natgillin/translations-raw huggingface dataset:
287/1, s. 29-46.
It is necessary to assess whether the ANOVA assumption of normal distribution (ND) and variance homogeneity (VH) of variance holds.
Locke-Huhle, C.
This assessment should be performed by Shapiro-Wilks-test (ND) or Levene's test (VH).
(1983), Endoreduplication in Chinese hamster cells during alpha-radiation induced G2 arrest, Mutation Research, Vol.
Failure to meet the assumption of ND and homogeneity of variances can sometimes be corrected by logarithmic transformation of the data.
119/3, s. 403-413.
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.
Huang, Y., C.
Additional guidance on determining the NOEC can be found in (16).
Change, J.E.
REPORTING
Trosko (1983), Aphidicolin – induced endoreduplication in Chinese hamster cells, Cancer Research, Vol.
The test report includes the following details:
43/3, s. 1362-1364.
scientific name and source.
Soper, K.A., S.M.
duration and conditions of establishment phase;
Galloway (1994), Cytotoxicity measurement in in vitro chromosome aberration test and micronucleus test, Mutation Research, Vol.
test procedure used (static, semi-static, pulsed);
312, s. 139-149.
date of start of the test and its duration;
u zkoušek prováděných podle této zkušební metody s použitím buněčných linií se cytotoxicita vyjadřuje jako snížení relativního zdvojnásobení populace (RPD) nebo relativního nárůstu počtu buněk (RICC) u exponovaných buněk v porovnání s negativní kontrolou (viz odstavec 17 a dodatek 2).
test medium, i.e. sediment and liquid nutrient medium;
U zkoušek prováděných podle této zkušební metody s použitím primárních kultur lymfocytů se cytotoxicita vyjadřuje jako snížení mitotického indexu (MI) exponovaných buněk v porovnání s negativní kontrolou (viz odstavec 18 a dodatek 2).
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;
50-18-0 (6055-19-2)
test concentrations (nominal and measured as appropriate) and number of replicates per concentration;
2,4,6-tris(aziridin-1-yl)- 1,3,5-triazin
methods of preparation of stock and test solutions including the use of any solvents or dispersants;
U každého zvířete by mělo být analyzováno alespoň 200 metafází na strukturní chromozómové aberace včetně gapů a s vyloučením gapů (6), Pokud však z historické databáze negativních kontrol vyplývá, že střední četnost spontánního výskytu strukturních chromozómových aberací v dané laboratoři je < 1 %, mělo by se zvážit vyhodnocení dalších buněk.
temperature during the test;
u krátkodobých studií: hmotnost jednotlivých zvířat na začátku a na konci zkoušky; u studií delších než jeden týden: hmotnosti jednotlivých zvířat během studie a spotřeba potravy.
light source, irradiance (μE·m–2 s–1)
Mělo by být uvedeno rozpětí tělesné hmotnosti, střední hodnota a směrodatná odchylka pro každou skupinu.
pH values of the test and control media as well as appearance of test media at test initiation and end;
Adler, I.D.
oxygen concentrations;
Preston, R.J. et al.
the method of analysis with appropriate quality assessment data (validation studies, standard deviations or confidence limits of analyses);
Analysis of chromosome aberrations in bone marrow cells, Mutation Research, Vol.
methods for determination of measurement variables, e.g., length, dry weight, fresh weight;
189/2, s. 157–165.
all deviations from this test method.
Richold, M. et al.
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;
Tice, R.R. et al.
means and standard deviations for each measurement variable;
, Report from the working group on the in vivo mammalian bone marrow chromosomal aberration test, Mutation Research, Vol.
growth curves for each concentration;
312/3, s. 305-312.
doubling time/growth rate in the control based on shoot length and fresh weight including the coefficient of variation for yield of fresh weight;
Adler, I.D. et al.
calculated response variables for each treatment replicate, with mean values and coefficient of variation for replicates;
, Recommendations for statistical designs of in vivo mutagenicity tests with regard to subsequent statistical analysis, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
graphical representation of the concentration/effect relationship;
417/1, s. 19-30.
estimates of toxic endpoints for response variables e.g. EC50, and associated confidence intervals.
Ryan, T.P.
If calculated, LOEC and/or NOEC and the statistical methods used for their determination;
, Compilation and use of genetic toxicity historical control data, 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);
723/2, s. 87–90.
any stimulation of growth found in any treatment;
, in vivo rodent erythrocyte micronucleus assay, Mutation Research/Environmental Mutagenesis and Related Subjects, Vol.
any visual signs of phytotoxicity as well as observations of test solutions;
312/3, s. 293-304.
discussion of the results, including any influence on the outcome of the test resulting from deviations from this test method.
Fielder, R.J. et al.
Chapter C.26 of this Annex: Lemna sp.
Dose setting in in vivo mutagenicity assays, Mutagenesis, Vol.
Growth Inhibition Test.
7/5, s. 313-319.
Chapter C.3 of this Annex: Freshwater Alga and Cyanobacteria, Growth Inhibition Test.
Pacchierotti, F., V.
ISO 16191:2013 Water quality — Determination of the toxic effect of sediment on the growth behaviour of Myriophyllum aquaticum.
Stocchi (2013), Analysis of chromosome aberrations in somatic and germ cells of the mouse, Methods in Molecular Biology, Vol.
Chapter C.50 of this Annex: Sediment-free Myriophyllum spicatum Toxicity Test.
1044, s. 147-163.
Chapter C.28 of this Annex: Sediment-Water Chironomid Toxicity Using Spiked Water.
Lovell, D.P. et al.
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.
Bylo prokázáno, že u potkana vzorek s malými objemy odebraný před expozicí (např. méně než 100 μl/den) má minimální dopad na četnost výskytu mikrojader na pozadí (25).
, Herbicide risk assessment for non-target aquatic plants: sulfosulfuron — a case study, Pest Management Science, Vol.
POSTUP
59/2, pp. 231 - 237.
Počet a pohlaví zvířat
SMART AND BARKO MEDIUM COMPOSITION
u krátkodobých studií: hmotnost jednotlivých zvířat na začátku a na konci zkoušky; u studií delších než jeden týden: hmotnosti jednotlivých zvířat během studie a spotřeba potravy.
Amount of reagent added to water [1] (mg/l)
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.
pH (air equilibrium)
627/1, s. 10-30.
Demineralised (i.e. distilled or deionised) water.
MacGregor, J.T. et al.
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.
An efficient method of monitoring chromosomal damage in the rat, Toxicology Sciences, 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.
94/1, s. 92-107.
1).
Dertinger, S.D. et al.
The US Interagency Coordinating Committee on the Validation of Alternative Methods.
, Flow cytometric analysis of micronuclei in peripheral blood reticulocytes: I.
The area of corneal opacity should be noted.
Intra- and interlaboratory comparison with microscopic scoring, Toxicological Sciences, 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
94/1, s. 83-91.
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.
, Flow cytometric scoring of micronucleated erythrocytes: an efficient platform for assessing in vivo cytogenetic damage, Mutagenesis, Vol.
1).
26/1, s. 139-145.
Highest mean score observed at any time point.
Parton, J.W., W.P.
Maximum mean score observed at any time point (based on opacity scores as defined in Table 1).
Garriott (1996), Validation of an automated image analysis micronucleus scoring system, Mutation Research, Vol.
Based on scores as defined in Table 2.
370/1, s. 65-73.
Combinations less likely to occur.
Asano, N. et al.
For mean it is meant arithmetic mean throughout the document.
, 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.
The numbers refer to statistically generated threshold values and are not related to the precision of the measurement.
404/1-2, s. 149-154.
A DPRA prediction should be considered in the framework of an IATA and in accordance with the provisions of paragraphs 9 and 12.
Styles, J.A. et al.
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.
, Automation of mouse micronucleus genotoxicity assay by laser scanning cytometry, Cytometry, Vol.
1.
44/2, s. 153-155.
See Appendix 1 for definitions and units
Heddle, J.A.
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).
, A rapid in vivo test for chromosomal damage, Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis, Vol.
The generator-column technique is occasionally used for the determination of log KOW.
18/2, s. 187-190.
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).
Schmid, W.
For substances that might ionise, log KOW should refer to the unionised form.
, The micronucleus test, Mutation Research, Vol.
See Appendix 1 for definitions and units
31/1, s. 9-15.
TLC: thin layer chromatography; HPLC: high pressure liquid chromatography; GC: gas chromatography
Heddle, J.A. et al.
In some regulatory frameworks analysis of metabolites may be obligatory when certain conditions are met (cf. paragraph 65).
Environmental Protection Agency Gene-Tox Program, Mutation Research/Reviews in Genetic Toxicology, Vol.
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.
123/1, s. 61-118.
For most test substances, there should ideally be no detections in the control water.
Mavournin, K.H. et al.
Background concentrations should only be relevant to naturally occurring materials (e.g., some metals) and substances that are ubiquitous in the environment.
Environmental Protection Agency Gene-Tox Program, Mutation Research/Reviews in Genetic Toxicology, Vol.
If first order kinetics is obviously not obeyed, more complex models should be employed (see references in Appendix 5 and advice from a biostatistician sought.
239/1, s. 29-80.
Uptake may be limited by low exposure concentrations because of low water solubility in the bioconcentration test, whereas far higher exposure concentrations can be achieved with the dietary test.
, Micronuclei in circulating erythrocytes: a rapid screen for chromosomal damage during routine toxicity testing in mice, Developments in Toxicology Environmental Science, Vol.
For multi-constituent substances, UVCBs and mixtures, the water solubility of each relevant component should be considered to determine the appropriate exposure concentrations.
11, s. 555-558.
TOC includes organic carbon from particles and dissolved organic carbon, i.e. TOC = POC + DOC.
, Guidelines for the conduct of micronucleus assays in mammalian bone marrow erythrocytes, Mutation Research/Genetic Toxicology, Vol.
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.
189/2, s. 103-112.
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.
, The in vivo erythrocyte micronucleus test: measurement at steady state increases assay efficiency and permits integration with toxicity studies, Fundamental and Applied Toxicology, Vol.
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.
14/3, s. 513-522.
This ensures that fish growth in all test groups is similar, if the tested concentration is below the toxic range.
, The micronucleus assay with mouse peripheral blood reticulocytes using acridine orange-coated slides, Mutation Research/Genetic Toxicology, Vol.
If the growth is similar, also the lipid content is expected to be similar.
245/4, s. 245-249.
A different growth in the control would indicate a substance effect and invalidate the study.
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.
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.
278/2-3, s. 83-98.
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.
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.
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).
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.
These percentages assume that the analytical methods are reliable and the half life is < 14 days.
10/3, s. 153-159.
If the analytical methods are less reliable or the half life is (greatly) increased these numbers will become larger.
Salamone, M.F., K.H.
CI confidence interval (where possible to estimate)
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.
SD Standard deviation (where possible to estimate)
23/4, s. 239-273.
The minimised test may in fact be used to demonstrate rapid metabolism when it is known that rapid metabolism is likely.
Krishna, G., G.
When only two data points are measured, estimates of the confidence limits for BCFKm can be made using bootstrap methods.
Urda, J.
When intermediate data points are also available confidence limits for BCFKm can be calculated as in the full test.
Paulissen (2000), Historical vehicle and positive control micronucleus data in mice and rats, Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis, Vol.
For the purpose of Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 396, 30.12.2006, p.
453/1, s. 45-50.
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.
Hayes, J. et al.
As the BMF is defined as the ratio of the concentration of a substance in an organism to that in the organism's food at steady-state, lipid is taken into account by correcting for the contents of lipid in the organism and in the food, hence it is described more accurately as a “correction”.
, The rat bone marrow micronucleus test--study design and statistical power, Mutagenesis, Vol.
This approach differs from “normalisation” to a set organism lipid content as is done in the aqueous exposure bioconcentration test.
24/5, s. 419-424.
Total length should also be recorded during the test as it is a good indicator of whether an adverse effect has occurred.
Wakata, A. et al.
HCB is listed in Annexes A and C to the Stockholm Convention, and in Annexes I and III of Regulation (EC) No 850/2004 on persistent organic pollutants (OJ L 158, 30.4.2004, p.
Mammalian Mutagenicity Study Group, Environmental and Molecular Mutagenesis, Vol.
7)
32/1, s. 84-100.
For rapid growth during the uptake phase the true feeding rate will decrease below that set at the beginning of exposure.
Rothfuss, A. et al.
In an aqueous exposure study, a 14-day half-life would correspond to a BCF of ca.
, Improvement of in vivo genotoxicity assessment: combination of acute tests and integration into standard toxicity testing, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
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)).
723/2, s. 108-120.
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.
LeBaron, M.J. et al.
Equation A5.8 in Appendix 5).
, Influence of counting methodology on erythrocyte ratios in the mouse micronucleus test, Environmental and Molecular Mutagenesis, Vol.
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.
54/3, s. 222-228.
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.
Some aspects of protocol design including repeated treatments, integration with toxicity testing, and automated scoring, Environmental and Molecular Mutagenesis, 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.
35/3, s. 234-252.
A foodstuff analysis technique for protein, lipid, crude fibre and ash content; this information is usually available from the feed supplier.
Asanami, S., K.
CI confidence interval (where possible to estimate).
Shimono (1997), High body temperature induces micronuclei in mouse bone marrow, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
SD Standard deviation (where possible to estimate).
390/1-2, s. 79-83.
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).
Asanami, S., K.
If other daphnid are used they should be clearly identified and their use justified.
Shimono, S.
Accidental mortality: non chemical related mortality caused by an accidental incidence (i.e. known cause)
Kaneda (1998), Transient hypothermia induces micronuclei in mice, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
Inadvertent mortality: non chemical related mortality with no known cause
413/1, s. 7-14.
The test solution is determined by titration with the standard base or acid solution as appropriate, measuring the pH after each addition of titrant.
Spencer, P.J. et al.
At least 10 incremental additions should be made before the equivalence point.
, Induction of micronuclei by phenol in the mouse bone marrow: I.
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.
Association with chemically induced hypothermia, Toxicological Sciences, Vol.
Precautions must be taken to exclude CO2.
97/1, s. 120-127.
Albert, A. & Sergeant, E.P.: Ionization Constants of Acids and Bases, Wiley, Inc., New York, 1962.
Hayashi, M., T.
Nelson, N.H.
Sofuni, M.
& Faust, S.D.: Acidic dissociation constants of selected aquatic herbicides, Env.
Jr.
Sci.
Ishidate (1983), An application of Acridine Orange fluorescent staining to the micronucleus test, Mutation Research Letters, Vol.
Tech.
120/4, s. 241-247.
3, II, pp. 1186-1188 (1969).
MacGregor, J.T., C.M.
ASTM D 1293 — Annual ASTM Standards, Philadelphia, 1974.
Langlois (1983), A simple fluorescent staining procedure for micronuclei and RNA in erythrocytes using Hoechst 33258 and pyronin Y, Mutation Research, Vol.
Standard Method 242.
120/4, s. 269-275.
Clark, J. & Cunliffe, A.E.: Rapid spectrophotometric measurement of ionisation constants in aqueous solution.
Romagna, F., C.D.
ASTM D 1125 — Annual ASTM Standards, Philadelphia, 1974.
Staniforth (1989), The automated bone marrow micronucleus test, Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis, Vol.
Handbook of Chemistry and Physics, 60th ed.
213/1, s. 91-104.
source, housing conditions, diet, etc.
Sun, J.T., M.J.
Anaesthetics and analgesics
Galloway (1999), Rapid method for improving slide quality in the bone marrow micronucleus assay; an adapted cellulose column procedure, Mutation Research, Vol.
Barratt, M.D., et al.
439/1, s. 121-126.
de Silva, O., et al.
Miller, B.M., I.D.
Worth A.P. and Fentem J.H.
Adler (1990), Application of antikinetochore antibody staining (CREST staining) to micronuclei in erythrocytes induced in vivo, Mutagenesis, Vol.
Young, J.R., et al.
5/4, s. 411-415.
Neun, D.J.
Miller, B.M. et al.
Fentem, J.H., et al.
, Classification of micronuclei in murine erythrocytes: immunofluorescent staining using CREST antibodies compared to in situ hybridization with biotinylated gamma satellite DNA, Mutagenesis, Vol.
OECD (2000), Guidance Document on the Recognition, Assessment and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation.
6/4, s. 297-302.
Wright EM, Marcella KL, Woodson JF.
Russo, A.
National Research Council (NRC) (2008), Recognition and Alleviation of Distress in Laboratory Animals, Washington, DC: The National Academies Press.