natgillin/translations-raw huggingface dataset:
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.
eläinten alkuperä, häkkijärjestelyt, ruokavalio ja niin edelleen.
Alternatively, plant pots may be placed in the test vessels after the addition of the media.
Puudutusaineet ja kipulääkkeet
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.
Neun, D. J. (1993).
The shoot length above sediment is measured, either prior to or after the addition of the medium.
YK (2011).
The relevant amounts of the test chemical may be added to the test medium before it is added to the test vessels.
United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Alternatively, the test chemical may be introduced into the medium after it has been added to the test vessels.
4. tarkistettu painos.
In this case, care should be taken to ensure that the test chemical is homogeneously distributed throughout the test system without disturbing the sediment.
United Nations Publications.
In all cases, the appearance (e.g. clear, cloudy, etc.) of the test media is recorded at test initiation.
ECHA:n ohjeet tietovaatimuksista ja kemikaaliturvallisuusarvioinnista, R.7a luku: Päätepisteitä koskevat erityisohjeet (Endpoint specific guidance)
Exposure via sediment
Kemikaali, joka aiheuttaa silmälle kudosvauriota, joka ei korjaudu 21 päivän kuluessa annostelusta tai joka aiheuttaa näkökyvyn vakavaa fyysistä rappiota; b) kemikaalit, jotka on luokiteltu GHS:n kategoriaan 1 silmää ärsyttäviksi aineiksi tai EPAn kategoriaan I silmää ärsyttäviksi aineiksi tai EU:n kategoriaan 1 (17) (18) (19).
Spiked sediments of the chosen concentration are prepared by addition of a solution of the test chemical directly to fresh sediment.
OECD (1998) Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances, as endorsed by the 28th Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, marraskuu 1998 (http://www.oecd.org/ehs/Class/HCL6.htm).
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.
Worth A.P. and Fentem J.H.
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).
Young, J. R., How, M. J., Walker, A. P., Worth W.
This solution is then mixed with ca.
Effects of Alkalinity on the Eye Irritation Potential of Solutions Prepared at a Single pH.
10 g of fine quartz sand for one test vessel.
J. Toxicol.
The solvent is allowed to evaporate and the sand is then mixed with the suitable amount of sediment per test beaker.
In vitro-kromosomipoikkeavuustesti nisäkässoluilla
Only agents that volatilise readily can be used to solubilise, disperse or emulsify the test chemical.
CAS-nro
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).
10, s. 1–175.
Care should be taken to ensure that the test chemical added to sediment is thoroughly and evenly distributed within the sediment.
ILSI paper (luonnos), Lorge, E., M. Moore, J. Clements, M. O Donovan, F. Darroudi, M. Honma, A. Czich, J van Benthem, S. Galloway, V. Thybaud, B. Gollapudi, M. Aardema, J. Kim, D.J.
The spiked sediment is filled into the pots (as described above).
A report from ICPEMC Task Group 9, Mutation Research/Reviews in Genetic Toxicology, Vol.257/2, s. 147–204.
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.
, Clastogenicity of Low pH to Various Cultured Mammalian Cells, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
Pots are placed into the test vessels as required for the experimental design.
268/2, s. 297–305.
Smart and Barko medium is then added carefully (i.e. using a funnel) in order to avoid disturbance of the sediment.
Brusick, D. (1986), Genotoxic effects in cultured mammalian cells produced by low pH treatment conditions and increased ion concentrations, Environmental and Molecular Mutagenesis, Vol.
The shoot length above sediment is measured, either prior to or after the addition of the media.
8/6, s. 789–886.
Maintenance of water levels over the test duration
, 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.
The final water volume must be recorded and the water level marked on each test vessel.
634/1-2, s. 177–183.
If water evaporates during the test by more than 10 %, the water level should be adjusted with distilled water.
, Characterization of the Genotoxicity of Nitrilotriacetic Acid, Environmental and Molecular Mutagenesis, Vol.
If necessary, beakers may be loosely covered by a transparent cover such as transparent plastic lids to minimise evaporation and contamination with algal spores.
49/6, s. 439–452.
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.
Galloway, S. (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.
Any differences from the selected light irradiance over the test area should not exceed the range of ± 15 %.
35/3, s. 191–201.
The temperature in the test vessels is 20 ± 2 °C.
I: Sensitivity, specificity and relative predictivity, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
The pH of the control medium should not increase by more than 1,5 units during the test.
584/1-2, s. 1–256.
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.
, 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.
Test duration
43/1, s. 36–44.
The exposure period is 14 days.
, Chromosome aberrations in vitro related to cytotoxicity of nonmutagenic chemicals and metabolic poisons, Environmental and Molecular Mutagenesis, Vol.
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.
31/4, s. 316–326.
For plants transferred into the exposure phase, the following assessments are made as shown in Table 1:
, Sister chromatid exchanges and structural chromosomal aberrations in relation to age and sex, Human Genetics, 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).
62, s. 305–309.
Visual assessments of plant health are recorded at least three times during the exposure period (e.g. on days 0, 7 and 14).
, The effects of age and lifestyle factors on the accumulation of cytogenetic damage as measured by chromosome painting, Mutation Research, Vol.
Assessments of shoot fresh weight and dry weight are made at the end of the test (i.e. on Day 14).
338, s. 95–106.
Shoot length is determined using a ruler.
A Report of the Second ECVAM Task Force on Good Cell Culture Practice, ATLA, Vol.
If side shoots are present, their numbers and length should also be measured.
33/3, s. 261–287.
Visual assessments of plant health are made by recording the appearance of plants and the general condition of the test medium.
, Industrial Genotoxicology Group collaborative trial to investigate cell cycle parameters in human lymphocyte cytogenetics studies, Mutagenesis, Vol.12/3, s.163–167.
Necrosis, chlorosis or other discoloration such as excessive reddening relative to control plants.
31/6, s. 347–363.
Development of bacterial or algal contamination;
Ames (1983), Revised Methods for the Salmonella Mutagenicity Test, Mutation Research/Environmental Mutagenesis and Related Subjects, Vol.
few roots
66/3, s. 277–290.
moderate root development
, 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.
Care should be taken to remove sediment particles that may adhere to the base of the shoot.
7/3, s. 175–177.
60 °C and dried to a constant weight, prior to re-weighing and recording the dry weight.
312/3, s. 241–261.
A summary of the minimum biological assessments required over the test duration is provided in Table 1.
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.
(DAT)
190/3, s. 225-8.
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.
Honma, M. (2011), Cytotoxicity measurement in in vitro chromosome aberration test and micronucleus test, Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis, Vol.
Irradiance should be measured in the growth chamber, incubator or room at points equivalent to level of the water surface.
724/1-2, s. 86–87.
Measurements should be made at least once at test initiation or during the test.
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 (testiohjeet 473, 476 ja 487) ENV/JM/TG(2014)17.
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.
54/1, s. 36–43.
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).
ISCN (2013), An International System for Human Cytogenetic Nomenclature, Schaffer, L.G., J. MacGowan-Gordon, M. Schmid (toim.), Karger Publishers Inc., Connecticut.
Sampling of sediment at test initiation is likely to disrupt the test system.
723/2, s. 87–90.
Centrifugation at, for example, 10000 g and 4 °C for 30 minutes is recommended to isolate interstitial water.
Locke-Huhle, C. (1983), Endoreduplication in Chinese hamster cells during alpha-radiation induced G2 arrest, Mutation Research, Vol.
However, if the test chemical is demonstrated not to absorb to filters, filtration may also be acceptable.
119/3, s. 403–413.
Alternatively, the test solutions of all replicates for each concentration may be pooled for analyses.
lyhytkestoisissa tutkimuksissa: kunkin eläimen paino kokeen alkaessa ja päättyessä; yli viikon kestävissä tutkimuksissa: kunkin eläimen paino tutkimuksen aikana ja ravinnonkulutus.
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.
312/3, s. 305–312.
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.
417/1, s. 19–30.
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:
723/2, s. 87–90.
Percent inhibition of growth rate (Ir) may then be calculated for each test concentration (treatment group) according to the following formula:
312/3, s. 293–304.
μC mean value for μin the control
Dose setting in in vivo mutagenicity assays, Mutagenesis, Vol.
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.
Pacchierotti, F., V. Stocchi (2013), Analysis of chromosome aberrations in somatic and germ cells of the mouse, Methods in Molecular Biology, Vol.
final biomass minus starting biomass for the control group
lyhytkestoisissa tutkimuksissa: kunkin eläimen paino kokeen alkaessa ja päättyessä; yli viikon kestävissä tutkimuksissa: kunkin eläimen paino tutkimuksen aikana ja ravinnonkulutus.
final biomass minus starting biomass in the treatment group
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.
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.
An efficient method of monitoring chromosomal damage in the rat, Toxicology Sciences, Vol.
Approaching either zero or total inhibition such irregularities may be magnified by the transformation, interfering with the analysis (13).
, Flow cytometric analysis of micronuclei in peripheral blood reticulocytes: I. Intra- and interlaboratory comparison with microscopic scoring, Toxicological Sciences, Vol.
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.
, Flow cytometric scoring of micronucleated erythrocytes: an efficient platform for assessing in vivo cytogenetic damage, Mutagenesis, 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).
Garriott (1996), Validation of an automated image analysis micronucleus scoring system, Mutation Research, Vol.
This assessment should be performed by Shapiro-Wilks-test (ND) or Levene's test (VH).
, 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.
If heterogeneity of variance and/or deviation from ND is extreme and cannot be corrected by transformation, analysis by methods such as Bonferroni-Welch-t-test, step-down Jonkheere Terpstra test and Bonferroni-Median-Test should be considered.
, Automation of mouse micronucleus genotoxicity assay by laser scanning cytometry, Cytometry, Vol.
REPORTING
, A rapid in vivo test for chromosomal damage, Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis, Vol.
The test report includes the following details:
18/2, s. 187–190.
duration and conditions of establishment phase;
31/1, s. 9–15.
date of start of the test and its duration;
123/1, s. 61–118.
description of the experimental design: growth chamber/room or laboratory, test vessels and covers, solution volumes, length and weight of test plants per test vessel at the beginning of the test, ratio of sediment surface to water surface, sediment and water volume ratio;
239/1, s. 29–80.
methods of preparation of stock and test solutions including the use of any solvents or dispersants;
11, s. 555–558.
light source, irradiance (μE·m–2 s–1)
189/2, s. 103–112.
oxygen concentrations;
14/3, s. 513–522.
methods for determination of measurement variables, e.g., length, dry weight, fresh weight;
245/4, s. 245–249.
all deviations from this test method.
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.
means and standard deviations for each measurement variable;
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.
calculated response variables for each treatment replicate, with mean values and coefficient of variation for replicates;
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.
estimates of toxic endpoints for response variables e.g. EC50, and associated confidence intervals.
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.
if ANOVA has been used, the size of the effect which can be detected (e.g. the minimum significant difference);
, The rat bone marrow micronucleus test--study design and statistical power, Mutagenesis, Vol.
any visual signs of phytotoxicity as well as observations of test solutions;
Mammalian Mutagenicity Study Group, Environmental and Molecular Mutagenesis, Vol.
discussion of the results, including any influence on the outcome of the test resulting from deviations from this test method.
32/1, s. 84–100.
Growth Inhibition Test.
723/2, s. 108–120.
Chapter C.3 of this Annex: Freshwater Alga and Cyanobacteria, Growth Inhibition Test.
, Influence of counting methodology on erythrocyte ratios in the mouse micronucleus test, Environmental and Molecular Mutagenesis, Vol.
Chapter C.50 of this Annex: Sediment-free Myriophyllum spicatum Toxicity Test.
Some aspects of protocol design including repeated treatments, integration with toxicity testing, and automated scoring, Environmental and Molecular Mutagenesis, Vol.
, Herbicide risk assessment for non-target aquatic plants: sulfosulfuron — a case study, Pest Management Science, Vol.
390/1-2, s. 79–83.
SMART AND BARKO MEDIUM COMPOSITION
413/1, s. 7–14.
No value for 20 °C is available, but it can be assumed that the variability of measurement results is higher than the temperature dependence to be expected.
120/4, s. 241–247.
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.
Langlois (1983), A simple fluorescent staining procedure for micronuclei and RNA in erythrocytes using Hoechst 33258 and pyronin Y, Mutation Research, Vol.
The US Interagency Coordinating Committee on the Validation of Alternative Methods.
Staniforth (1989), The automated bone marrow micronucleus test, Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis, Vol.
For the use of an integrated testing strategy for eye irritation under the REACH see also the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.7a: Endpoint specific guidance http://echa.europa.eu/documents/10162/13632/information_requirements_r7a_en.pdf
Galloway (1999), Rapid method for improving slide quality in the bone marrow micronucleus assay; an adapted cellulose column procedure, Mutation Research, Vol.
Combinations less likely to occur.
Russo, A. (2002), PRINS tandem labeling of satellite DNA in the study of chromosome damage, American Journal of Medical Genetics, Vol.
For mean it is meant arithmetic mean throughout the document.
107/2, s. 99–104.
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.
, Statistical analysis of data in mutagenicity assays: rodent micronucleus assay, Environmental Health Perspectives, Vol.
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).
469/2, s. 233–241.
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).
Molemmat protokollat perustuivat BCOP-testimenetelmään, jonka raportoivat ensimmäisenä Gautheron et al.
See Appendix 1 for definitions and units
YK (2011).
TLC: thin layer chromatography; HPLC: high pressure liquid chromatography; GC: gas chromatography
In: ICCVAM Test Method Evaluation Report – in vitro Ocular Toxicity Test Methods for Identifying Ocular Severe Irritants and Corrosives.
In general, measured concentrations in water during the uptake phase should be at least an order of magnitude above the limit of quantification so that more than one half-life of body burden can be measured in the depuration phase of the study.
Protocol 124: Bovine Corneal Opacity and Permeability Assay – SOP of Microbiological Associates Ltd.
For most test substances, there should ideally be no detections in the control water.
Ispra, Italy: European Centre for the Validation of Alternative Methods (ECVAM).
TOC includes organic carbon from particles and dissolved organic carbon, i.e. TOC = POC + DOC.
Sina, J.F., Galer, D.M., Sussman, R.S., Gautheron, P.D., Sargent, E.V., Leong, B., Shah, P.V., Curren, R.D. ja Miller, K. (1995).
Although not generally recommended, if a solvent or solubilising agent is used the organic carbon originating from this agent should be added to the organic carbon from the test substance to evaluate the concentration of organic carbon in the test vessels.
Kun laboratorio alkaa käyttää tätä määritysmenetelmää, sen olisi käytettävä lisäyksessä 2 mainittuja pätevyyden osoittamiseen tarkoitettuja kemikaaleja.
This alternative is only valid if the fish in all test groups are held in similar group sizes, fish are removed according to the same pattern and fed in the same way.
Sarveiskalvon turpoaminen (taulukko 3), sameus (taulukko 4) ja fluoreseiinin retentio (taulukko 5) käyttäen neljää ICE-luokkaa tulkitaan alla olevien asteikkojen mukaisesti.
If the growth is similar, also the lipid content is expected to be similar.
0,0–0,5
A different growth in the control would indicate a substance effect and invalidate the study.
0,6–1,5
A t-test on growth rate constants can be performed, to test whether growth differs between control and test groups, or an F-test in case of analysis of variance.
2,6–4,0
These percentages assume that the analytical methods are reliable and the half life is < 14 days.
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.
CI confidence interval (where possible to estimate)
Prinsen, M.K. ja Koëter, B.W.M.
The minimised test may in fact be used to demonstrate rapid metabolism when it is known that rapid metabolism is likely.
Chamberlain, M., Gad, S.C., Gautheron, P. ja Prinsen, M.K.
When intermediate data points are also available confidence limits for BCFKm can be calculated as in the full test.
Burton, A.B.G., M. York ja R.S.