natgillin/translations-raw huggingface dataset:
If the analytical methods are less reliable or the half life is (greatly) increased these numbers will become larger.
Zhang, L.S. et al. (1995).
CI confidence interval (where possible to estimate)
ECVAM (2006).
SD Standard deviation (where possible to estimate)
ESAC (2006).
When only two data points are measured, estimates of the confidence limits for BCFKm can be made using bootstrap methods.
ILSI paper (draft).
Total length should also be recorded during the test as it is a good indicator of whether an adverse effect has occurred.
Josse, R. et al. (2012).
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.
Ehrlich, V. et al. (2002).
7)
Knasmüller, S. et al. (2004).
For rapid growth during the uptake phase the true feeding rate will decrease below that set at the beginning of exposure.
Gibson, D.P. et al. (1997).
In an aqueous exposure study, a 14-day half-life would correspond to a BCF of ca.
Bonassi, S. et al. (2001).
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)).
Elliott, B.M. et al. (1992).
Equation A5.8 in Appendix 5).
UNEP (2001).
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.
Phelps, J.B., M.L.
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.
Surralles, J. et al. (1995).
A foodstuff analysis technique for protein, lipid, crude fibre and ash content; this information is usually available from the feed supplier.
Honma, M. (2011).
CI confidence interval (where possible to estimate).
Pfuhler, S. et al. (2011).
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).
Morita T., M. Honma, K. Morikawa (2012).
If other daphnid are used they should be clearly identified and their use justified.
Brookmire L., J.J.
Accidental mortality: non chemical related mortality caused by an accidental incidence (i.e. known cause)
EPA, Office of Chemical Safety and Pollution Prevention (2011).
Inadvertent mortality: non chemical related mortality with no known cause
Sobol, Z. et al. (2012).
At least 10 incremental additions should be made before the equivalence point.
Bryce, S.M. et al. (2011).
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.
Shi, J., R. Bezabhie, A. Szkudlinska (2010).
Precautions must be taken to exclude CO2.
Fenech, M. et al. (2003).
Albert, A. & Sergeant, E.P.: Ionization Constants of Acids and Bases, Wiley, Inc., New York, 1962.
Elhajouji, A., M. Cunha, M. Kirsch-Volders (1998).
Nelson, N.H.
Ryan, T. P. (2000).
Sci.
International Conference on Harmonisation (ICH) Guidance S2 (R1) on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended For Human Use.
3, II, pp. 1186-1188 (1969).
Výsledky získané vo validačnej štúdii (18) a v uverejnených štúdiách (19) celkovo indikujú, že presnosť DPRA pri odlišovaní senzibilizátorov (t. j. kategória 1 GHS OSN/CLP) od nesenzibilizujúcich chemikálií predstavuje 80 % (N = 157) s citlivosťou 80 % (88/109) a špecifickosťou 77 % (37/48) v porovnaní s výsledkami LLNA.
Standard Method 242.
Testované chemikálie, ktoré však nie sú rozpustné pri tejto koncentrácii, možno napriek tomu testovať pri nižších koncentráciách, pri ktorých sú rozpustné.
ASTM D 1125 — Annual ASTM Standards, Philadelphia, 1974.
vzhľad zrazeniny v reakčnej zmesi (ak sa spozoruje) na konci inkubačnej doby, informácia o tom, či bola zrazenina opäť rozpustená alebo odstredená,
source, housing conditions, diet, etc.
OECD (2012).
Anaesthetics and analgesics
Adler et al. (2011).
Barratt, M.D., et al.
Gerberick et al. (2004).
de Silva, O., et al.
EC EURL-ECVAM (2013).
Young, J.R., et al.
Bauch et al. (2012).
Neun, D.J.
Nukada et al. (2013).
OECD (2000), Guidance Document on the Recognition, Assessment and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation.
Landsteiner and Jacobs (1936).
National Research Council (NRC) (2009), Recognition and Alleviation of Pain in Laboratory Animals, Washington, DC: The National Academies Press.
EC EURL ECVAM (2012).
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.
Natsch et al. (2013).
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.
DB-ALM (INVITTOX) Protocol 154: Direct Peptide Reactivity assay (DPRA) for skin sensitisation testing 17pp.
U.S.
OECD (2005).
UN (2011), Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Fourth revised edition, New York & Geneva: United Nations Publications.
FDA (Food and Drug Administration (2001).
ECHA Guidance on information requirements and chemical safety assessment, Chapter R.7a: Endpoint specific guidance.
ECETOC (2003).
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).
90 – 100
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).
15 – 45
Tiered approach
60 – 80
If that test does not reveal any corrosive or severe irritant effects, a confirmatory test is conducted with two additional animals.
10 – 55
Depending upon the results of the confirmatory test, further tests may be needed.
30 – 60
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).
0 – 24
Worth, A.P. and Fentem J.H.
80 – 100
A General Approach for Evaluating Stepwise Testing Strategies.
0 – 7
Young, J.R., How, M.J., Walker, A.P., Worth W.M.H.
15 – 55
Toxicol.
0 – 25
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.
60 – 100
Effects of Alkalinity on the Eye Irritation Potential of Solutions Prepared at a Single pH.
10 – 45
J. Toxicol.
0 – 5,5
In Vitro Mammalian Chromosomal Aberration Test
Adler S., Basketter D., Creton S., Pelkonen O., van Benthem J., Zuang V., Andersen K.E., Angers-Loustau A., Aptula A., Bal-Price A., Benfenati E., Bernauer U., Bessems J., Bois F.Y., Boobis A., Brandon E., Bremer S., Broschard T., Casati S., Coecke S., Corvi R., Cronin M., Daston G., Dekant W., Felter S., Grignard E., Gundert-Remy U., Heinonen T., Kimber I., Kleinjans J., Komulainen H., Kreiling R., Kreysa J., Leite S.B., Loizou G., Maxwell G., Mazzatorta P., Munn S., Pfuhler S., Phrakonkham P., Piersma A., Poth A., Prieto P., Repetto G., Rogiers V., Schoeters G., Schwarz M., Serafimova R., Tähti H., Testai E., van Delft J., van Loveren H., Vinken M., Worth A., Zaldivar J.M.
The choice of the cell lines used should be scientifically justified.
Emter R., Ellis G., Natsch A. (2010).
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.
Dinkova-Kostova A.T., Holtzclaw W.D., Kensler T.W.
It is necessary to demonstrate that the cells have divided from the beginning of treatment with the test chemical to cell sampling.
Natsch A., Ryan C.A., Foertsch L., Emter R., Jaworska J., Gerberick G.F., Kern P. (2013).
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.
EURL-ECVAM (2014).
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).
Natsch A., Emter R., Ellis G. (2009).
The use of synchronized cells during treatment is not recommended, but can be acceptable if justified.
Ball N., Cagen S., Carrillo J.C., Certa H., Eigler D., Emter R., Faulhammer F., Garcia C., Graham C., Haux C., Kolle S.N., Kreiling R., Natsch A., Mehling A. (2011).
Media and culture conditions
Bauch C., Kolle S.N., Ramirez T., Eltze T., Fabian E., Mehling A., Teubner W., van Ravenzwaay B., Landsiedel R. (2012).
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.
Jaworska J., Dancik Y., Kern P., Gerberick F., Natsch A. (2013).
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.
Andres E., Sa-Rocha V.M., Barrichello C., Haupt T., Ellis G., Natsch A. (2013).
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.
Fabian E., Vogel D., Blatz V., Ramirez T., Kolle S., Eltze T., van Ravenzwaay B., Oesch F., Landsiedel R. (2013).
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.
Thorne N., Inglese J., Auld D.S.
CASRN
Gildea L.A., Ryan C.A., Foertsch L.M., Kennedy J.M., Dearman R.J., Kimber I., Gerberick G.F.
Procedures in use in the laboratory should ensure that analysis of chromosomal aberrations is performed by well-trained scorers and peer-reviewed if appropriate.
Ryan C.A., Gildea L.A., Hulette B.C., Dearman R.J., Kimber I., Gerberick G.F.
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.
Emter R., van der Veen J.W., Adamson G., Ezendam J., van Loveren H., Natsch A. (2013).
(See paragraph 2).
OECD (2015).
Proficiency of the laboratory
NAFTA (North American Free Trade Agreement) (2012).
Evans, H.J.
Technical Working Group on Pesticides – (Quantitative) Structure Activity Relationship ((Q)SAR) Guidance Document.
Galloway, S.M. et al.
(v mg/ml)
10, pp. 1-175.
US EPA C&L
Hedner K. et al.
184-91.
, Sister chromatid exchanges and structural chromosomal aberrations in relation to age and sex, Human Genetics, Vol.
40-69.
62, pp. 305-309.
OECD (2014), Reports of the JaCVAM initiative international pre-validation and validation studies of the in vivo rodent alkaline comet assay for the detection of genotoxic carcinogens, Series on Testing and Assessment, Nos.
Ramsey M.J. et al.
195 and 196, OECD Publishing, Paris.
, The effects of age and lifestyle factors on the accumulation of cytogenetic damage as measured by chromosome painting, Mutation Research, Vol.
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Collins, A.R (2004), The Comet assay for DNA damage and repair: principles, applications, and limitations, Molecular Biotechnology, Vol.
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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.
Kushwaha, S. et al. (2010), Evaluation of multi-organ DNA damage by Comet assay from 28 days repeated dose oral toxicity test in mice: A practical approach for test integration in regulatory toxicity testing, Regulatory Toxicology and Pharmacology, Vol.
31/6, pp. 347-363.
145–54.
113/3-4, pp. 173-215.
Recio, L. et al. (2012), Comparison of Comet assay dose-response for ethyl methanesulfonate using freshly prepared versus cryopreserved tissues, Environmental and Molecular Mutagenesis, Vol.
, 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.
149-62.
Ishidate (1979), Chromosomal Aberration Tests on 29 Chemicals Combined with S9 Mix in vitro, Mutation Research/Genetic Toxicology, Vol.
621-3.
Ong, T.-m. et al.
19/1, pp.
4/1, pp. 55-65.
Nesslany, F. (2007), In vivo Comet assay on isolated kidney cells to distinguish genotoxic carcinogens from epigenetic carcinogens or cytotoxic compounds, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
Alternatives to Aroclor 1254-induced S9 in in vitro Genotoxicity Assays, Mutagenesis, Vol.
28-41.
Matsushima, T. et al.
Toyoizumi, T. et al. (2011), Use of the in vivo skin Comet assay to evaluate the DNA-damaging potential of chemicals applied to the skin, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
312/3, pp. 241-261.
175-80.
Johnson, T.E., D.R.
Struwe, M. et al. (2008), Detection of photogenotoxicity in skin and eye in rat with the photo Comet assay, Photochemical and Photobiological Sciences, Vol.
UNEP (2001), Stockholm Convention on Persistent Organic Pollutants, United Nations Environment Programme (UNEP).
Wada, K. et al. (2012), A comparison of cell-collecting methods for the Comet assay in urinary bladders of rats, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
Christensen (1987), Effects of anticoagulants upon sister-chromatid exchanges, cell-cycle kinetics, and mitotic index in human peripheral lymphocytes, Mutation Research, Vol.
26-30.
Zamora, P.O. et al.
51-9.
5/6, pp. 795-801.
28/6, pp.
, An improved system for exposure of cultured mammalian cells to gaseous compounds in the chromosomal aberration assay, Mutation Research, Vol.
Sekihashi, K. et al. (2002), Comparative investigations of multiple organs of mice and rats in the Comet assay, Mutation Research, Vol.
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Speit, G, M. Vasquez, A. Hartmann (2009), The comet assay as an indicator test for germ cell genotoxicity, Mutation Research, Vol.
655/1-2, pp. 1-3.
681/1, pp.
, 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.
Zheng, H., P.L.
Honma, M. (2011), Cytotoxicity measurement in in vitro chromosome aberration test and micronucleus test, Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis, Vol.
443-451.
Richardson, C. et al.
33/2, pp.
741/1-2, pp. 32-56.
Wu, J.H., N.J.
Levy (2013), Evaluation of the Highest Concentrations Used in the In Vitro Chromosome Aberrations Assay, Environmental and Molecular Muagenesis, Vol.
Kumaravel, T.S., A.N.
EPA, Office of Chemical Safety and Pollution Prevention (2011), Chemical Substances of Unknown or Variable Composition, Complex Reaction Products and Biological Materials: UVCB Substances, http://www.epa.gov/opptintr/newchems/pubs/uvcb.txt.
Kumaravel, T.S. et al. (2009), Comet Assay measurements: a perspective, Cell Biology and Toxicology, Vol.
ISCN (2013), An International System for Human Cytogenetic Nomenclature, Schaffer, L.G., J. MacGowan-Gordon, M. Schmid (eds.), Karger Publishers Inc., Connecticut.
53-64.
, Compilation and use of genetic toxicity historical control Data, Mutation Research, Vol.
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Ryan, T. P. (2000), Statistical Methods for Quality Improvement, 2nd Edition, John Wiley and Sons, New York.
Møller, P. et al. (2010), Assessment and reduction of Comet assay variation in relation to DNA damage: studies from the European Comet Assay Validation Group, Mutagenesis, Vol.
Fleiss, J. L., B. Levin, M.C.
25/2, pp.
Warr, T.J., E.M.
109-11.
287/1, pp. 29-46.
25/2, pp.
Trosko (1983), Aphidicolin — induced endoreduplication in Chinese hamster cells, Cancer Research, Vol.
41-45.
For the assays covered in this test method using cell lines, cytotoxicity is identified as a reduction in relative population doubling (RPD) or relative increase in cell count (RICC) of the treated cells as compared to the negative control (see paragraph 17 and Appendix 2).
Blakey, D.H., G.R.
50-18-0 (6055-19-2) Triethylenemelamine
34/1, pp.
If a solvent/vehicle is used in administering the test chemical, the control group should receive this solvent/vehicle.
Atlas of Comet Assay Images, Scientist Press Co., Ltd., Tokyo, Japan.
Where a single sampling is used for negative controls, it should be the first sampling time used in the study.
19/2, pp.
At least 200 metaphases should be analysed for each animal for structural chromosomal aberrations including and excluding gaps (6).
Wiklund, S.J., E. Agurell (2003), Aspects of design and statistical analysis in the Comet assay, 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.
167-75.
Adler, I.D.
10/6, pp.
Analysis of chromosome aberrations in bone marrow cells, Mutation Research, Vol.
Lovell, D.P., T. Omori (2008), Statistical issues in the use of the Comet assay, Mutagenesis, Vol.
Richold, M. et al.
171-82.
Adler, I.D. et al.
Mead, R. (1990) The Design of Experiments.
417/1, pp. 19-30.
Winer, B.J.
, Compilation and use of genetic toxicity historical control data, Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis, Vol.
Guerard, M., C. Marchand, U. Plappert-Helbig (2014), Influence of Experimental Conditions on Data Variability in the Liver Comet Assay, Environmental and Molecular Mutagenesis, Vol.
Fielder, R.J. et al.
427-32.
7/5, pp. 313-319.
101-13.
Lovell, D.P. et al.
Ďalším argumentom v prospech tejto metódy bolo, že k možnej expozícii životného prostredia účinkom týchto slabo rozpustných látok (t. j. s hodnotou log KOW > 5) dochádza prevažne z potravy [pozri (40) (41) (42) (43) (44)].
PROCEDURE Number and sex of animals
Treba si však uvedomiť, že v rámci tu opísanej metódy je potrebné dôsledne sa vyhýbať expozícii vo vodnej fáze, preto hodnotu BMF z tejto testovacej metódy nemožno priamo porovnať s hodnotou BMF zo skúšok v teréne (kde je možné kombinovať expozíciu vo vodnom prostredí s expozíciou z potravy).
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.
Tento alternatívny test umožňuje priamo v kontrolovaných laboratórnych podmienkach preskúmať dráhu expozície z potravy.
It might be appropriate to use the factorial design in case both sexes are used.
(OECD (1997), OECD Environmental Health and Safety Publications Series on Testing and Assessment Number 7: Guidance Document on Direct Phototransformation of Chemicals in Water OCDE/GD(97)21.
Details on how to analyse the data using this design are given in Appendix 2.
Organisation for Economic Co-operation and Development (OECD), Paris, France.
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, Flow cytometric analysis of micronuclei in peripheral blood reticulocytes: I. Intra- and interlaboratory comparison with microscopic scoring, Toxicological Sciences, Vol.
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, Flow cytometric scoring of micronucleated erythrocytes: an efficient platform for assessing in vivo cytogenetic damage, Mutagenesis, Vol.
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18/2, pp. 187-190.
54: Current approaches in the statistical analysis of ecotoxicity data: a guidance to application.
Schmid, W.
Springer T.A., Guiney P.D., Krueger H.O. and Jaber M.J.
31/1, pp. 9-15.
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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.
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189/2, pp. 103-112.
Anonymous (2004), Background document to the fish dietary study protocol, document submitted to the TC-NES WG on PBT.
, The in vivo erythrocyte micronucleus test: measurement at steady state increases assay efficiency and permits integration with toxicity studies, Fundamental and Applied Toxicology, Vol.
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