The EC/HO international validation study on alternatives to the draize eye irritation test

Balls, Michael; Botham, Philip A.; Bruner, Leon H.; Spielmann, Horst

doi:10.1016/0887-2333(95)00092-5

Cited by 220 publications

(130 citation statements)

References 16 publications

Supporting

Mentioning

124

Contrasting

Unclassified

Order By: Relevance

“…For the eight VOCs, the average difference in the two measures of potency is 0.7 log units with considerable variation. As the standard error in the log(DES) values is almost one log unit (Balls et al, 1995), we do not expect any better agreement. However, we can say that there is some match between log(DES/P o ) and log(1/EIT).…”

Section: Methodsmentioning

confidence: 86%

Draize Eye Scores and Eye Irritation Thresholds in Man Combined into one Quantitative Structure–Activity Relationship

Abraham

Kumarsingh

Cometto‐Muñiz

et al. 1998

Toxicology in Vitro

View full text Add to dashboard Cite

is the gas-hexadecane partition coefficient. The number of data points is n, the correlation coefficient is r, the standard deviation is sd, and F is the F-statistic. LogSP is then either [log(DES/P o ) -0.66], or log(1/EIT). It is suggested that equation i can be used to predict eye irritation of organic vapours and pure liquids as eye irritation thresholds.Abbreviations: DES = Draize eye scores; EIT = eye irritation threshold; VOCs = volatile organic compounds.3

show abstract

Section: Methodsmentioning

confidence: 86%

Draize Eye Scores and Eye Irritation Thresholds in Man Combined into one Quantitative Structure–Activity Relationship

Abraham

Kumarsingh

Cometto‐Muñiz

et al. 1998

Toxicology in Vitro

View full text Add to dashboard Cite

show abstract

“…Because the Draize eye test has been the most widely criticised toxicity test, a worldwide validation study on 9 alternatives to the Draize eye test was coordinated by the EU and the British Home Office. However this and other extensive international validation attempts failed (4). Therefore, the leading scientists involved met for a 2nd validation workshop in Amden in 1994 to improve the concept of the validation procedure.…”

Section: Principles Of Scientific Validation: the Amden Validation Womentioning

confidence: 99%

Validation and Regulatory Acceptance of New Carcinogenicity Tests

Spielmann

2003

Toxicol Pathol

View full text Add to dashboard Cite

The 3 Rs concept, which was developed by Russell and Burch in 1959, was implemented into the legal framework in the European Union (EU) for the protection of vertebrate animals used for experimental and other scientific purposes, when Directive 86/609/EEC was adopted in 1986. To reduce or replace animal testing for regulatory purposes, nonanimal tests must be independently validated to prove that they can provide information that is relevant and reliable for hazard prediction in vivo. At the end of the 1980s, no scientific concept existed for the formal validation of in vitro toxicity tests, so a small group of European and American scientists developed a set of principles for experimental validation, which was accepted internationally by the OECD in 1996. A major breakthrough was the acceptance in the EU of the scientifically validated in vitro toxicity test for phototoxic potential in 2000, which was accepted by the OECD at the worldwide level in 2002. Taking the progress in the development and validation of alternative toxicity tests during the past decade into account, the current concepts of developing alternatives to the standard 2-year rodent bioassay for carcinogenicity testing are discussed.

show abstract

“…For more than 40 years, the Draize rabbit eye test has been criticized for its lack of reproducibility, overestimation of human responses, and the use of live animals [5][6][7][8] . These concerns have encouraged many proposals for refinement, reduction, and replacement of the in vivo test 9 .…”

Section: Introductionmentioning

confidence: 99%

Eye Irritation Test (EIT) for Hazard Identification of Eye Irritating Chemicals using Reconstructed Human Cornea-like Epithelial (RhCE) Tissue Model

Kaluzhny

Kanďárová

d’Argembeau-Thornton

et al. 2015

JoVE

View full text Add to dashboard Cite

To comply with the Seventh Amendment to the EU Cosmetics Directive and EU REACH legislation, validated non-animal alternative methods for reliable and accurate assessment of ocular toxicity in man are needed. To address this need, we have developed an eye irritation test (EIT) which utilizes a three dimensional reconstructed human cornea-like epithelial (RhCE) tissue model that is based on normal human cells. The EIT is able to separate ocular irritants and corrosives (GHS Categories 1 and 2 combined) and those that do not require labeling (GHS No Category). The test utilizes two separate protocols, one designed for liquid chemicals and a second, similar protocol for solid test articles. The EIT prediction model uses a single exposure period (30 min for liquids, 6 hr for solids) and a single tissue viability cut-off (60.0% as determined by the MTT assay). Based on the results for 83 chemicals (44 liquids and 39 solids) EIT achieved 95.5/68.2/ and 81.8% sensitivity/specificity and accuracy (SS&A) for liquids, 100.0/68.4/ and 84.6% SS&A for solids, and 97.6/68.3/ and 83.1% for overall SS&A. The EIT will contribute significantly to classifying the ocular irritation potential of a wide range of liquid and solid chemicals without the use of animals to meet regulatory testing requirements. The EpiOcular EIT method was implemented in 2015 into the OECD Test Guidelines as TG 492.

show abstract

The EC/HO international validation study on alternatives to the draize eye irritation test

Cited by 220 publications

References 16 publications

Draize Eye Scores and Eye Irritation Thresholds in Man Combined into one Quantitative Structure–Activity Relationship

Draize Eye Scores and Eye Irritation Thresholds in Man Combined into one Quantitative Structure–Activity Relationship

Validation and Regulatory Acceptance of New Carcinogenicity Tests

Eye Irritation Test (EIT) for Hazard Identification of Eye Irritating Chemicals using Reconstructed Human Cornea-like Epithelial (RhCE) Tissue Model

Contact Info

Product

Resources

About