natgillin/translations-raw huggingface dataset:
Every test should include controls consisting of the same nutrient medium, test organism (choosing plant material as homogeneous as possible, fresh lateral branches from pre-cultures, shortened to 2,5 cm from base), environmental conditions and procedures as the test vessels but without the test chemical.
Miller, B.M. et al.
If an auxiliary solvent or dispersant is used, an additional control treatment with the solvent/dispersant present at the same concentration as that in the vessels with the test chemical should be included.
(1991), „Classification of micronuclei in murine erythrocytes: immunofluorescent staining using CREST antibodies compared to in situ hybridization with biotinylated gamma satellite DNA“, Mutagenesis, Vol.
The number of replicate control vessels (and solvent vessels, if applicable) should be at least ten.
6/4, pp.
If determination of NOEC is not required, the test design may be altered to increase the number of concentrations and reduce the number of replicates per concentration.
297–302.
However, in any case the number of control replicates should be at least ten.
Russo, A. (2002), „PRINS tandem labeling of satellite DNA in the study of chromosome damage“, American Journal of Medical Genetics, Vol.
Exposure
107/2, pp. 99–104.
Fresh lateral branches from pre-culture shortened to 2,5 cm from base are assigned randomly to the test vessels under aseptic conditions; each test vessel should contain one 2,5 cm lateral branch that should have an apical meristem on one end.
McFadden (1995), „Sample size for the estimation of polychromatic to normochromatic erythrocyte ratio in the bone marrow micronucleus test“, Mutation Research, Vol.
The chosen plant material should be the same quality in each test vessel.
347/2, pp. 97–99.
A randomised design for location of the test vessels in the incubator is required to minimise the influence of spatial differences in light intensity or temperature.
49–52.
A blocked design or random repositioning of the vessels (or repositioning more frequently) when observations are made is also required.
Kim (2000), „Statistical analysis of in vivo rodent micronucleus assay“, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.
If a preliminary stability test shows that the test chemical concentration cannot be maintained (i.e. the measured concentration falls below 80 % of the measured initial concentration) over the test duration (14 days), a semi-static test regime is recommended.
469/2, pp. 233–241.
In this case, the plants should be exposed to freshly prepared test and control solutions on at least one occasion during the test (e.g. day 7).
Viimast kasutati Euroopa Ühenduse rahastatud eelvalideerimisuuringus aastatel 1997–1998.
The frequency of exposure to fresh medium will depend on the stability of the test chemical; a higher frequency may be needed to maintain near-constant concentrations of highly unstable or volatile chemicals.
IVIS = keskmine hägususe väärtus + (15 × keskmine läbilaskvuse OD490 väärtus)
The exposure scenario through a foliar application (spray) is not covered in this test method.
Test Method Evaluation Report – In Vitro Ocular Toxicity Test Methods for Identifying Ocular Severe Irritants and Corrosives.
Warm and/or cool white fluorescent lighting should be used to provide light irradiance in the range of about of 100-150 μE m–2 s–1 when measured as a photosynthetically active radiation (400-700 nm) at points the same distance from the light source as the bottom of the test vessels (equivalent ca. 6000 to 9000 lux) and using a light-dark cycle of 16:8 h.
Scott, L., Eskes, C., Hoffmann, S., Adriaens, E., Alépée, N., Bufo, M., Clothier, R., Facchini, D., Faller, C., Guest, R., Harbell, J., Hartung, T., Kamp, H., Le Varlet, B., Meloni, M., McNamee, P., Osborne, R., Pape, W., Pfannenbecker, U., Prinsen, M., Seaman, C., Spielman, H., Stokes, W., Trouba, K., Van den Berghe, C., Van Goethem, F., Vassallo, M., Vinardell, P. and Zuang, V. (2010).
The method of light detection and measurement, in particular the type of sensor, will affect the measured value.
In: „Test Method Evaluation Report – In Vitro Ocular Toxicity Test Methods for Identifying Ocular Severe Irritants and Corrosives“.
Spherical sensors (which respond to light from all angles above and below the plane of measurement) and “cosine” sensors (which respond to light from all angles above the plane of measurement) are preferred to unidirectional sensors, and will give higher readings for a multi-point light source of the type described here.
In: „Current Validation Status of In Vitro Test Methods Proposed for Identifying Eye Injury Hazard Potential of Chemicals and Products“.
The temperature in the test vessels should be 23 ± 2 °C.
„Protocol 124: Bovine Corneal Opacity and Permeability Assay – SOP of Microbiological Associates Ltd.“ Ispra, Italy: European Centre for the Validation of Alternative Methods (ECVAM).
Additional care is needed on pH drift in special cases such as when testing unstable chemicals or metals; the pH should remain in a range of 6-9.
Siegel, J.D., Rhinehart, E., Jackson, M., Chiarello, L. and the Healthcare Infection Control Practices Advisory Committee (2007).
See (5) for further guidance.
Collee, J. and Bradley, R. (1997). „BSE: A decade on – Part I“.
The test is terminated 14 days after the plants are transferred into the test vessels.
The Lancet 349: 636–641.
Measurements and analytical determinations
Sina, J.F., Galer, D.M., Sussman, R.S., Gautheron, P.D., Sargent, E.V., Leong, B., Shah, P.V., Curren, R.D. and Miller, K. (1995).
At the start of the test, the main shoot length of test organism is 2,5 cm (see paragraph 29); it is measured with a ruler (see Appendix 4) or by photography and image analysis.
sarvkest on täielikult hägune; vikerkesta ei ole näha
The main shoot length of test organism appearing normal or abnormal needs to be determined at the beginning of the test, at least once during the 14-day exposure period and at test termination.
> 5 kuni 12 II > 12 kuni 18 (> 75 minutit pärast töötlemist) II > 12 kuni 18 (≤ 75 minutit pärast töötlemist) III > 18 kuni 26 III > 26 kuni 32 (> 75 minutit pärast töötlemist) III > 26 kuni 32 (≤ 75 minutit pärast töötlemist) IV > 32 IV Tabel 4
Note: As an alternative for those who do not have image analysis, if the workbench is sterilised prior to addition of plants to test vessels, a sterile ruler can also be used to measure the length of the main shoot at test initiation and during the test.
0,5 üksikud rakud on väga nõrgalt värvunud 1 üksikuid värvunud rakke on hajusalt kogu töödeldud sarvkesta alal
Changes in plant development, e.g. in deformation in the shoots, appearance, indication of necrosis, chlorosis, break-up or loss of buoyancy and in root length and appearance, should be noted.
0,6 kuni 1,5 II 1,6 kuni 2,5 III 2,6 kuni 4,0 IV Tabel 5
Significant features of the test medium (e.g. presence of undissolved material, growth of algae, fungi and bacteria in the test vessel) should also be noted.
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.
In addition to determinations of main shoot length during the test, effects of the test chemical on three (or more) of the following measurement variables should be also assessed:
Maurer, J.K., Parker, R.D. and Jester, J.V.
Total lateral branches length
ICE-katses objektiivselt mõõdetav suurus, millega väljendatakse pärast sarvkesta kokkupuudet uuritava kemikaaliga tekkinud tursumuse ulatust.
Total shoot length
see on aine, näiteks detergent, mis võib vähendada vedeliku pindpinevust ja võimaldab sellel vahutada või tungida tahketesse ainetesse; sama mis märgav aine.
Total root length
Täpsus
Fresh weight
kõikide negatiivsete kemikaalide osakaal, mis on katsemeetodiga ekslikult määratud positiivseks.
Dry weight
katsemeetod, mille valideerimisuuringud on lõpule viidud, st on määratud selle asjakohasus (sealhulgas täpsus) ja usaldusväärsus konkreetse eesmärgi suhtes.
Number of whorls
Negatiivse tulemuse kohta järelduse tegemiseks võib vaja minna põhjalikku hindamist, milleks tuleb läbi viia katsed kõigis kolmes eri katsetingimustega olukorras: kasutades lühiajalist töötlust kemikaaliga metaboolse aktivatsiooniga ja ilma selleta ning pikaajalist töötlust kemikaaliga ilma metaboolse aktivatsioonita (vt punktid 56–58).
Note 1:
Kui kasutatakse automatiseeritud hindamist, näiteks läbivoolutsütomeetriat, laserskaneerivat tsütomeetriat või pildianalüüsi, tuleb kasutada asjakohaseid meetodeid süstemaatilise hälbe või triivi ohjamiseks.
The observations made during the range-finding test could help in selecting relevant additional measurements among the six variables listed above.
Sõltumata sellest, kas mikrotuumade loendamiseks kasutatakse automaatsüsteemi, tuleb samaaegselt hinnata selliseid näitajaid nagu CBPI, RI, RPD või RICC.
Note 2:
3–15.
The determination of the fresh and dry weights (parameters iv and v) is highly desirable.
233–246.
Note 3:
167–172.
Due to the fact that sucrose and light (exposure of roots to light during the test) may have an influence on auxin (plant growth hormone) transport carriers, and that some chemicals may have an auxin-type mode of action, the inclusion of root endpoints (parameter iii) is questionable.
1084–1104.
Note 4:
193–198.
The ring test results show high coefficients of variation (> 60 %) for the total lateral branch length (parameter i).
34–43.
Total lateral branch length is in any case encompassed within the total shoot length measurement (parameter ii) which shows more acceptable coefficients of variation of < 30 %.
9–20.
Note 5:
297–302.
Resulting from the above considerations, the recommended main measurement endpoints are: total shoot length, fresh weight and dry weight (parameters ii, iv and v); parameter vi — number of whorls — is left to the experimenter's judgment.
329–334.
Main shoot length and number of whorls have an advantage, in that they can be determined for each test and control vessel at the start, during, and at the end of the test by photography and image analysis, although a (sterile) ruler can also be used.
205–213.
Total lateral branches length, total root length (as a sum of all lateral branches or roots) and total shoot length (as a sum of main shoot length and total lateral branches length) can be measured with a ruler at the end of exposure.
519–525.
The fresh and/or dry weight should be determined at the start of the test from a sample of the pre-culture representative of what is used to begin the test, and at the end of the test with the plant material from each test and control vessel.
9–20.
Total lateral branches length, total shoot length, total root length, fresh weight, dry weight and number of whorls may be determined as follows:
233–245.
The lateral branch length may be determined by measuring all lateral branches with a ruler at the end of exposure.
153–163.
The total lateral branches length is the sum of all lateral branches of each test and control vessel.
13–36.
The main shoot length may be determined by image analysis or using a ruler.
37-60.
The total shoot length is the sum of the total lateral branches length and the main shoot length of each test and control vessel at the end of exposure.
61–87.
The root length may be determined by measuring all roots with a ruler at the end of exposure.
88–124.
The total root length is the sum of all roots of each test and control vessel.
125–152.
The fresh weight may be determined by weighing the test organisms at the end of exposure.
187–208.
All plant material of each test and control vessel will be rinsed with distilled water, dabbed dry with cellulose paper.
45–59.
After this preparation the fresh weight will be determined by weighing.
81–116.
The starting biomass (fresh weight) is determined on the basis of a sample of test organisms taken from the same batch used to inoculate the test vessels.
183–190.
After the preparations for the determination of the fresh weight the test organisms will be dried at 60 °C to a constant weight.
55–71.
This mass is the dry weight.
137–163.
The starting biomass (dry weight) is determined on the basis of a sample of test organisms taken from the same batch used to inoculate the test vessels.
123–134.
All whorls will be counted out along the main shoot.
569–580.
Frequency of measurement and analytical determinations
139–147.
If a static test design is used, the pH of each treatment should be measured at the beginning and at the end of the test.
28–36.
If there is evidence that the test concentration has been satisfactorily maintained within ± 20 % of the nominal or measured initial concentration throughout the test, analysis of the results can be based on nominal or measured initial values.
825–840.
If the deviation from the nominal or measured initial concentration is not within ± 20 %, 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 (5).
Environmental and Molecular Mutagenesis, 51/3, pp. 251–259.
Under some circumstances, e.g. when a preliminary test indicates that the test chemical has no toxic effects at concentrations up to 100 mg/l or up to its limit of solubility in the test medium or in case of a formulation up to its limit of dispersibility, a limit test involving a comparison of responses in a control group and one treatment group (100 mg/l or a concentration equal to the limit of solubility), may be undertaken.
555–560.
It is strongly recommended that this is supported by analysis of the exposure concentration.
295–304.
All previously described test conditions and validity criteria apply to a limit test, with the exception that the number of treatment replicates should be doubled.
257–260.
Response variables
61–70.
The purpose of the test is to determine the effects of a test chemical on the vegetative growth of Myriophyllum spicatum.
31–45.
This test method describes two response variables.
173–215.
Average specific growth rate
55–65.
This response variable is calculated on the basis of changes in the logarithms of main shoot length, and in addition, on the basis of changes in the logarithms of other measurement parameters, i.e. total shoot length, fresh weight, dry weight or number of whorls over time (expressed per day) in the controls and each treatment group.
175–177.
At the beginning of the test, the test organism has no lateral branches and no roots (based on the preparation from the pre-culture); starting from the value zero, the calculation of the average specific growth rate is not defined.
225–8.
Yield
795–801.
This response variable is calculated on the basis of changes in main shoot length, and in addition, on the basis of changes in other measurement parameters — i.e. preferably total shoot length, fresh weight, dry weight or number of whorls, and other parameters if deemed useful — in the controls and in each treatment group until the end of the test.
122–130.
Toxicity estimates should be based on main shoot length and three additional measurement variables (i.e. preferably total shoot length, fresh weight, dry weight or number of whorls, see paragraph 37 and Notes 2, 4 and 5 to this paragraph), because some chemicals may affect other measurement variables much more than the main shoot length.
35–44.
This effect would not be detected by calculating main shoot length only.
103–112.
The average specific growth rate for a specific period is calculated as the logarithmic increase in the growth variables — main shoot length and three additional measurement variables (i.e. total shoot length, fresh weight, dry weight or number of whorls) — using the formula below for each replicate of control and treatments:
169–184.
average specific growth rate from time i to j
86–87.
measurement variable in the test or control vessel at time i
101–107.
measurement variable in the test or control vessel at time j
32–56.
t time period from i to j
Brookmire, L., J.J.
For each treatment group and control group, calculate a mean value for growth rate along with variance estimates.
36–43.
The average specific growth rate should be calculated for the entire test period (time “i” in the above formula is the beginning of the test and time “j” is the end of the test).
29–34.
For each test concentration and control, calculate a mean value for average specific growth rate along with the variance estimates.
241–247.
In addition, the section-by-section growth rate should be assessed in order to evaluate effects of the test chemical occurring during the exposure period (e.g. by inspecting log-transformed growth curves).
269–275.
Percent inhibition of growth rate (Ir) may then be calculated for each test concentration (treatment group) according to the following formula:
280–286.
% Ir percent inhibition in average specific growth rate
355–362.
μC mean value for μ in the control
33–40.
μT mean value for μ in the treatment group
65–75.
Effects on yield are determined on the basis of the measurement variable main shoot length and three additional measurement variables (i.e. preferably total shoot length, fresh weight, dry weight or number of whorls) present in each test vessel at the start and at the end of the test.
193–8.
For fresh weight or dry weight, the starting biomass is determined on the basis of a sample of test organisms taken from the same batch used to inoculate the test vessels.
873–99.
For each test concentration and control, calculate a mean value for yield along with variance estimates.
87–90.
The mean percent inhibition in yield ( % Iy) may be calculated for each treatment group as follows:
USFDA, „International Conference on Harmonisation (ICH) Guidance S2 (R1) on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended For Human Use“.
% Iy percent reduction in yield
ning:
bC final biomass minus starting biomass for the control group
Prognooside korratavuse tase, mida võib selle katsemeetodi puhul eeldada, on ligikaudu 85 % laborisisese ja 80 % laboritevahelise korratavuse puhul (10).
bT final biomass minus starting biomass in the treatment group
Sellest valideerimisuuringust saadud (18) ja kõigist avaldatud uuringute tulemustest kokku (19) nähtub, et LLNA tulemustega võrreldes on DPRA puhul sensibilisaatorite (st ÜRO GHSi /CLP-määruse 1. kategooria kemikaalide) mittesensibiliseerivatest kemikaalidest eristamise täpsus 80 % (N = 157), tundlikkus 80 % (88/109-st) ja spetsiifilisus 77 % (37/48-st).
Doubling time
Uuritav kemikaal peab olema lahustuv asjakohases lahustis lõppkontsentratsioonini 100 mM (vt punkt 18).
To determine the doubling time (Td) of main shoot length and adherence to this validity criterion (see paragraph 8), the following formula is used with data obtained from the control vessels:
Uuritavaid kemikaale, mis ei ole sellel kontsentratsioonil lahustuvad, võib siiski uurida väiksemal kontsentratsioonil, millel kemikaal lahustub.
Td = ln 2/μ
Sel juhul võib positiivset tulemust siiski kasutada, et määrata uuritav kemikaal naha sensibilisaatoriks, kuid negatiivse tulemuse korral ei saa teha kindlaid järeldusi reaktsioonivõime puudumise kohta.
Where μ is the average specific growth rate determined as described in paragraphs 50-52.
sademe tekkimine reaktsioonisegus inkubeerimisaja lõpus, kui täheldatakse; kas sade lahustati uuesti või tsentrifuugiti;
Plotting concentration-response curves
„DB-ALM (INVITTOX) Protocol 154: Direct Peptide Reactivity assay (DPRA) for skin sensitisation testing“, 17 pp.
Concentration-response curves relating mean percentage inhibition of the response variable (Ir, or Iy calculated as shown in paragraph 53) and the log concentration of the test chemical should be plotted.
90–100
ECx estimation
15–45
Estimates of the ECx should be based upon both average specific growth rate (ErCx) and yield (EyCx), each of which should in turn be based upon main shoot length, and possibly additional measurement variables (i.e. preferably total shoot length, fresh weight, dry weight or number of whorls).
60–80
This is because there are chemicals that impact main shoot length and other measurement variables differently.
10–55
The desired toxicity parameters are therefore four ECx values for each inhibition level x calculated: ErCx (main shoot length); ErCx (i.e. preferably total shoot length, fresh weight, dry weight, or number of whorls); EyCx (main shoot length); and EyCx (i.e. preferably total shoot length, fresh weight, dry weight or number of whorls).
0-5,5 6-metüülkumariin 92-48-8 Tahke Sensibiliseeriva toimeta Negatiivne
It should be noted that ECx values calculated using these two response variables are not comparable and this difference is recognised when using the results of the test.
0–7 0-5,5 Piimhape 50-21-5 Vedelik Sensibiliseeriva toimeta Negatiivne 0–7 0–5,5 4-metoksüatsetofenoon 100-06-1 Tahke Sensibiliseeriva toimeta Negatiivne 0–7 0–5,5
ECx values based upon average specific growth rate (ErCx) will in most cases be higher than results based upon yield (EyCx) — if the test conditions of this test method are adhered to — due to the mathematical basis of the respective approaches.
Toxicol., 18, 1779–1791.
This difference should not be interpreted as a difference in sensitivity between the two response variables, simply the values are different mathematically.
1(1), 45–49.
Statistical procedures
Toxicol. in Vitro 25, 733–744.
The aim is to obtain a quantitative concentration-response relationship by regression analysis.
EC EURL-ECVAM (2014), „Recommendation on the KeratinoSensTM assay for skin sensitisation testing“, 42 pp.
It is possible to use a weighted linear regression after having performed a linearising transformation of the response data, for instance with probit or logit or Weibull models (7), but non-linear regression procedures are preferred techniques that better handle unavoidable data irregularities and deviations from smooth distributions.
107, 106–121.
Approaching either zero or total inhibition such irregularities may be magnified by the transformation, interfering with the analysis (7).
60, 389–400.
It should be noted that standard methods of analysis using probit, logit, or Weibull transforms are intended for use on quantal (e.g. mortality or survival) data, and should be modified to accommodate growth rate or yield data.
63, 489–504.
Specific procedures for determination of ECx values from continuous data can be found in (8) (9) (10).
33, 1353–1364.
For each response variable to be analysed, use the concentration-response relationship to calculate point estimates of ECx values.
87, 1683–1969.
When possible, the 95 % confidence limits for each estimate should be determined.
Assoc., 126, 1813–1822.
Goodness of fit of the response data to the regression model should be assessed either graphically or statistically.
150, 301–316.
Regression analysis should be performed using individual replicate responses, not treatment group means.
Technical Working Group on Pesticides – (Quantitative) Structure Activity Relationship ((Q)SAR) Guidance Document.
estimates and confidence limits may also be obtained using linear interpolation with bootstrapping (10), if available regression models/methods are unsuitable for the data.
Keap1
For estimation of the LOEC and hence the NOEC, it is necessary to compare treatment means using analysis of variance (ANOVA) techniques.
Uuritavad kemikaalid tuleb valmistada kaltsiumit (kontsentratsioonis 1,0–1,8 mM) sisaldavas fenoolpunaseta HBSSi söötmes, et vältida seerumi valkude seondumist.
The mean for each concentration is then compared with the control mean using an appropriate multiple comparison or trend test method.
EC-ECVAM (2009), „Statement on the scientific validity of cytotoxicity/cell-function based in vitro assays for eye irritation testing“.
Dunnett's or Williams'test may be useful (12) (13) (14) (15) (16).
EC-ECVAM (1999), „INVITOX Protocol 71: Fluorescein Leakage Test“, Ispra, Italy: European Centre for the Validation of Alternative Methods (ECVAM).
It is necessary to assess whether the ANOVA assumption of homogeneity of variance holds.
EC-ECVAM (2008), „Fluorescein Leakage Assay Background Review Document as an Alternative Method for Eye Irritation Testing“.