natgillin/translations-raw huggingface dataset:
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).
10, s.
If other daphnid are used they should be clearly identified and their use justified.
1–175.
Accidental mortality: non chemical related mortality caused by an accidental incidence (i.e. known cause)
Muehlbauer, P.A.m.fl.
Inadvertent mortality: non chemical related mortality with no known cause
Scott, D. m.fl.
The test solution is determined by titration with the standard base or acid solution as appropriate, measuring the pH after each addition of titrant.
A report from ICPEMC Task Group 9, Mutation Research/Reviews in Genetic Toxicology, vol.257/2, s.
At least 10 incremental additions should be made before the equivalence point.
147–204.
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.
Morita, T. m.fl.
Precautions must be taken to exclude CO2.
, Clastogenicity of Low pH to Various Cultured Mammalian Cells, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, vol.
Albert, A. & Sergeant, E.P.: Ionization Constants of Acids and Bases, Wiley, Inc., New York, 1962.
268/2, s.
& Faust, S.D.: Acidic dissociation constants of selected aquatic herbicides, Env.
Brusick, D. (1986), Genotoxic effects in cultured mammalian cells produced by low pH treatment conditions and increased ion concentrations, Environmental and Molecular Mutagenesis, vol.
Tech.
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ASTM D 1293 — Annual ASTM Standards, Philadelphia, 1974.
, 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.
Clark, J. & Cunliffe, A.E.: Rapid spectrophotometric measurement of ionisation constants in aqueous solution.
177–183.
Handbook of Chemistry and Physics, 60th ed.
, Characterization of the Genotoxicity of Nitrilotriacetic Acid, Environmental and Molecular Mutagenesis, vol.
source, housing conditions, diet, etc.
49/6, s.
Anaesthetics and analgesics
439–452.
Barratt, M.D., et al.
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.
Worth A.P. and Fentem J.H.
191–201.
Young, J.R., et al.
Kirkland, D. m.fl.
Fentem, J.H., et al.
584/1-2, s.
Wright EM, Marcella KL, Woodson JF.
Greenwood, S. m.fl.
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.
36–44.
UN (2011), Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Fourth revised edition, New York & Geneva: United Nations Publications.
31/4, s.
ECHA Guidance on information requirements and chemical safety assessment, Chapter R.7a: Endpoint specific guidance.
316–326.
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).
Hedner K. m.fl.
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).
, Sister chromatid exchanges and structural chromosomal aberrations in relation to age and sex, Human Genetics, vol.
Tiered approach
62, s.
If that test does not reveal any corrosive or severe irritant effects, a confirmatory test is conducted with two additional animals.
305–309.
Depending upon the results of the confirmatory test, further tests may be needed.
Ramsey M.J. m.fl.
Worth, A.P. and Fentem J.H.
338, s.
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.
33/3, s.
Effects of Alkalinity on the Eye Irritation Potential of Solutions Prepared at a Single pH.
261–287.
J. Toxicol.
Henderson, L. m.fl.
The choice of the cell lines used should be scientifically justified.
31/6, s.
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.
347–363.
This would ensure the background incidence of chromosomal aberrations to be low and consistent.
113/3-4, s.
The baseline incidence of chromosomal aberrations increases with age and this trend is more marked in females than in males (17) (18).
173–215.
It is necessary to demonstrate that the cells have divided from the beginning of treatment with the test chemical to cell sampling.
, 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.
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.
37/1, s.
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).
83–90.
The use of synchronized cells during treatment is not recommended, but can be acceptable if justified.
Ishidate (1979), Chromosomal Aberration Tests on 29 Chemicals Combined with S9 Mix in vitro, Mutation Research/Genetic Toxicology, vol.
Media and culture conditions
66/3, s.
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.
, 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.
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.
4/1, s.
CASRN
55–65.
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.
Alternatives to Aroclor 1254-induced S9 in in vitro Genotoxicity Assays, Mutagenesis, vol.
Proficiency of the laboratory
175–177.
Evans, H.J.
Matsushima, T. m.fl.
Galloway, S.M. et al.
Report from Working Group on in vitro Tests for Chromosomal Aberrations, Mutation Research/Environmental Mutagenesis and Related Subjects, vol.
10, pp. 1-175.
312/3, s.
Hedner K. et al.
86–87.
, Sister chromatid exchanges and structural chromosomal aberrations in relation to age and sex, Human Genetics, Vol.
Richardson, C. m.fl.
62, pp. 305-309.
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 och 487) ENV/JM/TG(2014)17.
Ramsey M.J. et al.
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.
338, pp. 95-106.
32–56.
A Report of the Second ECVAM Task Force on Good Cell Culture Practice, ATLA, Vol.
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Henderson, L. et al.
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, Industrial Genotoxicology Group collaborative trial to investigate cell cycle parameters in human lymphocyte cytogenetics studies, Mutagenesis, Vol.12/3, pp.163-167.
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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.
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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.
Ames (1983), Revised Methods for the Salmonella Mutagenicity Test, Mutation Research/Environmental Mutagenesis and Related Subjects, Vol.
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Natarajan, A.T. et al.
Locke-Huhle, C. (1983), Endoreduplication in Chinese hamster cells during alpha-radiation induced G2 arrest, Mutation Research, vol.
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403–413.
Matsuoka, A., M. Hayashi, M. Jr.
Trosko (1983), Aphidicolin – induced endoreduplication in Chinese hamster cells, Cancer Research, vol.
66/3, pp. 277-290.
1362–1364.
Ong, T.-m. et al.
Galloway (1994), Cytotoxicity measurement in in vitro chromosome aberration test and micronucleus test, Mutation Research, vol.
, 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.
312, s.
Elliot, B.M. et al.
För försök med användning av cellinjer som omfattas av denna testmetod avser cytotoxicitet en minskning av den relativa populationsfördubblingen (RPD) eller en relativ ökning av celltal (RICC) i behandlade celler jämfört med den negativa kontrollen (se punkt 17 och tillägg 2).
7/3, pp. 175-177.
För korttidsstudier: individuell vikt hos försöksdjuren vid försökets början och slutet av testet; för studier längre än en vecka: individuella kroppsvikter under studien och foderförbrukning.
Matsushima, T. et al.
Kroppsviktsintervallet, medelvärde och standardavvikelse för varje grupp bör inkluderas.
Report from Working Group on in vitro Tests for Chromosomal Aberrations, Mutation Research/Environmental Mutagenesis and Related Subjects, Vol.
Preston, R.J. m.fl.
312/3, pp. 241-261.
Analysis of chromosome aberrations in bone marrow cells, Mutation Research, vol.
Johnson, T.E., D.R.
189/2, s.
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.
157–165.
28/1, pp. 51-59.
Richold, M. m.fl.
UNEP (2001), Stockholm Convention on Persistent Organic Pollutants, United Nations Environment Programme (UNEP).
Tice, R.R. m.fl.
Tucker, J.D., M.L.
, Report from the working group on the in vivo mammalian bone marrow chromosomal aberration test, Mutation Research, vol.
Christensen (1987), Effects of anticoagulants upon sister-chromatid exchanges, cell-cycle kinetics, and mitotic index in human peripheral lymphocytes, Mutation Research, Vol.
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Adler, I.D. m.fl.
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, Recommendations for statistical designs of in vivo mutagenicity tests with regard to subsequent statistical analysis, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, vol.
, 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.
417/1, s.
5/6, pp. 795-801.
19–30.
Asakura, M. et al.
, Compilation and use of genetic toxicity historical control data, Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis, vol.
, An improved system for exposure of cultured mammalian cells to gaseous compounds in the chromosomal aberration assay, Mutation Research, Vol.
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652/2, pp. 122-130.
87–90.
Lorge, E. et al.
, in vivo rodent erythrocyte micronucleus assay, Mutation Research/Environmental Mutagenesis and Related Subjects, vol.
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655/1-2, pp. 1-3.
293–304.
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Fielder, R.J. m.fl.
, 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.
Dose setting in in vivo mutagenicity assays, Mutagenesis, vol.
723/2, pp. 77-83.
7/5, s.
Honma, M. (2011), Cytotoxicity measurement in in vitro chromosome aberration test and micronucleus test, Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis, Vol.
313–319.
724/1-2, pp. 86-87.
Pacchierotti, F., V. Stocchi (2013), Analysis of chromosome aberrations in somatic and germ cells of the mouse, Methods in Molecular Biology, vol.
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.
147–163.
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.
Lovell, D.P. m.fl.
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54/1, pp. 36-43.
MacGregor, J.T. m.fl.
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USFDA (2012), International Conference on Harmonisation (ICH) Guidance S2 (R1) on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended For Human Use.
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Hayashi, M. et al.
Dertinger, S.D. m.fl.
, Compilation and use of genetic toxicity historical control Data, Mutation Research, Vol.
, Flow cytometric analysis of micronuclei in peripheral blood reticulocytes: I. Intra- and interlaboratory comparison with microscopic scoring, Toxicological Sciences, vol.
723/2, pp. 87-90.
94/1, s.
Warr, T.J., E.M.
26/1, s.
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.
139–145.
119/3, pp. 403-413.
65–73.
Huang, Y., C. Change, J.E.
Asano, N. m.fl.
43/3, pp. 1362-1364.
404/1-2, s.
Soper, K.A., S.M.
149–154.
Galloway (1994), Cytotoxicity measurement in in vitro chromosome aberration test and micronucleus test, Mutation Research, Vol.
Styles, J.A. m.fl.
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, Automation of mouse micronucleus genotoxicity assay by laser scanning cytometry, Cytometry, vol.
For the assays covered in this test method using primary cultures of lymphocytes, cytotoxicity is identified as a reduction in mitotic index (MI) of the treated cells as compared to the negative control (see paragraph 18 and Appendix 2).
153–155.
50-18-0 (6055-19-2) Triethylenemelamine
, A rapid in vivo test for chromosomal damage, Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis, vol.
51-18-3 Negative controls Negative control group animals should be included at every sampling time and otherwise handled in the same way as the treatment groups, except for not receiving treatment with the test chemical.
18/2, s.
If a solvent/vehicle is used in administering the test chemical, the control group should receive this solvent/vehicle.
187–190.
However, if consistent inter-animal variability and frequencies of cells with structural aberrations are demonstrated by historical negative control data at each sampling time for the testing laboratory, only a single sampling for the negative control may be necessary.
, The micronucleus test, Mutation Research, vol.
Where a single sampling is used for negative controls, it should be the first sampling time used in the study.
31/1, s.
PROCEDURE Number and sex of animals
9–15.
At least 200 metaphases should be analysed for each animal for structural chromosomal aberrations including and excluding gaps (6).
Heddle, J.A. m.fl.
However, if the historical negative control database indicates the mean background structural chromosomal aberration frequency is < 1 % in the testing laboratory, consideration should be given to scoring additional cells.
Environmental Protection Agency Gene-Tox Program, Mutation Research/Reviews in Genetic Toxicology, vol.
for short-term studies: individual weight of the animals at the start and end of the test; for studies longer than one week: individual body weights during the study and food consumption.
123/1, s.
Body weight range, mean and standard deviation for each group should be included.
61–118.
Adler, I.D.
Mavournin, K.H. m.fl.
Preston, R.J. et al.
Environmental Protection Agency Gene-Tox Program, Mutation Research/Reviews in Genetic Toxicology, vol.
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189/2, pp. 157-165.
29–80.
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, Micronuclei in circulating erythrocytes: a rapid screen for chromosomal damage during routine toxicity testing in mice, Developments in Toxicology Environmental Science, vol.
Tice, R.R. et al.
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, Report from the working group on the in vivo mammalian bone marrow chromosomal aberration test, Mutation Research, Vol.
555–558.
312/3, pp. 305-312.
, Guidelines for the conduct of micronucleus assays in mammalian bone marrow erythrocytes, Mutation Research/Genetic Toxicology, vol.
Adler, I.D. et al.
189/2, s.
, Recommendations for statistical designs of in vivo mutagenicity tests with regard to subsequent statistical analysis, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
103–112.
Ryan, T.P.
14/3, s.
723/2, pp. 87-90.
, The micronucleus assay with mouse peripheral blood reticulocytes using acridine orange-coated slides, Mutation Research/Genetic Toxicology, vol.
, in vivo rodent erythrocyte micronucleus assay, Mutation Research/Environmental Mutagenesis and Related Subjects, Vol.
245/4, s.
312/3, pp. 293-304.
245–249.
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278/2-3, s.
Pacchierotti, F., V. Stocchi (2013), Analysis of chromosome aberrations in somatic and germ cells of the mouse, Methods in Molecular Biology, Vol.
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.
1044, pp. 147-163.
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Lovell, D.P. et al.
10/3, s.
It has been shown for rats that pre-treatment sampling of small volumes (e.g. below 100 μl/day) has minimal impact on micronucleus background frequency (25).
153–159.
In general, the micronucleus response is similar between male and female animals and, therefore, most studies could be performed in either sex (26).
23/4, s.
Data demonstrating relevant differences between males and females (e.g. differences in systemic toxicity, metabolism, bioavailability, bone marrow toxicity, etc. including e.g. in a range-finding study) would encourage the use of both sexes.
239–273.
In this case, it may be appropriate to perform a study in both sexes, e.g. as part of a repeated dose toxicity study.
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.
for short term studies: individual weight of the animals at the start and end of the test; for studies longer than one week: individual body weights during the study and food consumption.
Hayes, J. m.fl.
627/1, pp. 10-30.
24/5, s.
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Wakata, A. m.fl.
94/1, pp. 92-107.
Mammalian Mutagenicity Study Group, Environmental and Molecular Mutagenesis, vol.
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32/1, s.
94/1, pp. 83-91.
Rothfuss, A. m.fl.
, Flow cytometric scoring of micronucleated erythrocytes: an efficient platform for assessing in vivo cytogenetic damage, Mutagenesis, Vol.
, Improvement of in vivo genotoxicity assessment: combination of acute tests and integration into standard toxicity testing, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, vol.
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, 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.
222–228.
404/1-2, pp. 149-154.
Some aspects of protocol design including repeated treatments, integration with toxicity testing, and automated scoring, Environmental and Molecular Mutagenesis, vol.
, Automation of mouse micronucleus genotoxicity assay by laser scanning cytometry, Cytometry, Vol.
234–252.
44/2, pp. 153-155.
Asanami, S., K. Shimono (1997), High body temperature induces micronuclei in mouse bone marrow, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, vol.
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7–14.
31/1, pp. 9-15.
Spencer, P.J. m.fl.
Heddle, J.A. et al.
, Induction of micronuclei by phenol in the mouse bone marrow: I. Association with chemically induced hypothermia, Toxicological Sciences, vol.
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Mavournin, K.H. et al.
Ishidate (1983), An application of Acridine Orange fluorescent staining to the micronucleus test, Mutation Research Letters, vol.
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, Micronuclei in circulating erythrocytes: a rapid screen for chromosomal damage during routine toxicity testing in mice, Developments in Toxicology Environmental Science, Vol.
Langlois (1983), A simple fluorescent staining procedure for micronuclei and RNA in erythrocytes using Hoechst 33258 and pyronin Y, Mutation Research, vol.
, Guidelines for the conduct of micronucleus assays in mammalian bone marrow erythrocytes, Mutation Research/Genetic Toxicology, Vol.
269–275.
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Staniforth (1989), The automated bone marrow micronucleus test, Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis, vol.
, The micronucleus assay with mouse peripheral blood reticulocytes using acridine orange-coated slides, Mutation Research/Genetic Toxicology, Vol.
Galloway (1999), Rapid method for improving slide quality in the bone marrow micronucleus assay; an adapted cellulose column procedure, Mutation Research, vol.
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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.
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Adler (1990), Application of antikinetochore antibody staining (CREST staining) to micronuclei in erythrocytes induced in vivo, Mutagenesis, vol.