natgillin/translations-raw huggingface dataset:
The molecular formula, molecular mass and structural formula of the active substance, and where relevant, the structural formula of each stereo and optical isomer present in the active substance, must be provided.
Navesti je treba molekulsko formulo, molekulsko maso in strukturno formulo aktivne snovi ter, kadar je relevantno, strukturno formulo vsakega stereo in optičnega izomera, prisotnega v aktivni snovi.
Method of manufacture (synthesis pathway) of the active substance
Način proizvodnje (sinteza) aktivne snovi
The method of manufacture, in terms of the identity of the starting materials, the chemical pathways involved, and the identity of by-products and impurities present in the final product, must be provided, for each manufacturing plant.
Za vsak proizvodni obrat je treba navesti opis proizvodnega postopka, ki vključuje navedbo začetnih snovi, kemijskih postopkov ter navedbo stranskih proizvodov in nečistoč, prisotnih v končnem proizvodu.
Generally process engineering information is not required.
Na splošno podatkov o tehnoloških postopkih ni treba navesti.
Where the information provided relates to a pilot plant production system, the information required must again be provided once industrial scale production methods and procedures have stabilised.
Kadar se predložene informacije nanašajo na poskusno proizvodnjo, je treba zahtevane informacije ponovno predložiti po tem, ko se metode in postopki industrijskega obsega proizvodnje stabilizirajo.
Specification of purity of the active substance in g/kg
Specifikacija čistosti aktivne snovi v g/kg
The minimum content in g/kg of pure active substance (excluding inactive isomers) in the manufactured material used for production of formulated products, must be reported.
Navesti je treba najmanjšo vsebnost čiste aktivne snovi, v g/kg, (brez neaktivnih izomerov) v uporabljeni tehnični snovi, ki se uporablja pri proizvodnji formuliranih proizvodov.
Where the information provided relates to a pilot plant production system, the information required must again be provided to the Commission and the Member States once industrial scale production methods and procedures have stabilised, if production changes result in a changed specification of purity.
Kadar se navedene informacije nanašajo na pilotno proizvodnjo, je treba Komisiji in državam članicam zahtevane informacije ponovno predložiti, ko se industrijske proizvodne metode in postopki proizvodnje stabilizirajo, če spremembe v proizvodnji povzročajo spremembe v specifikaciji ali čistosti.
Identity of isomers, impurities and additives (e.g. stabilisers), together with the structural formula and the content expressed as g/kg
Identiteta izomerov, nečistoč in dodatkov (npr. stabilizatorjev), strukturna formula in vsebnost, izražena v g/kg
The maximum content in g/kg of inactive isomers as well as the ratio of the content of isomers/diastereo-isomers, where relevant, must be provided.
Navesti je treba najvišjo vsebnost neaktivnih izomerov (v g/kg) ter razmerje med vsebnostjo izomerov in diastereoizomerov, kadar je to relevantno.
In addition, the maximum content in g/kg of each further component other than additives, including by-products, and impurities, must be provided.
Navesti je treba tudi najvišjo vsebnost vsake druge sestavine (v g/kg), razen dodatkov, vključno s stranskimi proizvodi in nečistočami.
In the case of additives the content in g/kg must be provided.
Vsebnost dodatkov je treba navesti v g/kg.
For each component, present in quantities of 1 g/kg or more, the following information, where relevant, must be provided:
Za vsako sestavino, ki je prisotna v količini 1 g/kg ali več, je treba navesti, kadar je to relevantno, 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, če je na voljo,
CAS number, EC (Einecs or ELINCS) number, and CIPAC number if available,
številke CAS, ES (EINECS ali ELINCS) in CIPAC, če so na voljo,
molecular and structural formula,
molekulsko in strukturno formulo,
molecular mass, and
molekulsko maso in
maximum content in g/kg.
najvišjo vsebnost v g/kg.
Where the manufacturing process is such that impurities and by-products which are particularly undesirable because of their toxicological, ecotoxicological or environmental properties could be present in the active substance, the content of each such compound must be determined and reported.
Kadar je proizvodni postopek tak, da bi v aktivni snovi lahko bile prisotne nečistoče in stranski proizvodi, ki so nezaželeni zlasti zaradi svoje toksičnosti, ekotoksičnosti ali vplivov na okolje, je treba vsebnost vsake take spojine določiti in navesti.
In such cases, the analytical methods used and the limits of determination, which must be sufficiently low, for each compound of concern, must be reported.
V teh primerih je za vsako zadevno spojino treba navesti uporabljene analitske metode in meje določitve, ki morajo biti dovolj nizke.
Additionally the following information, where relevant, must be provided:
Kadar je to relevantno, je treba navesti tudi naslednje informacije:
Where the information provided relates to a pilot plant production system, the information required must again be provided once industrial scale production methods and procedures have stabilised, if production changes result in a changed specification of purity.
Kadar se predložene informacije nanašajo na poskusno proizvodnjo, je treba zahtevane informacije ponovno predložiti po tem, ko se metode in postopki industrijskega obsega proizvodnje stabilizirajo, če je posledica sprememb v proizvodnji spremenjena specifikacija čistosti.
Where the information provided does not fully identify a component, viz. condensates, detailed information on the composition must be provided for each such component.
Kadar v predloženih informacijah ni v celoti opredeljena sestavina, npr. kondenzati, je treba navesti podrobne informacije o sestavi za vsako tako sestavino.
The trade name of components added to the active substance, prior to manufacture of formulated product, to preserve stability and facilitate ease of handling, where they are used, must also be provided.
Navesti je treba tudi trgovsko ime sestavin, dodanih aktivnih snovi pred proizvodnjo formuliranega pripravka z namenom ohranjanja njegove stabilnosti in lažjega ravnanja pri uporabi, kadar so uporabljene.
Additionally the following information, where relevant, must be provided for such additives:
Kadar je to relevantno, je za take dodatke treba navesti še naslednje informacije:
For added components, other than active substance and other than impurities resulting from the manufacturing process, the function of the component (additive) must be given:
Za dodane sestavine, razen aktivnih snovi in nečistoč, ki so posledica proizvodnega postopka, je treba navesti delovanje sestavine (dodatka):
antifoaming agent,
sredstvo proti penjenju,
antifreeze,
sredstvo proti zmrzovanju,
binder,
vezivo,
stabiliser,
stabilizator,
dispersing agent,
dispergent,
other (specify).
drugo (določiti).
Analytical profile of batches
Analitske lastnosti serij
Representative samples of the active substance must be analysed for content of pure active substance, inactive isomers, impurities and additives, as appropriate.
Reprezentativne vzorce aktivne snovi je treba analizirati na vsebnost čiste aktivne snovi, neaktivnih izomerov, nečistoč in dodatkov, kakor je primerno.
The analytical results reported must include quantitative data, in terms of g/kg content, for all components present in quantities of more than 1 g/kg and typically shall account for at least 98 % of the material analysed.
Predloženi rezultati analiz morajo vključevati podatke o količini (vsebnost v g/kg) vseh sestavin, prisotnih v količinah več kakor 1 g/kg, kar predstavlja vsaj 98 % analizirane snovi.
The actual content of components which are particularly undesirable because of their toxicological, ecotoxicological or environmental properties, must be determined and reported.
Določiti in navesti je treba dejansko vsebnost sestavin, ki so posebej nezaželene zaradi svoje toksičnosti, ekotoksičnosti ali vplivov na okolje.
Data reported must include the results of the analysis of individual samples and a summary of that data, to show the minimum or maximum and typical content of each relevant component, as appropriate.
Predloženi podatki morajo zajemati tudi rezultate analize posameznih vzorcev ter povzetek navedenih podatkov, iz katerega sta razvidni najvišja in najnižja vrednost ter običajna vsebnost vsake relevantne sestavine, kakor je primerno.
Where an active substance is produced in different plants this information must be provided for each of the plants separately.
Kadar se aktivna snov proizvaja v različnih obratih, je treba te informacije navesti ločeno za vsak obrat.
In addition, where available and relevant, samples of the active substance produced in laboratory scale or pilot production systems, must be analysed, if such material was used in generating toxicological or ecotoxicological data.
Kadar je to na voljo in relevantno, je treba vzorce aktivne snovi, proizvedene v laboratoriju ali v poskusni proizvodnji tudi analizirati, če so se te snovi uporabljale za pridobitev toksikoloških ali ekotoksikoloških podatkov.
Physical and chemical properties of the active substance
Fizikalne in kemijske lastnosti aktivne snovi
The information provided, must describe the physical and chemical properties of active substances and together with relevant information, must serve to characterise them.
V predloženih informacijah je treba opisati fizikalne in kemijske lastnosti aktivnih snovi, ki morajo skupaj z drugimi relevantnimi informacijami omogočiti določitev njihovih značilnosti.
In particular, the information provided must permit:
Predložene informacije morajo zlasti omogočati:
physical, chemical, and technical hazards associated with active substances, to be identified,
opredelitev fizikalnih, kemijskih in tehničnih nevarnosti, povezanih z aktivnimi snovmi,
classification of active substance as to hazard,
razvrstitev aktivne snovi glede na nevarnost,
appropriate restrictions and conditions to be associated with approvals, and
opredelitev ustreznih omejitev in pogojev v zvezi z odobritvami in
appropriate hazard and precautionary statements to be specified.
opredelitev ustreznih opozorilnih besed in izjav o nevarnosti.
The information and data referred to are required for all active substances, except where otherwise specified.
Navedene informacije in podatki se zahtevajo za vse aktivne snovi, če ni določeno drugače.
The information provided, taken together with that provided for relevant preparations, must permit the physical, chemical and technical hazards associated with preparations, to be identified, permit preparations to be classified, and permit establishment that preparations can be used without unnecessary difficulty, and be such that exposure of man, animals, and the environment is minimised, taking account of manner of use.
Predložene informacije, skupaj z informacijami za ustrezne pripravke, morajo omogočati določitev fizikalnih, kemijskih in tehničnih nevarnosti, povezanih s pripravki, razvrstitev pripravkov in določitev, da je način uporabe pripravkov preprost in tak, da je izpostavljenost ljudi, živali in okolja zmanjšana na najmanjšo možno mero.
The extent to which active substances of which approval is sought, comply with relevant FAO specifications, must be stated.
Za aktivne snovi, za katere je vložena vloga za odobritev, je treba navesti stopnjo skladnosti s specifikacijami FAO.
Divergences from FAO specifications must be described in detail, and justified.
Odstopanja od specifikacij FAO je treba podrobno opisati in utemeljiti.
In certain specified instances, tests must be conducted using purified active substance of stated specification.
V nekaterih natančno navedenih primerih je treba teste opraviti s specificirano čisto aktivno snovjo.
A reasoned justification must be provided in cases where the degree of purity achieved is less than 980 g/kg.
Kadar je dosežena stopnja čistosti manjša kot 980 g/kg, je to treba utemeljiti.
Such justification must demonstrate that all technically feasible and reasonable possibilities for the production of the pure active substance have been exhausted.
Iz utemeljitve mora biti razvidno, da so bile izčrpane vse tehnično izvedljive možnosti za proizvodnjo čiste aktivne snovi.
Melting point and boiling point
Tališče in vrelišče
The melting point or where appropriate the freezing or solidification point of purified active substance must be determined and reported in accordance with method A 1 of Regulation (EC) No 440/2008.
Tališče ali, kadar je to primerno, ledišče ali točko strjevanja čiste aktivne snovi je treba določiti in navesti v skladu z metodo A1 Uredbe (ES) št. 440/2008.
Measurements shall be taken up to 360 °C.
Meritve potekajo do 360 °C.
Where appropriate the boiling point of purified active substances must be determined and reported in accordance with method A 2 of Regulation (EC) No 440/2008.
Kadar je to primerno, je treba vrelišče čistih aktivnih snovi določiti in navesti v skladu z metodo A2 Uredbe (ES) št. 440/2008.
Where melting point and/or boiling point cannot be determined because of decomposition or sublimation, the temperature at which decomposition or sublimation occurs, must be reported.
Kadar tališča in/ali vrelišča zaradi razgradnje ali sublimacije ni mogoče določiti, je treba navesti temperaturo, pri kateri nastopi razgradnja ali sublimacija.
In the case of active substances which are liquids or solids, the relative density of the purified active substance must be determined and reported in accordance with method A 3 of Regulation (EC) No 440/2008.
Relativno gostoto čiste aktivne snovi v tekoči ali trdni obliki je treba določiti in navesti v skladu z metodo A3 Uredbe (ES) št. 440/2008.
Vapour pressure (in Pa), volatility (e.g. Henry’s law constant)
Parni tlak (v Pa), hlapnost (npr. konstanta Henryevega zakona)
The vapour pressure of purified active substance must be reported in accordance with method A 4 of Regulation (EC) No 440/2008.
Parni tlak čiste aktivne snovi je treba navesti v skladu z metodo A4 Uredbe (ES) št. 440/2008.
Where vapour pressure is less than 10–5 Pa, the vapour pressure at 20 or 25 °C may be estimated by a vapour pressure curve.
Kadar je parni tlak manjši od 10–5 Pa, se ga pri temperaturi 20 °C ali 25 °C lahko oceni s pomočjo krivulje parnega tlaka.
In the case of active substances which are solids or liquids, volatility (Henry’s law constant) of purified active substance must 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 je treba določiti ali izračunati (konstanta Henryevega zakona) iz njene topnosti v vodi in parnega tlaka ter navesti rezultate (v Pa × m3 × mol–1).
Appearance (physical state, colour and odour; if known)
Videz (agregatno stanje, barva in vonj, če so znani)
A description of both the colour, if any, and the physical state of both the active substance as manufactured and purified active substance, must be provided.
Navesti je treba opis barve, če obstaja, in agregatno stanje tehnične aktivne snovi in čiste aktivne snovi.
A description of any odour associated with the active substance as manufactured and purified active substance, noted when handling the materials in laboratories or production plants, must be reported.
Navesti je treba opis vonja ki se zazna pri ravnanju s tehnično aktivno snovjo in čisto aktivno snovjo v laboratorijih ali proizvodnih obratih.
Spectra (UV/VIS, IR, NMR, MS), molecular extinction at relevant wavelengths
Spektri (UV/VSI, IR, NMR, MS), molekulska ekstinkcija pri določenih valovnih dolžinah
The following spectra including a table of signal characteristica needed for interpretation must be determined and reported: Ultraviolet/Visible (UV/VIS), infrared (R), nuclear magnetic resonance (NMR), and mass spectra (MS) of purified active substance and molecular extinction at relevant wavelengths, must be determined and reported.
Določiti in navesti je treba naslednje spektre in preglednico značilnosti signalov, ki je potrebna za razlago: ultravijolični/vidni (UV/VIS), infrardeči (IR), nuklearna magnetna resonanca (NMR), masni spekter (MS) čiste aktivne snovi ter molekulsko ekstinkcijo pri določenih valovnih dolžinah.
The wavelengths at which UV/visible molecular extinction occurs are to be determined and reported and must include where appropriate a wavelength at the highest absorption value above 290 nm.
Določiti in navesti je treba valovne dolžine, pri katerih pride do molekulske ekstinkcije UV/VIS, vključno z valovno dolžino z najvišjo absorpcijsko vrednostjo nad 290 nm, kadar je to primerno.
In the case of active substances which are resolved optical isomers their optical purity must be measured and reported.
Če so aktivne snovi ločeni optični izomeri, je treba določiti in navesti njihovo optično čistost.
The UV/visible absorption spectra, IR, NMR and MS spectra, where necessary for the identification of the impurities considered to be of toxicological, ecotoxicological or environmental significance must be determined and reported.
Za opredelitev nečistoč, ki so pomembne s toksikološkega ali ekotoksikološkega vidika ali zaradi vpliva na okolje, je treba določiti in navesti njihove UV/VIS absorpcijske spektre, IR, NMR in MS spektre.
Solubility in water including effect of pH (4 to 10) on solubility
Topnost v vodi in vpliv vrednosti pH (4 do 10) na topnost
The water solubility of purified active substances under atmospheric pressure must be determined and reported in accordance with method A 6 of Regulation (EC) No 440/2008.
Topnost čistih aktivnih snovi v vodi pri normalnem zračnem tlaku je treba navesti v skladu z metodo A6 Uredbe (ES) št. 440/2008.
These water solubility determinations must be made in the neutral range (i.e. in distilled water in equilibrium with atmospheric carbon dioxide).
Topnost v vodi je treba določiti v nevtralnem območju (tj. v destilirani vodi v ravnovesju z atmosferskim ogljikovim dioksidom).
Where the active substance is capable of forming ions, determinations must also be made in the acidic range (pH 4 to 6) and in the alkaline range (pH 8 to 10), and be reported.
Kadar aktivna snov lahko ionizira, je treba določiti in navesti topnost tudi v kislem (pH 4 do 6) in alkalnem območju (pH 8 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 must be provided.
Kadar je aktivna snov v vodnem okolju stabilna, tako da topnosti v vodi ni mogoče določiti, je treba predložiti utemeljitev na osnovi podatkov testa.
Solubility in organic solvents
Topnost v organskih topilih
The solubility of the active substances as manufactured in the following organic solvents at 15 to 25 °C must be determined and reported if less than 250 g/kg; the temperature applied must be specified:
Če je topnost tehnične aktivne snovi manjša od 250 g/kg, jo je treba je določiti in navesti pri 15 °C do 25 °C v naslednjih organskih topilih; navesti je treba tudi temperaturo, pri kateri se je topnost določala:
Aliphatic hydrocarbon: preferably n-heptane,
alifatski ogljikovodik: po možnosti n-heptan,
Aromatic hydrocarbon: preferably xylene,
aromatski ogljikovodik: po možnosti ksilen,
Halogenated hydrocarbon: preferably 1,2-dichlorethane,
halogenirani ogljikovodik: po možnosti 1,2-dikloretan,
Alcohol: preferably methanol or isopropyl alcohol,
alkohol: po možnosti metanol ali izopropil alkohol,
Ketone: preferably acetone,
keton: po možnosti aceton,
Ester: preferably ethyl acetate.
ester: po možnosti etil acetat.
If for a particular active substance, one or more of these solvents are unsuitable (e.g. reacts with test material), alternative solvents can be used instead.
Če je za določeno aktivno snov eno ali več od navedenih topil neprimernih (npr. reagirajo s testno snovjo), se namesto njih lahko uporabijo druga ustrezna topila.
In such cases, the choices made must be justified in terms of their structure and polarity.
V takem primeru je izbiro topil treba utemeljiti z njihovo strukturo in polarnostjo.
Partition coefficient n-octanol/water including effect of pH (4 to 10)
Koeficient porazdelitve n-oktanol/voda in vpliv vrednosti pH (4 do 10)
The n-octanol/water partition coefficient of purified active substance must be determined and reported in accordance with method A 8 of Regulation (EC) No 440/2008.
Koeficient porazdelitve n-oktanol/voda za čiste aktivne snovi je treba določiti in navesti v skladu z metodo A8 Uredbe (ES) št. 440/2008.
The effect of pH (4 to 10) must be investigated when the substance is acidic or basic as defined by its pKa value (< 12 for acids, > 2 for bases).
Vpliv vrednosti pH (4 do 10) je treba raziskati, če je snov glede na vrednost pKa (< 12 za kisline, > 2 za baze) kisla ali bazična.
Stability in water, hydrolysis rate, photochemical degradation, quantum yield and identity of breakdown product(s), dissociation constant including effect of pH (4 to 9)
Stabilnost v vodi, stopnja hidrolize, fotokemična razgradnja, količina in identiteta razgradnih produktov, konstanta disociacije in vpliv vrednosti pH (4 do 9)
The hydrolysis rate of purified active substances (usually radiolabelled active substance, > 95 % purity), for each of the pH values 4, 7 and 9, under sterile conditions, in the absence of light, must be determined and reported in accordance with method C 7 of Regulation (EC) No 440/2008.
Stopnjo hidrolize čistih aktivnih snovi (običajno označenih z radioaktivnimi markerji, čistost > 95 %) je treba za vrednosti pH 4, 7 in 9 določiti in navesti v skladu z metodo C7 Uredbe (ES) št. 440/2008 v sterilnih pogojih in temi.
For substances with a low rate of hydrolysis, the rate can be determined at 50 °C, or another appropriate temperature.
Za snovi z nizko stopnjo hidrolize lahko stopnjo določimo pri 50 °C ali pri drugi primerni temperaturi.
If degradation is observed at 50 °C, degradation rate at another temperature must be determined, and an Arrhenius plot must be constructed to permit an estimate to be made of hydrolysis at 20 °C.
Če pride pri 50 °C do razgradnje, je treba stopnjo razgradnje določiti pri drugi temperaturi; izdelati je treba Arrheniusov diagram, s katerim se hidroliza lahko oceni pri 20 °C.
The identity of hydrolysis products formed and the rate constantly observed, must be reported.
Določiti in navesti je treba nastale produkte hidrolize in njihovo stalno razmerje.
The estimated DT50 value must also be reported.
Navesti je treba tudi ocenjeno vrednost DT50.
For compounds with a molar (decadic) absorption coefficient (ε) > 10 (1 × mol–1 × cm–1) at a wavelength λ ≥ 290 nm, direct phototransformation in purified (e.g. distilled) water at 20 to 25 °C, of purified active substance usually radio labelled using artificial light under sterile conditions, if necessary using a solubiliser, must be determined and reported.
Za spojine z molarnim (dekadnim) absorpcijskim koeficientom (ε) > 10 (1 × mol–1 × cm–1) pri valovni dolžini λ ≥ 290 nm je treba določiti in navesti direktno fototransformacijo čiste aktivne snovi, običajno označene z radioaktivnimi markerji, v čisti (npr. destilirani) vodi pri 20 °C do 25 °C z umetno svetlobo in pri sterilnih pogojih, po potrebi z uporabo topljenca.
Sensitisers such as acetone must not be used as a cosolvent or solubiliser.
Uporaba snovi, ki povečajo občutljivost (npr. acetona), kot dodatnega topila ali topljenca ni dovoljena.
The light source must simulate sunlight and be equipped with filters to exclude radiation at wavelengths λ < 290 nm.
Svetlobni vir mora posnemati sončno svetlobo in mora biti opremljen s filtri, ki preprečujejo sevanje valovnih dolžin λ < 290 nm.