natgillin/translations-raw huggingface dataset:
Bez ohledu na typy buněk (buněčné linie nebo primární kultury lymfocytů) mohou být pro každou zkušební koncentraci použity buď jednotlivé exponované kultury nebo replikáty.I když je doporučováno použití duplicitních kultur, jednu kulturu lze rovněž akceptovat za předpokladu, že v této jediné kultuře je hodnocen stejný celkový počet buněk jako v duplicitních kulturách.
Establishment phase
Registrační číslo CAS
Healthy shoot apices/tips, i.e. without side shoots, are cut from the culture plants to give a shoot length of 6 cm (± 1 cm).
Postupy používané v laboratoři by měly zajistit, aby analýzu chromozómových aberací prováděli dobře odborně připravení hodnotitelé a aby tato analýza byla případně podrobena odborné revizi.
For Test Design A (one shoot per pot and three pots per vessel) single shoot tips are planted into each pot.
Ačkoli je účelem zkoušky detekovat strukturní chromozómové aberace, je důležité zaznamenat četnost výskytu polyploidií a endoreduplikací, jsou-li tyto jevy pozorovány (viz odstavec 2).
For Test Design B (three shoots per pot and one pot per vessel) four to five shoot apices are planted into each pot containing the sediment.
Evans, H.J.
In both cases surplus pots should be planted to allow for selection of uniform plants at test initiation, as well as to provide spare plants to be used for inspection of root growth immediately prior to treatment and spare plants to be harvested for shoot biomass and length measurements on Day 0.
Galloway, S.M. et al.
Shoots are inserted such that approximately three cm, covering at least two nodes, are beneath the sediment surface.
10, s. 1-175.
Pots are then transferred to test vessels under the same environmental conditions as for the exposure phase and maintained for seven days in Smart and Barko medium to induce root development.
Muehlbauer, P.A. et al.
After this time, several plants in spare pots should be removed for inspection of root growth.
ILSI paper (draft), Lorge, E., M.
If root growth is not visible (i.e. root tips are not visible), then the establishment phase should be extended until root growth is visible.
Moore, J.
This step is recommended to ensure that plants are actively growing at the time of test initiation.
Clements, M.
Selection of uniform plant material
O Donovan, F.
For Test Design A (one shoot per pot and three pots per vessel) pots are selected for uniformity prior to test initiation.
Darroudi, M.
For Test Design B (three shoots per pot and one pot per vessel), surplus plants are removed to leave three plants that are uniform in size and appearance.
Honma, A.
Exposure via the water phase
Czich, J van Benthem, S.
Pots, selected for uniformity, are placed into the test vessels as required for the experimental design.
Galloway, V.
Smart and Barko medium is then added to the test vessels.
Thybaud, B.
Care should be taken to avoid disturbance of the sediment.
Gollapudi, M.
For this purpose, media may be added using a funnel or a plastic disc to cover the sediment while the medium is poured into the test vessels provided that the disc is removed immediately afterwards.
Aardema, J.
Alternatively, plant pots may be placed in the test vessels after the addition of the media.
Kim, D.J.
In both cases, fresh media may be used at the beginning of the exposure phase, if necessary to minimise the potential build-up of algae and bacteria or to allow preparation of single batches of test solution across replicates.
Scott, D. et al.
The shoot length above sediment is measured, either prior to or after the addition of the medium.
A report from ICPEMC Task Group 9, Mutation Research/Reviews in Genetic Toxicology, Vol.257/2, s. 147-204.
The relevant amounts of the test chemical may be added to the test medium before it is added to the test vessels.
Morita, T. et al.
Alternatively, the test chemical may be introduced into the medium after it has been added to the test vessels.
, Clastogenicity of Low pH to Various Cultured Mammalian Cells, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
In this case, care should be taken to ensure that the test chemical is homogeneously distributed throughout the test system without disturbing the sediment.
268/2, s. 297-305.
In all cases, the appearance (e.g. clear, cloudy, etc.) of the test media is recorded at test initiation.
Brusick, D.
Exposure via sediment
(1986), Genotoxic effects in cultured mammalian cells produced by low pH treatment conditions and increased ion concentrations, Environmental and Molecular Mutagenesis, Vol.
Spiked sediments of the chosen concentration are prepared by addition of a solution of the test chemical directly to fresh sediment.
8/6, s. 789-886.
A stock solution of the test chemical dissolved in deionised water is mixed with the formulated sediment by rolling mill, feed mixer or hand mixing.
Long, L.H. et al.
If poorly soluble in water, the test chemical can be dissolved in as small a volume as possible of a suitable organic solvent (e.g. hexane, acetone or chloroform).
, Different cytotoxic and clastogenic effects of epigallocatechin gallate in various cell-culture media due to variable rates of its oxidation in the culture medium, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
This solution is then mixed with ca.
634/1-2, s. 177-183.
10 g of fine quartz sand for one test vessel.
Nesslany, F. et al.
The solvent is allowed to evaporate and the sand is then mixed with the suitable amount of sediment per test beaker.
, Characterization of the Genotoxicity of Nitrilotriacetic Acid, Environmental and Molecular Mutagenesis, Vol.
Only agents that volatilise readily can be used to solubilise, disperse or emulsify the test chemical.
49/6, s. 439-452.
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).
Galloway, S.
Care should be taken to ensure that the test chemical added to sediment is thoroughly and evenly distributed within the sediment.
(2000), Cytotoxicity and chromosome aberrations in vitro: Experience in industry and the case for an upper limit on toxicity in the aberration assay, Environmental and Molecular Mutagenesis, Vol.
The spiked sediment is filled into the pots (as described above).
35/3, s. 191-201.
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.
Kirkland, D. et al.
Pots are placed into the test vessels as required for the experimental design.
I: Sensitivity, specificity and relative predictivity, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
Smart and Barko medium is then added carefully (i.e. using a funnel) in order to avoid disturbance of the sediment.
584/1-2, s. 1-256.
The shoot length above sediment is measured, either prior to or after the addition of the media.
Greenwood, S. et al.
Maintenance of water levels over the test duration
, Population doubling: a simple and more accurate estimation of cell growth suppression in the in vitro assay for chromosomal aberrations that reduces irrelevant positive results, Environmental and Molecular Mutagenesis, Vol.
The final water volume must be recorded and the water level marked on each test vessel.
43/1, s. 36-44.
If water evaporates during the test by more than 10 %, the water level should be adjusted with distilled water.
Hilliard, C.A. et al.
If necessary, beakers may be loosely covered by a transparent cover such as transparent plastic lids to minimise evaporation and contamination with algal spores.
, Chromosome aberrations in vitro related to cytotoxicity of nonmutagenic chemicals and metabolic poisons, Environmental and Molecular Mutagenesis, Vol.
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.
31/4, s. 316-326.
Any differences from the selected light irradiance over the test area should not exceed the range of ± 15 %.
Hedner K. et al.
The temperature in the test vessels is 20 ± 2 °C.
, Sister chromatid exchanges and structural chromosomal aberrations in relation to age and sex, Human Genetics, Vol.
The pH of the control medium should not increase by more than 1,5 units during the test.
62, s. 305-309.
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.
Ramsey M.J. et al.
Test duration
, The effects of age and lifestyle factors on the accumulation of cytogenetic damage as measured by chromosome painting, Mutation Research, Vol.
The exposure period is 14 days.
338, s. 95-106.
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.
Coecke S. et al.
For plants transferred into the exposure phase, the following assessments are made as shown in Table 1:
A Report of the Second ECVAM Task Force on Good Cell Culture Practice, ATLA, Vol.
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).
33/3, s. 261-287.
Visual assessments of plant health are recorded at least three times during the exposure period (e.g. on days 0, 7 and 14).
Henderson, L. et al.
Assessments of shoot fresh weight and dry weight are made at the end of the test (i.e. on Day 14).
, Industrial Genotoxicology Group collaborative trial to investigate cell cycle parameters in human lymphocyte cytogenetics studies, Mutagenesis, Vol.12/3, s.163-167.
Shoot length is determined using a ruler.
Ames, B.N., J.
If side shoots are present, their numbers and length should also be measured.
McCann, E.
Visual assessments of plant health are made by recording the appearance of plants and the general condition of the test medium.
Yamasaki (1975), Methods for Detecting Carcinogens and Mutagens with the Salmonella/Mammalian Microsome Mutagenicity Test, Mutation Research/Environmental Mutagenesis and Related Subjects, Vol.
Observations to be noted include:
31/6, s. 347-363.
Necrosis, chlorosis or other discoloration such as excessive reddening relative to control plants.
Maron, D.M., B.N.
Development of bacterial or algal contamination;
Ames (1983), Revised Methods for the Salmonella Mutagenicity Test, Mutation Research/Environmental Mutagenesis and Related Subjects, Vol.
Growth abnormalities such as stunting, altered internodal length, distorted shoots/leaves, the proliferation of side shoots, leaf loss, loss of turgor and stem fragmentation.
113/3–4, s. 173-215.
Visual assessments of root health are made at test termination, by carefully washing sediment from roots to enable observation of the root system.
Natarajan, A.T. et al.
A proposed scale for assessment, relative to control plants, is shown below:
, Cytogenetic Effects of Mutagens/Carcinogens after Activation in a Microsomal System In Vitro, I.
roots absent
Induction of Chromosomal Aberrations and Sister Chromatid Exchanges by Diethylnitrosamine (DEN) and Dimethylnitrosamine (DMN) in CHO Cells in the Presence of Rat-Liver Microsomes, Mutation Research, Vol.
few roots
37/1, s. 83-90.
moderate root development
Matsuoka, A., M.
very good root development, similar to controls.
Hayashi, M.
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.
Jr.
Care should be taken to remove sediment particles that may adhere to the base of the shoot.
Ishidate (1979), Chromosomal Aberration Tests on 29 Chemicals Combined with S9 Mix in vitro, Mutation Research/Genetic Toxicology, Vol.
Shoot material is then placed in a drying oven at ca.
66/3, s. 277-290.
60 °C and dried to a constant weight, prior to re-weighing and recording the dry weight.
Ong, T.-m. et al.
A summary of the minimum biological assessments required over the test duration is provided in Table 1.
, Differential effects of cytochrome P450-inducers on promutagen activation capabilities and enzymatic activities of S-9 from rat liver, Journal of Environmental Pathology and Toxicology, Vol.
Assessment schedule
4/1, s. 55–65.
A indicates that assessments are required on these occasions
Elliot, B.M. et al.
indicates that measurements are not required.
Alternatives to Aroclor 1254-induced S9 in in vitro Genotoxicity Assays, Mutagenesis, Vol.
Day after treatment
7/3, s. 175-177.
(DAT)
Matsushima, T. et al.
Shoot length, side shoot length and number
Report from Working Group on in vitro Tests for Chromosomal Aberrations, Mutation Research/Environmental Mutagenesis and Related Subjects, Vol.
Visual assessment of shoots
312/3, s. 241-261.
Shoot fresh and dry weight,
Johnson, T.E., D.R.
Visual assessment of roots
Galloway (1996), Human liver S-9 metabolic activation: proficiency in cytogenetic assays and comparison with phenobarbital/beta-naphthoflavone or Aroclor 1254 induced rat S-9, Environmental and Molecular Mutagenesis, Vol.
Frequency of measurements and analytical determinations
28/1, s. 51-59.
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).
UNEP (2001), Stockholm Convention on Persistent Organic Pollutants, United Nations Environment Programme (UNEP).
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.
Tucker, J.D., M.L.
On each occasion, measurements should be taken at the same time of the day.
Christensen (1987), Effects of anticoagulants upon sister-chromatid exchanges, cell-cycle kinetics, and mitotic index in human peripheral lymphocytes, Mutation Research, Vol.
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.
190/3, s. 225-8.
Irradiance should be measured in the growth chamber, incubator or room at points equivalent to level of the water surface.
Krahn, D.F., F.C.
Measurements should be made at least once at test initiation or during the test.
Zamora, P.O. et al.
The method of light detection and measurement, in particular the type of sensor, will affect the measured value.
, Evaluation of an Exposure System Using Cells Grown on Collagen Gels for Detecting Highly Volatile Mutagens in the CHO/HGPRT Mutation Assay, Environmental and Molecular Mutagenesis, Vol.
Analytical measurements of test chemical
5/6, s. 795-801.
The correct application of the test chemical should be supported by analytical measurements of test chemical concentrations.
Asakura, M. et al.
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.
, An improved system for exposure of cultured mammalian cells to gaseous compounds in the chromosomal aberration assay, Mutation Research, Vol.
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).
652/2, s. 122-130.
Measurements in sediment and pore-water might not be necessary if the partitioning of the test chemical between water and sediment has been clearly determined in a water/sediment study under comparable conditions (e.g. sediment to water ratio, application method, sediment type).
Lorge, E. et al.
Sampling of sediment at test initiation is likely to disrupt the test system.
I.
Hence, additional treated test vessels may be required to facilitate analytical determinations at test initiation and test termination.
Theoretical aspects, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
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.
655/1-2, s. 1-3.
Centrifugation at, for example, 10000 g and 4 °C for 30 minutes is recommended to isolate interstitial water.
Galloway, S. et al.
However, if the test chemical is demonstrated not to absorb to filters, filtration may also be acceptable.
, 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.
In some cases, it might not be possible to analyse concentrations in the pore water if the sample size is too small.
723/2, s. 77-83.
In semi-static tests (i.e. exposure via the water phase) where the concentration of the relevant test chemical(s) is not expected to remain within 20 % of the nominal concentration over the test duration without renewal of test solutions, used and freshly prepared test solutions should be sampled for analyses of test chemical concentration at each renewal.
Honma, M.
In cases where the measured initial concentration of the test chemical is not within 20 % of nominal but where sufficient evidence can be provided to show that the initial concentrations are repeatable and stable (i.e. within the range of 80-120 % of the initial concentration), chemical determinations may be carried out on only the highest and lowest test concentrations.
(2011), Cytotoxicity measurement in in vitro chromosome aberration test and micronucleus test, Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis, Vol.
In all cases, determination of test chemical concentrations need only be performed on one replicate vessel at each test concentration.
724/1–2, s. 86–87.
Alternatively, the test solutions of all replicates for each concentration may be pooled for analyses.
Richardson, C. et al.
If there is evidence that the test chemical concentration has been maintained within 20 % of the nominal or measured initial concentration throughout the test, then analysis of the results and subsequent derivation of endpoints can be based on nominal or measured initial values.
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.
In these cases, effect concentrations should be based on nominal or measured water concentrations at the beginning of the test.
Morita, T., M.
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).
Honma, K.
DATA EVALUATION
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.
In cases where use of a solvent / dispersant is required, data from solvent and untreated controls may be pooled for the purposes of statistical analyses provided that the responses of the solvent and untreated controls are not statistically significantly different.
741/1–2, s. 32-56.
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:
Brookmire, L., J.J.
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.
Levy (2013), Evaluation of the Highest Concentrations Used in the In Vitro Chromosome Aberrations Assay, Environmental and Molecular Muagenesis, Vol.
This variable is calculated for each replicate of each control and treatment group.
54/1, s. 36-43.
The mean length and weight of the three plants per test vessel (replicate) and, subsequently, the growth rate for each replicate, should be calculated using the following formula:
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.
From the replicate responses, a mean value for growth rate along with variance estimates should be calculated for each treatment and control group.
USFDA (2012), International Conference on Harmonisation (ICH) Guidance S2 (R1) on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended For Human Use.
Percent inhibition of growth rate (Ir) may then be calculated for each test concentration (treatment group) according to the following formula:
ISCN (2013), An International System for Human Cytogenetic Nomenclature, Schaffer, L.G., J.
μC mean value for μin the control
MacGowan-Gordon, M.
μT mean value for μin the treatment group
Schmid (eds.), Karger Publishers Inc., Connecticut.
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.
Hayashi, M. et al.
percent reduction in yield
, Compilation and use of genetic toxicity historical control Data, Mutation Research, Vol.
final biomass minus starting biomass for the control group
723/2, s. 87-90.
final biomass minus starting biomass in the treatment group
Ryan, T.
Concentration-response curves relating mean percentage inhibition of the response variable (Ir, or Iy), calculated as shown above and the log concentration of the test chemical should be plotted.
P.
Estimates of the ECx (e.g. EC50) should be based upon both average specific growth rate (ErCx) and yield (EyCx), each of which should in turn be based upon total shoot fresh weight, total shoot dry weight and total shoot length.
(2000), Statistical Methods for Quality Improvement, 2nd Edition, John Wiley and Sons, New York.
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.
Fleiss, J.
Approaching either zero or total inhibition such irregularities may be magnified by the transformation, interfering with the analysis (13).
L., B.
Specific procedures for determination of ECx values from continuous data can be found in (14) (15) (16) (17).
Levin, M.C.
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.
Warr, T.J., E.M.
estimates and confidence limits may also be obtained using linear interpolation with bootstrapping (18), if available regression models/methods are unsuitable for the data.
Parry (1993), A comparison of two in vitro mammalian cell cytogenetic assays for the detection of mitotic aneuploidy using 10 known or suspected aneugens, Mutation Research, Vol.
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).