natgillin/translations-raw huggingface dataset:
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.
Kemikaali, johon testikemikaalia verrataan.
This approach differs from “normalisation” to a set organism lipid content as is done in the aqueous exposure bioconcentration test.
Se on eräs testimenetelmän suorituskyvyn indikaattoreista.
Total length should also be recorded during the test as it is a good indicator of whether an adverse effect has occurred.
Väärien positiivisten tulosten osuus
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.
YK:n GHS-järjestelmän ”Ei luokitusta”
7)
Vaihdettavissa määrityksen ”Ei luokiteltu” kanssa.
For rapid growth during the uptake phase the true feeding rate will decrease below that set at the beginning of exposure.
Negatiivisen tuloksen vahvistamiseksi tarvittavaa perusteellista arviointia varten testi on kuitenkin suoritettava kaikissa seuraavissa kolmessa testiolosuhteissa, joissa käytetään lyhytkestoista käsittelyä metabolisen aktivaatiojärjestelmän läsnäollessa sekä ilman metabolista aktivaatiota (ks. 56, 57 ja 58 kohta)
In an aqueous exposure study, a 14-day half-life would correspond to a BCF of ca.
Soluja on altistettava tutkittavalle aineelle ilman metabolista aktivaatiota 3–6 tunnin ajan, ja näytteet kerätään suunnilleen 1,5–2,0 normaalin solusyklin kuluttua altistuksen aloittamisesta (19).
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)).
Käytettäessä automatisoitua pisteytysjärjestelmää, kuten virtaussytometriaa, laserpyyhkäisysytometriaa tai kuva-analyysia, on käytettävä tarvittavia menetelmiä mahdollisten virheiden tai muutosten valvomiseksi.
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.
Riippumatta siitä, käytetäänkö mikrotumien laskentaan automaattista järjestelmää, olisi arvioitava samanaikaisesti sytokineesin eston proliferaatioindeksi, RI, PSK tai SMSL.
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.
392/1-2, s. 1–4.
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.
Mutation Research, Vol.
A foodstuff analysis technique for protein, lipid, crude fibre and ash content; this information is usually available from the feed supplier.
Cytobios, Vol.
SD Standard deviation (where possible to estimate).
Environmental and Molecular Mutagenesis, Vol.
If other daphnid are used they should be clearly identified and their use justified.
Nature Protocols, Vol.
Inadvertent mortality: non chemical related mortality with no known cause
Mutation Research, Vol.
The test solution is determined by titration with the standard base or acid solution as appropriate, measuring the pH after each addition of titrant.
161/2, s. 193–198.
At least 10 incremental additions should be made before the equivalence point.
Environmental and Molecular Mutagenesis, Vol.
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.
13/1, s. 34–43.
Albert, A. & Sergeant, E.P.: Ionization Constants of Acids and Bases, Wiley, Inc., New York, 1962.
234/5, s. 9–20.
& Faust, S.D.: Acidic dissociation constants of selected aquatic herbicides, Env.
6/4, s. 297–302.
Tech.
8/4, s. 329–334.
ASTM D 1293 — Annual ASTM Standards, Philadelphia, 1974.
319/3, s. 205–213.
Clark, J. & Cunliffe, A.E.: Rapid spectrophotometric measurement of ionisation constants in aqueous solution.
8/6, s. 519–525.
Handbook of Chemistry and Physics, 60th ed.
322/1, s. 9–20.
Anaesthetics and analgesics
372/2, s. 233–245.
Barratt, M.D., et al.
Mutation Research, Vol.
Worth A.P. and Fentem J.H.
Mutation Research, Vol.
Young, J.R., et al.
607/1, s. 13–36.
Fentem, J.H., et al.
607/1, s. 37–60.
OECD (2000), Guidance Document on the Recognition, Assessment and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation.
Mutation Research, Vol.
Wright EM, Marcella KL, Woodson JF.
607/1, s. 61–87.
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.
Mutation Research, Vol.
UN (2011), Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Fourth revised edition, New York & Geneva: United Nations Publications.
392/1-2, s. 187–208.
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).
392/1-2, s. 45–59.
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).
Gesellschaft fur Umwelt-Mutations-forschung, Mutation Research, Vol.
If that test does not reveal any corrosive or severe irritant effects, a confirmatory test is conducted with two additional animals.
Chemically induced micronucleus formation in V79 cells – comparison of three different test approaches.
Worth, A.P. and Fentem J.H.
Mutation Research, Vol.
Toxicol.
468/2, s. 137–163.
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.
Mutation Research, Vol.
Effects of Alkalinity on the Eye Irritation Potential of Solutions Prepared at a Single pH.
517/1-2, s. 123–134.
J. Toxicol.
Mutagenesis, Vol.
The choice of the cell lines used should be scientifically justified.
607/1, s. 1–152.
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.
Mutation Research, Vol.
This would ensure the background incidence of chromosomal aberrations to be low and consistent.
Regulatory Toxicology and Pharmacology, Vol.
The baseline incidence of chromosomal aberrations increases with age and this trend is more marked in females than in males (17) (18).
59/1, s. 28–36.
It is necessary to demonstrate that the cells have divided from the beginning of treatment with the test chemical to cell sampling.
52/5, s. 373–384.
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.
Mutation Research Letters, Vol.
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).
347/3-4, s. 105–115.
The use of synchronized cells during treatment is not recommended, but can be acceptable if justified.
Mutagenesis, Vol 23/4, s. 271–283.
Media and culture conditions
ILSI paper (luonnos).
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.
Mutation Research, 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.
268/2, s. 297–305.
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.
Mutation Research, Vol.
Proficiency of the laboratory
Environmental and Molecular Mutation., Vol.
Evans, H.J.
49, s. 439–452.
Galloway, S.M. et al.
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147/1-2, s. 29–36.
Long, L.H. et al.
27/3, s. 295–304.
49/6, pp. 439-452.
Mutation Research, Vol.
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.
392/1-2, s. 61–70.
I: Sensitivity, specificity and relative predictivity, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
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584/1-2, pp. 1–256.
113/3-4, s. 173–215.
Greenwood, S. et al.
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Mutation Research, Vol.
, Sister chromatid exchanges and structural chromosomal aberrations in relation to age and sex, Human Genetics, Vol.
190/3, s. 225–228.
62, pp. 305-309.
Environmental Mutagenesis, Vol.
Ramsey M.J. et al.
5/6, s. 795–801.
338, pp. 95-106.
652/2, s. 122–130.
A Report of the Second ECVAM Task Force on Good Cell Culture Practice, ATLA, Vol.
285/1, s. 35–44.
Henderson, L. et al.
521/1-2, s. 103–112.
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.
655/1-2, s. 1–3.
Maron, D.M., B.N.
341/3, s. 169–184.
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.
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37/1, pp. 83-90.
Mutation Research, Vol.
Matsuoka, A., M. Hayashi, M. Jr.
741, s. 32–56.
66/3, pp. 277-290.
54/1, s. 36–43.
, 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.
746/1, s. 29–34.
Elliot, B.M. et al.
120/4, s. 241–247.
7/3, pp. 175-177.
120/4, s. 269–275.
Report from Working Group on in vitro Tests for Chromosomal Aberrations, Mutation Research/Environmental Mutagenesis and Related Subjects, Vol.
52/4, s. 280–286.
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.
Mutagenesis, Vol.
28/1, pp. 51-59.
25/1, s. 33–40.
Tucker, J.D., M.L.
534/1-2, s. 65–75.
190/3, pp. 225-8.
13/2, s. 193–198.
Krahn, D.F., F.C.
Archives of Toxicology, 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.
Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.723/2, s. 87–90.
Asakura, M. et al.
Validointitutkimuksen (18) ja kaikkiaan julkaistujen tutkimusten (19) tulokset viittaavat siihen, että DPRA:n tarkkuus ihoa herkistävien aineiden erottelussa (YK:n GHS-järjestelmän / CLP-asetuksen luokka 1) herkistystä aiheuttamattomista aineista on 80 prosenttia (N = 157), herkkyys 80 prosenttia (88/109) ja spesifisyys 77 prosenttia (37/48) LLNA-kokeen tuloksiin verrattuna.
652/2, pp. 122-130.
Ellei testikemikaali liukene niin, että tällainen pitoisuus olisi saavutettavissa, sitä voidaan kuitenkin testata alhaisemmalla pitoisuudella.
Lorge, E. et al.
Tällöin positiivisen tuloksen perusteella testikemikaali voidaan edelleen määrittää ihoa herkistäväksi aineeksi, mutta negatiivisen tuloksen perusteella ei voida tehdä varmoja päätelmiä reaktiivisuuden puuttumisesta.
655/1-2, pp. 1-3.
Yhdistyneet Kansakunnat (YK) (2013).
Galloway, S. et al.
Ball et al.
723/2, pp. 77-83.
DB-ALM (INVITTOX) Protocol 154: Direct Peptide Reactivity assay (DPRA) for skin sensitisation testing 17s.
724/1-2, pp. 86-87.
Toxicological Sciences 113, 284–292.
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.
18, 1779–1791.
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.
1(1), 45–49.
Brookmire, L., J.J.
Journal of Applied Toxicology, 33, 1337–1352.
54/1, pp. 36-43.
60, 389–400.
USFDA (2012), International Conference on Harmonisation (ICH) Guidance S2 (R1) on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended For Human Use.
33, 1353–1364.
Hayashi, M. et al.
87, 1683–1969.
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Dermatol., 126, 1813–1822.
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.
Yhdysvaltojen EPA (luokitus ja merkitseminen)
287/1, pp. 29-46.
Spesifisyys
119/3, pp. 403-413.
Kemikaali, joka on luokiteltu YK:n GHS-järjestelmän luokkaan 1, EU:n CLP-asetuksen luokkaan 1 tai Yhdysvaltojen EPA:n luokkaan I kuuluvaksi silmää ärsyttäväksi aineeksi.
Huang, Y., C. Change, J.E.
Appropriate follow-up testing in vivo, Mutation Research, Vol.
43/3, pp. 1362-1364.
, The in vivo Comet assay: use and status in genotoxicity testing, Mutagenesis, Vol.
Soper, K.A., S.M.
20/4, s. 245–54.
Galloway (1994), Cytotoxicity measurement in in vitro chromosome aberration test and micronucleus test, Mutation Research, Vol.
, Fourth International Workgroup on Genotoxicity Testing: result of the in vivo Comet assay workgroup, Mutation Research, Vol.
312, pp. 139-149.
627/1, s. 31–5.
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).
817, s. 143–63.
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.
23/3, s. 233–40.
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.
18/1, s. 45–51.
PROCEDURE Number and sex of animals
288/1, s. 47–63.
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.
35/3, s. 206–21.
Body weight range, mean and standard deviation for each group should be included.
175/1, s. 184–91.
Preston, R.J. et al.
Strauss (1995), The single cell gel electrophoresis/Comet assay: a potential tool for detecting radiation-induced DNA damage in humans, Stem Cells, Vol.
189/2, pp. 157-165.
Collins, A.R (2004), The Comet assay for DNA damage and repair: principles, applications, and limitations, Molecular Biotechnology, Vol.
Tice, R.R. et al.
, Improvement of in vivo genotoxicity assessment: combination of acute tests and integration into standard toxicity testing, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
, Report from the working group on the in vivo mammalian bone marrow chromosomal aberration test, Mutation Research, Vol.
723/2, s. 108–20.
312/3, pp. 305-312.
, 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.
, Recommendations for statistical designs of in vivo mutagenicity tests with regard to subsequent statistical analysis, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
, Combining the in vivo Comet and micronucleus assays: a practical approach to genotoxicity testing and data interpretation, Mutagenesis, Vol.
Ryan, T.P.
, Evaluation of a multi-endpoint assay in rats, combining the bone-marrow micronucleus test, the Comet assay and the flow-cytometric peripheral blood micronucleus test, Mutation Research, Vol.
723/2, pp. 87-90.
, Dose-response assessment of four genotoxic chemicals in a combined mouse and rat micronucleus (MN) and Comet assay protocol, The Journal of Toxicological Science, Vol.
, in vivo rodent erythrocyte micronucleus assay, Mutation Research/Environmental Mutagenesis and Related Subjects, Vol.
35/2, s. 149–62.
312/3, pp. 293-304.
O'Donovan, M., B. Burlinson (2013), Maximum dose levels for the rodent comet assay to examine damage at the site of contact or to the gastrointestinal tract, Mutagenesis, Vol.
Dose setting in in vivo mutagenicity assays, Mutagenesis, Vol.
Hartmann, A. (2004), Use of the alkaline in vivo Comet assay for mechanistic genotoxicity investigations, Mutagenesis, Vol.
Pacchierotti, F., V. Stocchi (2013), Analysis of chromosome aberrations in somatic and germ cells of the mouse, Methods in Molecular Biology, Vol.
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.
1044, pp. 147-163.
630/1, s. 28–41.
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).
393(1–2), 175–8;
In general, the micronucleus response is similar between male and female animals and, therefore, most studies could be performed in either sex (26).
726/2, s. 175–80.
In this case, it may be appropriate to perform a study in both sexes, e.g. as part of a repeated dose toxicity study.
7/2, s. 240–9.
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.
, Measurement of DNA damage in rat urinary bladder transitional cells: improved selective harvest of transitional cells and detailed Comet assay protocols, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
627/1, pp. 10-30.
Fourth International Workgroup on Genotoxicity testing: results of the in vivo Comet assay workgroup, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
94/1, pp. 92-107.
6/5, s. 486–500.
Dertinger, S.D. et al.
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94/1, pp. 83-91.
, 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.
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Olive (1997), Influence of oxygen on radiation-induced DNA damage in testicular cells of C3H mice, International Journal of Radiation Biology, Vol.
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, Evaluation of DNA damage in different stages of mouse spermatogenesis after testicular X irradiation, Journal of Radiation Research, Vol. 160/4, s. 443–451.
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33/2, s. 167–72.
, Automation of mouse micronucleus genotoxicity assay by laser scanning cytometry, Cytometry, Vol.
27/3, s. 196–201.
44/2, pp. 153-155.
Jones (2012), Assessment of DNA interstrand crosslinks using the modified alkaline Comet assay, Methods in Molecular Biology, Vol.
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Environmental Protection Agency Gene-Tox Program, Mutation Research/Reviews in Genetic Toxicology, Vol.
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25/2, s. 109–11.
, 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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236/1, s. 35–41.
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18/2, s. 167–75.
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Kalanäytteiden otto
The latter represents the protocol used for the European Community-sponsored prevalidation study conducted in 1997-1998.
Vaadittu vähimmäistaajuus (vrk) [2]
IVIS = mean opacity value + (15 × mean permeability OD490 value) Sina et al.
Kalojen siirto veteen, jossa ei ole testiainetta
Test Method Evaluation Report — In Vitro Ocular Toxicity Test Methods for Identifying Ocular Severe Irritants and Corrosives.
05–10
OECD (2013).
5–10
In: ICCVAM Test Method Evaluation Report — in vitro Ocular Toxicity Test Methods for Identifying Ocular Severe Irritants and Corrosives.
(8–13) [11]
Gautheron, P., Dukic, M., Alix, D. and Sina, J.F.
(56–116) [10] [11]
OECD (1998).
Jos k1/k2 korvataan BCF:llä (ks. yhtälö A5.4) yhtälöissä A5.25 ja A5.26, voidaan arvioida myös BCF:n keskivirhetaso ja 95 prosentin luottamusväli.