natgillin/translations-raw huggingface dataset:
607/1, s. 13-36.
51-18-3 Negative controls Negative control group animals should be included at every sampling time and otherwise handled in the same way as the treatment groups, except for not receiving treatment with the test chemical.
Clare, G. et al.
If a solvent/vehicle is used in administering the test chemical, the control group should receive this solvent/vehicle.
Mutation Research, Vol.
However, if consistent inter-animal variability and frequencies of cells with structural aberrations are demonstrated by historical negative control data at each sampling time for the testing laboratory, only a single sampling for the negative control may be necessary.
607/1, s. 37-60.
Where a single sampling is used for negative controls, it should be the first sampling time used in the study.
Aardema, M.J. et al.
PROCEDURE Number and sex of animals
Mutation Research, Vol.
At least 200 metaphases should be analysed for each animal for structural chromosomal aberrations including and excluding gaps (6).
607/1, s. 61-87.
However, if the historical negative control database indicates the mean background structural chromosomal aberration frequency is < 1 % in the testing laboratory, consideration should be given to scoring additional cells.
Mutation Research, Vol.
for short-term studies: individual weight of the animals at the start and end of the test; for studies longer than one week: individual body weights during the study and food consumption.
607/1, s. 88-124.
Body weight range, mean and standard deviation for each group should be included.
Oliver, J. et al.
Adler, I.D.
Mutation Research, Vol.
Preston, R.J. et al.
607/1, s. 125-152.
Analysis of chromosome aberrations in bone marrow cells, Mutation Research, Vol.
Albertini, S. et al.
189/2, pp. 157-165.
Mutation Research, Vol.
Richold, M. et al.
392/1-2, s. 187-208.
Tice, R.R. et al.
Miller, B. et al.
, Report from the working group on the in vivo mammalian bone marrow chromosomal aberration test, Mutation Research, Vol.
Mutation Research, Vol.
312/3, pp. 305-312.
392/1-2, s. 45-59.
Adler, I.D. et al.
Gesellschaft fur Umwelt-Mutations-forschung, Mutation Research, Vol.
, Recommendations for statistical designs of in vivo mutagenicity tests with regard to subsequent statistical analysis, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
410, s. 81-116.
417/1, pp. 19-30.
Kalweit, S. et al.
Ryan, T.P.
Chemically induced micronucleus formation in V79 cells – comparison of three different test approaches.
, Compilation and use of genetic toxicity historical control data, Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis, Vol.
Mutation Research, Vol.
723/2, pp. 87-90.
439/2, s. 183-190.
, in vivo rodent erythrocyte micronucleus assay, Mutation Research/Environmental Mutagenesis and Related Subjects, Vol.
Kersten, B. et al.
312/3, pp. 293-304.
Mutation Research, Vol.
Fielder, R.J. et al.
445/1, s. 55-71.
Dose setting in in vivo mutagenicity assays, Mutagenesis, Vol.
von der Hude, W. et al.
7/5, pp. 313-319.
Mutation Research, Vol.
Pacchierotti, F., V. Stocchi (2013), Analysis of chromosome aberrations in somatic and germ cells of the mouse, Methods in Molecular Biology, Vol.
468/2, s. 137-163.
1044, pp. 147-163.
Garriott, M.L., J.B.
Lovell, D.P. et al.
Mutation Research, Vol.
It has been shown for rats that pre-treatment sampling of small volumes (e.g. below 100 μl/day) has minimal impact on micronucleus background frequency (25).
517/1-2, s. 123-134.
PROCEDURE Number and sex of animals
Mutagenesis, Vol.
In general, the micronucleus response is similar between male and female animals and, therefore, most studies could be performed in either sex (26).
14/6, s. 569-580.
Data demonstrating relevant differences between males and females (e.g. differences in systemic toxicity, metabolism, bioavailability, bone marrow toxicity, etc. including e.g. in a range-finding study) would encourage the use of both sexes.
Elhajouji, A., E.
In this case, it may be appropriate to perform a study in both sexes, e.g. as part of a repeated dose toxicity study.
Lorge (2006).
It might be appropriate to use the factorial design in case both sexes are used.
Mutation Research, Vol.
Details on how to analyse the data using this design are given in Appendix 2.
607/1, s. 1-152.
for short term studies: individual weight of the animals at the start and end of the test; for studies longer than one week: individual body weights during the study and food consumption.
Kirkland, D.
Validation and regulatory acceptance of automated scoring and the use of rat peripheral blood reticulocytes, with discussion of non-hematopoietic target cells and a single dose-level limit test, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
(2010).
627/1, pp. 10-30.
Mutation Research, Vol.
MacGregor, J.T. et al.
702/2, s. 139-147.
An efficient method of monitoring chromosomal damage in the rat, Toxicology Sciences, Vol.
Hashimoto K. et al.
94/1, pp. 92-107.
Regulatory Toxicology and Pharmacology, Vol.
Dertinger, S.D. et al.
59/1, s. 28-36.
, Flow cytometric analysis of micronuclei in peripheral blood reticulocytes: I. Intra- and interlaboratory comparison with microscopic scoring, Toxicological Sciences, Vol.
Honma, M., M.
94/1, pp. 83-91.
Hayashi (2011).
, Flow cytometric scoring of micronucleated erythrocytes: an efficient platform for assessing in vivo cytogenetic damage, Mutagenesis, Vol.
Environmental and Molecular Mutagenesis, Vol.
26/1, pp. 139-145.
52/5, s. 373-384.
Parton, J.W., W.P.
Zhang, L.S. et al.
Garriott (1996), Validation of an automated image analysis micronucleus scoring system, Mutation Research, Vol.
Mutation Research Letters, Vol.
370/1, pp. 65-73.
347/3-4, s. 105-115.
Asano, N. et al.
ECVAM (2006).
, An automated new technique for scoring the rodent micronucleus assay: computerized image analysis of acridine orange supravitally stained peripheral blood cells, Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis, Vol.
ESAC (2006).
404/1-2, pp. 149-154.
Corvi, R. et al.
Styles, J.A. et al.
Mutagenesis, Vol 23/4, s. 271-283.
, Automation of mouse micronucleus genotoxicity assay by laser scanning cytometry, Cytometry, Vol.
ILSI paper (draft).
44/2, pp. 153-155.
A report from ICPEMC Task Group 9.
Heddle, J.A.
Mutation Research, Vol.
, A rapid in vivo test for chromosomal damage, Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis, Vol.
257/2, s. 147-205.
18/2, pp. 187-190.
Mutation Research, Vol.
Schmid, W.
268/2, s. 297-305.
, The micronucleus test, Mutation Research, Vol.
Brusick, D.
31/1, pp. 9-15.
(1986).
Heddle, J.A. et al.
Environmental Mutagenesis, Vol.
Environmental Protection Agency Gene-Tox Program, Mutation Research/Reviews in Genetic Toxicology, Vol.
8/6, s. 789-886.
123/1, pp. 61-118.
Mutation Research, Vol.
Mavournin, K.H. et al.
634/1-2, s. 177-183.
Environmental Protection Agency Gene-Tox Program, Mutation Research/Reviews in Genetic Toxicology, Vol.
Environmental and Molecular Mutation., Vol.
239/1, pp. 29-80.
49, s. 439-452.
, Micronuclei in circulating erythrocytes: a rapid screen for chromosomal damage during routine toxicity testing in mice, Developments in Toxicology Environmental Science, Vol.
Mutation Research, Vol.
11, pp. 555-558.
147/1-2, s. 29-36.
, Guidelines for the conduct of micronucleus assays in mammalian bone marrow erythrocytes, Mutation Research/Genetic Toxicology, Vol.
Fenech, M.
189/2, pp. 103-112.
(1997).
, The in vivo erythrocyte micronucleus test: measurement at steady state increases assay efficiency and permits integration with toxicity studies, Fundamental and Applied Toxicology, Vol.
Mutation Research, Vol.
14/3, pp. 513-522.
392, s. 11-18.
, The micronucleus assay with mouse peripheral blood reticulocytes using acridine orange-coated slides, Mutation Research/Genetic Toxicology, Vol.
Payne, C.M. et al.
245/4, pp. 245-249.
Nutrition and Cancer, Vol.
CSGMT/JEMS.MMS — The Collaborative Study Group for the Micronucleus Test (1992), Micronucleus test with mouse peripheral blood erythrocytes by acridine orange supravital staining: the summary report of the 5th collaborative study, Mutation Research/Genetic Toxicology, Vol.
62/6, s. 825-840.
278/2-3, pp. 83-98.
Bazin, E. et al.
CSGMT/JEMS.MMS — The Mammalian Mutagenesis Study Group of the Environmental Mutagen Society of Japan (1995), Protocol recommended by the CSGMT/JEMS.MMS for the short-term mouse peripheral blood micronucleus test.
Environmental and Molecular Mutagenesis, Vol.
The Collaborative Study Group for the Micronucleus Test (CSGMT) (CSGMT/JEMS.MMS, The Mammalian Mutagenesis Study Group of the Environmental Mutagen Society of Japan), Mutagenesis, Vol.
51/3, s. 251-259.
10/3, pp. 153-159.
Le Hegarat, L. et al.
Salamone, M.F., K.H.
Mutagenesis, Vol.
Mavournin (1994), Bone marrow micronucleus assay: a review of the mouse stocks used and their published mean spontaneous micronucleus frequencies, Environmental and Molecular Mutagenesis, Vol.
25/6, s. 555-560.
23/4, pp. 239-273.
Josse, R. et al.
Krishna, G., G. Urda, J. Paulissen (2000), Historical vehicle and positive control micronucleus data in mice and rats, Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis, Vol.
Mutagenesis, Vol.
453/1, pp. 45-50.
27/3, s. 295-304.
Hayes, J. et al.
Ehrlich, V. et al.
, The rat bone marrow micronucleus test--study design and statistical power, Mutagenesis, Vol.
Mutagenesis, Vol.
24/5, pp. 419-424.
17/3, s. 257-260.
Wakata, A. et al.
Knasmüller, S. et al.
Mammalian Mutagenicity Study Group, Environmental and Molecular Mutagenesis, Vol.
Toxicology, Vol.
32/1, pp. 84-100.
198/1-3, s. 315-328.
Rothfuss, A. et al.
Gibson, D.P. et al.
, Improvement of in vivo genotoxicity assessment: combination of acute tests and integration into standard toxicity testing, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
Mutation Research, Vol.
723/2, pp. 108-120.
392/1-2, s. 61-70.
LeBaron, M.J. et al.
Bonassi, S. et al.
, Influence of counting methodology on erythrocyte ratios in the mouse micronucleus test, Environmental and Molecular Mutagenesis, Vol.
Environmental and Molecular Mutagenesis, Vol.
54/3, pp. 222-228.
37/1, s. 31-45.
Some aspects of protocol design including repeated treatments, integration with toxicity testing, and automated scoring, Environmental and Molecular Mutagenesis, Vol.
Mutation Research, Vol.
35/3, pp. 234-252.
113/3-4, s. 173-215.
Asanami, S., K. Shimono (1997), High body temperature induces micronuclei in mouse bone marrow, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
Journal of Environmental Pathology and Toxicology, Vol.
390/1-2, pp. 79-83.
4/1, s. 55-65.
Asanami, S., K. Shimono, S. Kaneda (1998), Transient hypothermia induces micronuclei in mice, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
Elliott, B.M. et al.
413/1, pp. 7-14.
Mutagenesis, Vol.
Spencer, P.J. et al.
7, s. 175-177.
, Induction of micronuclei by phenol in the mouse bone marrow: I. Association with chemically induced hypothermia, Toxicological Sciences, Vol.
Johnson, T.E., D.
97/1, pp. 120-127.
R.
Hayashi, M., T. Sofuni, M. Jr.
Umbenhauer, S.M.
Ishidate (1983), An application of Acridine Orange fluorescent staining to the micronucleus test, Mutation Research Letters, Vol.
Environmental and Molecular Mutagenesis, Vol.
120/4, pp. 241-247.
28, s. 51-59.
MacGregor, J.T., C.M.
UNEP (2001).
Langlois (1983), A simple fluorescent staining procedure for micronuclei and RNA in erythrocytes using Hoechst 33258 and pyronin Y, Mutation Research, Vol.
Mutation Research, Vol.190/3, s. 225-8.
120/4, pp. 269-275.
Environmental Mutagenesis, Vol.
Romagna, F., C.D.
5/6, s. 795-801.
Staniforth (1989), The automated bone marrow micronucleus test, Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis, Vol.
Mutation Research, Vol.
213/1, pp. 91-104.
652/2, s. 122-130.
Sun, J.T., M.J.
Fenech, M.
Galloway (1999), Rapid method for improving slide quality in the bone marrow micronucleus assay; an adapted cellulose column procedure, Mutation Research, Vol.
(1993).
439/1, pp. 121-126.
Mutation Research, Vol.
Miller, B.M., I.D.
285/1, s. 35-44.
Adler (1990), Application of antikinetochore antibody staining (CREST staining) to micronuclei in erythrocytes induced in vivo, Mutagenesis, Vol.
Phelps, J.B., M.L.
5/4, pp. 411-415.
Mutation Research, Vol.
Miller, B.M. et al.
521/1-2, s. 103-112.
, Classification of micronuclei in murine erythrocytes: immunofluorescent staining using CREST antibodies compared to in situ hybridization with biotinylated gamma satellite DNA, Mutagenesis, Vol.
Mutation Research, Vol.
6/4, pp. 297-302.
655/1-2, s. 1-3.
Russo, A. (2002), PRINS tandem labeling of satellite DNA in the study of chromosome damage, American Journal of Medical Genetics, Vol.
Surralles, J. et al.
107/2, pp. 99-104.
Mutation Research, Vol.
Gollapudi, B.B., L.G.
341/3, s. 169-184.
McFadden (1995), Sample size for the estimation of polychromatic to normochromatic erythrocyte ratio in the bone marrow micronucleus test, Mutation Research, Vol.
Honma, M.
347/2, pp. 97-99.
(2011).
, Statistical analysis of data in mutagenicity assays: rodent micronucleus assay, Environmental Health Perspectives, Vol.
Mutation Research, Vol.
102/Suppl 1, pp. 49-52.
724, s. 86-87.
Kim, B.S., M. Cho, H.J.
Pfuhler, S. et al.
Kim (2000), Statistical analysis of in vivo rodent micronucleus assay, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
Mutation Research, Vol.
469/2, pp. 233-241.
723/2, s. 101-107.
The latter represents the protocol used for the European Community-sponsored prevalidation study conducted in 1997-1998.
OECD (2014).
Both of these protocols were based on the BCOP test method first reported by Gautheron et al.
Morita T., M.
IVIS = mean opacity value + (15 × mean permeability OD490 value) Sina et al.
Honma, K.
ICCVAM (2006).
Morikawa (2012).
Test Method Evaluation Report — In Vitro Ocular Toxicity Test Methods for Identifying Ocular Severe Irritants and Corrosives.
Mutation Research, Vol.
ICCVAM (2010).
741, s. 32-56.
OECD (2013).
Brookmire L., J.J.
UN (2011).
Environmental and Molecular Mutagenesis, Vol.
Scott, L., Eskes, C., Hoffmann, S., Adriaens, E., Alépée, N., Bufo, M., Clothier, R., Facchini, D., Faller, C., Guest, R., Harbell, J., Hartung, T., Kamp, H., Le Varlet, B., Meloni, M., McNamee, P., Osborne, R., Pape, W., Pfannenbecker, U., Prinsen, M., Seaman, C., Spielman, H., Stokes, W., Trouba, K., Van den Berghe, C., Van Goethem, F., Vassallo, M., Vinardell, P., and Zuang, V. (2010).
54/1, s. 36-43.
In: ICCVAM Test Method Evaluation Report — in vitro Ocular Toxicity Test Methods for Identifying Ocular Severe Irritants and Corrosives.
EPA, Office of Chemical Safety and Pollution Prevention (2011).
In: ICCVAM Test Method Evaluation Report — Current Validation Status of In Vitro Test Methods Proposed for Identifying Eye Injury Hazard Potential of Chemicals and Products.
Sobol, Z. et al.
INVITTOX (1999).
Mutation Research, Vol.746/1, s. 29-34.
Protocol 124: Bovine Corneal Opacity and Permeability Assay — SOP of Microbiological Associates Ltd.
Mutation Research, Vol.
Ispra, Italy: European Centre for the Validation of Alternative Methods (ECVAM).
120/4, s. 241-247.
Gautheron, P., Dukic, M., Alix, D. and Sina, J.F.
MacGregor, J.
Prinsen, M.K.
T., C.M.
Siegel, J.D., Rhinehart, E., Jackson, M., Chiarello, L., and the Healthcare Infection Control Practices Advisory Committee (2007).
Mutation Research, Vol.
Maurer, J.K., Parker, R.D. and Jester, J.V.
120/4, s. 269-275.
OECD (2011).
Bryce, S.M. et al.
Doughty, M.J., Petrou, S. and Macmillan, H. (1995).
Environmental and Molecular Mutagenesis, Vol.
Collee, J. and Bradley, R. (1997).
52/4, s. 280-286.
BSE: A decade on — Part I. The Lancet 349: 636-641.
Nicolette, J. et al.
Sina, J.F., Galer, D.M., Sussman, R.S., Gautheron, P.D., Sargent, E.V., Leong, B., Shah, P.V., Curren, R.D., and Miller, K. (1995).
Environmental and Molecular Mutagenesis, Vol.
OECD (1998).
52/5, s. 355-362.
Classification as 2A or 2B depends on the interpretation of the UN GHS criterion for distinguishing between these two categories, i.e. 1 out of 3 vs. 2 out of 3 animals with effects at day 7 necessary to generate a Category 2A classification.
Shi, J., R.
The in vivo study included 3 animals.
Bezabhie, A.
For any laboratory initially establishing this assay, the proficiency chemicals provided in Appendix 2 should be used.
Szkudlinska (2010).
A laboratory can use these chemicals to demonstrate their technical competence in performing the ICE test method prior to submitting ICE data for regulatory hazard classification purposes.
Mutagenesis, Vol.
Fluorescein retention scores Score
25/1, s. 33-40.
Interpretation of corneal swelling (Table 3), opacity (Table 4), and fluorescein retention (Table 5) using four ICE classes is done according to the scales shown below.
Fenech, M. et al.
It is important to note that the corneal swelling scores shown in Table 3 are only applicable if thickness is measured with a slit-lamp microscope (for example Haag-Streit BP900) with depth-measuring device no.
Mutation Research, Vol.
1 and slit-width setting at 91
534/1-2, s. 65-75.
> 32
Elhajouji, A., M.
0,0-0,5
Cunha, M.
0,6-1,5
Kirsch-Volders (1998).
1,6-2,5
Mutagenesis, Vol.
2,6-4,0
13/2, s. 193-8.
2,6-3,0
Archives of Toxicology, Vol.
ICCVAM (2007).
85/8, s. 873-99.
ESAC (2007).
Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.723/2, s. 87-90.
ICCVAM Test Method Evaluation Report — Current Status of in vitro Test Methods for Identifying Mild/Moderate Ocular Irritants: The Isolated Chicken Eye (ICE) Test Method.
Ryan, T.
United Nations (UN) (2011).
P.
Scott L, Eskes C, Hoffman S, Adriaens E, Alepee N, Bufo M, Clothier R, Facchini D, Faller C, Guest R, Hamernik K, Harbell J, Hartung T, Kamp H, Le Varlet B, Meloni M, Mcnamee P, Osborn R, Pape W, Pfannenbecker U, Prinsen M, Seaman C, Spielmann H, Stokes W, Trouba K, Vassallo M, Van den Berghe C, Van Goethem F, Vinardell P, Zuang V (2010).
(2000).
ICCVAM.
Hoffman, W.P., M.L.
Prinsen, M.K. and Koëter, B.W.M.
International Conference on Harmonisation (ICH) Guidance S2 (R1) on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended For Human Use.
DB-ALM (INVITTOX) (2009).
přičemž:
Balls, M., Botham, P.A., Bruner, L.H. and Spielmann H. (1995).
Míra reprodukovatelnosti předpovědí, které lze od této zkušební metody očekávat, činí řádově 85 % v rámci laboratoří a 80 % mezi laboratořemi (10).
Chamberlain, M., Gad, S.C., Gautheron, P. and Prinsen, M.K.
Výsledky validační studie (18) a zveřejněných studií (19) celkově ukazují, že přesnost zkušební metody DPRA při odlišení senzibilizujících látek (tj. kategorie 1 GHS OSN / CLP) od nesenzibilizujících látek činí 80 % (N=157) při citlivosti 80 % (88/109) a specifičnosti 77 % (37/48) ve srovnání s výsledky zkušební metody LLNA.
Maurer, J.K., Parker, R.D. and Jester J.V.
Tuto zkušební metodu nelze použít k testování sloučenin kovů, protože je o nich známo, že s proteiny reagují prostřednictvím jiných mechanismů, než je kovalentní vazba.
Burton, A.B.G., M. York and R.S.
Zkoušená chemická látka by měla být rozpustná ve vhodném rozpouštědle při konečné koncentraci 100 mM (viz odstavec 18).
Production of changes in the eye following the application of test chemical to the anterior surface of the eye, which are fully reversible within 21 days of application.
Chemické látky, které nejsou při této koncentraci rozpustné, je nicméně přesto možné testovat při koncentracích nižších, ve kterých jsou rozpustné.
Interchangeable with “Reversible effects on the Eye” and with “UN GHS Category 2” (4).
V takovém případě by přesto mohl být pozitivní výsledek použit na podporu identifikace zkoušené chemické látky jako látky senzibilizující kůži, avšak z negativního výsledku by se neměl vyvozovat závěr, že není dostatečné reaktivní.
False negative rate
vzhled sraženiny v reakční směsi na konci inkubační doby, byla-li zjištěna; zda byla sraženina rozpuštěna nebo odstředěna,
The proportion of all positive chemicals falsely identified by a test method as negative.
United Nations (UN) (2013).
It is one indicator of test method performance.
OECD (2012).
False positive rate
Adler et al.
The proportion of all negative chemicals that are falsely identified by a test method as positive.
Gerberick et al.
It is one indicator of test method performance.
EC EURL-ECVAM (2013).
Fluorescein retention
Direct Peptide Reactivity assay (DPRA) for skin sensitisation testing.
A subjective measurement in the ICE test of the extent of fluorescein sodium that is retained by epithelial cells in the cornea following exposure to a test substance.
Jaworska et al.
The degree of fluorescein retention is indicative of damage to the corneal epithelium.
Bauch et al.
Hazard
Nukada et al.
Inherent property of an agent or situation having the potential to cause adverse effects when an organism, system or (sub) population is exposed to that agent.
Ball et al (2011).
Irreversible effects on the eye see “Serious eye damage” and “UN GHS Category 1”.
Landsteiner and Jacobs (1936).
Mixture
Dupuis and Benezra (1982).
A mixture or a solution composed of two or more substances in which they do not react (4) Negative control
Lepoittevin et al.
An untreated replicate containing all components of a test system.
EC EURL-ECVAM (2012).
This sample is processed with test chemical-treated samples and other control samples to determine whether the solvent interacts with the test system.
Direct Peptide Reactivity assay (DPRA) for skin sensitisation testing 74pp.
Not Classified
Natsch et al.
Substances that are not classified for eye irritation (UN GHS Category 2) or serious damage to eye (UN GHS Category 1).
DB-ALM (INVITTOX) Protocol 154: Direct Peptide Reactivity assay (DPRA) for skin sensitisation testing 17pp.
Interchangeable with “UN GHS No Category”.
OECD (2005).
A replicate containing all components of a test system and treated with a chemical known to induce a positive response.
FDA (Food and Drug Administration (2001).
To ensure that variability in the positive control response across time can be assessed, the magnitude of the severe response should not be excessive.
ECETOC (2003).
Measures of the extent that a test method can be performed reproducibly within and between laboratories over time, when performed using the same protocol.
Hodnotí se to výpočtem laboratorní a mezilaboratorní reprodukovatelnosti a laboratorní opakovatelnosti (21).
It is assessed by calculating intra- and inter-laboratory reproducibility and intra-laboratory repeatability.
Chemické prvky nebo jejich sloučeniny v přírodním stavu nebo získané výrobním procesem včetně všech přídatných látek nutných k uchování stability výrobku a všech nečistot vznikajících v použitém procesu, ale s vyloučením všech rozpouštědel, která je možno oddělit bez ovlivnění stability látky nebo změny jejího složení (1).
Reversible effects on the Eye see “Eye Irritation” and “UN GHS Category 2”.
Termín „zkoušená chemická látka“ se používá k označení toho, co se podrobuje zkoušení.
Serious eye damage
Globálně harmonizovaný systém klasifikace a označování chemických látek Organizace spojených národů (GHS OSN)
Production of tissue damage in the eye, or serious physical decay of vision, following application of a test chemical to the anterior surface of the eye, which is not fully reversible within 21 days of application.
90–100
Interchangeable with “Irreversible effects on the eye” and with “UN GHS Category 1” (4).
15–45
Slit-lamp microscope An instrument used to directly examine the eye under the magnification of a binocular microscope by creating a stereoscopic, erect image.
60–80
In the ICE test method, this instrument is used to view the anterior structures of the chicken eye as well as to objectively measure corneal thickness with a depth-measuring device attachment.
10–55
Solvent/vehicle control
30–60
An untreated sample containing all components of a test system, including the solvent or vehicle that is processed with the test chemical-treated samples and other control samples to establish the baseline response for the samples treated with the test chemical dissolved in the same solvent or vehicle.
0–24
When tested with a concurrent negative control, this sample also demonstrates whether the solvent or vehicle interacts with the test system.
80–100
Substance