). Alternative (Non-Animal) Methods for Chemicals Testing: Current Status and Future Prospects. A report prepared by ECVAM and the ECVAM working group on chemicals. ATLA30, Suppl. 1, 1–115.
25.
ChamberlainM., GadS.C., GautheronP., PrinsenM.K. (1997). IRAG (Interagency Regulatory Alternatives Group) working group 1. Organotypic models for the assessment/prediction of ocular irritation. Food and Chemical Toxicology35, 23–37.
26.
SpielmannH. (1997). Ocular irritation. In In Vitro Methods in Pharmaceutical Research (ed. CastellJ.V., & Gómez-LechónM.J.), pp. 265–287. London, UK: Academic Press.
MaurerJ.K., & ParkerR.D. (1996). Light microscopic comparison of surfactant-induced eye irritation in rabbits and rats at three hours and recovery/day 35. Toxicologic Pathology24, 403–411.
29.
CurrenR., EvansM., RaabeH., DobsonT., & HarbellJ. (1999). Optimisation of the bovine corneal opacity and permeability assay: histopathology aids understanding of the EC/HO false negative materials. ATLA27, 344.
30.
MaurerJ.K., MolaiA., ParkerR.D., LiL., CarrG.J., PetrollM.W., CavanaghD.H., & JesterJ.V. (2001). Pathology of ocular irritation with bleaching agents in the rabbit low-volume eye test. Toxicological Pathology29, 308–319.
31.
SwansonJ.E., WhiteB.T., GranB.P., MerrillJ.C., & HarbellJ.W. (2003). Evaluating oxidizing/reactive cleaning products in the bovine corneal opacity and permeability (BCOP) assay. The Toxicologist72, 220–221.
32.
CuellarN., LloydP.H., SwansonJ.E., MerrillJ.C., ClearM.L., MunG., HarbellJ.H., & BonnetteK.L. (2003). Evaluating the eye irritancy of solvents in a simple fragrance mixture with the bovine corneal opacity and permeability (BCOP) assay. The Toxicologist72, 312.
33.
GautheronP., DukicM., AlixD., & SinaJ.F. (1992). Bovine corneal opacity and permeability test: an in vitro assay of ocular irritancy. Fundamental and Applied Toxicology18, 442–449.
34.
GautheronP. (1996). INVITTOX Protocol 98: The Bovine Corneal Opacity and Permeability Assay. ECVAM SIS Database. Ispra, Italy: ECVAM, European Commission JRC. Website http://ecvam-sis.jrc.it (Accessed 25.08.04).
35.
GautheronP., GirouxJ., CottinM., AudegondL., MorillaA., Mayordomo-BlancoL., TortajadaA., HaynesG., & VericatJ.A. (1994). Interlaboratory assessment of the bovine corneal opacity and permeability (BCOP) assay. Toxicology in Vitro8, 381–392.
36.
SinaJ.F., GalerD.M., SussmanR.G., GautheronP.D., SargentE.V., LeongB., ShahP.V., CurrenR.D., & MillerK. (1995). A collaborative evaluation of seven alternatives to the Draize eye irritation test using pharmaceutical intermediates. Fundamental and Applied Toxicology26, 20–31.
37.
KayJ.H., & CalendraJ.C. (1962). Interpretation of eye irritation tests. Journal of the Society of Cosmetic Chemists13, 281–289.
38.
TchaoR. (1988). Trans-epithelial permeability of fluorescein in vitro as an assay to determine eye irritants. In Alternative Methods in Toxicology (ed. GoldbergA.M.), vol. 6, pp. 271–283. New York, USA: Mary Ann Liebert Inc.
39.
VanparysP., DeknudtG., SysmansM., TeunsG., CoussementW., & CauternH. (1993). Evaluation of the bovine corneal opacity permeability assay as an in vitro alternative to the Draize eye irritation test. Toxicology in Vitro7, 471–476.
40.
CastertonP.L., PottsL.F., & KleinB.D. (1996). A novel approach to assessing eye irritation potential using the bovine corneal opacity and permeability assay. Journal of Toxicology — Cutaneous and Ocular Toxicology15, 147–163.
41.
BallsM., BrantomP.G., CassidyS., EsdaileD., FentemJ., LiebschM., McPhersonJ., PfannenbeckerU., & PrinsenM. (1999). Preliminary evaluation of the application of reference standards in the prevalidation and validation of in vitro test for eye irritation. In Alternatives to animal testing II (ed. ClarkD.G., LisanskyS.G., & MacmillanR.), pp. 201–204. Newbury, Berkshire, UK: CPL Press.
42.
RachuiS.R., RobertsonW.D., DukeM.A., PallerB.S., & ZietsG.A. (1994). Predicting the ocular irritation potential of cosmetics and personal care products using two in vitro models. In Vitro Toxicology7, 45–52.
43.
SwansonJ.E., LakeL.K., DonnellyT.A., HarbellJ.W., & HugginsJ. (1995). Prediction of ocular irritancy of full-strength cleaners and strippers by tissue equivalent and bovine corneal assays. Journal of Toxicology — Cutaneous and Ocular Toxicology14, 179–195.
44.
SinaJ.F., & GautheronP.D. (1994). A multitest approach to evaluating ocular irritation in vitro.Toxicology Methods4, 41–49.
45.
HarbellJ.W., & CurrenR.D. (2001). In vitro methods for the prediction of ocular and dermal toxicity. In Handbook of Toxicology, (ed. DerelankoM.J., & HollingerM.A.), 2nd edn, pp. 835–866. Boco Raton, FL, USA: CRC Press.
46.
SoutheeJ.A. (1998). Evaluation of the prevalidation process. The fluorescein leakage assay. Part 2, final report. European Community contract no. 11279-95-10F1ED ISP GB. 68 pp. Ispra, Italy: ECVAM, European Commission JRC.
47.
CooperK.J., EarlL.K., HarbellJ., & RaabeH. (2001). Prediction of ocular irritancy of prototype shampoo formulations by the isolated rabbit eye (IRE) test and bovine corneal opacity and permeability (BCOP) assay. Toxicology in Vitro15, 95–103.
48.
Anon. (2001). Zebet 103: The use of bovine corneal opacity and permeability as parameters for the eye irritation potential of chemical substances (BCOP assay). AnimAlt-Zebet database. Website http://www.bfr.bund.de/cd/1508 (Accessed 25.08.04).
49.
BurtonA.B.G., YorkM., & LawrenceR.S. (1981). The in vitro assessment of severe eye irritants. Food and Cosmetics Toxicology19, 471–480.
WhittleE., BasketterD., YorkM., KellyL., McCallJ., BothamP., EsdaileD., & GardnerJ. (1992). Findings of an interlaboratory trial of the enucleated eye method as an alternative eye irritation test. Toxicology Methods2, 30–41.
52.
YorkM., WilsonA.P., & NewsomeC.S. (1994). The classification of soluble silicates for eye hazard using the enucleated rabbit eye test. Toxicology in Vitro8, 1265–1268.
53.
LewisR.W., McCallJ.C., & BothamP.A. (1994). Use of an in vitro test battery as a prescreen in the assessment of ocular irritancy. Toxicology in Vitro8, 75–79.
54.
JonesP.A., BudynskyE., CooperK.J., DeckerD., GriffithsH.A., & FentemJ.H. (2001). Comparative evaluation of five in vitro tests for assessing the eye irritation potential of hair-care products. ATLA29, 669–692.
55.
MishimaS., & KudoT. (1967). In vitro incubation of rabbit cornea. Investigative Ophthalmology6, 329.
56.
MishimaS. (1968). Corneal thickness. Survey of Ophthalmology13, 57.
57.
MishimaS., & HedbysB.O. (1968). Measurement of corneal thickness with a Haag-Streit pachometer. Archives of Ophthalmology80, 710.
58.
YorkM., LawrenceR.S., & GibsonG.B. (1982). An in vitro test for the assessment of eye irritancy in consumer products — preliminary findings. International Journal of Cosmetic Science4, 223–234.
59.
PriceJ.B., & AndrewsI.J. (1985). The in vitro assessment of eye irritancy using isolated eyes. Food and Chemical Toxicology23, 313–315.
60.
KoëterH.B.W.M., & PrinsenM.K. (1985). Comparison of in vivo and in vitro eye irritancy test systems: a study with 34 substances. In Alternative Methods in Toxicology (ed. GoldbergA.M.), vol. 3, pp. 569–579. New York, US: Mary Ann Liebert Inc.
61.
BerryM., & EastyD.L. (1993). Isolated human and rabbit eye: models of corneal toxicity. Toxicology in Vitro7, 461–464.
62.
Anon. (2001). Zebet 105: The assessment of the eye irritation potential of chemical substances using the isolated rabbit eye test (IRE test). AnimAlt-Zebet database. Website http://www.bfr.bund.de/cd/1508 (Accessed 25.08.04).
63.
PrinsenM.K., & KoëterH.B.W.M. (1993). Justification of the enucleated eye test with eyes of slaughterhouse animals as an alternative to the Draize eye irritation test with rabbits. Food and Chemical Toxicology31, 69–76.
64.
PrinsenM.K. (1996). The chicken enucleated eye test (CEET): a practical (pre)screen for the assessment of eye irritation/corrosion potential of test materials. Food and Chemical Toxicology34, 291–296.
BurtonA.B.G. (1972). A method for the objective assessment of eye irritation. Food and Cosmetics Toxicology10, 209–217.
67.
Anon. (1991). Collaborative study on the evaluation of alternative methods to the eye irritation test, Part I EC Document XI/632/91, V/E/1/131/91.54 pp. Brussels, Belgium: Directorates General V and XI, European Commission.
68.
Anon. (1991). Collaborative study on the evaluation of alternative methods to the eye irritation test, Part II, EC Document XI/632/91, V/E/1/131/91. 296 pp. Brussels, Belgium: Directorates General V and XI, European Commission.
69.
Anon. (2001). Zebet 107: The assessment of the eye irritation potential of chemical substances using the chicken enucleated eye test (CEET). AnimAlt-Zebet database. Website http://www.bfr.bund.de/cd/1508 (Accessed 25.08.04).
70.
LuepkeN.P. (1985). Hen's egg chorioallantoic membrane test for irritation potential. Food and Chemical Toxicology23, 287–291.
71.
LuepkeN.P., & WallatS. (1987). HET-CAM — reproducibility studies. In Alternative methods in toxicology (ed GoldbergA.M. ed.), vol. 5 pp. 353–363. New York, USA: Mary Ann Liebert, Inc.
Silva deO., RougierA., & DossouK.G. (1992). The HET-CAM test: a study of the irritation potential of chemicals and formulations. ATLA20, 432–437.
74.
SteilingW. (1994). INVITTOX Protocol 96: The Hen's EggTest on the Chorioallantoic Membrane (HET-CAM). ECVAM SIS Database. Ispra, Italy: ECVAM, European Commission DG-JRC. Website http://ecvam-sis.jrc.it (Accessed 25.08.04).
75.
GilleronL., CoeckeS., SysmansM., HansenE., van OproyS., MarzinD., van CauterenH, & VanparysP. (1996). Evaluation of a modified HET-CAM assay as a screening test for eye irritancy. Toxicology in Vitro10, 431–446.
76.
Anon. (1996). Arreté du 29 Novembre 1996 rélatif aux méthodes officielles d'analyse nécessaires aux contrôles des produits cosmetiques. Journal Officiel de la République Française, 19137–19138.
77.
SchledeE., & GernerI. (1995). The Draize eye test and progress in development and acceptance of alternatives to this test in Europe. In The World Congress on Alternatives and Animals Use in the Life Sciences: Education, Research, Testing (ed. GoldbergA.M., & van ZutphenL.F.M.), pp. 333–336. New York, USA: Mary Ann Liebert, Inc.
78.
SpielmannH. (1998). Target 2000 - case studies -chemicals testing - reducing animal experiments by 50%. In Target 2000: Reducing Animal Experiments by 50%. Proceedings of the Conference held on 14 and 15 April 1997, Brussels, Belgium, pp. B1–B12. London, UK: Ideal Conferences.
79.
BagleyD.M., BrunerL.H., de SilvaO., CottinM., O'BrienK.A.F., UttleyM., & WalkerA.P. (1992). An evaluation of five potential alternatives in vitro to the rabbit eye irritation test in vivo.Toxicology in Vitro6, 136–149.
80.
RougierA., CottinM., de SilvaO., CatrouxP., RoguetR., & DossouK.G. (1994). The use of in vitro methods in the ocular irritation assessment of cosmetic products. Toxicology in Vitro8, 893–905.
81.
SteilingW., BracherM., CourtellemontP., & Silva deO. (1999). The HET-CAM, a useful in vitro assay for assessing the eye irritation properties of cosmetic formulations and indigrents. Toxicology in Vitro13, 375–384.
82.
SpielmannH., GernerI., KalweitS., MoogR., WirnsbergerT., KrauserK., KreilingR., KreuzerH., LuepkeN.P., MiltenburgerH.G., MuellerN., MuermannP., PapeW., SiegemundB., SpenglerJ., SteilingW., & WiebelF.J. (1991). Interlaboratory assessment of alternatives to the Draize eye irritation test in Germany. Toxicology in Vitro5, 539–542.
83.
SpielmannH., LiebschM., MoldenhauerF., HolzhuetterH.G., & de SilvaO. (1995). Modern biostatistical methods for assessing in vitro/in vivo correlation of severely eye irritating chemicals in a validation study of in vitro alternatives to the Draize eye test. Toxicology in Vitro9, 549–556.
84.
BleinO., AdolpheM., LakhdarB., CambarJ., GubanskiG., CastelliD., ContieC., HubertF., LatrilleF., MassonP., ClouzeauJ., le BigotJ.F., de SilvaO., & DossouK.G. (1991). Correlation and validation of alternative methods to the Draize eye irritation test (OPAL project). Toxicology in Vitro5, 555–557.
85.
HaginoS., KinoshitaS., TaniN., NakamuraT., OnoN., KonishiK., IimuraH., KojimaH., & OhnoY. (1999). Interlaboratory validation of in vitro eye irritation tests for cosmetic ingredients: (2) Chorio-allantoic membrane (CAM) test. Toxicology in Vitro13, 99–113.
86.
SpielmannH., LiebschM., MoldenhauerF., HolzhuetterH.G., BagleyD.M., LipmanJ.M., PapeW.J.W., MiltenburgerH., de SilvaO., HoferH., & SteilingW. (1997). IRAG working group 2: CAM-based assays. Food and Chemical Toxicology35, 39–66.
87.
GilleronL., CoeckeS., SysmansM., HansenE., van OproyS., MarzinD., van CauterenH., & VanparysP. (1997). Evaluation of the HET-CAM-TSA method as an alternative to the Draize eye irritation test. Toxicology in Vitro11, 641–644.
88.
Anon. (2001). Zebet 25: The hen's egg-chorioallantoic membrane test (HET-CAM test) for the assessment of the eye irritation potential of chemical substances. AnimAlt-Zebet database. Website http://www.bfr.bund.de/cd/1508 (Accessed 25.08.04).
89.
BagleyD.M., WatersD., & KongB.M. (1994). Development of a 10-day chorioallantoic membrane vascular assay as an alternative to the Draize rabbit eye irritation test. Food and Chemical Toxicology33, 1155–1160.
90.
LeightonJ., NassauerJ., & TchaoR. (1985). The chick embryo in toxicology: an alternative to the rabbit eye. Food and Chemical Toxicology23, 293–298.
91.
BagleyD.M., KongB.M., & DesalvaS.J. (1989). Assessing the eye irritation potential of surfactant-based materials using the chorioallantoic membrane vascular assay (CAMVA). In Alternative Methods in Toxicology Series — Symposium on in vitro toxicology: new directions (ed. GoldbergA.M.), vol. 7, pp. 265–272. New York, USA: Mary Ann Liebert, Inc.
92.
BagleyD.M., RizviP.Y., KongB.M., & SalvaS.J. (1991). Factors affecting use of the hens egg chorioallantoic membrane as a model for predicting eye irritation potential. Journal of Toxicology — Cutaneous and Ocular Toxicology10, 95–104.
93.
BagleyD., BoomanK.A., BrunerL.H., CastertonP.L., DemetruliasJ., HeinzeJ.E., InnisJ.D., McCormickW.C.III, & NeunD.J. (1994). The SDA alternatives program phase III: comparison of in vitro data with animal eye irritation data on solvents, surfactants, oxidizing agents, and prototype cleaning products. Journal of Toxicology — Cutaneous and Ocular Toxicology13, 127–155.
94.
BagleyD.M., CervinD., & HarbellJ.W. (1999). Assessment of the chorioallantoic membrane vascular assay (CAMVA) in the COLIPA in vitro eye irritation validation study. Toxicology in Vitro13, 285–293.
95.
CervenD., & MorenoO. (1998). Bovine corneal opacity and permeability test validation as an alternative to the Draize eye irritation assay. In Adv Anim Altern Saf Efficacy Test (ed. SalemH., & KatzS.A.), pp. 261–267. Washington, DC, USA: Taylor & Francis.
96.
Anon. (2001). Zebet 272: The chicken egg chorio-allantoic membrane vascular assay (CAMVA) as an alternative to the rabbit eye irritation test. AnimAlt-Zebet database. Website http://www.bfr.bund.de/cd/1508 (Accessed 25.08.04).
97.
HaginoS., ItagakiH., KatoS., KobayashiT., & TanakaM. (1991). Quantitative evaluation to predict the eye irritancy of chemicals: Modification of chorioallantoic membrane test by using trypan blue. Toxicology in Vitro5, 301–304.
98.
HaginoS., ItagakiH., KatoS., & KobayashiT. (1993). Further evaluation of the quantitative chorioallantoic membrane test using trypan blue stain to predict the eye irritancy of chemicals. Toxicology in Vitro7, 35–39.
SoutheeJ.A., McPhersonJ.P., OsborneR., CarrG.J., & RasmussenE. (1999). The performance of the tissue equivalent assay using the Skin2™ ZK1200 model in the COLIPA International Validation Study on Alternatives to the Draize Eye Irritation Test. Toxicology in Vitro13, 355–373.
101.
McCainN.E., BinettiR.R., GettingsS.D., & JonesB.C. (2002). Assessment of ocular irritation ranges of market-leading cosmetic and personal-care products using an in vitro tissue equivalent. The Toxicologist66, 243.
102.
GhassemiA., OsborneR., KohrmanK. A., RoddyM. T., HarbellJ.W., & KanengiserB.E. (1997). Demonstrating the ocular safety of an eye cosmetic product using alternatives to animal eye irritation tests. The Toxicologist36, 42.
103.
SternM., KlausnerM., AlvaradoR., ReskersK., & DickensM. (1998). Evaluation of EpiOcular™ Tissue model as an alternative to the Draize eye irritation test. Toxicology in Vitro12, 455–461.
104.
BlazkaM.E., HarbellJ.W., KlauznerM., RaabeH., KubilusJ., HsiaF., MinerathB., KotlerM., & BagleyD.M. (2000). Colgate-Palmolive's program to validate the EpiOcular™ human tissue construct model. The Toxicologist54, 188.
105.
BlazkaM., HarbellJ.W., KlausnerM., MerrillJ.C., KubilusJ., KlossC., & BagleyD.M. (2003). Evaluating the ocular irritation potential of 54 test articles using the EpiOcular human tissue construct model (OCL-200). The Toxicologist72, 221.
106.
NguyenD.H., BeuermanR.W., De WeverB., & RosdyM. (2003). Three-dimensional construct of the human corneal epithelium for in vitro toxicology. In Alternative Methods for the New Millenium (ed. SalemH., & KatzS.A.), Chapter 14, pp. 145–157. Boca Raton, FL, USA: CRC Press.
107.
De WeverB., TornierC., RosdyC., & BeuermanR. (2002). In vitro corneal recovery assay using a reconstituted human corneal epithelial model. In Fourth World Congress on Alternatives and Animal Use in the Life Sciences: Program and Abstracts. Website http://www.worldcongress.net/abstract-book/posters/posters-a1.htm (Accessed 20.8.04).
108.
JonesP., KingA., & FentemJ. (2001). The effect of known eye irritants on the SkinEthic and Epiocular models of corneal epithelium. In Matteck Corporation: Technical References: Abstract 253. Website http://www.mattek.com/pages/abstracts/253 (Accessed 20.08.04).
109.
BrinchD.S., & ElvigS.G. (2001). Evaluation of an in vitro human corneal model as alternative to the in vivo eye irritation testing of enzymes. Toxicology Letters123 suppl. 1, 22.
110.
CourtellemontP., PannetierM., PerrierP., & PericoiM. (1999). The use of alternative methods and clinical tests in the ocular risk assessment of cosmetic formulations. In Alternatives to Animal Testing II (ed. ClarckD.G., LisanskyS.G., & MacMillanR.), pp 82–86. Newbury, Berkshire, UK: CPL Press.
111.
DoucetO., LanvinM., & ZastrowL. (1998). A new in vitro human epithelium model for assessing the eye irritation potential of formulated cosmetic products. In Vitro and Molecular Toxicology11, 273–283.
112.
DoucetO., LanvinM., & ZastrowL. (1999). Comparison of three in vitro methods for the assessment of the eye irritation potential of formulated cosmetic products. In Vitro and Molecular Toxicology12, 63–76.
113.
KahnC.R., YoungE., LeeI.H., & RhimJ.S. (1993). Human corneal epithelial primary cultures and cell lines with extended life span: in vitro model for ocular studies. Investigative Ophthalmology & Visual Science34, 3429–41.
114.
MauriceD.M. (1967). The use of fluorescein in ophthalmological research. Investigative Ophthalmologyl6, 464–77.
115.
KruszewskiF.H., WalkerT.L., WardS.L., & DipasqualeL.C. (1995). Progress in the use of human ocular tissues for in vitro alternative methods. Comments in Toxicology5, 203–224.
116.
BorenfreundE., & PuernerJ.A. (1984). A simple quantitative procedure using monolayer cultures for cytotoxicity assays (HTD/NR-90). Journal of Tissue Culture Methods9, 7–9.
117.
BorenfreundE., & PuernerJ.A. (1985). Toxicity determined in vitro by morphological alterations and neutral red absorption. Toxicology Letters24, 119–124.
118.
BarstadtR., CortesiJ., & JanusJ. (1991). Use of Clonetics neutral red bioassay to optimize components of serum-free medium for normal human anchorage-dependent cells. In Vitro Cellular & Developmental Biology27, 160.
119.
HarbellJ.W., KoontzS.W., LewisR.W., LovellD., & AcostaD. (1997). IRAG Working Group 4. Cell cytotoxicity assays. Food and Chemical Toxicology35, 79–126.
120.
ClothierR.H. (1990). INVITTOX Protocol 3: The FRAME Modified Neutral Red Uptake Cytotoxicity Test. ECVAM SIS Database. Ispra, Italy: ECVAM, European Commission JRC. Website http://ecvam-sis.jrc.it (Accessed 25.08.04).
121.
HarbellJ.W. (1994). INVITTOX Protocol no. 100: Neutral Red Bioassay Using BALB/c 3T3 Cells. European Commission DG-JRC, ECVAM, SIS Database. Website http://ecvam-sis.jrc.it (Accessed 25.08.04).
JonesP.A., BracherM., MarenusK., & KojimaH. (1999). Performance of the neutral red uptake assay in the COLIPA international validation study on alternatives to the rabbit eye irritation test. Toxicology in Vitro13, 325–333.
126.
KalweitS., BesokeR., GernerI., & SpielmannH (1990). A national validation project of alternative methods to the Draize rabbit eye test. Toxicology in Vitro4, 702–706.
127.
TaniN., KinoshitaS., OkamotoY., KotaniM., ItagakiH., MurakamiN., SugiuraS., UsamiM., KatoK., KojimaH., OhnoT., SaijoK., KatoM., HayashiM., & OhnoY. (1999). Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (8) Evaluation of cytotoxicity tests on SIRC cells. Toxicology in Vitro13, 175–187.
128.
BrunerL.H., DenverJ.K., DeirdreA.R., & ParkerR.D. (1991). Evaluation of seven in vitro alternatives for ocular safety testing. Fundamental and Applied Toxicology17, 136–149.
129.
RougierA., CottinM., DeSilvaO., RoguetR., CatrouxP., TougicA., & DossouK. (1992). In vitro methods: their relevance and complementarity in ocular safety assessment. Lens and Eye Toxicity Research9, 229–245.
130.
StricklandJ.A., StokesW.S., CasatiS., ParisM.W., WorthA., RaabeH., CaoC., ClothierR., HarbellJ., CurrenR., HasemanJ., & TiceR.R. (2003). Design of a validation study to evaluate in vitro cytotoxicity assays for predicting rodent and human acute systemic toxicity. In ICCVAM-NICEA™: Test Method Evaluations: In Vitro Methods for Assessing Acute Systemic Toxicity: In Vitro Cytotoxicity Validation Study: Validation Study Posters and Presentation Abstracts. Website http://iccvam.niehs.nih.gov/meetings/SOT03/poster/strickl.pdf (Accessed 20.08.04).
131.
Anon. (2001). Zebet 26: The neutral red uptake (NRU) cytotoxicity assay for the in vitro assessment of the eye irritation potential of chemical substances. AnimAlt-Zebet database. Website http://www.bfr.bund.de/cd/1508 (Accessed 25.08.04).
132.
ReaderS.J., BlackwellV., O'HaraR., ClothierR.H., GriffinG., & BallsM. (1989). A vital dye release method for assessing the short term cytotoxic effects of chemicals and formulations. ATLA17, 28–37.
133.
ReaderS.J., BlackwellV., O'HaraR., ClothierR.H., GriffinG., & BallsM. (1990). Neutral red release from pre-loaded cells as in vitro approach to testing for eye irritancy potential. Toxicology in Vitro4, 264–266.
134.
ZuangV. (2001). The neutral red release assay: a review. ATLA29, 575–599.
135.
ClothierR.H. (1992). INVITTOX Protocol 54: The FRAME Neutral Red Release Assay. ECVAM SIS Database. Ispra, Italy,: ECVAM, European Commission JRC. Website http://ecvam-sis.jrc.it (Accessed 25.08.04).
136.
GuyomardC., BouffechouxJ., BournicheJ., & ChesneC. (1994). Evaluation of PREDISAFE, a cell kit for predicting eye irritancy of cosmetic raw materials and formulations. Cell Biology and Toxicology10, 375–379.
137.
BrunerL.H., de SilvaO., EarlL.K., EastyD.L., PapeW., & SpielmannH. (1998). Report on the COLIPA workshop on mechanisms of eye irritation. ATLA26, 811–820.
138.
CourtellemontP., HebertP., BiesseJ.P., CastelliD., FriteauL., SerranoJ., & RoblesC. (1999). Relevance and reliability of the PREDISAFE assay in the COLIPA eye irritation validation program (phase 1). Toxicology in Vitro13, 305–312.
139.
de SilvaO., CottinM., DamiN., RoguetR., CatrouxP., TouficA., SicardC., DossouK.G., GernerI., SchledeE., SpielmannH., GuptaK.C., & HillR.N. (1997). Evaluation of eye irritation potential: statistical analysis and tier testing strategies. Food and Chemical Toxicology35, 159–164.
140.
MuirC.K., FlowerC., & van AbbN.J. (1983). A novel approach to the search for in vitro alternatives to in vivo eye irritancy testing. Toxicology Letters18, 1–5.
141.
PapeW.J.W., PfannenbeckerU., & HoppeU. (1987). Validation of the red blood cell test system as in vitro assay for the rapid screening of irritation potential of surfactants. Molecular Toxicology1, 525–536.
142.
PapeW.J.W., & HoppeU. (1990). Standardization of an in vitro red blood cell test for evaluating the acute cytotoxic potential of tensides. Arzneimittelforschung40, 498–502.
143.
LewisR.W., McCallJ.C., & BothamP.A. (1993). A comparison of two cytotoxicity tests for predicting the ocular irritancy of surfactants. Toxicology in Vitro7, 155–158.
144.
LewisW. (1994). INVITTOX Protocol 99: Red Blood Cell Lysis and Protein Denaturation. RCVAM SIS Database. Ispra, Italy: ECVAM, European Commission JRC. Website http://ecvam-sis.jrc.it (Accessed 25.08.04).
145.
PapeW.J.W., & HoppeU. (1991). In vitro methods for the assessment of primary local effects of topically applied preparations. Skin Pharmacology4, 205–212.
146.
PapeW.J.W., & PfannenbeckerU. (1992). INVITTOX Protocol 37: Red Blood Cell Test System. ECVAM SIS Database. Ispra, Italy: ECVAM, European Commission JRC. Website http://ecvam-sis.jrc.it (Accessed 25.08.04).
147.
OkamotoY., OhkoshiK., ItagakiH., TsudaT., KakishimaH., OgawaT., KasaiY., OhuchiJ., KojimaH., KurishitaA., KanekoT., MatsushimaY., IwabuchiY., & OhnoY. (1999). Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (3) Evaluation of the haemolysis test. Toxicology in Vitro13, 115–124.
148.
HataoM., MurakamiN., SakamotoK., OhnumaM., MatsushigeC., KakishimaH., OgawaT., KojimaH., MatsukawaK., MasudaK., ChibaK., YoshizawaK., KanekoT., IwabuchiY., & MatsushimaY. (1999). Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (4) Haemoglobin denaturation test. Toxicology in Vitro13, 125–137.
149.
PapeW.J.W., PfannenbeckerU., ArgembeauxH., BracherM., EsdaileD.J., HaginoS., KasaiY., & LewisR.W. (1999). COLIPA validation project on in vitro eye irritation tests for cosmetic ingredients and finished products (phase I): the red blood cell test for the estimation of acute eye irritation potentials. Present status. Toxicology in Vitro13, 343–354.
150.
Anon. (2001). Zebet 30: The red blood cell haemolysis and protein denaturation test (RBC test) as an in vitro alternative assay to the in vivo rabbit eye irritation test. AnimAlt-Zebet database. Website http://www.bfr.bund.de/cd/1508 (Accessed 25.08.04).
151.
CookJ., GabrielsJ., PatroneL., RhoadsL., & van BuskirkR.G. (1992). A human epidermal model that can be used in an automated multiple endpoint assay. ATLA20, 313–324.
152.
RhoadsL.S., CookJ.R., PatroneL.M., & van BuskirkR.G. (1993). A human epidermal model can be assayed employing a multiple fluorescent endpoint assay and the CytoFluor 2300. Journal of Toxicology — Cutaneous and Ocular Toxicology12, 87–108.
153.
CottinM., & ZanvitA. (1997). Flourescein leakage test: a useful tool in ocular safety assessment. Toxicology in Vitro11, 399–405.
154.
ShawA.J., ClothierR.H., & BallsM. (1990). Loss of trans-epithelial impermeability of a confluent monolayer of Madin-Darby Canine Kidney (MDCK) cells as a determinant of ocular irritancy potential. ATLA18, 145–151.
155.
ShawA.J., BallsM., ClothierR.H., & BatemanN.D. (1991). Predicting ocular irritancy and recovery from injury using madindarby canine kidney cells. Toxicology in Vitro5/6, 569–571.
CottinM., DossouK.G., de SilvaO., TolleM., RoguetR., CohenC., CatrouxP., DelabarreI., SicardC., & RougierA. (1994). Relevance and reliability of in vitro methods in ocular safety assessment. In Vitro Toxicology7, 277–282.
158.
BothamP., OsborneR., AtkinsonK., CarrG., CottinM., & van BuskirkR.G. (1997). IRAG (Interagency Regulatory Alternatives Group) working group 3. Cell function based assays. Food and Chemical Toxicology35, 67–77.
159.
Drewitt-BarlowB., McPhersonF., BroydF., & WilliamsonP. (2000). No tears for baby. Global Cosmetic Industry167, 16–20.
160.
WardR.K., MungallS., CarterJ., & ClothierR.H. (1997). Evaluation of tissue culture insert membrane compatibility in the fluorescein leakage assay. Toxicology in Vitro11, 761–768.
161.
ClothierR.H., StarzecG., StiphoS., & KwongY.C. (1999). Assessment of initial damage and recovery following exposure of MDCK cells to an irritant. Toxicology in Vitro13, 713–717.
162.
Anon. (2001). Zebet 270. The assessment of the eye irritation potential of chemical substances with the fluorescence leakage test. AnimAlt-Zebet database. Website http://www.bfr.bund.de/cd/1508 (Accessed 25.08.04).
163.
BrunerL.H., MillerK.R., OwickiJ.C., ParceJ.W., & MuirV.C. (1991). Testing ocular irritancy in vitro with the silicon microphysiometer. Toxicology in Vitro5, 277–284.
164.
McConnellH.M., OwickiJ.C., ParceJ.W., MillerD.L., BaxterG.T., WadaH.G., & PitchfordS. (1992). The cytosensor microphysiometer: biological applications of silicon technology. Science, New York257, 1906–1912.
165.
CatrouxP., RougierA., DossouK.G., & CottinM. (1993). The silicon microphysiometer for testing ocular toxicity in vitro.Toxicology in Vitro7, 465–469.
166.
HarbellJ.W., OsborneR., CarrG.J., & PetersonA. (1999). Assessment of the cytosensor microphysiometer assay in the COLIPA in vitro eye irritation validation study. Toxicology in Vitro13, 313–323.
167.
Anon. (2001). Zebet 245. The assessment of the eye irritation potential of chemical substances using the silicon microphysiometer. AnimAlt-Zebet database. Website http://www.bfr.bund.de/cd/1508 (Accessed 25.08.04).
168.
AdriaensE., & RemonJ.P. (2002). The evaluation of an alternative mucosal irritation test using slugs. Toxicology and Applied Pharmacology182, 169–175.
169.
AdriaensE., & RemonJ.P. (1999). Gastropods as an evaluation tool for screening the irritating potency of absorption enhancers and drugs. Pharmaceutical Research16, 1240–1244.
170.
AdriaensE., DierckensK., BautersT.G.M., NelisH.J., Van GoethemF., VanparysP., & RemonJ.P. (2001). The mucosal toxicity of different benzalkonium chloride analogues with an alternative test using slugs. Pharmaceutical Research18, 937–942.
171.
AdriaensE., AmeyeD., DhondtM.M.M., ForemanP., & RemonJ.P. (2003). Evaluation of the mucosal irritation potency of co-spray dried Amioca/Poly(Acrylic Acid) and Amioca/Carbopol 974P mixtures. Journal of Controlled Release88, 393–399.
172.
CallensC., AdriaensE., DierckensK., & RemonJ.P. (2001). Toxicological evaluation of a bioadhesive nasal powder containing a starch and carbopol 974 p on rabbit nasal mucosa and slug mucosa. Journal of Controlled Release76, 81–91.
173.
CeulemansJ., VermeireA., AdriaensE., RemonJ.P., & LudwigA. (2001). Evaluation of a mucoadhesive tablet for ocular use. Journal of Controlled Release77, 333–344.
174.
DhondtM.M.M., AdriaensE., & RemonJ.P. (2004). The evaluation of the local tolerance of vaginal formulations, with or without nonoxynol-9, using the slug mucosal irritation test. Sexually Transmitted Diseases31, 229–235.
175.
KellyC.P. (1989). EYTEX: an in vitro method of predicting ocular safety. Pharmacopeial Forum15, 4815–5824.
176.
GordonV.C. (1992). The scientific basis of the EYTEX system. ATLA20, 537–548.
177.
DeckerD., & HarperR. (1993). Evaluation of the EYTEX system for use as a predictor of ocular irritancy of shampoos. In Alternative Methods in Toxicology (ed. GoldbergA.M. ed.), pp. 236. New York, USA: Mary Ann Liebert Inc.
178.
MatsukawaK., MasudaK., KakishimaH., SuzukiK., NakagawaY., MatsushigeC., ImanishiY., NakamuraT., MizutaniA., WatanabeR., ShingaiT., KanekoT., HiroseA., & OhnoY. (1999). Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. Toxicology in Vitro13, 209–217.
179.
CurrenR.D., SinaF.J., FederP., KruszewskiF.H., OsborneR., & RegnierJ.F. (1997). IRAG (Interagency Regulatory Alternatives Group) working group 5 — other assays. Food and Chemical Toxicology35, 127–158.
180.
CourtellemontP., PannetierM., BiesseJ.P., LarnicolM., BaretJ.P., & BredaB. (1999). Evaluation of the EYTEX system in the COLIPA eye irritation program. Toxicology in Vitro13, 295–304.
181.
Anon. (2001). Zebet 271: The EYTEX assay system as an in vitro alternative to the Draize rabbit eye irritation test. AnimAlt-Zebet database. Website http://www.bfr.bund.de/cd/1508 (Accessed 25.08.04).
182.
GentileA.G., VaughanA.W., & PfeifferD.G. (1978). Cucumber pollen germination and tube elongation inhibited or reduced by pesticides and adjuvants. Environmental Entomology7, 689–691.
183.
WoltersJ.H.B., & MartensM.J.M. (1987). Effects of air pollutants on pollen. The Botanical Review53, 372–414.
184.
KapplerR., & KristenU. (1987). Photometric quantification of in vitro pollen tube growth: a new method suited to determine the cytotoxicity of various environmental substances. Environmental and Experimental Botany27, 305–309.
185.
KapplerR., & KristenU. (1988). Photometric quantification of water-insoluble polysaccharides produced by in vitro grown pollen tubes. Environmental and Experimental Botany28, 33–36.
186.
KapplerR., & KristenU. (1990). INVITTOX Protocol 55: The Pollen Tube Growth Test (PTG-TEST). ECVAM SIS Database.Ispra, Italy: ECVAM, European Commission JRC. Website http://ecvam-sis.jrc.it (Accessed 25.08.04).
187.
KristenU., & KapplerR. (1995). The pollen tube growth test. In Methods in Molecular Biology: In Vitro Toxicity Testing Protocols (ed. O'HareS., & AtterwillC.K.), vol. 43, pp. 189–198. Totowa, NJ, USA: Humana Press.
188.
StrubeK., JankeD., KapplerR., & KristenU. (1991). Toxicity of some herbicides to in vitro growing tobacco pollen tubes (the pollen test). Environmental and Experimental Botany31, 217–222.
189.
FederP.I., LordoR.A., DipasqualeL.C., BagleyD.M., ChudkowskiM., DemetruliasJ.L., HintzeK.L., MarenusK.D., PapeW.J.W., RoddyM., SchnetzingerR., SilberP.M., TealJ.J., WeiseS.L., & GettingsS.D. (1991). The CTFA evaluation of alternatives program: an evaluation of in vitro alternatives to the Draize primary eye irritation test (phase I) hydro-alcoholic formulations: (part I) statistical methods. In Vitro Toxicology4, 231–246.
190.
KristenU., JungK., PapeW., PfannenbeckerU., RenschA., & SchellR. (1999). Performance of the pollen tube growth test in the COLIPA validation study on alternatives to the rabbit eye irritation test. Toxicology in Vitro13, 335–342.
191.
EkwallB., BarileF., BjarregaardH., ChesneC., ClothierR., & DierickxP. (1990). Preliminary results from the Scandinavian multicentre evaluation of in vitro cytotoxicity (MEIC). Toxicology in Vitro4, 688–691.
192.
ClemedsonC., McFarlane-AbdullaE., AnderssonM., BarileF.A., CallejaM.C., ChesneC., ClothierR., CottinM., CurrenR., DierickxP., FerroM., FiskesjoeG., Garza-OcanasL., Gomez-LechonM.J., & GueldenM. (1996). MEIC evaluation of acute systemic toxicity. Part II: In vitro results from 68 toxicity assays used to test the first 30 reference chemicals and a comparative cytotoxicity analysis. ATLA24, 273–311.
193.
Anon. (2001). Zebet 101: The pollen tube growth (PTG) test as a pre-screening alternative for the determination of cytotoxicity and eye irritation potential of chemical substances. AnimAlt-Zebet database. Website http://www.bfr.bund.de/cd/1508 (Accessed 25.08.04).
194.
GriffithJ.F., NixonG.A., BruceR.D., ReerP.J., & BannanE.A. (1980). Dose-response studies with chemical irritants in the albino rabbit eye as a basis for selecting optimum testing conditions for predicting hazard to the human eye. Toxicology and Applied Pharmacology55, 501–513.
195.
GriffithJ.F. (1987). The low volume eye irritation test. Soap Cosmetics Chemical Specialities63, 32–63.
196.
BrunerL.H., ParkerR.D., & BruceR.D. (1992). Reducing the number of rabbits in the low volume eye test. Fundamental and Applied Toxicology19, 330–335.
197.
TalsmaD.M., LeachC.L., HatoumN.S., GibbonsR.D., RogerJ.C., & GarvinP.J. (1988). Reducing the number of rabbits in the Draize eye irritancy test: a statistical analysis of 155 studies conducted over 6 years. Fundamental and Applied Toxicology10, 146–153.
198.
BerdascoN.A.M., GiblertK.S., LacherJ.W., & MattsonJ.L. (1996). Low rate of severe injury from dermal and ocular irritation tests and the validity of using fewer animals. Journal of the American College of Toxicology15, 177–193.
199.
AllgoodG.S., (1989). Use of animal eye test data and human experience for determining the ocular irritation potential of shampoos. Journal of Toxicology — Cutaneous and Ocular Toxicology8, 321–326.
200.
CormierE.M., HunterJ.E., BillheimerW., MayJ., & FarageM.A. (1995). Use of clinical and consumer eye irritation data to evaluate the low volume eye test. Journal of Toxicology — Cutaneous and Ocular Toxicology14, 197–205.
201.
RoggebandR., YorkM., PericoiM., & BraunW. (2000). Eye irritation responses in rabbit and man after single applications of equal volumes of undiluted model liquid detergent products. Food and Chemical Toxicology38, 727–734.
202.
CormierE.M., ParkerR.D., HensonC., CruzeL.W., MerrittA.K., BruceR.D., & OsborneR. (1996). Determination of the intra- and interlaboratory reducibility of the low volume eye test and its statistical relationship to the Draize eye test. Regulatory Toxicology and Pharmacology23, 156–161.
203.
GettingsS.D., LordoR.A., DemetruliasJ., FederP.I., & HintzeK.L. (1996). Comparison of low volume, Draize and in vitro eye irritation test data. I. Hydroalcoholic formulations. Food and Chemical Toxicology34, 737–749.
204.
GettingsS.D., LordoR.A., FederP.I., & HintzeK.L. (1998). A comparison of low volume, Draize and in vitro eye irritation test data. III. surfactant-based formulations. Food and Chemical Toxicology36, 209–231.
205.
GettingsS.D., LordoR.A., FederP.I., & HintzeK.L. (1998). A comparison of low volume, Draize and in vitro eye irritation test data. II. Oil/water emulsions. Food and Chemical Toxicology36, 47–59.
206.
LambertL.A., ChambersW.A., GreenS., GuptaK.C., HillR.N., HurleyP.M., LeeC.C., LeeJ.K., LiuP.T., & LowtherD.K. (1993). The use of low volume dosing in the eye irritation test. Food and Chemical Toxicology31, 99–103.
207.
EC (1992). Council Directive 92/32/EEC of 30 April 1992 amending for the seventh time Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Official Journal of the European CommunitiesL154, 05.06.1992.
208.
Anon. (2001). Zebet 236: The in vivo low volume eye test as a refinement of the Draize eye test to assess the eye irritation potential of chemical substances. AnimAlt-Zebet database. Website http://www.bfr.bund.de/cd/1508 (Accessed 25.08.04).
209.
CroninM.T.D., JaworskaJ.S., WalkerJ.D., ComberM.H.I., WattsC.D., & WorthA.P. (2003). Use of QSARs in international decision-making frameworks to predict health effects of chemical substances. Environmental Health Perspectives111, 1391–1401.
210.
CroninM.T.D., BasketterD.A., & YorkM. (1994). A quantitative structure-activity relationship (QSAR) investigation of a Draize eye irritation database. Toxicology in vitro8, 21–28.
211.
AbrahamM.H., KumarsinghR., Cometto-MunizJ.E., & CainW.S. (1998). A quantitative structure-activity relationship (QSAR) for a Draize eye irritation database. Toxicology in vitro12, 201–207.
212.
AbrahamM.H., HassanisadiM., Jalali-HeraviM., GhafourianT., CainW.S., & Cometto-MunizJ.E. (2003). Draize rabbit eye test compatibility with eye irritation thresholds in humans: a quantitative structure-activity relationship analysis. Toxicological Sciences76, 384–392.
213.
BarrattM.D. (1995). A quantitative structure-activity relationship for the eye irritation potential of neutral organic chemicals. Toxicology Letters80, 69–74.
214.
CroninM.T.D. (1996). The use of cluster significance analysis to identify asymmetric QSAR data sets in toxicology. An example with eye irritation data. SAR and QSAR in Environmental Research5, 167–175.
215.
WorthA.P., & CroninM.T.D. (1999). Embedded cluster modelling — a novel method for analysing embedded data sets. Quantitative Structure-Activity Relationships18, 229–235.
216.
WorthA.P., & CroninM.T.D. (2000). Embedded cluster modelling: a novel QSAR method for generating elliptic models of biological activity. In Progress in the Reduction, Refinement and Replacement of Animal Experimentation (ed. BallsM., van ZellerA-M., & HalderM.E.), pp. 479–491. Amsterdam. The Netherlands: Elsevier Science.
217.
KulkarniA.S., & HopfingerA.J. (1999). Membrane-interaction QSAR analysis: application to the estimation of eye irritation by organic compounds. Pharmaceutical Research16, 1245–1253.
218.
PatlewiczG.Y., RodfordR.A., EllisG., & BarrattM.D. (2000). A QSAR model for the eye irritation of cationic surfactants. Toxicology in Vitro14, 79–84.
219.
RosenkranzH.S., ZhangY.P., & KlopmanG. (1998). The development and characterisation of a structure-activity relationship model of the Draize eye irritation test. ATLA26, 779–809.
220.
GriffithM., OsborneR., MungerR., XiongX., DoillonC.J., LaycockN.L., HakimM., SongY., & WatskyM.A. (1999). Functional human corneal equivalents constructed from cell lines. Science, New York286, 2169–2172.
221.
de SilvaO., & BasketterD. (2004). The Research Programme SCAAT. ATLA32, Suppl. 1, 679–682.
222.
BallsM., BlaauboerB.J., FentemJ.H., BrunerL., CombesR.D., EkwallB., FielderR.J., GuillouzoA., LewisR.W., LovellD.P., ReinhardtC.A., RepettoG., SladowskiD., SpielmannH., & ZuccoF. (1995). Practical aspects of the validation of toxicity test procedures. The report and recommendations of ECVAM workshop 5. ATLA23, 129–147.
223.
EC (2004). Manual of Decisions for Implementation of the 6th and 7th Amendments to Directive 67/548/EEC on Dangerous Substances. Updated version of July 2004 (EUR 20519). 189 pp. Ispra, Italy: European Chemicals Bureau, European Commission JRC. Website http://ecb.jrc.it/classification-labelling.