natgillin/translations-raw huggingface dataset:
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;
Greenwood, S. et al.
means and standard deviations for each measurement variable;
(2004), 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.
growth curves for each concentration;
43/1, str. 36.
doubling time/growth rate in the control based on shoot length and fresh weight including the coefficient of variation for yield of fresh weight;
Hilliard, C.A. et al.
graphical representation of the concentration/effect relationship;
31/4, str. 316.
If calculated, LOEC and/or NOEC and the statistical methods used for their determination;
(1982), Sister chromatid exchanges and structural chromosomal aberrations in relation to age and sex, Human Genetics, Vol.
if ANOVA has been used, the size of the effect which can be detected (e.g. the minimum significant difference);
62, str. 305.
any stimulation of growth found in any treatment;
Ramsey M.J. et al.
discussion of the results, including any influence on the outcome of the test resulting from deviations from this test method.
338, str. 95.
Chapter C.26 of this Annex: Lemna sp.
A Report of the Second ECVAM Task Force on Good Cell Culture Practice, ATLA, Vol.
Growth Inhibition Test.
33/3, str. 261. – 287.
Chapter C.3 of this Annex: Freshwater Alga and Cyanobacteria, Growth Inhibition Test.
Henderson, L. et al.
Chapter C.50 of this Annex: Sediment-free Myriophyllum spicatum Toxicity Test.
Ames, B.N., J. McCann, E. Yamasaki (1975), Methods for Detecting Carcinogens and Mutagens with the Salmonella/Mammalian Microsome Mutagenicity Test, Mutation Research/Environmental Mutagenesis and Related Subjects, Vol.
Chapter C.28 of this Annex: Sediment-Water Chironomid Toxicity Using Spiked Water.
31/6, str. 347. – 363.
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.
Maron, D.M., B.N.
, Herbicide risk assessment for non-target aquatic plants: sulfosulfuron — a case study, Pest Management Science, Vol.
Ames (1983), Revised Methods for the Salmonella Mutagenicity Test, Mutation Research/Environmental Mutagenesis and Related Subjects, Vol.
59/2, pp. 231 - 237.
113/3-4, str. 173. – 215.
Amount of reagent added to water [1] (mg/l)
(1976), Cytogenetic Effects of Mutagens/Carcinogens after Activation in a Microsomal System In Vitro, I. 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.
pH (air equilibrium)
37/1, str. 83.
Demineralised (i.e. distilled or deionised) water.
Matsuoka, A., M. Hayashi, M. Jr.
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.
Ishidate (1979), Chromosomal Aberration Tests on 29 Chemicals Combined with S9 Mix in vitro, Mutation Research/Genetic Toxicology, Vol.
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.
66/3, str. 277. – 290.
1).
Ong, T.-m. et al.
The US Interagency Coordinating Committee on the Validation of Alternative Methods.
(1980).
The area of corneal opacity should be noted.
Alternatives to Aroclor 1254-induced S9 in in vitro Genotoxicity Assays, 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
7/3, str. 175. – 177.
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.
Matsushima, T. et al.
1).
(1999).
Combinations less likely to occur.
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.
For mean it is meant arithmetic mean throughout the document.
28/1, str. 51. – 59.
The numbers refer to statistically generated threshold values and are not related to the precision of the measurement.
UNEP (2001), Stockholmska konvencija o postojanim organskim onečišćujućim tvarima, Program Ujedinjenih naroda za zaštitu okoliša (UNEP).
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.
Christensen (1987), Effects of anticoagulants upon sister-chromatid exchanges, cell-cycle kinetics, and mitotic index in human peripheral lymphocytes, Mutation Research, Vol.
See Appendix 1 for definitions and units
Krahn, D.F., F.C.
The generator-column technique is occasionally used for the determination of log KOW.
(1983).
For substances that might ionise, log KOW should refer to the unionised form.
(2008).
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.
655/1-2, str. 1. – 3.
For most test substances, there should ideally be no detections in the control water.
Galloway, S. et al.
TOC includes organic carbon from particles and dissolved organic carbon, i.e. TOC = POC + DOC.
Richardson, C. et al.
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.
(1989).
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.
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.
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.
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.
This ensures that fish growth in all test groups is similar, if the tested concentration is below the toxic range.
741/1-2, str. 32. – 56.
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.
EPA, Ured za kemijsku sigurnost i sprječavanje onečišćenja (2011), Kemijske tvari nepoznatog ili promjenjivog sastava, složeni reakcijski proizvodi i biološki materijal: UVCB tvari, http://www.epa.gov/opptintr/newchems/pubs/uvcb.txt.
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.
USFDA (2012), International Conference on Harmonisation (ICH) Guidance S2 (R1) on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended For Human Use.
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).
ISCN (2013), An International System for Human Cytogenetic Nomenclature, Schaffer, L.G., J. MacGowan-Gordon, M. Schmid (eds.), Karger Publishers Inc., Connecticut.
If the analytical methods are less reliable or the half life is (greatly) increased these numbers will become larger.
(2010).
SD Standard deviation (where possible to estimate)
Fleiss, J. L., B. Levin, M.C.
The minimised test may in fact be used to demonstrate rapid metabolism when it is known that rapid metabolism is likely.
Warr, T.J., E.M.
When only two data points are measured, estimates of the confidence limits for BCFKm can be made using bootstrap methods.
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.
When intermediate data points are also available confidence limits for BCFKm can be calculated as in the full test.
287/1, str. 29. – 46.
1), this issue is addressed in the “Guidance on Information Requirements and Chemical Safety Assessment”, chapter R.7c, R.7.10.3.1; R.7.10.4.1; and figure R7.10-2.
119/3, str. 403. – 413.
This approach differs from “normalisation” to a set organism lipid content as is done in the aqueous exposure bioconcentration test.
Trosko (1983), Aphidicolin – induced endoreduplication in Chinese hamster cells, Cancer Research, Vol.
In an aqueous exposure study, a 14-day half-life would correspond to a BCF of ca.
za testove obuhvaćene ovom ispitnom metodom u kojima se upotrebljavaju stanične linije citotoksičnost je utvrđena kao smanjenje relativnog udvostručenja populacije (RPD) ili relativnog povećanja broja stanica (RICC) tretiranih stanica u odnosu na negativnu kontrolu (vidjeti stavak 17. i Dodatak 2.).
10000 L/kg using fish of 1 g with a corresponding uptake rate of about 500 L/kg/d (according to the equation of Sijm et al (46)).
Za testove obuhvaćene ovom ispitnom metodom u kojima se upotrebljavaju primarne kulture limfocita citotoksičnost je utvrđena kao smanjenje mitotskog indeksa tretiranih stanica u odnosu na negativnu kontrolu (vidjeti stavak 18. i Dodatak 2.).
Since the actual internal concentrations can only be determined after the test has been performed, an estimate of the expected internal concentration is needed (e.g. based on the expected BMF and the concentration in the food; cf.
za kratkotrajna istraživanja: pojedinačna tjelesna masa životinja na početku i na kraju ispitivanja; za istraživanja dulja od tjedan dana: pojedinačna tjelesna masa tijekom istraživanja i unos hrane.
Equation A5.8 in Appendix 5).
Trebalo bi uključiti i raspon tjelesne mase te srednju izmjerenu vrijednost i standardno odstupanje za svaku skupinu.
The presence of the test substance in the test medium as a result of excretion by the fish or leaching from food may not be totally avoidable.
Adler, I.D.
Therefore one option is to measure the substance concentration in water at the end of the uptake period, especially if a semi-static set up is used, to help to establish whether any aqueous exposure has occurred.
Analysis of chromosome aberrations in bone marrow cells, Mutation Research, Vol.
This approach is specific to the dietary study, distinct from the procedure followed in the aqueous exposure, hence the word “correction” has been used rather than “normalisation” to prevent confusion — see also footnote in paragraph 106.
189/2, str. 157. – 165.
CI confidence interval (where possible to estimate).
(1994), Report from the working group on the in vivo mammalian bone marrow chromosomal aberration test, Mutation Research, Vol.
SD Standard deviation (where possible to estimate).
312/3, str. 305.
Other daphnids may be used provided they meet the validity criteria as appropriate (the validity criterion relating to the reproductive output in the controls should be relevant for all species).
Adler, I.D. et al.
Accidental mortality: non chemical related mortality caused by an accidental incidence (i.e. known cause)
417/1, str. 19.
The test solution is determined by titration with the standard base or acid solution as appropriate, measuring the pH after each addition of titrant.
Dose setting in in vivo mutagenicity assays, Mutagenesis, Vol.
At least 10 incremental additions should be made before the equivalence point.
7/5, str. 313. – 319.
The degree of dissociation may then be calculated from the conductivity of each solution using the Onsager equation, and hence using the Ostwald Dilution Law the dissociation constant may be calculated as K = α2C/(1 – α) where C is the concentration in moles per litre and α is the fraction dissociated.
Pacchierotti, F., V. Stocchi (2013), Analysis of chromosome aberrations in somatic and germ cells of the mouse, Methods in Molecular Biology, Vol.
Precautions must be taken to exclude CO2.
1044, str. 147. – 163.
Nelson, N.H.
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.
& Faust, S.D.: Acidic dissociation constants of selected aquatic herbicides, Env.
627/1, str. 10. – 30.
Sci.
MacGregor, J.T. et al.
Tech.
(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.
3, II, pp. 1186-1188 (1969).
14/3, str. 513.
ASTM D 1293 — Annual ASTM Standards, Philadelphia, 1974.
An efficient method of monitoring chromosomal damage in the rat, Toxicology Sciences, Vol.
Standard Method 242.
94/1, str. 92. – 107.
Clark, J. & Cunliffe, A.E.: Rapid spectrophotometric measurement of ionisation constants in aqueous solution.
Dertinger, S.D. et al.
ASTM D 1125 — Annual ASTM Standards, Philadelphia, 1974.
(2011), Flow cytometric scoring of micronucleated erythrocytes: an efficient platform for assessing in vivo cytogenetic damage, Mutagenesis, Vol.
Handbook of Chemistry and Physics, 60th ed.
26/1, str. 139.
source, housing conditions, diet, etc.
Parton, J.W., W.P.
Barratt, M.D., et al.
370/1, str. 65. – 73.
de Silva, O., et al.
Asano, N. et al.
Worth A.P. and Fentem J.H.
(1998), 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.
Neun, D.J.
Styles, J.A. et al.
Fentem, J.H., et al.
(2001), Automation of mouse micronucleus genotoxicity assay by laser scanning cytometry, Cytometry, Vol.
OECD (2000), Guidance Document on the Recognition, Assessment and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation.
44/2, str. 153.
National Research Council (NRC) (2009), Recognition and Alleviation of Pain in Laboratory Animals, Washington, DC: The National Academies Press.
18/2, str. 187. – 190.
ICCVAM (2010), ICCVAM Test Method Evaluation Report: Recommendations for Routine Use of Topical Anesthetics, Systemic Analgesics, and Humane Endpoints to Avoid or Minimize Pain and Distress in Ocular Safety Testing, NIH Publication No. 10-7514, Research Triangle Park, NC, USA: National Institute of Environmental Health Sciences.
Schmid, W.
OECD (2006), Test No. 435: In vitro Membrane Barrier Test Method for Skin corrosion, OECD Guidelines for the Testing of Chemicals, Section 4, OECD Paris.
, The micronucleus test, Mutation Research, Vol.
U.S.
31/1, str. 9. – 15.
UN (2011), Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Fourth revised edition, New York & Geneva: United Nations Publications.
Environmental Protection Agency Gene-Tox Program, Mutation Research/Reviews in Genetic Toxicology, Vol.
ECHA Guidance on information requirements and chemical safety assessment, Chapter R.7a: Endpoint specific guidance.
123/1, str. 61. – 118.
A chemical that produces a reversible change in the eye; (b) Chemicals that are classified as EPA Category II or III ocular irritants; or GHS eye irritants Category 2, 2A or 2B; or EU Category 2 (17) (18) (19).
Environmental Protection Agency Gene-Tox Program, Mutation Research/Reviews in Genetic Toxicology, Vol.
A chemical that causes tissue damage in the eye that does not resolve within 21 days of application or causes serious physical decay of vision; (b) Chemicals that are classified as GHS eye irritant Category 1, or EPA Category I ocular irritants, or EU Category 1 (17) (18) (19).
239/1, str. 29. – 80.
Tiered approach
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.
If that test does not reveal any corrosive or severe irritant effects, a confirmatory test is conducted with two additional animals.
278/2-3, str. 83. – 98.
Depending upon the results of the confirmatory test, further tests may be needed.
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.
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, November 1998 (http://www.oecd.org/ehs/Class/HCL6.htm).
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.
Worth, A.P. and Fentem J.H.
10/3, str. 153. – 159.
A General Approach for Evaluating Stepwise Testing Strategies.
Salamone, M.F., K.H.
Young, J.R., How, M.J., Walker, A.P., Worth W.M.H.
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.
Toxicol.
23/4, str. 239. – 273.
Fentem, J.H., Archer, G.E.B., Balls, M., Botham, P.A., Curren, R.D., Earl, L.K., Edsail, D.J., Holzhutter, H.G. and Liebsch, M. (1998) The ECVAM international validation study on in vitro tests for skin corrosivity.
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.
Effects of Alkalinity on the Eye Irritation Potential of Solutions Prepared at a Single pH.
453/1, str. 45. – 50.
J. Toxicol.
Hayes, J. et al.
In Vitro Mammalian Chromosomal Aberration Test
(2009), The rat bone marrow micronucleus test--study design and statistical power, Mutagenesis, Vol.
The choice of the cell lines used should be scientifically justified.
Wakata, A. et al.
When primary cells are used, for animal welfare reasons, the use of primary cells from human origin should be considered where feasible and sampled in accordance with the human ethical principles and regulations.
(2006).
This would ensure the background incidence of chromosomal aberrations to be low and consistent.
32/1, str. 84. – 100.
The baseline incidence of chromosomal aberrations increases with age and this trend is more marked in females than in males (17) (18).
Rothfuss, A. et al.
If cells from more than one donor are pooled for use, the number of donors should be specified.
(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.
It is necessary to demonstrate that the cells have divided from the beginning of treatment with the test chemical to cell sampling.
723/2, str. 108.
Cell cultures are maintained in an exponential cell growth phase (cell lines) or stimulated to divide (primary cultures of lymphocytes), to expose the cells at different stages of the cell cycle, since the sensitivity of cell stages to the test chemicals may not be known.
LeBaron, M.J. et al.
The primary cells that need to be stimulated with mitogenic agents in order to divide are generally no longer synchronized during exposure to the test chemical (e.g. human lymphocytes after a 48-hour mitogenic stimulation).
(2013), Influence of counting methodology on erythrocyte ratios in the mouse micronucleus test, Environmental and Molecular Mutagenesis, Vol.
The use of synchronized cells during treatment is not recommended, but can be acceptable if justified.
54/3, str. 222.
Media and culture conditions
Some aspects of protocol design including repeated treatments, integration with toxicity testing, and automated scoring, Environmental and Molecular Mutagenesis, Vol.
Generally organic solvents should not exceed 1 % (v/v) and aqueous solvents (saline or water) should not exceed 10 % (v/v) in the final treatment medium.
35/3, str. 234. – 252.
If not well-established solvents are used (e.g. ethanol or acetone), their use should be supported by data indicating their compatibility with the test chemicals, the test system and their lack of genetic toxicity at the concentration used.
Asanami, S., K. Shimono (1997), High body temperature induces micronuclei in mouse bone marrow, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
Whatever the types of cells (cell lines or primary cultures of lymphocytes), either replicate or single treated cultures may be used at each concentration tested.
390/1-2, str. 79. – 83.
While the use of duplicate cultures is advisable, single cultures are also acceptable provided that the same total number of cells are scored for either single or duplicate cultures.
Asanami, S., K. Shimono, S. Kaneda (1998), Transient hypothermia induces micronuclei in mice, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
CASRN
413/1, str. 7. – 14.
Procedures in use in the laboratory should ensure that analysis of chromosomal aberrations is performed by well-trained scorers and peer-reviewed if appropriate.
Spencer, P.J. et al.
Although the purpose of the test is to detect structural chromosomal aberrations, it is important to record polyploidy and endoreduplication frequencies when these events are seen.
(2007), Induction of micronuclei by phenol in the mouse bone marrow: I. Association with chemically induced hypothermia, Toxicological Sciences, Vol.
(See paragraph 2).
97/1, str. 120.
Proficiency of the laboratory
Hayashi, M., T. Sofuni, M. Jr.
Evans, H.J.
Ishidate (1983), An application of Acridine Orange fluorescent staining to the micronucleus test, Mutation Research Letters, Vol.
Galloway, S.M. et al.
120/4, str. 241. – 247.
10, pp. 1-175.
MacGregor, J.T., C.M.
Hedner K. et al.
UN (2011).
, Sister chromatid exchanges and structural chromosomal aberrations in relation to age and sex, Human Genetics, Vol.
Scott, L., Eskes, C., Hoffmann, S., Adriaens, E., Alépée, N., Bufo, M., Clothier, R., Facchini, D., Faller, C., Guest, R., Harbell, J., Hartung, T., Kamp, H., Le Varlet, B., Meloni, M., McNamee, P., Osborne, R., Pape, W., Pfannenbecker, U., Prinsen, M., Seaman, C., Spielman, H., Stokes, W., Trouba, K., Van den Berghe, C., Van Goethem, F., Vassallo, M., Vinardell, P., and Zuang, V. (2010).
62, pp. 305-309.
U: ICCVAM Test Method Evaluation Report – in vitro Ocular Toxicity Test Methods for Identifying Ocular Severe Irritants and Corrosives.