natgillin/translations-raw huggingface dataset:
Column leaching of metabolites, breakdown and reaction products
Izpiranje metabolitov ter razgradnih in reakcijskih produktov v kolonah
Fate and behaviour in water and sediment
Končno stanje in obnašanje v vodi in usedlini
Route and rate of degradation in aquatic systems (chemical and photochemical degradation)
Pot in stopnja razgradnje v vodnih sistemih (kemijska in fotokemijska razgradnja)
Direct photochemical degradation
Neposredna fotokemijska razgradnja
Indirect photochemical degradation
Posredna fotokemijska razgradnja
Route and rate of biological degradation in aquatic systems
Pot in stopnja biološke razgradnje v vodnih sistemih
Aerobic mineralisation in surface water
Aerobna mineralizacija v površinskih vodah
Irradiated water/sediment study
Študija o obsevani vodi/usedlini
Route and rate of degradation in air
Pot in stopnja razgradnje v zraku
Transport via air
Prenos po zraku
Local and global effects
Lokalni in globalni učinki
Definition of the residue for risk assessment
Opredelitev ostanka za oceno tveganja
Definition of the residue for monitoring
Opredelitev ostanka za spremljanje
SECTION 8.
ODDELEK 8
Effects on birds and other terrestrial vertebrates
Učinki na ptice in druge kopenske vretenčarje
Acute oral toxicity to birds
Akutna oralna toksičnost za ptice
Short-term dietary toxicity to birds
Kratkotrajna toksičnost pri vnosu s hrano za ptice
Sub-chronic and reproductive toxicity to birds
Subkronična in reproduktivna toksičnost za ptice
Effects on terrestrial vertebrates other than birds
Učinki na kopenske vretenčarje, razen ptic
Acute oral toxicity to mammals
Akutna oralna toksičnost za sesalce
Long-term and reproductive toxicity to mammals
Dolgotrajna in reproduktivna toksičnost za sesalce
Active substance bioconcentration in prey of birds and mammals
Biokoncentracija aktivne snovi v plenu ptic in sesalcev
Effects on terrestrial vertebrate wildlife (birds, mammals, reptiles and amphibians)
Učinki na prostoživeče kopenske vretenčarje (ptice, sesalce, plazilce in dvoživke)
Acute toxicity to fish
Akutna toksičnost za ribe
Long-term and chronic toxicity to fish
Dolgotrajna in kronična toksičnost za ribe
Fish early life stage toxicity test
Preskus toksičnosti za ribe v zgodnji fazi življenja
Fish full life cycle test
Preskus v celotnem življenjskem ciklu rib
Acute toxicity to Daphnia magna
Akutna toksičnost za vodno bolho (Daphnia magna)
Acute toxicity to an additional aquatic invertebrate species
Akutna toksičnost za dodatne vrste vodnih nevretenčarjev
Long-term and chronic toxicity to aquatic invertebrates
Dolgotrajna in kronična toksičnost za vodne nevretenčarje
Reproductive and development toxicity to Daphnia magna
Reproduktivna in razvojna toksičnost za vodno bolho (Daphnia magna)
Reproductive and development toxicity to an additional aquatic invertebrate species
Reproduktivna in razvojna toksičnost za dodatne vrste vodnih nevretenčarjev
Development and emergence in Chironomus riparius
Razvoj in pojav pri vrsti Chironomus riparius
Sediment dwelling organisms
Organizmi, ki živijo v usedlinah
Effects on algal growth
Učinki na rast alg
Effects on growth of green algae
Učinki na rast zelenih alg
Effects on growth of an additional algal species
Učinki na rast dodatnih vrst alg
Further testing on aquatic organisms
Dodatni preskusi na vodnih organizmih
Effect on arthropods
Učinek na členonožce
Acute toxicity to bees
Akutna toksičnost za čebele
Acute contact toxicity
Akutna kontaktna toksičnost
Chronic toxicity to bees
Kronična toksičnost za čebele
Effects on honeybee development and other honeybee life stages
Učinki na razvoj čebele in njene druge življenjske faze
Sub-lethal effects
Subletalni učinki
Effects on non-target arthropods other than bees
Učinki na neciljne členonožce, razen čebel
Effects on Aphidius rhopalosiphi
Učinki na vrsto Aphidius rhopalosiphi
Effects on Typhlodromus pyri
Učinki na vrsto Typhlodromus pyri
Effects on non-target soil meso- and macrofauna
Učinki na neciljno mezofavno in makrofavno v tleh
Earthworm — sub-lethal effects
Deževniki – subletalni učinki
Effects on non-target soil meso- and macrofauna (other than earthworms)
Učinki na neciljno mezofavno in makrofavno v tleh (razen deževnikov)
Species level testing
Preskusi na ravni vrste
Effects on soil nitrogen transformation
Učinki na transformacijo dušika v tleh
Effects on terrestrial non-target higher plants
Učinki na kopenske neciljne višje rastline
Summary of screening data
Povzetek podatkov v zvezi s presejalnimi pregledi
Testing on non-target plants
Preskusi na neciljnih rastlinah
Effects on other terrestrial organisms (flora and fauna)
Učinki na druge kopenske organizme (flora in favna)
Effects on biological methods for sewage treatment
Učinki na biološke metode v postopkih čiščenja odplak
SECTION 9.
ODDELEK 9
Literature data
Podatki iz literature
SECTION 10.
ODDELEK 10
The information provided shall be sufficient to precisely identify each active substance and define it in terms of its specification and nature.
Predložene informacije zadoščajo za natančno opredelitev posamezne aktivne snovi ter določitev njene specifikacije in narave.
The name and address of the applicant shall be provided, as well as the name, position, telephone, e-mail address and telefax number of a contact point.
Navedejo se ime in naslov vlagatelja ter ime, položaj, telefonska številka, e-poštni naslov in številka telefaksa osebe za stike.
The name and address of the producer of the active substance shall be provided, as well as the name and address of each manufacturing plant in which the active substance is manufactured.
Navedejo se ime in naslov proizvajalca aktivne snovi ter ime in naslov vseh proizvodnih obratov, v katerih se aktivna snov proizvaja.
A contact point (name, telephone, e-mail address and telefax number) shall be provided.
Navede se oseba za stike (ime, telefonska številka, e-poštni naslov in številka telefaksa).
Where following approval of the active substances, there are changes in the location or number of producers, the information required shall again be notified to the Commission, the Authority and the Member States.
Kadar se po odobritvi aktivnih snovi spremeni lokacija ali število proizvajalcev, se zahtevane informacije ponovno posredujejo Komisiji, Agenciji in državam članicam.
The International Organization for Standardization (ISO) common name, or proposed ISO common name and where relevant, other proposed or accepted common names (synonyms), including the name (title) of the nomenclature authority concerned, shall be provided.
Navedejo se splošno ali predlagano ime po Mednarodni organizaciji za standardizacijo (ISO) in, kadar je ustrezno, druga predlagana ali sprejeta splošna imena (sinonimi), vključno z imenom (nazivom) zadevnega organa za nomenklaturo.
The chemical name as given in Part III of Annex VI to Regulation (EC) No 1272/2008, or, if not included in that Regulation, in accordance with both the International Union of Pure and Applied Chemistry (IUPAC) and Chemical Abstracts (CA) nomenclature, shall be provided, where applicable.
Kadar je primerno, se navede kemijsko ime iz dela III Priloge VI k Uredbi (ES) št. 1272/2008 ali, kadar ime ni vključeno v navedeno uredbo, v skladu z nomenklaturama Mednarodne zveze za čisto in uporabno kemijo (IUPAC) ter Službe za izmenjavo kemijskih izvlečkov (CA).
Code numbers used to identify the active substance, and where available, formulations containing the active substance, during development work, shall be reported.
Navedejo se šifre, ki se med razvojem uporabljajo za opredelitev aktivne snovi, in, kadar so na voljo, formulacije, ki vsebujejo aktivno snov.
For each code number reported, the material to which it relates, the period for which it was used, and the Member States or other countries in which it was used and is being used, shall be stated.
Za vsako navedeno šifro se navedejo snov, na katero se nanaša, obdobje, v katerem se je uporabljala, in države članice ali druge države, v katerih se je uporabljala in se še uporablja.
Chemical Abstracts Service (CAS), European Commission (EC) and Collaborative International Pesticides Analytical Council (CIPAC) numbers, where they exist, shall be reported.
Navedejo se številke Službe za izmenjavo kemijskih izvlečkov (CAS), Evropske komisije (ES) in Kolaborativnega mednarodnega sveta za analizo pesticidov (CIPAC), kadar obstajajo.
The molecular formula, molar mass and structural formula of the active substance, and where relevant, the structural formula of each isomer present in the active substance, shall be provided.
Navedejo se molekulska formula, molska masa in strukturna formula aktivne snovi ter, kadar je ustrezno, strukturna formula vsakega izomera, prisotnega v aktivni snovi.
For plant extracts, a different approach may be taken if adequately justified.
Za rastlinske izvlečke se lahko uporabi drugačen pristop, ki se ustrezno utemelji.
The method of manufacture, in terms of the identity (name, CAS number, structural formula) and purity of the starting materials and whether they are commercially available, the chemical pathways involved, and the identity of impurities present in the final product, shall be provided, for each manufacturing plant.
Za vsak proizvodni obrat se navedejo način proizvodnje, ki vključuje opredelitev (ime, številka CAS, strukturna formula) in čistost začetnih snovi ter njihovo razpoložljivost na trgu, uporabljenih kemijskih postopkov ter opredelitev nečistoč v končnem proizvodu.
Detailed information shall be given as to the origin of those impurities.
Navedejo se podrobne informacije o izvoru teh nečistoč.
Each impurity shall be categorised as resulting from side reactions, impurities in the starting material, remaining reaction intermediates or starting materials.
Nečistoče se razvrstijo kot produkti stranskih reakcij, nečistoče v začetni snovi, reakcijski vmesni produkti ali začetne snovi.
Their toxicological, ecotoxicological and environmental relevance shall be addressed.
Obravnava se njihov toksikološki in ekotoksikološki učinek ter vpliv na okolje.
This information shall also include impurities that are not detected but that could theoretically be formed.
Te informacije zajemajo tudi nečistoče, ki niso zaznane, vendar bi teoretično lahko nastale.
Generally process engineering information is not required.
Podatki o tehnoloških postopkih na splošno niso potrebni.
Where the required information is provided for a pilot plant production system, that information shall again be provided once industrial scale production methods and procedures have stabilised.
Kadar se zahtevane informacije predložijo za poskusno proizvodnjo, se te informacije ponovno predložijo po tem, ko se metode in postopki industrijske proizvodnje stabilizirajo.
Where available, industrial scale data shall be provided before approval under Regulation (EC) No 1107/2009.
Podatki o industrijski proizvodnji, kadar so na voljo, se predložijo pred odobritvijo v skladu z Uredbo (ES) št. 1107/2009.
Where data on industrial scale production are not available, a justification shall be provided.
Če podatki o industrijski proizvodnji niso na voljo, se to utemelji.
this shall include a statistical analysis of the data on at least five representative batches, as referred to in point 1.11.
Zagotovi se utemeljitev najmanjše vsebnosti iz specifikacije, pri čemer utemeljitev vključuje statistično analizo podatkov o najmanj petih reprezentativnih serijah, kot je navedeno v točki 1.11.
Additional supporting data may be provided to further justify the technical specification.
Za dodatno utemeljitev tehnične specifikacije se lahko predložijo dodatni podporni podatki.
If the active substance is manufactured as technical concentrate (TK), the minimum and maximum content of the pure active substance shall be given, along with its content in the theoretical dry weight material.
Kadar se aktivna snov proizvaja kot tehnični koncentrat (TK), se navedejo najmanjša in največja vsebnost čiste aktivne snovi ter njena vsebnost v teoretični suhi snovi.
If the active substance is a mixture of isomers, the ratio or the ratio range of the content of isomers shall be provided.
Če je aktivna snov mešanica izomerov, se navede razmerje ali obseg razmerja vsebnosti izomerov.
The relative biological activity of each isomer, both in terms of efficacy and toxicity, shall be reported.
Navede se relativna biološka aktivnost vsakega izomera glede učinkovitosti in toksičnosti.
The minimum and maximum content in g/kg of each additive shall be provided.
Navedeta se najmanjša in največja vsebnost, v g/kg, vsakega aditiva.
The maximum content in g/kg of each further component other than additives shall also be provided.
Navede se tudi največja vsebnost, v g/kg, vsake druge sestavine, razen aditivov.
If the active substance is manufactured as technical concentrate (TK), the maximum content of each impurity shall be given, along with their content in the theoretical dry weight material.
Kadar se aktivna snov proizvaja kot tehnični koncentrat (TK), se navedeta največja vsebnost vsake nečistoče in njena vsebnost v teoretični suhi snovi.
Isomers that are not part of the ISO common name are considered as impurities.
Izomeri, ki niso del splošnega imena po ISO, se obravnavajo kot nečistoče.
Where the information provided does not fully identify a component (for example condensates), detailed information on the composition shall be provided for each such component.
Kadar v predloženih informacijah sestavina (na primer kondenzati) ni v celoti opredeljena, se za vsako tako sestavino navedejo podrobne informacije o sestavi.
The trade name of components added to the active substance, prior to manufacture of the plant protection product, to preserve stability and facilitate ease of handling, hereinafter ‘additives’, shall also be provided.
Navede se tudi trgovsko ime sestavin, ki se dodajo aktivni snovi pred proizvodnjo fitofarmacevtskega sredstva za ohranjanje njegove stabilnosti in lažje ravnanje pri uporabi (v nadaljnjem besedilu: aditivi).
The following information shall, where relevant, be provided for such additives:
Kadar je ustrezno, se za take aditive navedejo naslednje informacije:
chemical name in accordance with IUPAC and CA nomenclature;
kemijsko ime po nomenklaturah IUPAC in CA;
ISO common name or proposed common name if available;
splošno ali predlagano splošno ime po ISO, kadar je na voljo;
CAS number, EC number;
številka CAS, številka ES;
molecular and structural formula;
molekulska in strukturna formula;
molar mass;
molska masa;
function (for example stabiliser).
delovanje (na primer stabilizator).
Impurities present in quantities of 1 g/kg or more shall be considered as significant.
Nečistoče, prisotne v količinah, večjih od 1 g/kg, se štejejo za pomembne.
For significant impurities the following information, where relevant, shall be provided:
Kadar je ustrezno, se za pomembne nečistoče navedejo naslednje informacije:
ISO common name or proposed common name, if available;
splošno ali predlagano splošno ime po ISO, kadar je na voljo;
maximum content in g/kg.
največja vsebnost v g/kg.
Information on how the structural identity of the impurities was determined shall be given.
Navedejo se informacije o načinu določanja strukturne identitete nečistoč.
Impurities that are particularly undesirable because of their toxicological, ecotoxicological or environmental properties, shall be considered as relevant.
Nečistoče, ki so posebno nezaželene zaradi svoje toksičnosti, ekotoksičnosti ali vplivov na okolje, se štejejo za relevantne.
For relevant impurities the following information, where relevant, shall be provided:
Kadar je ustrezno, se za relevantne nečistoče navedejo naslednje informacije:
Information on how the structural identity of the impurities was determined shall be reported.
Navedejo se informacije o načinu določanja strukturne identitete nečistoč.
At least five representative batches from recent and current industrial scale production of the active substance shall be analysed for content of pure active substance, impurities, additives and each further component other than additives, as appropriate.
Glede vsebnosti čiste aktivne snovi, nečistoč, aditivov in vsake druge sestavine, razen aditivov, se, kadar je primerno, analizira najmanj pet reprezentativnih serij iz nedavne in sedanje industrijske proizvodnje aktivne snovi.
All of the representative batches shall be within the last five years of manufacture.
Vse reprezentativne serije morajo biti proizvedene v zadnjih petih letih.
Where data from the last five years of production are not available, a justification shall be provided.
Kadar podatki za zadnjih pet let proizvodnje niso na voljo, se to utemelji.
The analytical results reported shall include quantitative data, in terms of g/kg content, for all components present in quantities of 1 g/kg or more and typically should account for at least 980 g/kg of the material analysed.
Predloženi rezultati analiz vključujejo podatke o količini (vsebnost v g/kg) vseh sestavin, prisotnih v količinah, enakih ali večjih od 1 g/kg, kar naj bi predstavljalo vsaj 980 g/kg analizirane snovi.
For plant extracts and semiochemicals (such as pheromones), justified exemptions can be made.
Za rastlinske izvlečke in semiokemikalije (na primer feromone) lahko veljajo utemeljene izjeme.
The statistical basis for the content proposed in the technical specification shall be explained (for example: maximum level found in practice, average plus three standard deviations of levels found in practice, etc.).
Pojasni se statistična podlaga za vsebnost, ki je predlagana v tehnični specifikaciji (na primer: zgornja mejna vrednost iz prakse, povprečje plus trije standardni odmiki mejnih vrednosti iz prakse itd.).
Supporting data may be provided to further justify the technical specification.
Za dodatno utemeljitev tehnične specifikacije se lahko predložijo podporni podatki.
The actual content of components which are particularly undesirable because of their toxicological, ecotoxicological or environmental properties shall be determined and reported even if present in quantities below 1 g/kg.
Dejanska vsebnost sestavin, ki so posebno nezaželene zaradi svoje toksičnosti, ekotoksičnosti ali vplivov na okolje, se določi in navede, tudi če so prisotne v količinah, manjših od 1 g/kg.
Data reported shall include the results of the analysis of individual samples and a summary of that data, to show the minimum, maximum and mean content of each relevant component.
Predloženi podatki vključujejo rezultate analize posameznih vzorcev ter povzetek navedenih podatkov, iz katerega je razvidna najmanjša, največja in povprečna vsebnost vsake relevantne sestavine.
Where an active substance is produced in different plants the information set out in the first paragraph shall be provided for each of the plants separately.
Kadar se aktivna snov proizvaja v različnih obratih, se informacije iz prvega odstavka navedejo ločeno za vsak obrat.
In addition, where relevant, samples of the active substance produced at laboratory scale or in pilot production systems, shall be analysed, if such material was used in generating toxicological or ecotoxicological data.
Kadar je ustrezno, se analizirajo vzorci aktivne snovi, proizvedene v laboratoriju ali v poskusni proizvodnji, če so se te snovi uporabljale za pridobitev toksikoloških ali ekotoksikoloških podatkov.
If this data is not available a justification shall be provided.
Če navedeni podatki niso na voljo, se to utemelji.
Where the information provided relates to a pilot plant production system, the information required shall again be provided once industrial scale production methods and procedures have stabilised.
Kadar se predložene informacije nanašajo na poskusno proizvodnjo, se zahtevane informacije ponovno predložijo po tem, ko se metode in postopki industrijske proizvodnje stabilizirajo.
The melting point or where appropriate the freezing or solidification point of purified active substance shall be determined and reported.
Določi in navede se tališče ali, kadar je primerno, ledišče ali točka strjevanja čiste aktivne snovi.
The boiling point of purified active substance shall be determined and reported.
Določi in navede se vrelišče čiste aktivne snovi.
Where melting point or boiling point cannot be determined because of decomposition or sublimation, the temperature at which decomposition or sublimation occurs shall be reported.
Kadar tališča ali vrelišča zaradi razgradnje ali sublimacije ni mogoče določiti, se navede temperatura, pri kateri nastopi razgradnja ali sublimacija.
The vapour pressure of purified active substance at 20 °C or 25 °C shall be reported.
Navede se parni tlak čiste aktivne snovi pri 20 °C ali 25 °C.
Where vapour pressure is less than 10–5 Pa at 20 °C the vapour pressure at 20 °C or 25 °C shall be estimated by a vapour pressure curve with measurements at higher temperatures.
Kadar je parni tlak pri 20 °C manjši od 10–5 Pa, se pri temperaturi 20 °C ali 25 °C oceni s krivuljo parnega tlaka z meritvami pri višjih temperaturah.
In the case of active substances which are solids or liquids, volatility (Henry’s law constant) of purified active substance shall be determined or calculated from its water solubility and vapour pressure and be reported (in Pa × m3 × mol–1).
Hlapnost čiste aktivne snovi v trdni ali tekoči obliki se določi ali izračuna (konstanta Henryjevega zakona) iz njene topnosti v vodi in parnega tlaka, pri čemer se navedejo rezultati (v Pa × m3 × mol–1).
A description of both the colour, if any, and the physical state of both the active substance as manufactured and purified active substance, shall be provided.
Opišeta se barva, če obstaja, in agregatno stanje tehnične aktivne snovi in čiste aktivne snovi.
The following spectra, including a table of signal characteristics needed for interpretation, shall be determined and reported:
Določijo in navedejo se naslednji spektri in preglednica značilnosti signalov, ki je potrebna za razlago:
ultraviolet/visible (UV/VIS), infrared (IR), nuclear magnetic resonance (NMR) and mass spectra (MS) of purified active substance.
ultravijolični/vidni (UV/VIS), infrardeči (IR), nuklearna magnetna resonanca (NMR) in masni spekter (MS) čiste aktivne snovi.
Molar extinction at relevant wavelengths shall be determined and reported (ε in L × mol–1 × cm–1).
Določi in navede se molekulska ekstinkcija pri ustreznih valovnih dolžinah (ε v L × mol–1 × cm–1).
Relevant wavelengths include all maxima in the UV/visible absorption spectrum, as well as the wavelength range of 290-700 nm.
Ustrezne valovne dolžine vključujejo vse najvišje vrednosti absorpcijskih spektrov UV/VIS ter valovne dolžine 290–700 nm.
In the case of active substances which are resolved optical isomers, the optical purity shall be measured and reported.
Kadar so aktivne snovi ločeni optični izomeri, se izmeri in navede njihova optična čistost.
Where necessary for the identification of the impurities considered to be of toxicological, ecotoxicological or environmental significance, the UV/visible absorption spectra, IR, NMR and MS spectra, shall be determined and reported.
Za opredelitev nečistoč, ki so pomembne s toksikološkega ali ekotoksikološkega vidika ali zaradi vpliva na okolje, se določijo in navedejo njihovi absorpcijski spektri UV/VIS ter spektri IR, NMR in MS.
The water solubility of purified active substances under atmospheric pressure shall be determined and a value reported for 20 °C.
Določi in navede se topnost čistih aktivnih snovi v vodi pri atmosferskem tlaku in pri 20 °C.
These water solubility determinations shall be made in the neutral range (that is to say in distilled water in equilibrium with atmospheric carbon dioxide).
Topnost v vodi se določi v nevtralnem območju (tj. v destilirani vodi v ravnovesju z atmosferskim ogljikovim dioksidom).
If the pKa is between 2 and 12, water solubility shall also be determined in the acidic range (pH 4 to 5) and in the alkaline range (pH 9 to 10).
Če vrednost pKa znaša 2–12, se topnost v vodi določi tudi v kislem (pH 4 do 5) in alkalnem območju (pH 9 do 10).
Where the stability of the active substance in aqueous media is such that water solubility cannot be determined, a justification based on test data shall be provided.
Kadar je aktivna snov v vodnem okolju stabilna, tako da topnosti v vodi ni mogoče določiti, se predloži utemeljitev na podlagi podatkov preskusa.