natgillin/translations-raw huggingface dataset:
Concentrations in sediment and sediment pore-water should be determined at test initiation and test termination, at least in the highest test concentration, unless the test chemicals are known to be stable in water (> 80 % of nominal).
Sina, J. F., Galer, D. M., Sussman, R. S., Gautheron, P. D., Sargent, E. V., Leong, B., Shah, P. V., Curren, R. D. in Miller, K. (1995).
Measurements in sediment and pore-water might not be necessary if the partitioning of the test chemical between water and sediment has been clearly determined in a water/sediment study under comparable conditions (e.g. sediment to water ratio, application method, sediment type).
Vsak laboratorij, ki ta preskus izvaja prvič, mora uporabiti kemikalije za preverjanje usposobljenosti iz Dodatka 2.
Hence, additional treated test vessels may be required to facilitate analytical determinations at test initiation and test termination.
Pri razlagi debeline roženice (preglednica 3), motnjave roženice (preglednica 4) in zadrževanja fluoresceina (preglednica 5) se uporabljajo štirje razredi ICE v skladu z spodnjimi lestvicami.
Similarly, where intermediate assessments are considered necessary, i.e. on day 7, and analyses require large samples of sediment that cannot be easily removed from the test system, analytical determinations should be performed using additional test vessels treated in the same way as those used for biological assessments.
Opozoriti je treba, da so vrednosti nabreklosti roženice iz preglednice 3 uporabne le, če je debelina izmerjena z biomikroskopom s špranjsko svetilko (npr. z modelom Haag-Streit BP900) z napravo za merjenje globine št. 1 in nastavitvijo širine špranje na 91
Centrifugation at, for example, 10000 g and 4 °C for 30 minutes is recommended to isolate interstitial water.
> 32
However, if the test chemical is demonstrated not to absorb to filters, filtration may also be acceptable.
0,0–0,5
Alternatively, the test solutions of all replicates for each concentration may be pooled for analyses.
ICCVAM Test Method Evaluation Report – Current Status of in vitro Test Methods for Identifying Mild/Moderate Ocular Irritants: The Isolated Chicken Eye (ICE) Test Method.
However, if there is evidence that the concentration has declined (i.e. is not maintained within 20 % of the nominal or measured initial concentration in the treated compartment) throughout the test, then analysis of the results should be based on the geometric mean concentration during exposure or models describing the decline of the concentration of the test chemical in the treated compartment (11).
F., Vinardell, P. in Zuang, V. (2010).
DATA EVALUATION
Prinsen, M. K. in Koëter, B. W.
In cases where use of a solvent / dispersant is required, data from solvent and untreated controls may be pooled for the purposes of statistical analyses provided that the responses of the solvent and untreated controls are not statistically significantly different.
Balls, M., Botham, P. A., Bruner, L. H. in Spielmann, H. (1995).
The purpose of the test is to determine the effects of the test chemical on the vegetative growth of the test species, using two response variables, average specific growth rate and yield, as follows:
Chamberlain, M., Gad, S. C., Gautheron, P. in Prinsen, M. K. (1997).
This variable is calculated for each replicate of each control and treatment group.
Za temeljito oceno, ki bi bila potrebna za sklep o negativnem rezultatu, je treba izvesti vse tri naslednje preskusne pogoje ter pri tem uporabiti kratkotrajno tretiranje s presnovno aktivacijo in brez nje ter dolgotrajno tretiranje brez presnovne aktivacije (glej odstavke 56, 57 in 58):
The mean length and weight of the three plants per test vessel (replicate) and, subsequently, the growth rate for each replicate, should be calculated using the following formula:
celice je treba za 3 do 6 ur izpostaviti preskusni kemikaliji brez presnovne aktivacije in vzorčiti ob času, ki ustreza približno 1,5 do 2,0 dolžine normalnega celičnega cikla po začetku tretiranja (19),
From the replicate responses, a mean value for growth rate along with variance estimates should be calculated for each treatment and control group.
Pri uporabi avtomatiziranega sistema štetja, na primer pretočne citometrije, laserske vrstične citometrije ali analize slike, je treba uporabiti ustrezne tehnike za nadzor kakršnih koli izkrivljanj ali sprememb.
Percent inhibition of growth rate (Ir) may then be calculated for each test concentration (treatment group) according to the following formula:
Ne glede na to, ali se za štetje mikronukleusov uporablja avtomatizirana platforma, je treba sočasno oceniti proliferacijski indeks citokinetskega bloka, indeks pomnoževanja, relativno podvojitev populacije ali relativno povečanje števila celic.
μC mean value for μin the control
392/1–2, str. 1–4.
μT mean value for μin the treatment group
Parry, J. M. in Sors, A. (1993).
This response variable is based on changes in total shoot length, total shoot fresh weight and total shoot dry weight, over time in the controls and each treatment group.
287/1, str. 3–15.
percent reduction in yield
Fenech, M. in Morley, A. A. (1985).
final biomass minus starting biomass for the control group
43/172–173, str. 233–246.
final biomass minus starting biomass in the treatment group
Kirsch-Volders, M. idr.
Concentration-response curves relating mean percentage inhibition of the response variable (Ir, or Iy), calculated as shown above and the log concentration of the test chemical should be plotted.
35/3, str. 167–172.
Estimates of the ECx (e.g. EC50) should be based upon both average specific growth rate (ErCx) and yield (EyCx), each of which should in turn be based upon total shoot fresh weight, total shoot dry weight and total shoot length.
2/5, str. 1084–1104.
It is possible to use a weighted linear regression after having performed a linearising transformation of the response data, for instance into probit or logit or Weibull units (13), but non-linear regression procedures are preferred techniques that better handle unavoidable data irregularities and deviations from smooth distributions.
161/2, str. 193–198.
Approaching either zero or total inhibition such irregularities may be magnified by the transformation, interfering with the analysis (13).
13/1, str. 34–43.
Specific procedures for determination of ECx values from continuous data can be found in (14) (15) (16) (17).
Eastmond, D. A. in Pinkel, D. (1990).
The 95 % confidence limits for each estimate are determined and goodness of fit of the response data to the regression model should be assessed either graphically or statistically.
234/5, str. 9–20.
estimates and confidence limits may also be obtained using linear interpolation with bootstrapping (18), if available regression models/methods are unsuitable for the data.
6/4, str. 297–302.
The mean for each concentration is then compared with the control mean using an appropriate test method (e.g. Dunnett's, Williams'tests) (19) (20) (21) (22).
Farooqi, Z., Darroudi, F. in Natarajan, A. T. (1993).
It is necessary to assess whether the ANOVA assumption of normal distribution (ND) and variance homogeneity (VH) of variance holds.
8/4, str. 329–334.
This assessment should be performed by Shapiro-Wilks-test (ND) or Levene's test (VH).
Migliore, L. idr.
Failure to meet the assumption of ND and homogeneity of variances can sometimes be corrected by logarithmic transformation of the data.
319/3, str. 205–213.
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.
Norppa, H., Renzi, L. in Lindholm, C. (1993).
Additional guidance on determining the NOEC can be found in (16).
8/6, str. 519–525.
REPORTING
322/1, str. 9–20.
The test report includes the following details:
Marshall, R. R. idr.
scientific name and source.
372/2, str. 233–245.
duration and conditions of establishment phase;
Zijno, P. idr.
test procedure used (static, semi-static, pulsed);
Kirsch-Volders idr.
date of start of the test and its duration;
540/2, str. 153–163.
test medium, i.e. sediment and liquid nutrient medium;
607/1, str. 13–36.
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;
Clare, G. idr.
test concentrations (nominal and measured as appropriate) and number of replicates per concentration;
607/1, str. 37–60.
methods of preparation of stock and test solutions including the use of any solvents or dispersants;
Aardema, M. J. idr.
temperature during the test;
607/1, str. 61–87.
light source, irradiance (μE·m–2 s–1)
607/1, str. 88–124.
pH values of the test and control media as well as appearance of test media at test initiation and end;
Oliver, J. idr.
oxygen concentrations;
607/1, str. 125–152.
methods for determination of measurement variables, e.g., length, dry weight, fresh weight;
392/1–2, str. 187–208.
all deviations from this test method.
Miller, B. idr.
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;
392/1–2, str. 45–59.
means and standard deviations for each measurement variable;
410, str. 81–116.
doubling time/growth rate in the control based on shoot length and fresh weight including the coefficient of variation for yield of fresh weight;
Chemically induced micronucleus formation in V79 cells – comparison of three different test approaches.
calculated response variables for each treatment replicate, with mean values and coefficient of variation for replicates;
Mutation Research, zv.
graphical representation of the concentration/effect relationship;
439/2, str. 183–190.
estimates of toxic endpoints for response variables e.g. EC50, and associated confidence intervals.
Kersten, B. idr.
If calculated, LOEC and/or NOEC and the statistical methods used for their determination;
445/1, str. 55–71.
if ANOVA has been used, the size of the effect which can be detected (e.g. the minimum significant difference);
von der Hude, W. idr.
any stimulation of growth found in any treatment;
468/2, str. 137–163.
any visual signs of phytotoxicity as well as observations of test solutions;
517/1–2, str. 123–134.
discussion of the results, including any influence on the outcome of the test resulting from deviations from this test method.
14/6, str. 569–580.
Chapter C.26 of this Annex: Lemna sp.
Elhajouji, A. in Lorge, E. (2006).
Growth Inhibition Test.
607/1, str. 1–152.
Chapter C.3 of this Annex: Freshwater Alga and Cyanobacteria, Growth Inhibition Test.
702/2, str. 139–147.
ISO 16191:2013 Water quality — Determination of the toxic effect of sediment on the growth behaviour of Myriophyllum aquaticum.
Hashimoto, K. idr.
Chapter C.50 of this Annex: Sediment-free Myriophyllum spicatum Toxicity Test.
59/1, str. 28–36.
Chapter C.28 of this Annex: Sediment-Water Chironomid Toxicity Using Spiked Water.
Honma, M. in Hayashi, M. (2011).
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.
52/5, str. 373–384.
, Herbicide risk assessment for non-target aquatic plants: sulfosulfuron — a case study, Pest Management Science, Vol.
Zhang, L. S. idr.
59/2, pp. 231 - 237.
347/3–4, str. 105–115.
SMART AND BARKO MEDIUM COMPOSITION
Corvi, R. idr.
Amount of reagent added to water [1] (mg/l)
23/4, str. 271–283.
pH (air equilibrium)
ILSI paper (osnutek).
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.
Mutation Research, zv.
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.
257/2, str. 147–205.
1).
268/2, str. 297–305.
The US Interagency Coordinating Committee on the Validation of Alternative Methods.
8/6, str. 789–886.
The area of corneal opacity should be noted.
634/1–2, str. 177–183.
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
49, str. 439–452.
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.
147/1–2, str. 29–36.
Combinations less likely to occur.
51/3, str. 251–259.
For mean it is meant arithmetic mean throughout the document.
Le Hegarat, L. idr.
The numbers refer to statistically generated threshold values and are not related to the precision of the measurement.
25/6, str. 555–560.
A DPRA prediction should be considered in the framework of an IATA and in accordance with the provisions of paragraphs 9 and 12.
Josse, R. idr.
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.
27/3, str. 295–304.
1.
Kalweit, S. idr.
See Appendix 1 for definitions and units
17/3, str. 257–260.
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).
Knasmüller, S. idr.
The generator-column technique is occasionally used for the determination of log KOW.
198/1–3, str. 315–328.
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).
Gibson, D. P. idr.
For substances that might ionise, log KOW should refer to the unionised form.
392/1–2, str. 61–70.
See Appendix 1 for definitions and units
Bonassi, S. idr.
TLC: thin layer chromatography; HPLC: high pressure liquid chromatography; GC: gas chromatography
37/1, str. 31–45.
In some regulatory frameworks analysis of metabolites may be obligatory when certain conditions are met (cf. paragraph 65).
113/3–4, str. 173–215.
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.
4/1, str. 55–65.
For most test substances, there should ideally be no detections in the control water.
Elliott, B. M. idr.
Background concentrations should only be relevant to naturally occurring materials (e.g., some metals) and substances that are ubiquitous in the environment.
7, str. 175–177.
TOC includes organic carbon from particles and dissolved organic carbon, i.e. TOC = POC + DOC.
652/2, str. 122–130.
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.
285/1, str. 35–44.
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.
521/1–2, str. 103–112.
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.
655/1–2, str. 1–3.
This ensures that fish growth in all test groups is similar, if the tested concentration is below the toxic range.
Surralles, J. idr.
If the growth is similar, also the lipid content is expected to be similar.
341/3, str. 169–184.
A different growth in the control would indicate a substance effect and invalidate the study.
724, str. 86–87.
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.
723/2, str. 101–107.
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).
Morita, T., Honma, M. in Morikawa, K. (2012).
These percentages assume that the analytical methods are reliable and the half life is < 14 days.
741, str. 32–56.
If the analytical methods are less reliable or the half life is (greatly) increased these numbers will become larger.
54/1, str. 36–43.
CI confidence interval (where possible to estimate)
Sobol, Z. idr.
SD Standard deviation (where possible to estimate)
746/1, str. 29–34.
The minimised test may in fact be used to demonstrate rapid metabolism when it is known that rapid metabolism is likely.
120/4, str. 241–247.
When intermediate data points are also available confidence limits for BCFKm can be calculated as in the full test.
Bryce, S. M. idr.
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.
52/4, str. 280–286.
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.
Nicolette, J. idr.
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”.
52/5, str. 355–362.
This approach differs from “normalisation” to a set organism lipid content as is done in the aqueous exposure bioconcentration test.
Shi, J., Bezabhie, R. in Szkudlinska, A. (2010).
Total length should also be recorded during the test as it is a good indicator of whether an adverse effect has occurred.
25/1, str. 33–40.
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.
Fenech, M. idr.
7)
534/1–2, str. 65–75.
For rapid growth during the uptake phase the true feeding rate will decrease below that set at the beginning of exposure.
Elhajouji, A., Cunha, M. in Kirsch-Volders, M. (1998).
In an aqueous exposure study, a 14-day half-life would correspond to a BCF of ca.
13/2, str. 193–8.
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)).
85/8, str. 873–99.
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.
723/2, str. 87–90.
Equation A5.8 in Appendix 5).
Ryan, T. P. (2000).
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.
Hoffman, W.
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.
Stopnja ponovljivosti napovedi, ki jo je mogoče pričakovati pri preskusni metodi, je v enem laboratoriju 85-odstotna, v več laboratorijih pa 80-odstotna (10).
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.
Rezultati, pridobljeni z validacijsko študijo (18) in objavljenimi študijami (19), na splošno kažejo, da je točnost preskusa DPRA pri razlikovanju povzročiteljev preobčutljivosti (tj. kategorija 1 po GHS ZN/uredbi CLP) in snovi, ki niso povzročitelji preobčutljivosti, 80-odstotna (N = 157), pri čemer je občutljivost v primerjavi z rezultati pri preskusu LLNA 80-odstotna (88/109), specifičnost pa 77-odstotna (37/48).
A foodstuff analysis technique for protein, lipid, crude fibre and ash content; this information is usually available from the feed supplier.
Preskusna kemikalija mora biti topna v ustreznem topilu v končni koncentraciji 100 mM (glej odstavek 18).
CI confidence interval (where possible to estimate).
Za preskusne kemikalije, ki niso topne pri tej koncentraciji, pa se lahko še vedno preskusi, ali so topne pri nižjih koncentracijah.
SD Standard deviation (where possible to estimate).
V takem primeru je s pozitivnim rezultatom še vedno mogoče podpreti opredelitev, da je preskusna kemikalija povzročiteljica preobčutljivosti kože, iz negativnega rezultata pa ni mogoče izpeljati trdnega sklepa o pomanjkanju reaktivnosti.
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).
videz oborine v reakcijski zmesi ob koncu časa inkubacije, če je opažena ter navedba o tem, ali se je oborina ponovno raztopila ali centrifugirala;
If other daphnid are used they should be clearly identified and their use justified.
Združeni narodi (ZN) (2013).
Accidental mortality: non chemical related mortality caused by an accidental incidence (i.e. known cause)
OECD (2012).
Inadvertent mortality: non chemical related mortality with no known cause
Adler idr.
The test solution is determined by titration with the standard base or acid solution as appropriate, measuring the pH after each addition of titrant.
Gerberick idr.
At least 10 incremental additions should be made before the equivalence point.
Jaworska idr.
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.
Bauch idr.
Precautions must be taken to exclude CO2.
Nukada idr.
Albert, A. & Sergeant, E.P.: Ionization Constants of Acids and Bases, Wiley, Inc., New York, 1962.
Gerberick idr.
Nelson, N.H.
Landsteiner in Jacobs.
& Faust, S.D.: Acidic dissociation constants of selected aquatic herbicides, Env.
Dupuis in Benezra.
Tech.
Direct Peptide Reactivity Assay (DPRA) Validation Study Report, str. 74.
3, II, pp. 1186-1188 (1969).
Natsch idr.
ASTM D 1293 — Annual ASTM Standards, Philadelphia, 1974.
DB-ALM (INVITTOX) Protocol 154: Direct Peptide Reactivity assay (DPRA) for skin sensitisation testing, str. 17.
Standard Method 242.
OECD (2005).
Clark, J. & Cunliffe, A.E.: Rapid spectrophotometric measurement of ionisation constants in aqueous solution.
FDA (Food and Drug Administration) (2001).
ASTM D 1125 — Annual ASTM Standards, Philadelphia, 1974.
ECETOC (2003).
Handbook of Chemistry and Physics, 60th ed.
90–100
source, housing conditions, diet, etc.
15–45
Anaesthetics and analgesics
60–80
Barratt, M.D., et al.
10–55
de Silva, O., et al.
30–60
Worth A.P. and Fentem J.H.
0–24
Young, J.R., et al.
80–100
Neun, D.J.
0–7
Fentem, J.H., et al.
15–55
OECD (2000), Guidance Document on the Recognition, Assessment and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation.
0–25
Wright EM, Marcella KL, Woodson JF.
60–100