Assessment of the Eye Irritating Properties of Chemicals by Applying Alternatives to the Draize Rabbit Eye Test: The Use of QSARs and In Vitro Tests for the Classification of Eye Irritation

2005 ◽  
Vol 33 (3) ◽  
pp. 215-237 ◽  
Author(s):  
Ingrid Gerner ◽  
Manfred Liebsch ◽  
Horst Spielmann
Keyword(s):  
Alternative Methods ◽  
In Vitro Assays ◽  
In Vitro Tests ◽  
Eye Irritation ◽  
Limit Values ◽  
Oecd Principles ◽  
Irritation Test ◽  
Definition Of ◽  
Eye Lesions

Huggins has reported on the current situation relating to the development of alternatives to the Draize eye irritation test with rabbits, and an ECVAM Working Group have reviewed the efforts needed in order to replace this animal test within the next 10 years by using the results of non-animal assessment methods. Our report reviews regulatory experience gained over the last 20 years with the EU chemicals notification procedure with respect to the assessment of eye lesions observed in Draize tests. The nature of eye lesions and their importance for classification and labelling of possible hazards to human eyes are evaluated and discussed, with a view to promoting the development of specific in vitro assays which are able to discriminate between eye damage, moderate eye irritation, and minor irritation effects which are completely reversible within a few days. Structural alerts for the prediction of eye irritation/corrosion hazards to be classified and labelled according to international classification criteria, are presented, which should be validated in accordance with internationally agreed (OECD) principles for (Q)SAR system validation. Physicochemical limit values for prediction of the absence of any eye irritation potential relevant for human health can make available a definition of the applicability domains of alternative methods developed for the replacement of the Draize eye irritation test.

Recent Progress in the Eye Irritation Test

1993 ◽  
Vol 9 (6) ◽  
pp. 1017-1025 ◽  
Author(s):  
Ih Chu ◽  
Peter Toft
Keyword(s):  
Animal Studies ◽  
In Vitro Tests ◽  
Animal Testing ◽  
Regulatory Requirements ◽  
Eye Irritation ◽  
Significant Development ◽  
In Vivo Test ◽  
Irritation Test

The rabbit eye irritation test based on the Draize method is required for the hazard assessment of chemicals and products that may come into contact with the eye. Due to the potential for the suffering of animals and subjectivity of the test, many modifications of the method have been made that involved a reduction in the number of animals and a refinement of techniques. Additionally, there has been significant development of in vitro alternatives. This paper reviews recent advances in the in vivo test and in vitro alternatives, as well as regulatory requirements. While the refinement of in vivo protocols has resulted in a reduction in the number and discomfort on animals, the development of in vitro alternatives could lead to an eventual replacement of animal studies. In view of the inherent simplicity of many in vitro methods, some of which comprise cell cultures, further research into the relevance/mechanism of effects is required. Batteries of in vitro tests, when properly validated, may be considered as replacements for animal testing.

HET-CAM test for determining the possible eye irritancy of pesticides

2010 ◽  
Vol 58 (3) ◽  
pp. 369-377 ◽  
Author(s):  
Péter Budai ◽  
József Lehel ◽  
Judit Tavaszi ◽  
Éva Kormos
Keyword(s):  
Screening Method ◽  
Chorioallantoic Membrane ◽  
Alternative Methods ◽  
Eye Irritation ◽  
Parallel Data ◽  
Hen’S Egg ◽  
Irritation Test ◽  
Veterinary Products

Agrochemicals and veterinary products must undergo numerous toxicological tests before registration. The use of animals in these studies is a controversial issue. The Draize eye irritation test is one of the most criticised methods because of the injuries inflicted on the test animals. Several in vitro methods have been used to investigate the toxicity of potential eye irritants with a view to replacing in vivo eye irritation testing. One of these alternative methods is the Hen’s Egg Test — Chorioallantoic Membrane (HET-CAM) test. In the present studies comparative screening was performed with a set of agrochemicals to establish parallel data on in vitro (HET-CAM) and in vivo (Draize) results. The examined materials were: Totril (ioxynil), Omite 57 E (propargit), Actellic 50 EC (pyrimiphos-methyl), Stomp 330 EC (pendimethalin), Mospilan 3 EC (acetamiprid), Alirox 80 EC (EPTC), Match 050 EC (lufenuron), Nonit (dioctyl sulphosuccinate sodium), Perenal (haloxyfop-R methyl ester), Pyrinex 48 EC (chlorpyrifos). These experiments showed good correlation between results obtained by the HET-CAM test and those of the Draize rabbit eye test in most cases. The present form of the HET-CAM test can be proposed as a pre-screening method for the determination of eye irritative potential, therefore the number of test animals can be reduced and/or experimental animals can be replaced.

Analogy Models for Prediction of Human Toxicity

1990 ◽  
Vol 18 (1_part_1) ◽  
pp. 103-116
Author(s):  
Sven Hellberg ◽  
Lennart Eriksson ◽  
Jörgen Jonsson ◽  
Fredrik Lindgren ◽  
Michael Sjöström ◽  
...  
Keyword(s):  
Human Subjects ◽  
Toxicity Testing ◽  
In Vitro Cytotoxicity ◽  
Alternative Methods ◽  
Laboratory Animals ◽  
In Vitro Tests ◽  
Human Toxicity ◽  
Efficient Data ◽  
Basal Cytotoxicity

Estimating the toxicity to humans of chemicals by testing on human subjects is not considered to be ethically acceptable, and toxicity testing on laboratory animals is also questionable. Therefore, there is a need for alternative methods that will give estimates of various aspects of human toxicity. Batteries of in vitro tests, together with physicochemical and toxicokinetic data, analysed by efficient data analytical methods, may enable analogy models to be constructed that can predict human toxicity. It may be possible to model non-specific toxicity relating to lipophilicity, or basal cytotoxicity, for a series of diverse compounds with large variation in chemical structure and physicochemical properties. However, local models for a series of similar compounds are generally expected to be more accurate, as well as being capable of modelling more-specific interactions. Analogy models for the prediction of human toxicity are discussed and exemplified with physicochemical and cytotoxicity data from the first ten chemicals in the multicenter evaluation of in vitro cytotoxicity (MEIC) project.

The EYTEX™ System and the Neutral Red Uptake Inhibition Assay in Cultured Hep G2 Cells as Alternative Methods for In Vivo Eye Irritation Following the EEC Protocol

1990 ◽  
Vol 17 (4) ◽  
pp. 325-333
Author(s):  
Paul J. Dierickx ◽  
Virginia C. Gordon
Keyword(s):  
Neutral Red ◽  
Alternative Methods ◽  
Inhibition Assay ◽  
Hep G2 ◽  
Hep G2 Cells ◽  
Eye Irritation ◽  
Uptake Inhibition ◽  
In Vitro Methods ◽  
Neutral Red Uptake

The neutral red uptake inhibition assay and the EYTEX™ system were investigated as alternative methods for the assessment of eye irritation, determined according to the EEC protocol. The 17 test chemicals used were mainly organic solvents. The xenobiotics were applied to Hep G2 cells for 24 hours at different concentrations. Neutral red uptake inhibition was then measured. The results are expressed as the NI50 value, which is the concentration of test compound required to induce a 50% reduction in neutral red uptake. The same chemicals were also tested as coded samples by the EYTEX™ test according to the manufacturer's directions. A nearly identical quantitative correlation was found for both in vitro methods with corneal opacity scores: r = 0.84 for EYTEX™ scores and r = 0.83 for log NI50, expressed in μg/ml. Whilst these correlations are certainly not perfect, it is clear that both in vitro methods can be used as valuable prescreening methods.

The CTFA evaluation of alternatives program: An evaluation of in vitro alternatives to the draize primary eye irritation test. (Phase II) oil/water emulsions

1994 ◽  
Vol 32 (10) ◽  
pp. 943-976 ◽  
Author(s):  
S.D. Gettings ◽  
L.C. Dipasquale ◽  
D.M. Bagley ◽  
P.L. Casterton ◽  
M. Chudkowski ◽  
...  
Keyword(s):  
Phase Ii ◽  
Test Phase ◽  
Eye Irritation ◽  
Irritation Test ◽  
Oil Water

Correlation and validation of alternative methods to the Draize eye irritation test (OPAL project)

1991 ◽  
Vol 5 (5-6) ◽  
pp. 555-557 ◽  
Author(s):  
O. Blein ◽  
M. Adolphe ◽  
B. Lakhdar ◽  
J. Cambar ◽  
G. Gubanski ◽  
...  
Keyword(s):  
Alternative Methods ◽  
Eye Irritation ◽  
Irritation Test

Me-too validation study for in vitro eye irritation test with 3D-reconstructed human cornea epithelium, MCTT HCETM

2019 ◽  
Vol 55 ◽  
pp. 173-184 ◽  
Author(s):  
Song-E Lim ◽  
Su Jin Ha ◽  
Won-Hee Jang ◽  
Kyung-Mi Jung ◽  
Mi-Sook Jung ◽  
...  
Keyword(s):  
Validation Study ◽  
Human Cornea ◽  
Eye Irritation ◽  
Irritation Test ◽  
Cornea Epithelium

scholarly journals GREEN TEA EXTRACT IN AN EYELASH GROWTH ENHANCER GEL FORMULATION: STABILITY TEST, EYE IRRITATION TEST, AND HUMAN EYELASH GROWTH ACTIVITY

2017 ◽  
Vol 10 (6) ◽  
pp. 243
Author(s):  
Indra Syahputra Roes Lie ◽  
Joshita Djajadisastra ◽  
Fadlina Chany Saputri
Keyword(s):  
Green Tea ◽  
Chorioallantoic Membrane ◽  
Test Group ◽  
Green Tea Extract ◽  
Stability Test ◽  
Eye Irritation ◽  
Before And After ◽  
Irritation Test ◽  
Tea Extract

Objective: To formulate a green tea extract (GTE), which is often used as a hair growth product, to produce an eyelash gel with good stability, effectiveness, and safety for growing eyelashes.Methods: GTE was formulated into a gel. A stability test was performed at a high temperature (40±2°C), room temperature (25±2°C), low temperature (4±2°C), and a cycling temperature. An in vitro hen’s egg test-chorioallantoic membrane assay was performed to evaluate potential eye irritation. An eyelash growth test was conducted by length measurement using an eyelash ruler before and after 2 mo of application in human volunteers. Results: The GTE gel was stable in storage at high, room, and low temperatures and at cycling temperatures and did not cause eye irritation. Eyelashes grew significantly more in the test group than in the placebo group after 2 mo of application (p<0.05). Conclusion: GTE gel provides a new, safe, and effective option for growing natural eyelashes.

Estimation of the proportion of C3 and C4 plant species in the diet of animals from the ratio of natural 12C and 13C isotopes in the faeces

1979 ◽  
Vol 92 (1) ◽  
pp. 91-100 ◽  
Author(s):  
R. J. Jones ◽  
M. M. Ludlow ◽  
J. H. Troughton ◽  
C. G. Blunt
Keyword(s):  
Time Lag ◽  
Alternative Methods ◽  
C4 Plant ◽  
Advantages And Disadvantages ◽  
C Isotopes ◽  
Tropical Legumes ◽  
C Value ◽  
13C Isotopes ◽  
Definition Of

SummaryThe relation between the ratio of the natural 12C and 13C isotopes of carbon in the feed and resultant faeces of animals was studied to develop a technique for estimating the proportion of C3 species (tropical legumes) and C4 species (tropical grasses) selected by grazing animals.In general, theδ13C values (see text for definition) of faeces from rabbits, sheep, goats and cattle were lower (more negative) than those of the corresponding feeds by from 0·4 to 2·0. This was possibly due to contamination in the gut by tissues or fluids with lower δ13C values. When C4 and C3 feeds were alternated, cattle took about a week to fully achieve the new level (δ13C of – 28·7 on the C3 feed and – 13·1 on the C4 feed) in the faeces. This time lag is associated with the time taken for the feed to move through the digestive tract.When mixed C3 and C4 feeds were fed to rabbits, sheep, goats and cattle there was a negative linear relation between percentage legume (C3) in the feed and the δ13C of the faeces (P < 0·01). A decrease in one unit in the δ13C value was associated with an increase of 7·0–8·5% legume in the diet.Estimation of the percentage legume in the feed from the δ13C value of the faeces and of the C3 and C4 components of the diet, resulted in a consistent over estimation of the legume component because the faeces had lower values than the corresponding feeds. This bias was removed if the prediction was based on the δ13C of the feeds minus 1 unit; the legume percentage in the diets of the sheep, goats and cattle could then be estimated with a precision of about ± 5%.Differences in digestibility between the C3 and C4 components greatly bias the estimations. This bias in the diets fed to rabbits was effectively removed by using in vitro organic matter digestibility values of the two components to correct for the differences. Legume percentage in the diet could then be estimated with a RSD of ± 3%.Advantages and disadvantages compared with alternative methods of estimating the diet of grazing animals are discussed.

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