natgillin/translations-raw huggingface dataset:
This solution is then mixed with ca.
Report from Working Group on in vitro Tests for Chromosomal Aberrations, Mutation Research/Environmental Mutagenesis and Related Subjects, Vol.
10 g of fine quartz sand for one test vessel.
312/3, pp.
The solvent is allowed to evaporate and the sand is then mixed with the suitable amount of sediment per test beaker.
241-261.
Only agents that volatilise readily can be used to solubilise, disperse or emulsify the test chemical.
Johnson, T.E., D.R.
It should be borne in mind that the volume/weight of sand spiked with the test chemical has to be taken into account in the final preparation of the sediment (i.e. the sediment should thus be prepared with less sand).
UNEP (2001), Stockholm Convention on Persistent Organic Pollutants, United Nations Environment Programme (UNEP).
Care should be taken to ensure that the test chemical added to sediment is thoroughly and evenly distributed within the sediment.
Tucker, J.D., M.L.
The spiked sediment is filled into the pots (as described above).
Krahn, D.F., F.C.
Plants, selected for uniformity and an adequate root system, are removed from the pots used during the establishment phase and transplanted into the spiked sediment as described above.
Zamora, P.O. et al. (1983).
Pots are placed into the test vessels as required for the experimental design.
795-801.
Smart and Barko medium is then added carefully (i.e. using a funnel) in order to avoid disturbance of the sediment.
Asakura, M. et al. (2008).
The shoot length above sediment is measured, either prior to or after the addition of the media.
122-130.
Maintenance of water levels over the test duration
Lorge, E. et al. (2006).
The final water volume must be recorded and the water level marked on each test vessel.
Galloway, S. et al. (2011), Workshop summary: Top concentration for in vitro mammalian cell genotoxicity assays; and Report from working group on toxicity measures and top concentration for in vitro cytogenetics assays (chromosome aberrations and micronucleus), Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
If water evaporates during the test by more than 10 %, the water level should be adjusted with distilled water.
723/2, pp.
If necessary, beakers may be loosely covered by a transparent cover such as transparent plastic lids to minimise evaporation and contamination with algal spores.
77-83.
Warm and/or cool white fluorescent lighting are used to provide light irradiance in the range of about 140 (± 20) μE·m–2 s–1 when measured as a photosynthetically active radiation (400-700 nm) at the water surface and using a light:dark ratio of 16:8 h.
Honma, M. (2011), Cytotoxicity measurement in in vitro chromosome aberration test and micronucleus test, Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis, Vol.
Any differences from the selected light irradiance over the test area should not exceed the range of ± 15 %.
724/1-2, pp.
The temperature in the test vessels is 20 ± 2 °C.
86-87.
The pH of the control medium should not increase by more than 1,5 units during the test.
Richardson, C. et al. (1989).
However, deviation of more than 1,5 units would not invalidate the test when it can be shown that the validity criteria specified previously are met.
OECD (2014), Document supporting the WNT decision to implement revised criteria for the selection of the top concentration in the in vitro mammalian cell assays on genotoxicity (Test Guidelines 473, 476 and 487) ENV/JM/TG(2014)17.
Test duration
Morita, T., M. Honma, K. Morikawa (2012), Effect of reducing the top concentration used in the in vitro chromosomal aberration test in CHL cells on the evaluation of industrial chemical genotoxicity, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
The exposure period is 14 days.
741/1-2, pp.
After the establishment phase and immediately prior to treatment (i.e. on Day 0), spare plants from five randomly selected pots for the three plants per pot design or 15 pots for the one plant per pot design, are harvested for assessment of shoot length and fresh and dry weight as described below.
32-56.
For plants transferred into the exposure phase, the following assessments are made as shown in Table 1:
Brookmire, L., J.J.
Assessments of main shoot length, side shoot number and side shoot length are recorded at least at the end of the exposure period (e.g. on day 14).
EPA, Office of Chemical Safety and Pollution Prevention (2011), Chemical Substances of Unknown or Variable Composition, Complex Reaction Products and Biological Materials: UVCB Substances, http://www.epa.gov/opptintr/newchems/pubs/uvcb.txt.
Visual assessments of plant health are recorded at least three times during the exposure period (e.g. on days 0, 7 and 14).
USFDA (2012), International Conference on Harmonisation (ICH) Guidance S2 (R1) on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended For Human Use.
If side shoots are present, their numbers and length should also be measured.
723/2, pp.
Visual assessments of plant health are made by recording the appearance of plants and the general condition of the test medium.
87-90.
Necrosis, chlorosis or other discoloration such as excessive reddening relative to control plants.
Fleiss, J. L., B. Levin, M.C.
Development of bacterial or algal contamination;
Warr, T.J., E.M.
Growth abnormalities such as stunting, altered internodal length, distorted shoots/leaves, the proliferation of side shoots, leaf loss, loss of turgor and stem fragmentation.
Locke-Huhle, C. (1983), Endoreduplication in Chinese hamster cells during alpha-radiation induced G2 arrest, Mutation Research, Vol.
Visual assessments of root health are made at test termination, by carefully washing sediment from roots to enable observation of the root system.
119/3, pp.
A proposed scale for assessment, relative to control plants, is shown below:
403-413.
roots absent
Huang, Y., C. Change, J.E.
few roots
Trosko (1983), Aphidicolin – induced endoreduplication in Chinese hamster cells, Cancer Research, Vol.
moderate root development
43/3, pp.
very good root development, similar to controls.
1362-1364.
Assessments of fresh weight are made at the beginning and end of the test by cutting the shoot at sediment level and then blotting dry prior to weighing.
Soper, K.A., S.M.
Care should be taken to remove sediment particles that may adhere to the base of the shoot.
V prípade skúšok uvedených v tejto testovacej metóde s využitím bunkových línií je cytotoxicita identifikovaná ako zníženie relatívneho zdvojenia populácie (RPD) alebo relatívne zvýšenie počtu buniek (RICC), pokiaľ ide o ovplyvňované bunky v porovnaní s negatívnou kontrolnou (pozri bod 17 a dodatok 2).
Shoot material is then placed in a drying oven at ca.
V prípade skúšok uvedených v tejto testovacej metóde s využitím primárnych kultúr lymfocytov je cytotoxicita identifikovaná ako zníženie mitotického indexu (MI) ošetrených buniek v porovnaní s negatívnou kontrolnou (pozri bod 18 a dodatok 2).
60 °C and dried to a constant weight, prior to re-weighing and recording the dry weight.
v prípade krátkodobých štúdií: hmotnosť jednotlivých zvierat na začiatku a na konci testu, v prípade štúdií dlhších ako jeden týždeň: hmotnosť jednotlivých zvierat počas štúdie a konzumácie potravy.
A summary of the minimum biological assessments required over the test duration is provided in Table 1.
Mal by sa zahrnúť rozsah telesnej hmotnosti, priemer a štandardná odchýlka pre každú skupinu.
indicates that measurements are not required.
35/3, pp.
(DAT)
Adler, I.D. et al. (1998), Recommendations for statistical designs of in vivo mutagenicity tests with regard to subsequent statistical analysis, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
Visual assessment of shoots
19-30.
Shoot fresh and dry weight,
Ryan, T.P.
Visual assessment of roots
87-90.
Frequency of measurements and analytical determinations
293-304.
The temperature of the medium in a supplementary vessel held under the same conditions in the growth chamber, incubator or room should be recorded at least daily (or continuously with a data logger).
Pacchierotti, F., V. Stocchi (2013), Analysis of chromosome aberrations in somatic and germ cells of the mouse, Methods in Molecular Biology, Vol.
The pH and dissolved oxygen concentration of the test medium should be checked at test initiation, at least once during the study and at the end of the study in all replicate vessels.
1044, pp.
On each occasion, measurements should be taken at the same time of the day.
147-163.
If bulk solutions are used to prepare all replicates at each test concentration, then a single measurement of each bulk solution is acceptable on Day 0.
v prípade krátkodobých štúdií: hmotnosť jednotlivých zvierat na začiatku a na konci testu; v prípade štúdií dlhších ako jeden týždeň: hmotnosť jednotlivých zvierat počas štúdie a konzumácia potravy.
Irradiance should be measured in the growth chamber, incubator or room at points equivalent to level of the water surface.
MacGregor, J.T. et al. (1990), The in vivo erythrocyte micronucleus test: measurement at steady state increases assay efficiency and permits integration with toxicity studies, Fundamental and Applied Toxicology, Vol.
Measurements should be made at least once at test initiation or during the test.
14/3, pp.
The method of light detection and measurement, in particular the type of sensor, will affect the measured value.
Dertinger, S.D. et al. (2011), Flow cytometric scoring of micronucleated erythrocytes: an efficient platform for assessing in vivo cytogenetic damage, Mutagenesis, Vol.
Analytical measurements of test chemical
26/1, pp.
Water samples should be collected for test chemical analysis shortly after test initiation (i.e. on the day of application for stable test chemicals or one hour after application for chemicals that are not stable) and at test termination for all test concentrations.
139-145.
Concentrations in sediment and sediment pore-water should be determined at test initiation and test termination, at least in the highest test concentration, unless the test chemicals are known to be stable in water (> 80 % of nominal).
Parton, J.W., W.P.
Sampling of sediment at test initiation is likely to disrupt the test system.
404/1-2, pp.
Similarly, where intermediate assessments are considered necessary, i.e. on day 7, and analyses require large samples of sediment that cannot be easily removed from the test system, analytical determinations should be performed using additional test vessels treated in the same way as those used for biological assessments.
Styles, J.A. et al. (2001), Automation of mouse micronucleus genotoxicity assay by laser scanning cytometry, Cytometry, Vol.
However, if the test chemical is demonstrated not to absorb to filters, filtration may also be acceptable.
153-155.
Alternatively, the test solutions of all replicates for each concentration may be pooled for analyses.
513-522.
However, if there is evidence that the concentration has declined (i.e. is not maintained within 20 % of the nominal or measured initial concentration in the treated compartment) throughout the test, then analysis of the results should be based on the geometric mean concentration during exposure or models describing the decline of the concentration of the test chemical in the treated compartment (11).
278/2-3, pp.
DATA EVALUATION
83-98.
The purpose of the test is to determine the effects of the test chemical on the vegetative growth of the test species, using two response variables, average specific growth rate and yield, as follows:
Salamone, M.F., K.H.
This response variable is based on changes in the logarithms of total shoot length, total shoot fresh weight and total shoot dry weight, over time in the controls and each treatment group.
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.
This variable is calculated for each replicate of each control and treatment group.
453/1, pp.
From the replicate responses, a mean value for growth rate along with variance estimates should be calculated for each treatment and control group.
Hayes, J. et al. (2009), The rat bone marrow micronucleus test--study design and statistical power, Mutagenesis, Vol.
Percent inhibition of growth rate (Ir) may then be calculated for each test concentration (treatment group) according to the following formula:
24/5, pp.
μC mean value for μin the control
419-424.
μT mean value for μin the treatment group
Wakata, A. et al. (2006).
This response variable is based on changes in total shoot length, total shoot fresh weight and total shoot dry weight, over time in the controls and each treatment group.
Rothfuss, A. et al. (2011), Improvement of in vivo genotoxicity assessment: combination of acute tests and integration into standard toxicity testing, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
percent reduction in yield
723/2, pp.
final biomass minus starting biomass for the control group
108-120.
final biomass minus starting biomass in the treatment group
LeBaron, M.J. et al. (2013), Influence of counting methodology on erythrocyte ratios in the mouse micronucleus test, Environmental and Molecular Mutagenesis, Vol.
It is possible to use a weighted linear regression after having performed a linearising transformation of the response data, for instance into probit or logit or Weibull units (13), but non-linear regression procedures are preferred techniques that better handle unavoidable data irregularities and deviations from smooth distributions.
Asanami, S., K. Shimono (1997), High body temperature induces micronuclei in mouse bone marrow, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
Approaching either zero or total inhibition such irregularities may be magnified by the transformation, interfering with the analysis (13).
390/1-2, pp.
Specific procedures for determination of ECx values from continuous data can be found in (14) (15) (16) (17).
79-83.
The 95 % confidence limits for each estimate are determined and goodness of fit of the response data to the regression model should be assessed either graphically or statistically.
Asanami, S., K. Shimono, S. Kaneda (1998), Transient hypothermia induces micronuclei in mice, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
estimates and confidence limits may also be obtained using linear interpolation with bootstrapping (18), if available regression models/methods are unsuitable for the data.
413/1, pp.
The mean for each concentration is then compared with the control mean using an appropriate test method (e.g. Dunnett's, Williams'tests) (19) (20) (21) (22).
7-14.
It is necessary to assess whether the ANOVA assumption of normal distribution (ND) and variance homogeneity (VH) of variance holds.
Spencer, P.J. et al. (2007), Induction of micronuclei by phenol in the mouse bone marrow: I. Association with chemically induced hypothermia, Toxicological Sciences, Vol.
This assessment should be performed by Shapiro-Wilks-test (ND) or Levene's test (VH).
97/1, pp.
The test report includes the following details:
Sun, J.T., M.J.
scientific name and source.
Miller, B.M., I.D.
test procedure used (static, semi-static, pulsed);
297-302.
date of start of the test and its duration;
Russo, A. (2002), PRINS tandem labeling of satellite DNA in the study of chromosome damage, American Journal of Medical Genetics, Vol.
test medium, i.e. sediment and liquid nutrient medium;
107/2, pp.
test concentrations (nominal and measured as appropriate) and number of replicates per concentration;
Gollapudi, B.B., L.G.
methods of preparation of stock and test solutions including the use of any solvents or dispersants;
49-52.
pH values of the test and control media as well as appearance of test media at test initiation and end;
ICCVAM (2006).
oxygen concentrations;
Test Method Evaluation Report – In Vitro Ocular Toxicity Test Methods for Identifying Ocular Severe Irritants and Corrosives.
the method of analysis with appropriate quality assessment data (validation studies, standard deviations or confidence limits of analyses);
ICCVAM (2010).
all deviations from this test method.
UN (2011).
raw data: shoot length and shoot weight of plants/pot and other measurement variables in each test and control vessel at each observation and occasion of analysis according to the assessment schedule provided in Table 1;
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).
growth curves for each concentration;
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.
doubling time/growth rate in the control based on shoot length and fresh weight including the coefficient of variation for yield of fresh weight;
INVITTOX (1999).
calculated response variables for each treatment replicate, with mean values and coefficient of variation for replicates;
Protocol 124: Bovine Corneal Opacity and Permeability Assay – SOP of Microbiological Associates Ltd.
graphical representation of the concentration/effect relationship;
Ispra, Italy: European Centre for the Validation of Alternative Methods (ECVAM).
estimates of toxic endpoints for response variables e.g. EC50, and associated confidence intervals.
Gautheron, P., Dukic, M., Alix, D. and Sina, J.F.
If calculated, LOEC and/or NOEC and the statistical methods used for their determination;
Prinsen, M.K.
any stimulation of growth found in any treatment;
Maurer, J.K., Parker, R.D. and Jester, J.V.
any visual signs of phytotoxicity as well as observations of test solutions;
OECD (2011).
discussion of the results, including any influence on the outcome of the test resulting from deviations from this test method.
Doughty, M.J., Petrou, S. and Macmillan, H. (1995).
Chapter C.26 of this Annex: Lemna sp.
Collee, J. and Bradley, R. (1997).
Growth Inhibition Test.
BSE: A decade on – Part I. The Lancet 349: 636-641.
Chapter C.3 of this Annex: Freshwater Alga and Cyanobacteria, Growth Inhibition Test.
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).
ISO 16191:2013 Water quality — Determination of the toxic effect of sediment on the growth behaviour of Myriophyllum aquaticum.
OECD (1998).
Chapter C.28 of this Annex: Sediment-Water Chironomid Toxicity Using Spiked Water.
Laboratórium môže použiť tieto chemikálie na účely preukázania svojej odbornej spôsobilosti na vykonávanie testovacej metódy izolovaného kuracieho oka pred predložením údajov o testovacej metóde izolovaného kuracieho oka na regulačné účely klasifikácie nebezpečnosti.
Ratte, M., H. Ratte (2014), “Myriophyllum Toxicity Test: Result of a ring test using M. aquaticum and M. spicatum grown in a water-sediment system”, OECD Environment, Health and Safety Publications (EHS), Series on Testing and Assessment, No. 206, OECD Publishing, Paris.
0,0 až 0,5
, Herbicide risk assessment for non-target aquatic plants: sulfosulfuron — a case study, Pest Management Science, Vol.
0,6 až 1,5
59/2, pp. 231 - 237.
1,6 až 2,5
SMART AND BARKO MEDIUM COMPOSITION
2,6 až 4,0
Amount of reagent added to water [1] (mg/l)
2,6 až 3,0
pH (air equilibrium)
ICCVAM (2007).
Demineralised (i.e. distilled or deionised) water.
ESAC (2007).
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 304, 22.11.2007, p.
United Nations (UN) (2011).
1).
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).
The US Interagency Coordinating Committee on the Validation of Alternative Methods.
ICCVAM.
The area of corneal opacity should be noted.
Prinsen, M.K. and Koëter, B.W.M.
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p.
Balls, M., Botham, P.A., Bruner, L.H. and Spielmann H. (1995).
1).
Chamberlain, M., Gad, S.C., Gautheron, P. and Prinsen, M.K.
Combinations less likely to occur.
bunky by mali byť vystavené testovanej chemikálii bez metabolickej aktivácie počas 3 – 6 hodín a vzorky z nich by sa mali odobrať v čase rovnajúcom sa približne 1,5 – 2,0-násobku dĺžky bežného bunkového cyklu po začatí ovplyvňovania (19),
For mean it is meant arithmetic mean throughout the document.
V prípade automatizovaného systému hodnotenia by sa mali použiť vhodné techniky, ako je napr. prietoková cytometria, laserová skenovacia cytometria alebo analýza obrazu, aby boli skreslenia a posuny pod kontrolou.
The numbers refer to statistically generated threshold values and are not related to the precision of the measurement.
Bez ohľadu na to, či sa pri vyčíslení mikrojadier používa automatizovaná platforma, mali by sa súbežne posudzovať hodnoty CBPI, RI, RPD alebo RICC.
See Appendix 1 for definitions and units
Kirsch-Volders, M. et al. (2000).
Sometimes denoted by POW; determined by a shake-flask method in TM A.8 (4), an HPLC method in TM A.24 (5) and a slow-stirring method in TM A.23 (6).
Fenech, M. (2007).
The generator-column technique is occasionally used for the determination of log KOW.
Eastmond, D.A., J.D.
A limited number of studies are available that makes use of this technique, primarily for chlorinated biphenyls and dibenzodioxins (e.g. Li and Doucette, 1993) (3).
Eastmond, D.A., D. Pinkel (1990).
For substances that might ionise, log KOW should refer to the unionised form.
Farooqi, Z., F. Darroudi, A. T. Natarajan (1993).
See Appendix 1 for definitions and units
Migliore, L. et al. (1993).
TLC: thin layer chromatography; HPLC: high pressure liquid chromatography; GC: gas chromatography
Norppa, H., L. Renzi, C. Lindholm (1993).
For most test substances, there should ideally be no detections in the control water.
Zijno, P. et al. (1996).
TOC includes organic carbon from particles and dissolved organic carbon, i.e. TOC = POC + DOC.
Albertini, S. et al. (1997).
If the lipid content is not analysed in the same fish as the test substance, fish should at least be of the similar weight, and (if relevant) the same sex.
Kalweit, S. et al. (1999).
This ensures that fish growth in all test groups is similar, if the tested concentration is below the toxic range.
Kersten, B. et al. (1999).
If the growth is similar, also the lipid content is expected to be similar.
von der Hude, W. et al. (2000).
A different growth in the control would indicate a substance effect and invalidate the study.
Garriott, M.L., J.B.
In addition to weight, total length should be recorded because comparison of the extent of length increase during the test is a good indicator of whether an adverse effect has occurred.
Elhajouji, A., E. Lorge (2006).
If needed, an F-test or likelihood ratio test can be used to assist in the choice of the appropriate growth model (OECD monograph 54, (32).
Hashimoto K. et al. (2011).
These percentages assume that the analytical methods are reliable and the half life is < 14 days.
Honma, M., M. Hayashi (2011).