OECD (2001). Revised Proposals for Updated Test Guidelines 404 and 405: Dermal and Eye Corrosion/Irritation Studies. ENV/JM/TG(2001)2, 112 pp. Paris, France: OECD.
2.
BarrattM.D. (1996). Quantitative structure–activity relationships for skin irritation and corrosivity of neutral and electrophilic organic chemicals. Toxicology in Vitro10, 247–256.
3.
BarrattM.D. (1996). Quantitative structure–activity relationships (QSARs) for skin corrosivity of organic acids, bases and phenols: principal components and neural network analysis of extended datasets. Toxicology in Vitro10, 85–94.
4.
BarrattM.D., BrantomP.G., FentemJ.H., GernerI., WalkerA.P., & WorthA.P. (1998). The ECVAM international validation study on in vitro tests for skin corrosivity. 1. Selection and distribution of the test chemicals. Toxicology in Vitro12, 471–482.
5.
WhittleE.G., BarrattM.D., CarterJ.A., BasketterD.A., & ChamberlainM. (1996). The skin corrosivity potential of fatty acids: in vitro rat and human skin testing and QSAR studies. Toxicology in Vitro10, 95–100.
6.
BarrattM.D., DixitM.B., & JonesP.A. (1996). The use of in vitro cytotoxicity measurements in QSAR methods for the prediction of the skin corrosivity potential of acids. Toxicology in Vitro10, 283–290.
7.
WorthA.P. (2000). The Integrated Use of Physicochemical and In Vitro Data for Predicting Chemical Toxicity. PhD Thesis. Liverpool John Moores University, UK.
8.
GernerI., GraetschelG., KahlJ., & SchledeE. (2000). Development of a decision support system for the introduction of alternative methods into local irritancy/corrosivity testing strategies: development of a relational database. ATLA28, 11–28.
9.
GernerI., ZinkeS., GraetschelG., & SchledeE. (2000). Development of a decision support system for the introduction of alternative methods into local irritancy/corrosivity testing strategies: creation of fundamental rules for a decision support system. ATLA28, 665–98.
10.
ZinkeS., GernerI., GraetschelG., & SchledeE. (2000). Local irritation/corrosion testing strategies: development of a decision support system for the introduction of alternative methods. ATLA28, 29–40.
11.
FentemJ.H., ArcherG.E.B., BallsM., BothamP.A., CurrenR.D., EarlL.K., EsdaileD.J., HolzhütterH.G., & LiebschM. (1998). The ECVAM international validation study on in vitro tests for skin corrosivity. 2. Results and evaluation by the Management Team. Toxicology in Vitro12, 483–524.
12.
LiebschM., TraueD., BarrabasC., SpielmannH., UphillP., WilkinsS., WiemannC., KaufmannT., RemmeleM., & HolzhütterH.G. (2000). The ECVAM prevalidation study on the use of EpiDerm for skin corrosivity testing. ATLA28, 371–401.
ECVAM (2000). Statement on the application of the Epiderm™ human skin model for skin corrosivity testing. ATLA28, 365–366.
15.
ECVAM (2001). Statement on the application of the CORROSITEX® assay for skin corrosivity testing. ATLA29, 96–97.
16.
NIH (1999). Corrositex®: an in vitro test method for assessing dermal corrosivity potential of chemicals. NIH Publication No. 99–4495. Research Triangle Park, NC, USA: NIEHS.
17.
EC (2000). Annex I to Commission Directive 2000/33/EC adapting to technical progress for the 27th 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 CommunitiesL136, 91–97.
18.
OECD (2002). OECD Guidelines for the Testing of Chemicals No. 430: In Vitro Skin Corrosion — Transcutaneous Electrical Resistance Test (TER).Paris, France: Organisation for Economic Cooperation and Development.
19.
OECD (2002). OECD Guidelines for the Testing of Chemicals No. 431: In Vitro Skin Corrosion —Human Skin Model Test.Paris, France: Organisation for Economic Cooperation and Development.
20.
WorthA.P., & CroninM.T.D. (2001). The use of bootstrap resampling to assess the uncertainty of Cooper statistics. ATLA29, 447–459.
21.
WorthA.P., FentemJ.H., BallsM., BothamP.A., CurrenR.D., EarlL.K., EsdaileD.J., & LiebschM. (1998). An evaluation of the proposed OECD testing strategy for skin corrosion. ATLA26, 709–720
22.
WorthA.P., & CroninM.T.D. (2001). The use of pH measurements to predict the potential of chemicals to cause acute dermal and ocular toxicity. Toxicology169, 119–131.
23.
HayashiH., NakamuraY., HigashiK., KatoH., KishidaF., & KanekoH. (1999). A quantitative structure–activity relationship study of the skin irritation potential of phenols. Toxicology in Vitro13, 915–922.
24.
SmithJ.S., MacinaO.T., SussmanN.B., LusterM.I., & KarolM.H. (2000). A robust structure–activity relationship (SAR) model for esters that cause skin irritation in humans. Toxicological Sciences55, 215–222.
25.
BothamP.A., EarlL.K., FentemJ.H., RoguetR., & van de SandtJ.J.M. (1998). Alternative methods for skin irritation testing: the current status. ECVAM skin irritation task force report 1. ATLA26, 195–211.
26.
FentemJ.H., BriggsD., ChesnéC., ElliottG.R., HarbellJ.W., HeylingsJ.R., PortesP., RoguetR., van de SandtJ.J.M., & BothamP.A. (2001). A prevalidation study on in vitro tests for acute skin irritation: results and evaluation by the Management Team. Toxicology in Vitro15, 57–93.
27.
HeylingsJ.R., ClowesH.M., & HughesL. (2001). Comparison of tissue sources for the skin integrity function test (SIFT). Toxicology in Vitro13, 597–600.
28.
ZuangV., BallsM., BothamP.A., CoquetteA., CorsiniE., CurrenR.D., ElliottG.R., FentemJ.H., HeylingsJ.R., LiebschM., MedinaJ., RoguetR., van de SandtH., WiemannC., & WorthA.P. (2002). Follow-up to the ECVAM prevalidation study on in vitro tests for acute skin irritation. ECVAM skin irritation task force report 2. ATLA30, 109–129.
29.
RobinsonM.K., OsborneR., & PerkinsM.A. (2000). In vitro and human testing strategies for skin irritation. Annals of the New York Academy of Sciences919, 192–204.
30.
BasketterD.A., ChamberlainM., GriffithsH.A., RowsonM., WhittleE., & YorkM. (1997). The classification of skin irritants by human patch test. Food and Chemical Toxicology35, 845–852.
31.
SpielmannH., LovellW.W., HölzleE., JohnsonB.E., MaurerT., MirandaM.A., PapeW.J.W., SaporaO., & SladowskiD. (1994). In vitro phototoxicity testing. The report and recommendations of ECVAM workshop 2. ATLA22, 314–348.
32.
SpielmannH., MüllerL., AverbeckD., BallsM., Brendler-SchwaabS., CastellJ.V., CurrenR., de SilvaO., GibbsN.K., LiebschM., LovellW.W., MerkH.F., NashJ.F., NeumannN.J., PapeW.J.W., UlrichP., & VohrH-W. (2000). The second ECVAM workshop on phototoxicity testing. The report and recommendations of ECVAM workshop 42. ATLA28, 777–814.
33.
SpielmannH., BallsM., DupuisJ., PapeW.J.W., PechovitchG., DeSilvaO., HolzhütterH.G., ClothierR.H., DesolleP., GerberickF., LiebschM., LovellW.W., MaurerT., PfannenbeckerU., PotthastJ.M., CsatoM., SladowskyD., SteilingW., & BrantomP. (1998). EU/COLIPA in vitro phototoxicity validation study, results of phase II (blind trial), part 1: the 3T3 NRU phototoxicity test. Toxicology in Vitro12, 305–327.
34.
SpielmannH., BallsM., DupuisJ., PapeW.J.W., DeSilvaO., HolzhütterH-G., GerberickF., LiebschM., LovellW.W., & PfannenbeckerU. (1998). A study on the phototoxic potential of UV filter chemicals from Annex VII of EU Directive 76/768/EEC in the 3T3 NRU in vitro phototoxicity test. ATLA26, 679–705.
35.
ECVAM (1998). Statement on the scientific validity of the EPISKIN™ test (an in vitro test for skin corrosivity). ATLA26, 277–280.
36.
ECVAM (1998). Statement on the scientific validity of the rat skin transcutaneous electrical resistance (TER) test (an in vitro test for skin corrosivity). ATLA26, 275–277.
37.
OECD (2002). OECD Guidelines for the Testing of Chemicals No. 432: In Vitro 3T3 NRU Phototoxicity.Paris, France: Organisation for Economic Cooperation and Development.
38.
DeanS.W., LaneM., DunmoreR.H., RuddockS.P., MartinC.N., KirklandD.J., & LoprienoN. (1991). Development of assays for the detection of photomutagenicity of chemicals during exposure to UV light. I. Assay development. Mutagenesis6, 335–341.
39.
ChetelatA., AlbertiniS., DrespJ.H., StrobelR., & GockeE. (1993). Photomutagenesis test development. I. 8-Methoxypsoralen, chlorpromazine and sunscreen compounds in bacterial and yeast assays. Mutation Research292, 241–250.
40.
ChetelatA., DrespJ.H., & GockeE. (1993). Photomutagenesis test development. II. 8-Methoxy-psoralen, chlorpromazine and sunscreen compounds in chromosomal aberration assays using CHO cells. Mutation Research292, 251–258.
41.
BallsM., BothamP.A., BrunerL.H., & SpielmannH. (1995). The EC/HO international validation study on alternatives to the Draize eye irritation test for classification and labelling of chemicals. Toxicology in Vitro9, 871–929.
42.
BrantomP.G., BrunerL.H., ChamberlainM., DeSilvaO., DupuisJ., EarlL.K., LovellD.P., PapeW.J.W., UttleyM., BagleyD.M., BakerF.W., BakerF.W., BracherM., CourtellemontP., DeclercqI., FreemanS., SteilingW., WalkerA.P., CarrG.J., DamiN., ThomasG., HarbellJ., JonesP.A., PfannenbeckerU., SoutheeJ.A., TchengM., ArgembeauxH., CastelliD., ClothierR.H., 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 irritation test. Toxicology in Vitro11, 141–179.
43.
SpielmannH., GernerI., KalweitS., MoogR., WirnserbergerT., KrauserK., KreilingR., KreuzerH., LuepkeN.P., MiltenburgerH.G., MüllerN., MürmannP., PapeW., SiegmundB., SpenglerJ., SteilingW., & WiebelF.J. (1991). Interlaboratory assessment of alternatives to the Draize eye irritation test in Germany. Toxicology in Vitro5, 539–542.
44.
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.
45.
SpielmannH., KalweitS., LiebschM., MoldenhauerF., WirnserbergerT., HolzhütterH-G., SchneiderB., GlaserS., GernerI., PapeW., KreilingR., KrauserK., MiltenburgerH.G., SteilingW., LuepkeN.P., MüllerN., KreuzerH., MürmannP., SpenglerJ., Bertram-NeisE., SiegmundB., & 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.
46.
GettingsS.D., BagleyD.M., DemetruliasJ.L., DipasqualeL.C., HintzeK.L., RozenM.G., TealJ.J., WeiseS.L., ChudkowskiM., MarenusK.D., PapeW.J.W., RoddyM.T., 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). Hydroalcoholic formulations; (Part 2) Data analysis and biological significance. In Vitro Toxicology4, 247–288.
47.
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.
48.
GettingsS.D., BagleyD.M., CastertonM., ChudkowskiM., CurrenR.D., DemetruliasJ.L., DipasqualeL.C., FederP.I., GalliC.L., GayR., GlazaS.M., HintzeK.L., JanusJ., KurtzP.J., LordoR.A., MarenusK.D., MoralJ., MuscatielloM.J., PapeW.J.W., RenskersK.J., RoddyM.T., & RozenM.G. (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.
49.
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., 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.
50.
BradlawJ., GuptaK., GreenS., HillR., & WilcoxN. (1997). Practical application of non-whole animal alternatives: summary of IRAG workshop on eye irritation testing. Interagency Regulatory Alternatives Group. Food and Chemical Toxicology35, 175–178.
51.
OhnoY., KanekoT., KobayashiT., InoueT., KuroiwaY., YoshidaT., MommaJ., HayashiM., AkiyamaJ., AtsumiT., ChibaK., EndoT., FujiiA., KakishimaH., KojimaH., MasamotoK., MasudaM., MatsukawaS., OhkoshiK., OkadaJ., SakamotoK., TakanoK., & TakanakaA. (1994). First-phase validation of the in vitro eye irritation tests for cosmetic ingredients. In Vitro Toxicology7, 89–94.
52.
BallsM., BergN., BrunerL.H., CurrenR.D., deSilva O., 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.
53.
WorthA.P., & CroninM.T.D. (2001). Prediction models for eye irritation potential based on endpoints of the HET-CAM and neutral red assays. In Vitro and Molecular Toxicology14, 143–156.
54.
CejkovaJ., LojdaZ., BrunovaB., VacikJ., & MichalekJ. (1988). Disturbances in the rabbit cornea after short-term and long-term wear of hydrogel contact lenses: usefulness of histochemical methods. Histochemistry89, 91–97.
55.
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.
56.
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.
57.
KulkarniA.S., & HopfingerA.J. (1999). Membrane-interaction QSAR analysis: application to the estimation of eye irritation by organic compounds. Pharmaceutical Research16, 1245–1253.
58.
BarrattM.D. (1995). A quantitative structure–activity relationship for the eye irritation potential of neutral organic chemicals. Toxicology Letters80, 69–74.
59.
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.
60.
WorthA.P., & CroninM.T.D. (1999). Embedded cluster modelling: a novel method for analysing embedded data sets. Quantitative Structure–Activity Relationships18, 229–235.
61.
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.
62.
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.
63.
PatlewiczG.Y., RodfordR.A., EllisG., & BarrattM.D. (2000). A QSAR model for the eye irritation of cationic surfactants. Toxicology in Vitro14, 79–84.
64.
ECVAM (2000). Preliminary Evaluation of the Application of Reference Standards in the Prevalidation and Validation of In Vitro Tests for Eye Irritation. Final report from TNO BIBRA to ECVAM. TNO BIBRA Report No. 2/3387/00. ECVAM Contract No. 1447–1998-11 F1ED ISP GB.Ispra, Italy: ECVAM.
65.
WorthA.P., & FentemJ.H. (1999). A general approach for evaluating stepwise testing strategies. ATLA27, 161–177.
66.
BrunerL.H., de SilvaO., EarlL.K., EastyD.L., PapeW., & SpielmannH. (1998). Report on the COLIPA workshop on mechanisms of eye irritation. ATLA26, 811–820.
SCCNFP (2000). Notes of Guidance for Testing of Cosmetic Ingredients for their Safety Evaluation. Adopted by the Plenary Session of the SCCNFP of 24 October 2000 (SCCNFP/0321/00 Final). Brussels, Belgium: DG SANCO/C/2.
69.
GautheronP., DukicM., AlixD., & SinaJ.F. (1992). Bovine corneal opacity and permeability test: an in vitro assay of ocular irritancy. Fundamental and Applied Toxicology8, 442–449.
70.
LüpkeN.P. (1985). Hen's egg chorioallantoic membrane test for irritation potential. Food and Chemical Toxicology23, 287–291.
71.
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.
72.
WhittleE., BasketterD., YorkM., KellyL., HallT., McCallJ., BothamP., EsdaileD., & GardnerJ. (1992). Findings of an interlaboratory trial of the enucleated eye method as an alternative eye irritation test. Journal of Pharmacological and Toxicological Methods2, 30–41.
73.
BurtonA.B.G., YorkM., & LawrenceR.S. (1981). The in vitro assessment of severe irritants. Food and Cosmetics Toxicology19, 471–480.
74.
TchaoR. (1988). Trans-epithelial permeability of fluorescein in vitro as an assay to determine eye irritants. In Alternative Methods in Toxicology, Vol. 6, Progress in In Vitro Toxicology (ed. GoldbergA.M.). pp. 271–283. New York, NY, USA: Mary Ann Liebert.
75.
BorenfreundE., & PuernerJ.A. (1985). Toxicity determined in vitro by morphological alterations and neutral red absorption. Toxicology Letters24, 119–124.
76.
ReaderS.J., BlackwellV., O'HaraR., ClothierR., GriffinG., & BallsM. (1989). A vital dye release method for assaying the short-term cytotoxic effects of chemicals and formulations. ATLA17, 28–33.
77.
PapeW.J.W., & HoppeU. (1991). In vitro methods for the assessment of primary local effects of topically applied preparations. Skin Pharmacology4, 205–212.
78.
WallinR.F., HumeR.D., & JacksonE.M. (1987). The agarose diffusion method for ocular irritancy screening cosmetic products, part I. Journal of Toxicology — Cutaneous and Ocular Toxicology6, 239–250.
79.
SternM., KlausnerM., AlvaradoR., RenskersK., & DickensM. (1998). Evaluation of the EpiOcular™ tissue model as an alternative to the Draize eye irritation test. Toxicology in Vitro12, 455–461.