natgillin/translations-raw huggingface dataset:
EPA (1996), Label Review Manual: 2nd Edition, EPA737-B-96-001, Washington DC: U.S. Environmental Protection Agency.
(3) Worth, A. P. in Fentem, J. H. (1999).
EC-ECVAM (2009), Statement on the scientific validity of cytotoxicity/cell-function based in vitro assays for eye irritation testing.
A General Approach for Evaluating Stepwise Testing Strategies.
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ATLA 27, str. 161–177.
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(4) Poglavje B.4 te priloge: Akutna toksičnost: dermalna dražilnost/jedkost.
EC-ECVAM (1999), INVITOX Protocol 71: Fluorescein Leakage Test, Ispra, Italy: European Centre for the Validation of Alternative Methods (ECVAM).
(5) Young, J. R., How, M. J., Walker, A. P. in Worth, W. M. H. (1988).
Ocular corrosive (a) A chemical that causes irreversible tissue damage to the eye.
Toxicol.
A chemical that produces a reversible change in the eye following application to the anterior surface of the eye; (b) Chemicals that are classified as UN GHS Categories 2A, or 2B; EU CLP Category 2; or U.S.
(6) Fentem, J. H., Archer, G. E. B., Balls, M., Botham, P. A., Curren, R. D., Earl, L. K., Edsail, D. J., Holzhutter, H. G. in Liebsch, M. (1998).
EPA Categories II or III ocular irritants.
The ECVAM international validation study on in vitro tests for skin corrosivity.
EPA Category I ocular irritants.
2.
A replicate containing all components of a test system and treated with a chemical known to induce a positive response.
Evaluation of the ability of a battery of three in vitro genotoxicity tests to discriminate rodent carcinogens and non-carcinogens.
Proficiency Chemicals A sub-set of the list of Reference Chemicals that can be used by a naïve laboratory to demonstrate proficiency with the validated reference test method.
Analysis of Data from In Vitro Cytogenetic Assays.
Relevance incorporates consideration of the accuracy (concordance) of a test method (8).
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Reliability
The Draize Eye Test and in vitro alternatives; a left-handed marriage?
An untreated sample containing all components of a test system, including the solvent or vehicle that is processed with the test chemical-treated and other control samples to establish the baseline response for the samples treated with the test chemical dissolved in the same solvent or vehicle.
Assessment of the genotoxic potential of indirect chemical mutagens in HepaRG cellsby the comet and the cytokinesis-block micronucleus assays.
When tested with a concurrent negative control, this sample also demonstrates whether the solvent or vehicle interacts with the test system.
Mutagenesis, zv.
The proportion of all negative/inactive chemicals that are correctly classified by the test.
Fourth International Workgroup on Genotoxicity testing: results of the in vivo Comet assay workgroup, Mutation Research/Genetic Toxicology and Environmental Mutagenesis, zv.
It is a measure of accuracy for a test method that produces categorical results and is an important consideration in assessing the relevance of a test method.
John Wiley & Sons Ltd, New York, NY, ZDA: 243-255.
Substance
American Society for Testing and Materials, Philadelphia, PA, ZDA: 304-315.
Used in the context of the UN GHS as chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the product and any impurities deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
Lewis Publishers, Boca Racton, FL, ZDA: 189-231.
Test chemical Any substance or mixture tested using this test method.
Standard Guide for Conducting Acute Toxicity Tests with Fishes, Macroinvertebrates, and Amphibians.
Tiered testing strategy
V: Annual Book of ASTM Standards; Water and Environmental Technology, zv.
If the irritancy potential of a test chemical cannot be assigned based on the existing information, a step-wise sequential animal testing procedure is performed until an unequivocal classification can be made.
Organizacija za gospodarsko sodelovanje in razvoj, Pariz.
Validated test method
Environment Canada (2005).
A test method for which validation studies have been completed to determine the relevance (including accuracy) and reliability for a specific purpose.
Guidance Document on Statistical Methods for Environmental Toxicity Tests, Report EPS 1/RM/46.
It is important to note that a validated test method may not have sufficient performance in terms of accuracy and reliability to be found acceptable for the proposed purpose (8).
Poursat, E. Jolivet (2003).
Data from other tissues e.g. stomach/duodenum/jejunum, blood etc. could be collected at the same time.
Statistical Tools for Nonlinear Regression: A Practical Guide with S-PLUS and R Examples.
The laboratory needs to demonstrate proficiency with each individual tissue in each species they are planning to study, and will need to demonstrate that an acceptable positive response with a known mutagen (e.g. EMS) can be obtained in that tissue.
Contemp Clin Trials, november 2008, št. 29(6): 878–886.
Animals should be given daily treatments over a duration of 2 or more days (i.e. two or more treatments at approximately 24 hour intervals), and samples should be collected once at 2-6 h (or at the Tmax) after the last treatment (12).
Morgan, B. J. T. (1992).
Samples from extended dose regimens (e.g. 28-day daily dosing) are acceptable.
15. december 2007.
However careful consideration should be given to the logistics involved in tissue sampling for comet analysis alongside the requirements of tissue sampling for other types of toxicological assessments.
Vitellogenesis as a biomarker for estrogenic contamination of the aquatic environment.
Harvest 24 hours after the last dose, which is typical of a general toxicity study, is not appropriate in most cases (see paragraph 40 on sampling time).
Environmental Health Perspectives, zv.
For each sample (per tissue per animal), at least 150 cells (excluding hedgehogs — see paragraph 56) should be analysed.
Successful detection of (anti-)androgenic and aromatase inhibitors in pre-spawning adult fathead minnows (Pimephales promelas) using easily measured endpoints of sexual development.
Scoring 150 cells per animal in at least 5 animals per dose (less in the concurrent positive control — see paragraph 29) provides adequate statistical power according to the analysis of Smith et al., 2008 (5).
Aquatic Toxicology, zv.
Changes in clinical chemistry measures (e.g. AST, ALT), can also provide useful information on tissue damage and additional indicators such as caspase activation, TUNEL stain, Annexin V stain, etc. may also be considered.
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However, there are limited published data where the latter have been used for in vivo studies and some may be less reliable than others.
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This alternative test allows the dietary exposure pathway to be directly investigated under controlled laboratory conditions.
Statistical Analysis of Fish Chronic Toxicity Test Data, Proceedings of 4th Aquatic Toxicology Symposium.
This method allows the determination of the substance-specific half-life (t1/2, from the depuration rate constant, k2), the assimilation efficiency (absorption across the gut; a), the kinetic dietary biomagnification factor (BMFK), the growth-corrected kinetic dietary biomagnification factor (BMFKg), and the lipid-corrected [45] kinetic dietary biomagnification factor (BMF KL) (and/or the growth- and lipid-corrected kinetic dietary biomagnification factor, BMFKgL) for the test substance in fish.
ASTM, Philadelphia.
As for the aqueous exposure method, increase in fish mass during the test will result in dilution of test substance in growing fish and thus the (kinetic) BMF will be underestimated if not corrected for growth (cf .paragraphs 162 and 163).
New tables for multiple comparisons with a control.
In addition, if it is estimated that steady-state was reached in the uptake phase an indicative steady-state BMF can be calculated.
Fung, K. Y., D. Krewski, J. N. K. Rao, A. J. Scott (1994).
Approaches are available that make it feasible to estimate a kinetic bioconcentration factor (BCFK) from data generated in the dietary study (e.g. (44) (45) (46) (47) (48).
Tests for Trend in Developmental Toxicity Experiments with Correlated Binary Data.
Pros and cons of such approaches are discussed in Appendix 8.
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The test was designed primarily for poorly soluble non-polar organic substances that follow approximately first order uptake and depuration kinetics in fish.
Fung, K. Y., D. Krewski, R. T. Smythe (1996).
For the periodic use of a reference substance (cf. paragraph 25), it is preferable that concentrations are measured in the test group at the end of uptake and at all depuration times specified for the test substance (whole fish); concentrations need only be analysed in the control group at end of uptake (whole fish).
A comparison of tests for trend with historical controls in carcinogen bioassay.
In certain circumstances (for example if analysis techniques for test substance and reference substance are incompatible, such that additional fish would be needed to follow the sampling schedule) another approach may be used as follows to minimise the number of additional fish required.
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Concentrations of the reference substance are measured during depuration only on days 1, 3 and two further sampling points, selected such that reliable estimations of time zero concentration (C0,d) and k2 can be made for the reference substance.
Analysis of Quantal Response Data.
If possible the lipid content of the individual fish should be determined on each sampling occasion, or at least at the start and end of the uptake phase and at the end of the depuration phase.
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Phase 2: Testing Negative Substances.
First order rate constant for uptake into fish (l·kg– 1·day– 1). k2
strukturna poškodba kromosoma, izražena kot prelom posameznih kromatid ali prelom in združitev med kromatidama.
First order rate constant for faecal egestion (day– 1) Cw
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Cw-SS
EGDMA 1,95
However, sections 5, 6 and 8 are only relevant for the aqueous exposure method but are included here as they are “general” techniques.
EGDMA 31,25