natgillin/translations-raw huggingface dataset:
where a substance undergoes immediate disintegration and there are sufficient data on the cleavage products, or
je vdihavanje snovi malo verjetno in
relevant human exposure can be excluded in accordance with Annex XI Section 3.
je verjeten stik s kožo pri proizvodnji in/ali uporabi ter
The appropriate route shall be chosen on the following basis:
fizikalno-kemijske in toksikološke lastnosti kažejo na možnost znatne absorpcije skozi kožo.
Testing by the dermal route is appropriate if:
Testiranje pri vdihavanju je ustrezno, če je izpostavljenost ljudi pri vdihavanju verjetna ob upoštevanju parnega tlaka snovi in/ali možnosti izpostavljenosti aerosolom, delcem ali kapljicam, ki jih je mogoče vdihniti.
inhalation of the substance is unlikely, and
Za nanooblike se upošteva toksikokinetika in, kjer je ustrezno, čas, potreben za izločanje iz pljuč.
skin contact in production and/or use is likely, and
Registracijski zavezanec predlaga študijo subkronične strupenosti (90 dni) (Priloga IX, 8.6.2), če: pogostost in trajanje izpostavljenosti ljudi kažeta, da je primerna dolgodobna študija,
the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin.
in je izpolnjen eden od naslednjih pogojev:
Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.
drugi razpoložljivi podatki kažejo, da ima snov lahko nevarno lastnost, ki je ni mogoče odkriti v študiji kratkodobne strupenosti, ali
For nanoforms toxicokinetics shall be considered including recovery period and, where relevant, lung clearance.
ustrezno oblikovane toksikokinetične študije odkrivajo kopičenje snovi ali njenih metabolitov v nekaterih tkivih ali organih, ki jih v študiji kratkodobne strupenosti morda ne bi odkrili, vendar bi lahko povzročili škodljive učinke po daljši izpostavljenosti.
The sub-chronic toxicity study (90 days) (Annex IX, Section 8.6.2) shall be proposed by the registrant if: the frequency and duration of human exposure indicates that a longer term study is appropriate;
Registracijski zavezanec predlaga nadaljnje študije ali pa jih lahko zahteva Agencija v skladu s členom 40 ali 41, če:
and one of the following conditions is met:
v 28- ali 90-dnevni študiji ni mogoče opredeliti NOAEL, razen če je razlog za to odsotnost škodljivih strupenih učinkov, ali
other available data indicate that the substance may have a dangerous property that cannot be detected in a short-term toxicity study, or
strupenost vzbuja posebno zaskrbljenost (npr. povzroča resne/hude učinke), ali
appropriately designed toxicokinetic studies reveal accumulation of the substance or its metabolites in certain tissues or organs which would possibly remain undetected in a short-term toxicity study but which are liable to result in adverse effects after prolonged exposure.
so razpoložljivi dokazi za indikacije učinka neustrezni za toksikološki opis in/ali opredelitev tveganja.
Further studies shall be proposed by the registrant or may be required by the Agency in accordance with Article 40 or 41 in case of:
V teh primerih utegne biti primerneje izvesti posebne toksikološke študije, ki so zasnovane za raziskavo teh učinkov (npr. imunotoksičnost, nevrotoksičnost in, posebej za nanooblike, posredna genotoksičnost), ali
failure to identify a NOAEL in the 28 or the 90 days study, unless the reason for the failure to identify a NOAEL is absence of adverse toxic effects, or
način izpostavljenosti, uporabljen v začetni študiji strupenosti pri ponovljenih odmerkih, ni bil primeren z vidika pričakovanega načina izpostavljenosti ljudi in ekstrapolacije z enega načina na drugega ni mogoče izvesti, ali
toxicity of particular concern (e.g. serious/severe effects), or
obstaja posebna zaskrbljenost v zvezi z izpostavljenostjo (npr. uporaba v izdelkih za široko potrošnjo, ki vodi k ravnem izpostavljenosti blizu ravnem odmerka, pri katerih se lahko pričakuje strupenost za ljudi), ali
indications of an effect for which the available evidence is inadequate for toxicological and/or risk characterisation.
v 28- ali 90-dnevni študiji niso bili odkriti učinki, dokazani pri snoveh, ki so v molekulski strukturi jasno povezane s preučevano snovjo.“
In such cases it may also be more appropriate to perform specific toxicological studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity, and in particular for nanoforms indirect genotoxicity), or
pododdelek 8.8 se nadomesti z naslednjim:
the route of exposure used in the initial repeated dose study was inappropriate in relation to the expected route of human exposure and route-to-route extrapolation cannot be made, or
Toksikokinetika
particular concern regarding exposure (e.g. use in consumer products leading to exposure levels which are close to the dose levels at which toxicity to humans may be expected), or
Ocena toksikokinetičnega vedenja snovi v obsegu, ki ga je mogoče izpeljati iz ustreznih razpoložljivih informacij.
effects shown in substances with a clear relationship in molecular structure with the substance being studied, were not detected in the 28 or the 90 days study.’;
Študijo toksikokinetike za nanooblike z majhno hitrostjo raztapljanja v bioloških medijih predlaga registracijski zavezanec ali lahko zahteva Agencija v skladu s členom 40 ali 41, če take ocene ni mogoče izvesti na podlagi ustreznih razpoložljivih informacij, vključno iz študije, izvedene v skladu s točko 8.6.1.
Subsection 8.8. is replaced by the following:
Izbira študije je odvisna od preostalih informacijskih vrzeli in rezultatov ocene kemijske varnosti.“
Toxicokinetics
točka 9.1.3 se nadomesti z naslednjim:
Assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from the relevant available information.
„9.1.3
For nanoforms without high dissolution rate in biological media a toxicokinetics study shall be proposed by the registrant or may be required by the Agency in accordance with Article 40 or 41 in case such an assessment cannot be performed on the basis of relevant available information, including from the study conducted in accordance with 8.6.1.
Testiranje kratkodobne strupenosti za ribe: registracijski zavezanec lahko upošteva testiranje dolgodobne namesto kratkodobne strupenosti.
The choice of the study will depend on the remaining information gaps and the results of the chemical safety assessment.’;
olajševalni dejavniki kažejo na majhno verjetnost pojava strupenosti za vodno okolje, na primer, če je snov zelo slabo topna v vodi ali ni verjetno, da bo snov prešla biološke membrane, ali
Point 9.1.3 is replaced by the following:
je na razpolago študija dolgodobne strupenosti za vodno okolje za ribe.
‘9.1.3.
Testiranje dolgodobne strupenosti za vodno okolje, kakor je opisano v Prilogi IX, se upošteva, če ocena kemijske varnosti v skladu s Prilogo I kaže potrebo po preiskavi nadaljnjih učinkov na vodne organizme.
Short-term toxicity testing on fish: the registrant may consider long-term toxicity testing instead of short-term.
Izbira ustreznih testov je odvisna od rezultatov ocene kemijske varnosti.
there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance the substance is highly insoluble in water or the substance is unlikely to cross biological membranes, or
Študija dolgodobne strupenosti za vodno okolje za ribe (Priloga IX, pododdelek 9.1.6) se upošteva, če je snov slabo topna v vodi, ali pri nanooblikah, če imajo majhno hitrost raztapljanja v ustreznih testnih medijih.“
a long-term aquatic toxicity study on fish is available.
točka 9.1.4 se nadomesti z naslednjim:
Long-term aquatic toxicity testing as described in Annex IX shall be considered if the chemical safety assessment according to Annex I indicates the need to investigate further effects on aquatic organisms.
„9.1.4
The choice of the appropriate test(s) will depend on the results of the chemical safety assessment.
Testiranje inhibicije respiracije aktivnega blata
The long-term aquatic toxicity study on fish (Annex IX, Section 9.1.6) shall be considered if the substance is poorly water soluble, or for nanoforms if they have low dissolution rate in the relevant test media.’;
ni emisij na čistilno napravo ali
Point 9.1.4. is replaced by the following:
olajševalni dejavniki kažejo na majhno verjetnost pojava mikrobiološke strupenosti, na primer če je snov zelo slabo topna v vodi, ali
‘9.1.4.
se ugotovi, da je snov takoj biološko razgradljiva in so uporabljene testne koncentracije v območju koncentracij, ki jih je mogoče pričakovati v dotoku na čistilno napravo.
Activated sludge respiration inhibition testing
Študija se lahko nadomesti s testom zaviranja nitrifikacije, če razpoložljivi podatki kažejo, da je snov verjetno zaviralec rasti ali dejavnosti mikroorganizmov, zlasti nitrifikacijskih bakterij.“;
there is no emission to a sewage treatment plant, or
pododdelek 9.2 se nadomesti z naslednjim:
there are mitigating factors indicating that microbial toxicity is unlikely to occur, for instance the substance is highly insoluble in water, or
Razkroj
the substance is found to be readily biodegradable and the applied test concentrations are in the range of concentrations that can be expected in the influent of a sewage treatment plant.
Upošteva se nadaljnje preskušanje razkroja, če ocena kemijske varnosti v skladu s Prilogo I kaže potrebo po nadaljnji preiskavi razkroja snovi.
The study may be replaced by a nitrification inhibition test if available data show that the substance is likely to be an inhibitor of microbial growth or function, in particular nitrifying bacteria.’;
Pri netopnih nanooblikah ali nanooblikah z majhno hitrostjo raztapljanja se pri takih testih upoštevajo morfološke spremembe (npr. ireverzibilne spremembe velikosti, oblike in površinskih lastnosti delcev, izguba premaza), kemijske spremembe (npr. oksidacija, redukcija) in druge vrste abiotskega razkroja (npr. fotoliza).
Subsection 9.2. is replaced by the following:
Izbira ustreznih testov je odvisna od rezultatov ocene kemijske varnosti.“
Degradation
točka 9.2.2 se nadomesti z naslednjim:
Further degradation testing shall be considered if the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance.
„9.2.2
For nanoforms that are not soluble, nor have high dissolution rate, such test(s) shall consider morphological transformation (e.g. irreversible changes in particle size, shape and surface properties, loss of coating), chemical transformation (e.g. oxidation, reduction) and other abiotic degradation (e.g. photolysis).
Abiotski
The choice of the appropriate test(s) will depend on the results of the chemical safety assessment.’;
Hidroliza kot funkcija pH
Section 9.2.2 is replaced by the following:
je snov takoj biološko razgradljiva ali
‘9.2.2.
je snov zelo slabo topna v vodi.
Abiotic
točka 9.3.1 se nadomesti z naslednjim:
Hydrolysis as a function of pH.
Preverjanje adsorpcije/desorpcije
the substance is readily biodegradable, or
se na podlagi fizikalno-kemijskih lastnosti lahko pričakuje, da bo imela snov nizek adsorpcijski potencial (npr. snov ima nizek porazdelitveni koeficient oktanol/voda), ali
the substance is highly insoluble in water.
snov in njeni zadevni razkrojni produkti hitro razpadejo.
Point 9.3.1. is replaced by the following:
Pri nanooblikah mora biti uporaba katere koli fizikalno-kemijske lastnosti (npr. porazdelitveni koeficient oktanol/voda) kot razloga za opustitev študije primerno utemeljena glede na njeno ustreznost v zvezi z nizkim adsorpcijskim potencialom.“
Adsorption/desorption screening
Priloga IX k Uredbi (ES) št. 1907/2006 se spremeni:
based on the physicochemical properties the substance can be expected to have a low potential for adsorption (e.g. the substance has a low octanol-water partition coefficient), or
v uvodnem besedilu se za drugim odstavkom doda naslednje besedilo:
the substance and its relevant degradation products decompose rapidly.
točka 8.6.2 se nadomesti z naslednjim:
For nanoforms, use of any physicochemical property (e.g. octanol-water partition coefficient) as a reason for waiving the study shall include adequate justification of its relevance to low potential for adsorption.’;
„8.6.2
Annex IX to Regulation (EC) No 1907/2006 is amended as follows:
Študija subkronične strupenosti (90 dni), ena vrsta, glodalec, moškega in ženskega spola, najprimernejši način vnosa, ob upoštevanju verjetnega načina izpostavljenosti ljudi.
In the introductory text, the following text is added after the second paragraph:
Študije subkronične toksičnosti (90 dni) ni treba izvesti, če:
Point 8.6.2 is replaced by the following:
je na voljo zanesljiva študija kratkodobne strupenosti (28 dni), ki kaže resne učinke strupenosti v skladu s kriteriji za razvrstitev snovi kot R48, za katero opažena NOAEL (28 dni) z uporabo ustreznega dejavnika negotovosti omogoča ekstrapolacijo na NOAEL (90 dni) za enak način izpostavljenosti, ali
‘8.6.2.
je na voljo zanesljiva študija kronične strupenosti, v kateri so bile uporabljene ustrezne vrste in načini vnosa, ali
Sub-chronic toxicity study (90-day), one species, rodent, male and female, most appropriate route of administration, having regard to the likely route of human exposure.
snov takoj razpade in je na voljo dovolj podatkov o produktih razpada (tako za sistemske učinke kot tudi za učinke na mestu vnosa), ali
The sub-chronic toxicity study (90 days) does not need to be conducted if:
snov ni reaktivna, ni topna in je ni mogoče vdihniti ter ne obstajajo dokazi o absorpciji in strupenosti v 28-dnevnem ‚mejnem testu‘, zlasti če je tak vzorec povezan z omejeno izpostavljenostjo ljudi.
a reliable short-term toxicity study (28 days) is available showing severe toxicity effects according to the criteria for classifying the substance as R48, for which the observed NOAEL-28 days, with the application of an appropriate uncertainty factor, allows the extrapolation towards the NOAEL-90 days for the same route of exposure, or
je verjeten stik s kožo pri proizvodnji in/ali uporabi in
a reliable chronic toxicity study is available, provided that an appropriate species and route of administration were used, or
fizikalno-kemijske lastnosti kažejo na znatno absorpcijo skozi kožo ter
a substance undergoes immediate disintegration and there are sufficient data on the cleavage products (both for systemic effects and effects at the site of uptake), or
je izpolnjen eden od naslednjih pogojev:
the substance is unreactive, insoluble and not inhalable and there is no evidence of absorption and no evidence of toxicity in a 28-day “limit test”, particularly if such a pattern is coupled with limited human exposure.
pri testu akutne dermalne toksičnosti se opazi strupenost pri nižjih odmerkih kot pri testu oralne toksičnosti, ali
skin contact in production and/or use is likely; and
pri študijah draženja kože in/ali oči se opazijo sistemski učinki ali drugi dokazi za absorpcijo, ali
the physicochemical properties suggest a significant rate of absorption through the skin; and
testi in vitro kažejo znatno absorpcijo skozi kožo, ali
one of the following conditions is met:
za strukturno sorodne snovi se ugotovi znatna dermalna toksičnost ali prodiranje skozi kožo.
toxicity is observed in the acute dermal toxicity test at lower doses than in the oral toxicity test, or
Testiranje z vdihavanjem je ustrezno, če:
systemic effects or other evidence of absorption is observed in skin and/or eye irritation studies, or
je izpostavljenost ljudi pri vdihavanju verjetna ob upoštevanju parnega tlaka snovi in/ali možnosti izpostavljenosti aerosolom, delcem ali kapljicam, ki jih je mogoče vdihniti.
in vitro tests indicate significant dermal absorption, or
Registracijski zavezanec predlaga dodatne študije ali pa jih lahko zahteva Agencija v skladu s členom 40 ali 41, če:
significant dermal toxicity or dermal penetration is recognised for structurally-related substances.
v 90-dnevni študiji ni mogoče opredeliti NOAEL, razen če je razlog za to odsotnost škodljivih strupenih učinkov, ali
Testing by the inhalation route is appropriate if:
obstaja posebna zaskrbljenost v zvezi z izpostavljenostjo (npr. uporaba v izdelkih za široko potrošnjo, ki vodi k ravnem izpostavljenosti blizu ravnem odmerka, pri katerih se lahko pričakuje strupenost za ljudi).“
exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.
točka 9.2.1.2 se nadomesti z naslednjim:
Further studies shall be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 in case of:
„9.2.1.2
failure to identify a NOAEL in the 90 days study unless the reason for the failure to identify a NOAEL is absence of adverse toxic effects, or
Simulacijsko testiranje o dokončnem razkroju v površinski vodi
particular concern regarding exposure (e.g. use in consumer products leading to exposure levels which are close to the dose levels at which toxicity to humans may be expected).’;
Študije ni treba izvesti, če:
Point 9.2.1.2. is replaced by the following:
so snovi zelo slabo topne v vodi ali
‘9.2.1.2.
če je snov takoj biološko razgradljiva.
Simulation testing on ultimate degradation in surface water
pododdelek 9.3 se nadomesti z naslednjim:
The study need not be conducted if:
Usoda in vedenje v okolju
the substances is highly insoluble in water, or
Kopičenje snovi v vodnih vrstah, najprimerneje v ribah
the substance is readily biodegradable.
ima snov nizek potencial za kopičenje v organizmih (na primer log Kow ≤ 3) in/ali prehajanje skozi biološke membrane, ali
Subsection 9.3. is replaced by the following:
neposredna in posredna izpostavljenost vodnega prostora nista verjetni.
Fate and behaviour in the environment
Pri nanooblikah mora biti uporaba katere koli fizikalno-kemijske lastnosti (npr. porazdelitveni koeficient oktanol/voda, hitrost raztapljanja, disperzijska stabilnost) kot razloga za opustitev študije primerno utemeljena glede na njeno ustreznost v zvezi z nizkim potencialom za bioakumulacijo ali malo verjetno neposredno in posredno izpostavljenostjo vodnega prostora.
Bioaccumulation in aquatic species, preferably fish
Nadaljnje informacije o adsorpciji/desorpciji, ki so odvisne od rezultatov študije, zahtevane v Prilogi VIII
the substance has a low potential for bioaccumulation (for instance a log Kow ≤ 3) and/or a low potential to cross biological membranes, or
se na podlagi fizikalno-kemijskih lastnosti lahko pričakuje, da bo imela snov nizek adsorpcijski potencial (npr. snov ima nizek porazdelitveni koeficient oktanol/voda), ali
direct and indirect exposure of the aquatic compartment is unlikely.
snov in njeni razkrojni produkti hitro razpadejo.
For nanoforms, use of any physicochemical property (e.g. octanol water partition coefficient, dissolution rate, dispersion stability) as a reason for waiving the study shall include adequate justification of its relevance to low potential for bioaccumulation or unlikely direct and indirect exposure of the aquatic compartment.
Pri nanooblikah mora biti uporaba katere koli fizikalno-kemijske lastnosti (npr. porazdelitveni koeficient oktanol/voda, hitrost raztapljanja, disperzijska stabilnost) kot razloga za opustitev študije primerno utemeljena glede na njeno ustreznost v zvezi z nizkim adsorpcijskim potencialom.“
Further information on adsorption/desorption depending on the results of the study required in Annex VIII
pododdelek 9.4 se nadomesti z naslednjim:
based on the physicochemical properties, the substance can be expected to have a low potential for adsorption (e.g. the substance has a low octanol water partition coefficient), or
Učinki na kopenske organizme
the substance and its degradation products decompose rapidly.
Teh študij ni treba izvesti, če neposredna in posredna izpostavljenost tal nista verjetni.
For nanoforms, use of any physicochemical property (e.g. octanol water partition coefficient, dissolution rate, dispersion stability) as a reason for waiving the study shall include adequate justification of its relevance to low potential for adsorption.’;
Za oceno izpostavljenosti organizmov v tleh se v odsotnosti podatkov o strupenosti za organizme v tleh lahko uporabi metoda uravnotežene porazdelitve.
Subsection 9.4 is replaced by the following:
Kadar se za nanooblike uporablja metoda uravnotežene porazdelitve, se to znanstveno utemelji.
Effects on terrestrial organisms
Izbira ustreznih testov je odvisna od izida ocene kemijske varnosti.
These studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely.
Predvsem za snovi, ki imajo visoko zmožnost adsorpcije v tla ali so zelo obstojne, upošteva registracijski zavezanec testiranje dolgodobne namesto kratkodobne strupenosti.“
In the absence of toxicity data for soil organisms, the equilibrium partitioning method may be applied to assess the hazard to soil organisms.
Priloga X k Uredbi (ES) št. 1907/2006 se spremeni:
Where the equilibrium partitioning method is applied to nanoforms, this shall be scientifically justified.
točka 8.6.3 se nadomesti z naslednjim:
The choice of the appropriate tests depends on the outcome of the chemical safety assessment.
„8.6.3
In particular for substances that have a high potential to adsorb to soil or that are very persistent, the registrant shall consider long-term toxicity testing instead of short-term.’;
Registracijski zavezanec lahko predlaga dolgodobno študijo strupenosti pri ponovljenih odmerkih (≥ 12 mesecev) ali jo lahko zahteva Agencija v skladu s členom 40 ali 41, če pogostost in trajanje izpostavljenosti ljudi kažeta, da je primerna dolgodobna študija in je bil izpolnjen eden od naslednjih pogojev:
Annex X to Regulation (EC) No 1907/2006 is amended as follows:
v 28- ali 90-dnevni študiji so bili opaženi resni ali hudi učinki strupenosti, ki povzročajo posebno zaskrbljenost, razpoložljivi dokazi pa so neustrezni za oceno strupenosti ali opredelitev tveganja, ali
Point 8.6.3. is replaced by the following:
v 28- ali 90-dnevni študiji niso bili odkriti učinki, dokazani pri snoveh, ki so v molekulski strukturi jasno povezane s preučevano snovjo, ali
‘8.6.3.
ima snov lahko nevarno lastnost, ki je ni mogoče odkriti v 90-dnevni študiji.
A long-term repeated toxicity study (≥ 12 months) may be proposed by the registrant or required by the Agency in accordance with Articles 40 or 41 if the frequency and duration of human exposure indicates that a longer term study is appropriate and one of the following conditions is met:
Če so v registraciji zajete nanooblike, se pri ugotavljanju, ali je izpolnjen eden od zgoraj navedenih pogojev, upoštevajo fizikalno-kemijske lastnosti, zlasti velikost, oblika in drugi morfološki parametri delcev, površinska funkcionalizacija in velikost površine ter molekulska struktura.“
serious or severe toxicity effects of particular concern were observed in the 28-day or 90-day study for which the available evidence is inadequate for toxicological evaluation or risk characterisation, or
Priloga XI k Uredbi (ES) št. 1907/2006 se spremeni:
effects shown in substances with a clear relationship in molecular structure with the substance being studied were not detected in the 28-day or 90-day study, or
v uvodnem besedilu se za zadnjim odstavkom doda naslednje besedilo:
the substance may have a dangerous property that cannot be detected in a 90-day study.
„Zahteve v tej prilogi, ki so specifične za nanooblike, se uporabljajo brez poseganja v zahteve, ki veljajo za druge oblike snovi.“;
If nanoforms are covered by the registration, physicochemical characteristics, in particular particle size, shape and other morphological parameters, surface functionalisation and surface area, as well as molecular structure shall be taken into consideration when determining if one of the conditions above are met.’;
točka 1.1.3 se nadomesti z naslednjim:
Annex XI to Regulation (EC) No 1907/2006 is amended as follows:
„1.1.3
In the introductory text, the following text is added after the last paragraph:
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