natgillin/translations-raw huggingface dataset:
The sequential (sections 4 and 5) and simultaneous (section 6) methods allow the calculation of uptake and depuration constants which are used to derive kinetic BCFs.
EGDMA 62,5
[Equation A5.17]
EGDMA 500
When k1/k2 is substituted by BCF (cf.
Environmental Health and Safety Monograph Series on Testing and Assessment št. 54.
Equation A5.4) in Equation A5.25 and Equation A5.26, the standard error and 95 % CI of the BCF can be estimated as well.
OECD Series on Testing and Assessment, št. 88.
This is especially useful when comparing different estimates due to data transformation.
Vendar in vitro preskus mikronukleusov, kot je opisan v tej preskusni metodi, ne omogoča razlikovanja med kemikalijami, ki povzročajo spremembe števila kromosomov in/ali ploidijo, in tistimi, ki povzročajo klastogenost, brez posebnih tehnik, kot je fluorescenčna hibridizacija in situ (FISH), omenjena v odstavku 4.
The dependent variable (fish concentration) can be fitted with or without ln transformation, and the resulting BCF uncertainty can be evaluated.
Celice, ki imajo več kot dve glavni jedri, se ne analizirajo glede mikronukleusov, saj je lahko izhodiščna pogostost mikronukleusov v teh celicah večja (84).
One of the most common complications is fish growth during the test.
Evaluation of the Highest Concentrations Used in the in vitro Chromosome Aberrations Assay.
In such cases an alternative approach (i.e. mass approach), which also works when first order growth kinetics have not been obeyed, can be used which avoids the need for the correction.
8,0 ± 4,0 [3]
This approach is outlined at the end of this section.
4,0 ± 1,0
The uptake rate constant is divided by the growth-corrected depuration rate constant to give the growth-corrected kinetic BCF, denoted BCFKg (or BMFKg).
Prvo vzorčenje (1 v preglednici) je treba izvesti malo pred prvim hranjenjem (npr. eno uro).
[Equation A5.28]
NIH št. publikacije: 10-7553.
The growth rate constant derived for a dietary study is used in Equation A7.5 to calculate the growth corrected BMFKg (cf.
Regresijski Cochran- Armitageev test ali test po Jonckheerju ali Willamsov test po arkus sinus-korenski pretvorbi
Appendix 7).
Statistical Methods for Quality Improvement, druga izdaja, John Wiley and Sons, New York.
Mass based method for growth correction
The detection and assessment of the aneugenic potential of environmental chemicals: the European Community aneuploidy project.
An alternative to the above “growth rate constant subtraction method” that avoids the need to correct for growth can be used as follows.
Mutation Research, zv.
The principle is to use depuration data on a mass basis per whole fish rather than on a concentration basis.
Peta izdaja.
Convert depuration phase tissue concentrations (mass of test substance/unit mass of fish) into mass of test substance/fish: match concentrations and individual fish weights in tabular form (e.g. using a computer spreadsheet) and multiply each concentration by the total fish weight for that measurement to give a set of mass test substance/fish for all depuration phase samples.
Köbenhavn, 1988.
For the aqueous exposure method, derive the uptake rate constant routinely (see sections 4 and 6) note that the “normal” k2 value should be used in the curve fitting equations for k1) and derive the depuration rate constant from the above data.
Tatarazako, N., Oda, S., Abe, R., Morita, M. in Iguchi T., 2004.
Because the resulting value for the depuration rate constant is independent of growth as it has been derived on a mass basis per whole fish, it should be denoted as k2g and not k2.
Classification as Corrosive or Irritant to Skin of Preparations Containing Acidic or Alkaline Substance Without Testing on Animals, Toxicol.
LIPID NORMALISATION TO 5 % LIPID CONTENT (AQUEOUS EXPOSURE METHOD ONLY)
http://echa.europa.eu/documents/10162/13632/information_requirements_r7a_en.pdf.
Branson D.R., Blau G.E., Alexander H.C. and Neely W.B.
Dose setting in in vivo mutagenicity assays, Mutagenesis, zv.
Hawker D.W. and Connell D.W.
Burton, A. B. G., York, M. in Lawrence, R.S.
Konemann H. and van Leeuwen K. (1980), Toxicokinetics in fish: Accumulation and elimination of six chlorobenzenes by guppies.
Mutation Research, zv.
t duration of the feeding period (day)
in vitro micronucleus screening of pharmaceutical candidates by flow cytometry in Chinese hamster V79 cells.
Hendriks A.J., van der Linde A., Cornelissen G. and Sijm D.T.H.M.
Preskušanje ni potrebno.
Campfens J. and Mackay D. (1997), Fugacity-based model of PCB bioaccumulation in complex aquatic food webs.
Dražilna snov za oči
Crookes M. and Brooke D. (2010), Estimation of fish bioconcentration factor (BCF) from depuration data.
Končna točka preskusa na višjem nivoju biološke organizacije; upoštevati, da je snov dražilna za oči.
The number of surviving parents in the untreated controls is a validity criterion, and should be documented and reported.
ILSI paper (osnutek), Lorge, E., Moore, M., Clements, J., O Donovan, M., Darroudi, F., Honma, M., Czich, A., van Benthem, J., Galloway, S., Thybaud, V., Gollapudi, B., Aardema, M., Kim, J. in Kirkland, D. J. Recommendations for good cell culture practices in genotoxicity testing.
Also all other detrimental effects, e.g. abnormal behavior and toxicological significant findings, should be reported in the final report as well.
Guidance on Good Cell Culture Practice.
ECx-values, including their associated lower and upper confidence limits, are calculated using appropriate statistical methods (e.g. logistic or Weibull function, trimmed Spearman-Karber method, or simple interpolation).
A Report of the Second ECVAM Task Force on Good Cell Culture Practice, ATLA, zv.
Baird, D.J., et al.
Druga možnost za dokaz izpostavljenosti kostnega mozga je uporaba podatkov ADME (Absorption, Distribution, Metabolism, and Excretion – absorpcija, porazdelitev, metabolizem in izločanje), pridobljenih v neodvisni študiji, ki je bila opravljena z enakim načinom izpostavljenosti in istimi vrstami.
Vigano, L. (1991).
Environmental Mutagen Society of Japan.
ASTM.
Držalo se nato da v inkubator v vodoravnem položaju za 90 ± 5 minut pri 32 ± 1 °C.
Poole, R.W.
Identification of aneuploidy-inducing agents using cytokinesis-blocked human lymphocytes and an antikinetochore antibody.
Mc Graw Hill Series in Population Biology, New York, p 532.
Environmental and Molecular Mutagenesis, zv.
For a semi-static test, two different renewal procedures may be followed.
I. General conditions and overall conclusions of the study.
Either new test solutions are prepared in clean vessels and surviving eggs and larvae gently transferred into the new vessels, or the test organisms are retained in the test vessels whilst a proportion (at least two thirds) of the test solution / control volume is changed.
Mutation Research, zv.
26 pp.
Using human lymphocytes.
Brauhn, J.L. and R.A.
Mutation Research, zv.
Brungs, W.A. and B.R.
Comparison of in vitro micronucleus and gene mutation assay results for p53-competent versus p53-deficient human lymphoblastoid cells.
Adolfsson-Erici, et al.
Environmental and Molecular Mutagenesis, zv.
Hansen, D.J. and P.R.
Genotoxic effects in cultured mammalian cells produced by low pH treatment conditions and increased ion concentrations.
Kimmel, H. B.et al.
Environmental Mutagenesis, zv.
(1996), Prehatching Development of the Fathead Minnow, Pimephales promelas Rafinesque.
The advantages and disadvantages of cytokinesis-blood micronucleus method.
Belanger, and A.J.
Mutation Research, zv.
Rao, J.N.K. and A.J.
Maron, D. M. in Ames, B. N. (1983).
Rand, G.M. and S.R.
Mutation Research, zv.
15-35 [5]
„CHO/HGPRT Mutation Assay: Evaluation of Gases and Volatile Liquids“, in Genotoxic Effects of Airborne Agents.
Dunn or Mann-Whitney test No
Mutation Research, zv.
5 concentrations plus control Report model, ECx and its CI
Združeni narodi (ZN) (2013).
Draper, N.R. and Smith, H. (1999); Applied Regression Analysis, third edition.
Illuminating Insights into Firefly Luciferase and Other Bioluminescent Reporters Used in Chemical Biology.
Andersen L., et al (2006).
Meyer idr.
Short-term exposure to low concentrations of the synthetic androgen methyltestosterone affects vitellogenin and steroid levels in adult male zebrafish (Danio rerio).
(3 [6])
Aquatic Toxicology; 76(3-4):343-52.
Arnot J. A. in Gobas F. A. P. C. (2004), A food web bioaccumulation model for organic chemicals in aquatic ecosystems, Environ.
Evaluation of the aromatase inhibitor fadrozole in a short-term reproduction assay with the fathead minnow (Pimephales promelas).
Springer T. A., Guiney P. D., Krueger H. O. in Jaber M. J. (2008), Assessment of an approach to estimating aquatic bioconcentration factors using reduced sampling.
Toxicological Sciences; 67(1):121-30.
ODDELEK Z ENAČBAMI ZA PRESKUS PREHRANSKE IZPOSTAVLJENOSTI:
(2004).
Popravljanje glede na lipide
Aquatic Toxicology; 70(1):11-21.
ribja moka
Fathead minnow (Pimephales promelas) vitellogenin: purification, characterization and quantitative immunoassay for the detection of estrogenic compounds.
surove maščobe
Comparative Biochemistry and Physiology.
surove vlaknine
Medaka
Številni avtorji trdijo, da bi bilo treba intervale zaupanja za vse parametre modelov vključiti v poročilo in da široki intervali zaupanja za parametre modelov kažejo nesprejemljivost modelov (Ott in Longnecker 2008; Alvord in Rossio 1993; Motulsky in Christopoulos 2004; Lyles et al.
Photoperiod (dawn / dusk transitions are optional, however not considered necessary)
2008; Seber in Wild 2003; Bunke et al.
Commission Implementing Regulation (EU) 2017/736
Izvedbena uredba Komisije (EU) 2017/736
amending Annex VIII to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the approval of Slovenia's national control programme for classical scrapie
o spremembi Priloge VIII k Uredbi Evropskega parlamenta in Sveta (ES) št. 999/2001 glede odobritve nacionalnega programa nadzora klasičnega praskavca
Having regard to Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies [1], and in particular point 3.1(b) of Section A of Chapter A of Annex VIII thereof,
ob upoštevanju Uredbe Evropskega parlamenta in Sveta (ES) št. 999/2001 z dne 22. maja 2001 o določitvi predpisov za preprečevanje, nadzor in izkoreninjenje nekaterih transmisivnih spongiformnih encefalopatij [1] in zlasti točke 3.1(b) oddelka A poglavja A Priloge VIII k Uredbi,
Article 15 of Regulation (EC) No 999/2001 provides that the placing on the market or, if need be, the export of bovine, ovine or caprine animals and their semen, embryos and ova are subject to the conditions laid down in Annex VIII thereto.
Člen 15 Uredbe (ES) št. 999/2001 določa, da se dajanje na trg ali po potrebi izvoz živali iz vrst govedi, ovac ali koz in njihovega semena, zarodkov in jajčnih celic izvajata pod pogoji, določenimi v Prilogi VIII k navedeni uredbi.
Point 3.1(a) of Section A of Chapter A of that Annex provides that a Member State which has a national control programme for classical scrapie (‘national programme’) covering all of its territory may submit its national programme to the Commission for approval.
Točka 3.1(a) oddelka A poglavja A navedene priloge določa, da lahko država članica, ki ima nacionalni program nadzora klasičnega praskavca (v nadaljnjem besedilu: nacionalni program) na vsem ozemlju, Komisiji predloži svoj nacionalni program v odobritev.
Point 3.1(b) of that Section provides that the Commission may approve that national programme if it complies with the criteria laid down in point 3.1(a) of that Section.
Točka 3.1(b) navedenega oddelka določa, da lahko Komisija odobri navedeni nacionalni program, če ustreza merilom iz točke 3.1(a) navedenega oddelka.
Point 3.2 of that Section lists the Member States whose national programmes have been approved.
Točka 3.2 navedenega oddelka vsebuje seznam držav članic, katerih nacionalni programi so bili odobreni.
On 13 September 2016, Slovenia submitted to the Commission a request for approval of its national programme.
Slovenija je 13. septembra 2016 Komisiji predložila zahtevo za odobritev njenega nacionalnega programa.
On 8 January 2017, following requests for further information, Slovenia submitted an amended national programme, providing clarification and further information on certain aspects thereof.
Potem ko so bile zahtevane dodatne informacije, je Slovenija 8. januarja 2017 predložila spremenjeni nacionalni program s pojasnili in dodatnimi informacijami o nekaterih vidikih programa.
That amended national programme should be approved, as it complies with the criteria laid down in point 3.1(a) of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001.
Navedeni spremenjeni nacionalni program bi bilo treba odobriti, saj ustreza merilom iz točke 3.1(a) oddelka A poglavja A Priloge VIII k Uredbi (ES) št. 999/2001.
Point 3.2 of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001 should therefore be amended in order to add Slovenia to the list of Member States with approved national programmes.
Točko 3.2 oddelka A poglavja A Priloge VIII k Uredbi (ES) št. 999/2001 bi bilo treba spremeniti z vpisom Slovenije na seznam držav članic z odobrenimi nacionalnimi programi.
In Annex VIII to Regulation (EC) No 999/2001, point 3.2 of Section A of Chapter A is replaced by the following:
V Prilogi VIII k Uredbi (ES) št. 999/2001 se točka 3.2 oddelka A poglavja A nadomesti z naslednjim:
The national scrapie control programmes of the following Member States are hereby approved:
Odobrijo se nacionalni programi nadzora praskavca za naslednje države članice:
Slovenia.’.
Slovenija.“
Commission Implementing Regulation (EU) 2017/737
Izvedbena uredba Komisije (EU) 2017/737
Commission Implementing Regulation (EU) 2017/739
Izvedbena uredba Komisije (EU) 2017/739
Commission Regulation (EC) No 1484/95 [3] lays down detailed rules for implementing the system of additional import duties and fixes representative prices in the poultrymeat and egg sectors and for egg albumin.
Uredba Komisije (ES) št. 1484/95 določa [3] podrobna pravila za izvajanje sistema dodatnih uvoznih dajatev in reprezentativne cene v sektorjih perutninskega mesa in jajc ter za albumine iz jajc.
Done at Brussels, 26 April 2017.
V Bruslju, 26. aprila 2017
ANNEX
ANNESS
Commission Implementing Regulation (EU) 2017/740
Izvedbena uredba Komisije (EU) 2017/740
of 27 April 2017
z dne 27. aprila 2017
Done at Brussels, 27 April 2017.
V Bruslju, 27. aprila 2017
Regulation (EU) 2017/745 of the European Parliament and of the Council
Uredba (EU) 2017/745 Evropskega parlamenta in Sveta
on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
o medicinskih pripomočkih, spremembi Direktive 2001/83/ES, Uredbe (ES) št. 178/2002 in Uredbe (ES) št. 1223/2009 ter razveljavitvi direktiv Sveta 90/385/EGS in 93/42/EGS
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4)(c) thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije ter zlasti člena 114 in člena 168(4)(c) Pogodbe,
Council Directive 90/385/EEC [3] and Council Directive 93/42/EEC [4] constitute the Union regulatory framework for medical devices, other than in vitro diagnostic medical devices.
Direktiva Sveta 90/385/EGS [3] in Direktiva Sveta 93/42/EGS [4] sta regulativni okvir Unije za medicinske pripomočke, razen za in vitro diagnostične medicinske pripomočke.
However, a fundamental revision of those Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation.
Vendar je za vzpostavitev trdnega, preglednega, predvidljivega in trajnostnega regulativnega okvira za medicinske pripomočke, ki bo zagotavljal visoko stopnjo varnosti in zdravja ter hkrati podpiral inovacije, potrebna temeljita revizija navedenih direktiv.
This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector.
Cilj te uredbe je, temelječ na visoki ravni varovanja zdravja pacientov in uporabnikov ter upoštevajoč mala in srednja podjetja, dejavna v tem sektorju, zagotoviti nemoteno delovanje notranjega trga za medicinske pripomočke.
At the same time, this Regulation sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products.
Ta uredba določa tudi visoke standarde kakovosti in varnosti medicinskih pripomočkov, da bi tako zadostili skupnim potrebam po varnosti teh izdelkov.
Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other.
Oba cilja, ki sta neločljivo povezana in enakovredna, se bo poskušalo doseči hkrati.
As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation harmonises the rules for the placing on the market and putting into service of medical devices and their accessories on the Union market thus allowing them to benefit from the principle of free movement of goods.
V zvezi s členom 114 Pogodbe o delovanju Evropske unije (PDEU) ta uredba harmonizira pravila za dajanje medicinskih pripomočkov in njihovih dodatkov na trg Unije in v uporabo v njej, s čimer se bo zanje lahko uporabljalo načelo prostega pretoka blaga.
As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by ensuring, among other things, that data generated in clinical investigations are reliable and robust and that the safety of the subjects participating in a clinical investigation is protected.
V zvezi s členom 168(4)(c) PDEU ta uredba določa visoke standarde kakovosti in varnosti za medicinske pripomočke ter v ta namen med drugim zagotavlja zanesljivost in ponovljivost podatkov, pridobljenih v kliničnih raziskavah, ter ščiti varnost udeležencev v kliničnih raziskavah.
This Regulation does not seek to harmonise rules relating to the further making available on the market of medical devices after they have already been put into service such as in the context of second-hand sales.
Ta uredba ne harmonizira pravil, ki se nanašajo na nadaljnje omogočanje dostopnosti medicinskih pripomočkov na trgu, potem ko so že bili dani v uporabo, na primer v smislu prodaje rabljenih pripomočkov.
Key elements of the existing regulatory approach, such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding medical devices should be introduced, to improve health and safety.
Za višjo raven zdravja in varnosti bi bilo treba bistveno okrepiti ključne elemente obstoječega regulativnega pristopa, kot so nadzor priglašenih organov, postopki ugotavljanja skladnosti, klinične raziskave in klinična ocena, vigilanca in nadzor trga, ter vključiti določbe, ki bi zagotovile preglednost in sledljivost medicinskih pripomočkov.
To the extent possible, guidance developed for medical devices at international level, in particular in the context of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices Regulators Forum (IMDRF), should be taken into account to promote the global convergence of regulations which contributes to a high level of safety protection worldwide, and to facilitate trade, in particular in the provisions on Unique Device Identification, general safety and performance requirements, technical documentation, classification rules, conformity assessment procedures and clinical investigations.
Za promocijo mednarodne usklajenosti ureditev, ki prispeva k visoki stopnji zaščite varnosti po svetu, in za spodbujanje trgovine bi bilo treba kar se da upoštevati na mednarodni ravni pripravljene smernice za medicinske pripomočke, zlasti v okviru delovne skupine za svetovno usklajevanje (Global Harmonization Task Forc – GHTF) in njene nadaljnje pobude, tj. mednarodnega foruma regulativnih organov na področju medicinskih pripomočkov (International Medical Devices Regulators Forum – IMDRF), še zlasti v določbah o edinstveni identifikaciji pripomočka, splošnih zahtevah glede varnosti in učinkovitosti, tehnični dokumentaciji, pravilih za razvrščanje, postopkih ugotavljanja skladnosti ter kliničnih raziskavah.
For historical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and other medical devices, covered by Directive 93/42/EEC, were regulated in two separate legal instruments.
Iz zgodovinskih razlogov so bili aktivni medicinski pripomočki za vsaditev, ki jih zajema Direktiva 90/385/EGS, ter drugi medicinski pripomočki, ki jih zajema Direktiva 93/42/EGS, urejeni z ločenima pravnima instrumentoma.
In the interest of simplification, both directives, which have been amended several times, should be replaced by a single legislative act applicable to all medical devices other than in vitro diagnostic medical devices.
Zaradi poenostavitve bi bilo treba obe večkrat spremenjeni direktivi nadomestiti z enotnim zakonodajnim aktom, ki se bo uporabljal za vse medicinske pripomočke, razen za in vitro diagnostične medicinske pripomočke.
The scope of application of this Regulation should be clearly delimited from other Union harmonisation legislation concerning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and food.
Področje uporabe te uredbe bi bilo treba jasno razmejiti od druge zakonodaje Unije, ki harmonizira področja izdelkov, kot so in vitro diagnostični medicinski pripomočki, zdravila, kozmetični izdelki in živila.
Therefore, Regulation (EC) No 178/2002 of the European Parliament and of the Council [5] should be amended to exclude medical devices from its scope.
Zato bi bilo treba Uredbo (ES) št. 178/2002 Evropskega parlamenta in Sveta [5] spremeniti, da se iz njenega področja uporabe izključijo medicinski pripomočki.
It should be the responsibility of the Member States to decide on a case-by-case basis whether or not a product falls within the scope of this Regulation.
Države članice bi morale biti odgovorne, da za vsak posamezni primer odločijo, ali izdelek spada v področje uporabe te uredbe.
In order to ensure consistent qualification decisions in that regard across all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own initiative or at the duly substantiated request of a Member State, having consulted the Medical Device Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, category or group of products falls within the scope of this Regulation.
Da bi zagotovili dosledno tovrstno odločanje v vseh državah članicah, zlasti glede mejnih primerov, bi morala imeti Komisija možnost, da na svojo pobudo ali ustrezno utemeljeno zahtevo države članice ter po posvetovanju s Koordinacijsko skupino za medicinske pripomočke (Medical Device Coordination Group – MDCG), za vsak posamezni primer odloči, ali določen izdelek, kategorija ali skupina izdelkov spada v področje uporabe te uredbe.
When deliberating on the regulatory status of products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food products, the Commission should ensure an appropriate level of consultation of the European Medicines Agency (EMA), the European Chemicals Agency and the European Food Safety Authority, as relevant.
Pri odločanju o regulativnem statusu izdelkov iz skupine mejnih primerov, ki vključujejo zdravila, človeška tkiva in celice, biocide ali živila, bi Komisija morala zagotoviti ustrezno raven posvetovanja z Evropsko agencijo za zdravila (EMA), Evropsko agencijo za kemikalije in Evropsko agencijo za varnost hrane, kakor je ustrezno.