natgillin/translations-raw huggingface dataset:
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.
5/4, s.
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.
411–415.
10/3, pp. 153-159.
Miller, B.M. m.fl.
23/4, pp. 239-273.
297–302.
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.
Russo, A. (2002), PRINS tandem labeling of satellite DNA in the study of chromosome damage, American Journal of Medical Genetics, vol.
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49–52.
, Improvement of in vivo genotoxicity assessment: combination of acute tests and integration into standard toxicity testing, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
Kim (2000), Statistical analysis of in vivo rodent micronucleus assay, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, vol.
723/2, pp. 108-120.
469/2, s.
LeBaron, M.J. et al.
233–241.
, Influence of counting methodology on erythrocyte ratios in the mouse micronucleus test, Environmental and Molecular Mutagenesis, Vol.
Båda dessa protokoll baserades på den BCOP-testmetod som först rapporterades av Gautheron m.fl.
54/3, pp. 222-228.
Test Method Evaluation Report – In Vitro Ocular Toxicity Test Methods for Identifying Ocular Severe Irritants and Corrosives.
Some aspects of protocol design including repeated treatments, integration with toxicity testing, and automated scoring, Environmental and Molecular Mutagenesis, Vol.
FN (2011).
35/3, pp. 234-252.
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. och Zuang, V. (2010).
Asanami, S., K. Shimono (1997), High body temperature induces micronuclei in mouse bone marrow, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
I: ICCVAM Test Method Evaluation Report – in vitro Ocular Toxicity Test Methods for Identifying Ocular Severe Irritants and Corrosives.
390/1-2, pp. 79-83.
I: ICCVAM testmetod utvärderingsrapport – Aktuellt Validering status in vitro Testmetoder som föreslås för identifiering ögonskada farlighet av kemikalier och produkter.
Asanami, S., K. Shimono, S. Kaneda (1998), Transient hypothermia induces micronuclei in mice, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
JAGNVJAGTTOX (1999).
413/1, pp. 7-14.
Protocol 124: Bovine Corneal Opacity and Permeability Assay – SOP of Microbiological Associates Ltd.
Spencer, P.J. et al.
Ispra, Italien: Europeiska centret för bestämning av alternativa metoder (ECVAM).
Ishidate (1983), An application of Acridine Orange fluorescent staining to the micronucleus test, Mutation Research Letters, Vol.
BSE: A decade on – Part I. The Lancet 349: 636–641.
MacGregor, J.T., C.M.
Laboratorier som tar denna testmetod i bruk för första gången bör använda de kvalifikationskemikalier som förtecknas i tillägg 2.
120/4, pp. 269-275.
Tolkningen av hornhinnans svullnad (tabell 3), opacitet (tabell 4) och fluoresceinfärgning (tabell 5) med användning av fyra ICE-klasser görs enligt de skalor som visas nedan.
Staniforth (1989), The automated bone marrow micronucleus test, Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis, Vol.
Haag-Streit BP900) med djupmätanordning nr 1 och spaltbredd på 91
Sun, J.T., M.J.
0,6–1,5
439/1, pp. 121-126.
2,6–4,0
Adler (1990), Application of antikinetochore antibody staining (CREST staining) to micronuclei in erythrocytes induced in vivo, Mutagenesis, Vol.
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.
, Classification of micronuclei in murine erythrocytes: immunofluorescent staining using CREST antibodies compared to in situ hybridization with biotinylated gamma satellite DNA, Mutagenesis, Vol.
Prinsen, M.K. och Koëter, B.W.M.
Russo, A. (2002), PRINS tandem labeling of satellite DNA in the study of chromosome damage, American Journal of Medical Genetics, Vol.
Chamberlain, M., Gad, S.C., Gautheron, P. och Prinsen, M.K.
Gollapudi, B.B., L.G.
Burton, A.B.G., M. York och R.S.
347/2, pp. 97-99.
Cellerna bör exponeras för testkemikalien utan metabolisk aktivering, under 3–6 timmar och prov bör tas ut vid en tid som motsvarar cirka 1,5–2,0 gånger den normala cellcykelns längd efter det att behandlingen har påbörjats (19).
102/Suppl 1, pp. 49-52.
Oavsett om en automatisk plattform används för att räkna mikrokärnorna, bör CBPI, RI, RPD eller RICC bedömas samtidigt.
Kim (2000), Statistical analysis of in vivo rodent micronucleus assay, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
392/1-2, s.
The latter represents the protocol used for the European Community-sponsored prevalidation study conducted in 1997-1998.
Mutation Research, vol.
IVIS = mean opacity value + (15 × mean permeability OD490 value) Sina et al.
3–15.
Test Method Evaluation Report — In Vitro Ocular Toxicity Test Methods for Identifying Ocular Severe Irritants and Corrosives.
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Kirsch-Volders, M. m.fl.
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.
Nature Protocols, vol.
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193–198.
OECD (2011).
34–43.
Doughty, M.J., Petrou, S. and Macmillan, H. (1995).
Mutation Research, vol.
Collee, J. and Bradley, R. (1997).
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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).
Zijno, P. m.fl.
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DB-ALM (INVITTOX) (2009).
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Balls, M., Botham, P.A., Bruner, L.H. and Spielmann H. (1995).
153–163.
Chamberlain, M., Gad, S.C., Gautheron, P. and Prinsen, M.K.
Mutation Research, vol.
Maurer, J.K., Parker, R.D. and Jester J.V.
607/1, s.
Burton, A.B.G., M. York and R.S.
13–36.
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.
Clare, G. m.fl.
Interchangeable with “Reversible effects on the Eye” and with “UN GHS Category 2” (4).
Mutation Research, vol.
False negative rate
607/1, s.
The proportion of all positive chemicals falsely identified by a test method as negative.
37–60.
It is one indicator of test method performance.
Aardema, M.J. m.fl.
False positive rate
Mutation Research, vol.
The proportion of all negative chemicals that are falsely identified by a test method as positive.
607/1, s.
It is one indicator of test method performance.
61–87.
Fluorescein retention
Mutation Research, vol.
Hazard
Oliver, J. m.fl.
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.
Mutation Research, vol.
Irreversible effects on the eye see “Serious eye damage” and “UN GHS Category 1”.
607/1, s.
Mixture
125–152.
A mixture or a solution composed of two or more substances in which they do not react (4) Negative control
Albertini, S. m.fl.
This sample is processed with test chemical-treated samples and other control samples to determine whether the solvent interacts with the test system.
392/1-2, s.
Substances that are not classified for eye irritation (UN GHS Category 2) or serious damage to eye (UN GHS Category 1).
Miller, B. m.fl.
Interchangeable with “UN GHS No Category”.
Mutation Research, vol.
A replicate containing all components of a test system and treated with a chemical known to induce a positive response.
392/1-2, s.
To ensure that variability in the positive control response across time can be assessed, the magnitude of the severe response should not be excessive.
45–59.
Measures of the extent that a test method can be performed reproducibly within and between laboratories over time, when performed using the same protocol.
Gesellschaft fur Umwelt-Mutations-forschung, Mutation Research, vol.
It is assessed by calculating intra- and inter-laboratory reproducibility and intra-laboratory repeatability.
410, s.
Serious eye damage
Kalweit, S. m.fl.
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.
Chemically induced micronucleus formation in V79 cells – comparison of three different test approaches.
Interchangeable with “Irreversible effects on the eye” and with “UN GHS Category 1” (4).
Mutation Research, vol.
Slit-lamp microscope An instrument used to directly examine the eye under the magnification of a binocular microscope by creating a stereoscopic, erect image.
439/2, s.
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.
183–190.
Solvent/vehicle control
Kersten, B. m.fl.
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.
Mutation Research, vol.
When tested with a concurrent negative control, this sample also demonstrates whether the solvent or vehicle interacts with the test system.
445/1, s.
Substance
55–71.
Chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the product and any impurities deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition (4).
von der Hude, W. m.fl.
Surfactant
Mutation Research, vol.
Also called surface-active agent, this is a substance, such as a detergent, that can reduce the surface tension of a liquid and thus allow it to foam or penetrate solids; it is also known as a wetting agent.
468/2, s.
Top-Down Approach
137–163.
step-wise approach used for a chemical suspected of causing serious eye damage, which starts with the determination of chemicals inducing serious eye damage (positive outcome) from other chemicals (negative outcome).
Mutation Research, vol.
Test chemical
517/1-2, s.
Any substance or mixture tested using this Test Method.
123–134.
Tiered testing strategy
Mutagenesis, vol.
If the irritancy potential of a test chemical can be assigned based on the existing information, no additional testing is required.
569–580.
United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS) A system proposing the classification of chemicals (substances and mixtures) according to standardised types and levels of physical, health and environmental hazards, and addressing corresponding communication elements, such as pictograms, signal words, hazard statements, precautionary statements and safety data sheets, so that to convey information on their adverse effects with a view to protect people (including employers, workers, transporters, consumers and emergency responders) and the environment (4).
Mutation Research, vol.
UN GHS Category 1 see “Serious damage to eyes” and/or “Irreversible effects on the eye”.
607/1, s.
see “Eye Irritation” and/or “Reversible effects to the eye”.
1–152.
Validated test method A test method for which validation studies have been completed to determine the relevance (including accuracy) and reliability for a specific purpose.
702/2, s.
If cytoB is dissolved in DMSO, the total amount of organic solvent used for both the test chemical and cytoB should not exceed 1 % (v/v); otherwise, untreated controls should be used to ensure that the percentage of organic solvent has no adverse effect.
Hashimoto K. m.fl.
If other than well-established solvents are used (e.g. ethanol or acetone), their use should be supported by data indicating their compatibility with the test chemical, the test system and their lack of genetic toxicity at the concentration used.
59/1, s.
Cells should be exposed to the test chemical without metabolic activation for 3-6 hours, and sampled at a time equivalent to about 1,5 - 2,0 normal cell cycle lengths after the beginning of treatment (19),
Environmental and Molecular Mutagenesis, vol.
Appropriate techniques should be used to control any bias or drift when using an automated scoring system, for instance, flow cytometry, laser scanning cytometry or image analysis.
52/5, s.
Regardless of the automated platform is used to enumerate micronuclei, CBPI, RI, RPD, or RICC should be assessed concurrently.
373–384.
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Zhang, L.S. m.fl.
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Mutation Research Letters, vol.
392/1-2, pp. 1-4.
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Parry, J.M., A. Sors (1993).
105–115.
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Corvi, R. m.fl.
287/1, pp. 3-15.
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Fenech, M., A.A.
271–283.
Cytobios, Vol.
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43/172-173, pp. 233-246.
257/2, s.
Kirsch-Volders, M. et al.
147–205.
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Mutation Research, vol.
Fenech, M. (2007).
297–305.
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2/5, pp. 1084-1104.
8/6, s.
Mutation Research, Vol.
789–886.
Eastmond, D.A., J.D.
634/1-2, s.
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177–183.
13/1, pp. 34-43.
Environmental and Molecular Mutation., vol.
Eastmond, D.A., D. Pinkel (1990).
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439–452.
234/5, pp. 9-20.
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Migliore, L. et al.
Payne, C.M. m.fl.
Mutation Research, Vol.
Nutrition and Cancer, vol.
319/3, pp. 205-213.
62/6, s.
Norppa, H., L. Renzi, C. Lindholm (1993).
825–840.
8/6, pp. 519-525.
Environmental and Molecular Mutagenesis, vol.
Eastmond, D.A, D.S.
51/3, s.
Mutation Research, Vol.
25/6, s.
372/2, pp. 233-245.
555–560.
Mutation Research, Vol.
27/3, s.
540/2, pp. 153-163.
295–304.
Mutation Research, Vol.
257–260.
517/1-2, pp. 123-134.
795–801.
Mutagenesis, Vol.
Mutation Research, vol.
702/2, pp. 139-147.
521/1-2, s.
347/3-4, pp. 105-115.
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Sobol, Z. m.fl.
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634/1-2, pp. 177-183.
29–34.
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49, pp. 439-452.
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269–275.
392, pp. 11-18.
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Payne, C.M. et al.
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Nutrition and Cancer, Vol.
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62/6, pp. 825-840.
280–286.
Bazin, E. et al.
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51/3, pp. 251-259.
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Le Hegarat, L. et al.
355–362.
Mutagenesis, Vol.
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25/6, pp. 555-560.
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33–40.
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27/3, pp. 295-304.
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65–75.
17/3, pp. 257-260.
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193–198.
198/1-3, pp. 315-328.
Archives of Toxicology, vol.
37/1, pp. 31-45.
Testmetodens förväntade reproducerbarhet är i storleksordningen 85 % inom laboratorier och 80 % mellan laboratorier (10).
Mutation Research, Vol.
De resultat som genereras i valideringsstudien (18) och publicerade undersökningar (19) visar generellt att noggrannheten hos DPRA när det gäller att skilja mellan hudsensibiliserande ämnen (dvs. GHS-/CLP-kategori 1) och icke-hudsensibiliserande kemikalier är 80 % (N = 157) med en känslighet på 80 % (88/109) och en specificitet på 77 % (37/48) vid en jämförelse med LLNA-resultat.
113/3-4, pp. 173-215.
Testkemikalien bör vara löslig i ett lämpligt lösningsmedel vid en slutlig koncentration på 100 mM (se punkt 18).
Journal of Environmental Pathology and Toxicology, Vol.
Testkemikalier som inte är lösliga vid denna koncentration kan dock testas vid lägre lösliga koncentrationer.
4/1, pp. 55-65.
I ett sådant fall kan ett positivt resultat fortfarande användas som underlag för att identifiera testkemikalien som hudsensibiliserande.
Elliott, B.M. et al.
Definitiva slutsatser om avsaknad av reaktivitet bör dock inte dras från negativa resultat.
Mutagenesis, Vol.
Förenta nationerna (FN) (2013).
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Adler m.fl.
Johnson, T.E., D. R. Umbenhauer, S.M.
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UNEP (2001).
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Environmental Mutagenesis, Vol.
Landsteiner och Jacobs (1936).
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Dupuis och Benezra (1982).
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Lepoittevin m.fl.
652/2, pp. 122-130.
Natsch m.fl.
Fenech, M. (1993).
DB-ALM (INVITTOX) protokoll 154: Direct Peptide Reactivity assay (DPRA) for skin sensitisation testing 17pp.
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90–100
285/1, pp. 35-44.
15–45
Phelps, J.B., M.L.
60–80
Mutation Research, Vol.
10–55
521/1-2, pp. 103-112.
30–60
Mutation Research, Vol.
0–24
655/1-2, pp. 1-3.
80–100
Surralles, J. et al.
0–7
Mutation Research, Vol.
15–55
341/3, pp. 169-184.
0–25
Honma, M. (2011).
60–100
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10–45
724, pp. 86-87.
0–5,5
Pfuhler, S. et al.
Archives of Toxicology 85, 367–485.
723/2, pp. 101-107.
Toxicology and Applied Pharmacology 245, 281–290;:398–408.
OECD (2014).
18, 1779–1791.
Morita T., M. Honma, K. Morikawa (2012).
1(1), 45–49.
Mutation Research, Vol.
In Vitro 25, 733–744.
741, pp. 32-56.
Journal of Applied Toxicology, 33, 1337–1352.
Brookmire L., J.J.
107, 106–121.
Environmental and Molecular Mutagenesis, Vol.
60, 389–400.
54/1, pp. 36-43.
63, 489–504.
EPA, Office of Chemical Safety and Pollution Prevention (2011).
33, 1353–1364.
Sobol, Z. et al.
Toxicology In Vitro 27, 1220–1225.
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87, 1683–1969.
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Chemistry and Biology 17, 646–657.
120/4, pp. 241-247.
Dermatol., 126, 1813–1822.
MacGregor, J. T., C.M.
150, 301–316.
Bryce, S.M. et al.
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23/3, s.
The level of reproducibility in predictions that can be expected from the test method is in the order of 85 % within laboratories and 80 % between laboratories (10).
Hartmann, A. m.fl.
Results generated in the validation study (18) and published studies (19) overall indicate that the accuracy of the DPRA in discriminating sensitisers (i.e. UN GHS/CLP Cat.
, Recommendations for conducting the in vivo alkaline Comet assay, Mutagenesis, vol.
1) from non-sensitisers is 80 % (N=157) with a sensitivity of 80 % (88/109) and specificity of 77 % (37/48) when compared to LLNA results.
18/1, s.
On the basis of the overall data available, the DPRA was shown to be applicable to test chemicals covering a variety of organic functional groups, reaction mechanisms, skin sensitisation potency (as determined in in vivo studies) and physico-chemical properties (8) (9) (10) (19).
45–51.
The term “test chemical” is used in this test method to refer to what is being tested and is not related to the applicability of the DPRA to the testing of substances and/or mixtures.
, The single cell gel electrophoresis assay (Comet assay): a European review, Mutation Research, vol.
A test chemical should be soluble in an appropriate solvent at a final concentration of 100 mM (see paragraph 18).
47–63.
However, test chemicals that are not soluble at this concentration may still be tested at lower soluble concentrations.
, Single cell gel/Comet assay: guidelines for in vitro and in vivo genetic toxicology testing, Environmental and Molecular Mutagenesis, vol.
In such a case, a positive result could still be used to support the identification of the test chemical as a skin sensitiser but no firm conclusion on the lack of reactivity should be drawn from a negative result.
35/3, s.
Appearance of precipitate in the reaction mixture at the end of the incubation time, if observed.
206–221.
Ball et al (2011).
Collins, A.R (2004), The Comet assay for DNA damage and repair: principles, applications, and limitations, Molecular Biotechnology, vol.
Lepoittevin 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.
EC EURL ECVAM (2012).
723/2, s.
Direct Peptide Reactivity Assay (DPRA) Validation Study Report 74pp.
108–120.
Natsch et al.
Kushwaha, S. m.fl.
DB-ALM (INVITTOX) Protocol 154: Direct Peptide Reactivity assay (DPRA) for skin sensitisation testing 17pp.
, Evaluation of multi-organ DNA damage by Comet assay from 28 days repeated dose oral toxicity test in mice: A practical approach for test integration in regulatory toxicity testing, Regulatory Toxicology and Pharmacology, vol.
OECD (2005).
58/1, s.
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ECETOC (2003).
, Combining the in vivo Comet and micronucleus assays: a practical approach to genotoxicity testing and data interpretation, Mutagenesis, vol.
Relevance incorporates consideration of the accuracy (concordance) of a test method (21).
25/2, s.
Determination of instrument performance (e.g. sensitivity) by analysis of a reference standard prior to running the analytical batch (22).
7–19.
The term “test chemical” is used to refer to what is being tested.
, Dose-response assessment of four genotoxic chemicals in a combined mouse and rat micronucleus (MN) and Comet assay protocol, The Journal of Toxicological Science, vol.
60-80
28/6, s.
10-55
621–623.
30-60
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80-100
51–59.
0-7
Nesslany, F. (2007), In vivo Comet assay on isolated kidney cells to distinguish genotoxic carcinogens from epigenetic carcinogens or cytotoxic compounds, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, vol.
0-25
28–41.
10-45
393/1-2, s.
0-5,5
175–178.
The medium is then removed and replaced with fresh culture medium (150 μl culture medium containing serum but without Geneticin in the case of KeratinoSensTM) to which 50 μl of the 25 fold diluted test chemical and control substances are added.
Toyoizumi, T. m.fl.
At least one well per plate should be left empty (no cells and no treatment) to assess background values.
, Use of the in vivo skin Comet assay to evaluate the DNA-damaging potential of chemicals applied to the skin, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, vol.
Finally, for test chemicals generating a 1,5 fold or higher induction already at the lowest test concentration of 0,98 μM, the EC1,5 value of < 0,98 is set based on visual inspection of the dose-response curve.
726/2, s.