natgillin/translations-raw huggingface dataset:
Stolpec 1 te priloge določa zahteve po standardnih podatkih za vse snovi, ki so proizvedene ali uvožene v količini 1 tone ali več v skladu s
Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in quantities of 1 tonne or more in accordance with
členom 13(1)(a)
Article 13
Stolpec 2 te priloge navaja posebna pravila, po katerih se lahko zahtevani standardni podatki opuščajo, nadomestijo z drugimi podatki, zagotovijo na drugačni stopnji ali drugače prilagodijo.
Column 2 of this Annex lists specific rules according to which the required standard information may be omitted, replaced by other information, provided at a different stage or adapted in another way.
Če so izpolnjeni pogoji, pod katerimi stolpec 2 te priloge dovoljuje prilagoditve, prijavitelj to dejstvo in razloge za vsako prilagoditev jasno navede pod ustreznim naslovom v registracijski dokumentaciji.
If the conditions are met under which column 2 of this Annex allows adaptations, the registrant shall clearly state this fact and the reasons for each adaptation under the appropriate headings in the registration dossier.
Na ravni te priloge mora prijavitelj predložiti predlog in časovni razpored za izpolnjevanje zahtev po podatkih v tej prilogi v skladu s členom 13(1)(a), kjer se zahtevajo preskusi na vretenčarjih.
At the level of this Annex, the registrant must submit a proposal and a time schedule for fulfilling the information requirements of this Annex in accordance with Article 13(1)(a) where this involves tests on vertebrate animals.
Poleg teh posebnih pravil lahko prijavitelj prilagodi zahtevane standardne podatke iz stolpca 1 te priloge v skladu s splošnimi pravili iz Priloge IX.
In addition to these specific rules, a registrant may adapt the required standard information set out in column 1 of this Annex according to the general rules contained in Annex IX.
Tudi v tem primeru mora prijavitelj jasno navesti razloge za vsako odločitev o prilagoditvi standardnih podatkov pod ustreznimi naslovi v registracijski dokumentaciji, ki se nanašajo na ustrezno(-a) posebno(-a) pravilo(-a) v stolpcu 2 ali prilogah IX in X Opomba: prav tako veljajo pogoji za nezahtevanost določenega preskusa, ki so določeni v ustreznih preskusnih metodah Priloge X in ki se ne ponavljajo v stolpcu 2.
In this case as well, he shall clearly state the reasons for any decision to adapt the standard information under the appropriate headings in the registration dossier referring to the appropriate specific rule(s) in column 2 or in Annexes IX or X Note: conditions for not requiring a specific test that are set out in the appropriate test methods in Annex X itself that are not repeated in column 2, also apply.
Kadar za določene končne točke podatki niso zagotovljeni zaradi drugih razlogov, kakor so tisti iz stolpca 2 te priloge ali iz Priloge IX, je treba jasno navesti tudi to dejstvo in razloge.
When, for certain endpoints, information is not provided for other reasons than those mentioned in column 2 of this Annex or in Annex IX, this fact and the reasons shall also be clearly stated.
podatki o fizikalno-kemijskih lastnostih snovi
information on the physicochemical properties of the substance
stolpec 1
Column 1
zahtevani standardni podatki
Standard information required
stolpec 2
Column 2
posebna pravila za prilagoditev iz stolpca 1
Specific rules for adaptation from Column 1
Stanje snovi pri 20 oC in 101,3 kPa
State of the substance at 20o C and 101,3 kPa
Za trdne in tekoče snovi s tališčem/lediščem pod 0 °C študije ni treba izvesti.
The study does not need to be conducted for solids and liquids with a melting/freezing point below 0 °C.
Študije ni treba izvesti za:
The study does not need to be conducted:
– trdne snovi, ki se bodisi talijo nad 360 °C bodisi razpadejo pred vrenjem.
– for solids which either melt above 360 °C or decompose before boiling.
V teh primerih se lahko oceni ali izmeri vrelišče pod znižanim tlakom; ali
In such cases the boiling point under reduced pressure may be estimated or measured; or
– za snovi, ki razpadejo pred vrenjem (npr. avtooksidacija, prerazporeditev, razkroj, razgradnja itd.).
– for substances which decompose before boiling (e.g. auto-oxidation, rearrangement, degradation, decomposition, etc.).
Relativna gostota
Relative density
– je snov stabilna zgolj v raztopini posebnega topila, gostota raztopine pa je podobna gostoti topila.
– the substance is only stable in solution in a particular solvent and the solution density is similar to that of the solvent.
V takšnih primerih zadostuje navedba, ali je gostota raztopine višja ali nižja od gostote topila; ali
In such cases, an indication of whether the solution density is higher or lower than the solvent density is sufficient; or
– je snov plin.
– the substance is a gas.
V tem primeru je treba izvesti oceno na podlagi izračuna iz njene molekulske mase in zakonov o idealnem plinu.
In this case, an estimation based on calculation shall be made from its molecular weight and the Ideal Gas Laws.
Parni tlak
Vapour pressure
– se opazi prehod (sprememba fizikalnega stanja ali razgradnja).
– a transition (change of physical state or decomposition) is observed.
Nato je treba vključiti naslednje podatke: vrsta prehoda, temperatura, pri kateri nastopi prehod pri atmosferskem tlaku, parni tlak pri 10 in 20 °C nad to temperaturo (razen če gre za prehod iz trdnega v plinasto stanje); ali
The following information should then be included: nature of the transition, temperature at which the transition occurs at atmospheric pressure, vapour pressure at 10 and 20 °C above this temperature (unless the transition is from solid to gas); or
– je tališče nad 300 °C.
– the melting point is above 300 °C.
Če je tališče med 200 in 300 °C, zadostuje mejna vrednost na podlagi meritve ali priznana metoda izračunavanja.
If the melting point is between 200 °C and 300 °C, a limit value based on measurement or a recognised calculation method is sufficient.
Površinska napetost
Surface tension
- je topnost v vodi pod 1 mg/l pri 20 °C ali
– the water solubility is below 1 mg/l at 20 °C or
- če snov tvori micele v ustreznih območjih koncentracije za preskušanje.
– the substance forms micelles in the relevant concentration range for testing.
Topnost v vodi
Water solubility
– je snov hidrolitsko nestabilna (razpolovna doba manj kot 12 ur); ali
– the substance is hydrolytically unstable (half-life less than 12 hours); or
Porazdelitveni koeficient n-oktanol/voda
Partition coefficient n-octanol/water
Študije ni treba izvesti, če je snov anorganska.
The study does not need to be conducted if the substance is inorganic.
Če preskusa ni mogoče izvesti (npr. snov razpade, je na površini zelo aktivna, med izvajanjem preskusa reagira nasilno oziroma se v vodi ali oktanolu ne raztopi oziroma ni mogoče pridobiti dovolj čiste snovi), je treba zagotoviti izračunano vrednost za log P in podrobnosti metode izračunavanja.
If the test cannot be performed (e.g. the substance decomposes, has a high surface activity, reacts violently during the performance of the test or does not dissolve in water or in octanol, or it is not possible to obtain a sufficiently pure substance), a calculated value for log P as well as details of the calculation method shall be provided.
je snov anorganska; ali
the substance is inorganic; or
snov vsebuje samo hlapne organske komponente s plameniščem nad 100 °C za vodne raztopine; ali
the substance only contains volatile organic components with flash-points above 100 °C for aqueous solutions; or
je plamenišče mogoče natančno napovedati z uporabo podatkov za obstoječe opredeljene materiale.
the flash-point can be accurately predicted by interpolation from existing characterised materials.
Študije ni treba izvesti, če:
The study does not need to be conducted:
gre za trdno snov, ki je eksplozivna ali ima piroforne lastnosti.
if the substance is a solid which possesses explosive or pyrophoric properties.
Te lastnosti se morajo vedno upoštevati pred upoštevanjem vnetljivosti; ali
These properties should always be considered before considering flammability; or
za pline, če je koncentracija vnetljivega plina v mešanici z nevtralnimi plini tako nizka, da je koncentracija, ko jo zmešamo z zrakom, stalno pod spodnjo mejo; ali
for gases, if the concentration of the flammable gas in a mixture with inert gases is so low that, when mixed with air, the concentration is all time below the lower limit; or
za snovi, ki se spontano vžgejo, ko pridejo v stik z zrakom.
for substances which spontaneously ignite when in contact with air.
ni kemijskih skupin, povezanih z eksplozivnostjo, ki bi bile prisotne v molekuli; ali
there are no chemical groups associated with explosive properties present in the molecule; or
snov vsebuje kemijske skupine, povezane z eksplozivnostjo, ki vključujejo kisik, in so izračunane kisikove razmere manj kot –200; ali
the substance contains chemical groups associated with explosive properties which include oxygen and the calculated oxygen balance is less than –200; or
organska snov ali homogena mešanica organskih snovi vsebuje kemijske skupine, povezane z eksplozivnostjo, vendar je eksotermna energija razgradnje manj kot 500 J/g in je začetek eksotermne razgradnje pod 500 ºC; ali
the organic substance or a homogenous mixture of organic substances contains chemical groups associated with explosive properties, but the exothermic decomposition energy is less than 500 J/g and the onset of exothermic decomposition is below 500 ºC; or
za mešanice anorganskih oksidantskih snovi (oddelek 5.1 UN) z organskimi materiali, koncentracija anorganske oksidantske snovi je:
for mixtures of inorganic oxidising substances (UN Division 5.1) with organic materials, the concentration of the inorganic oxidising substance is:
manj kot 15 % po masi, če je uvrščena v embalažno skupino UN I (visoka nevarnost) ali II (srednja nevarnost)
less than 15%, by mass, if assigned to UN Packaging Group I (high hazard) or II (medium hazard)
Opomba: Če je eksotermna energija razgradnje organskih materialov manj kot 800 J/g, se ne zahteva niti preskus za širjenje eksplozije niti preskus občutljivosti za eksplozivne šoke.
Note: Neither a test for propagation of detonation nor a test for sensitivity to detonative shock is required if the exothermic decomposition energy of organic materials is less than 800 J/g.
Temperatura samovžiga
Self-ignition temperature
je snov eksplozivna ali se vžge spontano na zraku pri sobni temperaturi; ali
if the substance is explosive or ignites spontaneously with air at room temperature; or
za tekočine, ki na zraku niso vnetljive, npr. brez plamenišča do 200 °C; ali
for liquids non flammable in air, e.g. no flash point up to 200 °C; or
za pline, ki nimajo območja vnetljivosti; ali
for gases having no flammable range; or
je snov eksplozivna; ali
the substance is explosive; or
je snov zelo vnetljiva; ali
the substance is highly flammable; or
je snov organski peroksid; ali
the substance is an organic peroxide; or
snov ni sposobna reagirati eksotermno z vnetljivimi materiali, na primer na podlagi kemijske strukture (npr. organske snovi, ki ne vsebujejo kisika ali halogenih atomov in ti elementi niso kemijsko vezani na dušik ali kisik, ali anorganske snovi, ki ne vsebujejo kisika ali halogenih atomov).
the substance is incapable of reacting exothermically with combustible materials, for example on the basis of the chemical structure (e.g. organic substances not containing oxygen or halogen atoms and these elements are not chemically bonded to nitrogen or oxygen, or inorganic substances not containing oxygen or halogen atoms).
Popolnega preskusa ni treba izvesti za trdne snovi, če predhodni preskus jasno kaže, da je preskusna snov oksidativna.
The full test does not need to be conducted for solids if the preliminary test clearly indicates that the test substance has oxidising properties.
Treba se je izogibati preskušanju
toxicological information
Draženje kože ali jedkost za kožo
Skin irritation or skin corrosion
3. in 4. koraka ni treba izvesti, če:
Steps 3 and 4 do not need to be conducted if:
Ocena te končne točke vsebuje naslednje zaporedne korake:
The assessment of this endpoint shall comprise the following consecutive steps:
(1) ocena razpoložljivih podatkov o človeku in živali,
(1) an assessment of the available human and animal data,
(2) ocena kisle ali alkalne
(2) an assessment of the acid or alkaline
podatki, ki so na voljo, kažejo, da so izpolnjena merila za razvrstitev kot
the available information indicates that the criteria are met for classification as
za kožo ali dražilna za oči
to the skin or irritating to eyes
snov vnetljiva na zraku pri sobni temperaturi ali
substance is flammable in air at room temperature; or
– je snov
– the substance is
razvrščena kot
classified as
Draženje oči
Eye irritation
3. koraka ni treba izvesti, če:
Step 3 does not need to be conducted if:
snov vnetljiva na zraku pri sobni
substance is flammable in air at room
Preobčutljivost kože
Skin sensitisation
2. koraka ni treba izvesti, če:
Step 2 does not need to be conducted if:
(1) ocena razpoložljivih podatkov o človeku
(1) an assessment of the available
razvrstiti kot preobčutljivost kože ali jedkost
should be classified for skin sensitisation or corrosivity
– je snov močna kislina (pH < 2.0) ali baza (pH > 11.5); ali
– the substance is a strong acid (pH < 2.0) or base (pH > 11.5); or
– je snov vnetljiva na zraku pri sobni
– the substance is flammable in air at room
Lokalna analiza limfnih vozlov (
The Murine Local Lymph Node Assay (
) pri glodavcih je metoda prve izbire za testiranje in vivo.
) is the first-choice method for in vivo testing.
Le v izjemnih okoliščinah je treba uporabiti drug test.
Only in exceptional circumstances should another test be used.
Pri pozitivnem rezultatu je treba razmisliti o dodatnih študijah mutagenosti.
Further mutagenicity studies shall be considered in case of a positive result.
Študije običajno ni treba izvesti, če je znano, da spada snov v skupino rakotvornosti 1 ali 2 ali skupino mutagenosti 1, 2 ali 3.
A study does not usually need to be conducted if the substance is known to be carcinogenic category 1 or 2 or mutagenic category 1, 2 or 3.
Če so merila za pregled iz točke (a) Priloge 1c za rakotvornost in mutagenost izpolnjena in podjetje ne uvede in priporoči ustreznega obvladovanja tveganja, potem registracijski zavezanec izvede nadaljnje ustrezno testiranje mutagenosti.
If the screening criteria in point (a) of Annex Ic are fulfilled for carcinogenicity and mutagenicity and the company does not introduce and recommend appropriate risk management then suitable further mutagenicity testing shall be performed by the registrant.
– je snov jedka ali
the substance is corrosive; or
– je snov vnetljiva na zraku pri sobni temperaturi.
the substance is flammable in air at room temperature.
Študije ni treba izvesti, če je na voljo študija o akutni strupenosti z vdihavanjem (6.5.2) ali dermalno (6.5.3).
The study need not be conducted if a study on acute toxicity by the inhalation route (6.5.2) or dermal route (6.5.3) is available.
ekotoksikološki podatki
ecotoxicological information
Strupenost vode
Aquatic toxicity
Preskušanje kratkotrajne strupenosti za
Short-term toxicity testing on
nevretenčarje (najprimernejša vrsta je vodna bolha)
invertebrates (preferred species
lahko upošteva preskušanje dologoročne namesto kratkoročne strupenosti.
The registrant may consider long-term toxicity testing instead of short-term.
obstajajo olajševalni dejavniki, ki kažejo na to, da strupenost vode ni verjetna, na primer če je snov zelo netopna v vodi ali ni verjetno, da bo snov predrla biološke membrane; ali
there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes; or
je na voljo kratkoročna ali dolgoročna študija za ribe; ali
a short-term or long-term study on fish is available; or
– je na
– a long-term
Študija dolgoročne strupenosti vode za vodno bolho (Priloga VII, 7.1.5) se upošteva, če je snov v vodi slabo
The long-term aquatic toxicity study on Daphnia (Annex VII, 7.1.5) shall be considered if the substance is poorly water
Če so merila za pregled iz Priloge 1c(a) za PBT ali vPvB izpolnjena ali Priloge 1c(b) za okoljske zadeve in podjetje ne uvede in priporoči ustreznega obvladovanja tveganja, potem registracijski zavezanec izvede nadaljnje okoljsko testiranje.
If the screening criteria in Annex Ic (a) are fulfilled for PBT or vPvB or Annex Ic(b) for environmental concerns and the company does not introduce and recommend appropriate risk management then suitable further environmental testing shall be performed by the registrant.
Takojšnji biološki razkroj
Ready biodegradability
drugi razpoložljivi fizikalno-kemijski, toksikološki in ekotoksikološki podatki
OTHER AVAILABLE PHYSICOCHEMICAL, TOXICOLOGICAL AND ECOTOXICOLOGICAL INFORMATION
Treba je zagotoviti vse druge pomembne fizikalno-kemijske, toksikološke in ekotoksikološke podatke, ki so na voljo.
Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided.
DODATNE ZAHTEVE PO STANDARDNIH PODATKIH ZA SNOVI, PROIZVEDENE ALI UVOŽENE V KOLIČINI 10 TON ALI VEČ
Additional standard information requirements for substances manufactured or imported in quantities of 10 tonnes or more
Stolpec 1 te priloge določa zahtevane standardne podatke za vse snovi, ki so proizvedene ali uvožene v količini 10 ton ali več v skladu s
Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in quantities of 10 tonnes or more in accordance with
členom 13(1)(b)
Article 13
Če so izpolnjeni pogoji, pod katerimi stolpec 2 te priloge dovoljuje prilagoditve, prijavitelj jasno navede to dejstvo in razloge za vsako prilagoditev pod ustreznim naslovom v registracijski dokumentaciji.
If the conditions are met under which column 2 of this Annex allows adaptations, the registrant shall clearly state this fact and the reasons for each adaptation under the appropriate headings in the registration dossier.
Tudi v tem primeru mora prijavitelj jasno navesti razloge za vsako odločitev o prilagoditvi standardnih podatkov pod ustreznimi naslovi v registracijski dokumentaciji, ki se nanašajo na ustrezno(-a) posebno(-a) pravilo(-a) v stolpcu 2 ali v prilogah IX in X Opomba: prav tako veljajo pogoji za nezahtevanost določenega preskusa, ki so določeni v ustreznih preskusnih metodah Priloge X in ki se ne ponavljajo v stolpcu 2.
In this case as well, he shall clearly state the reasons for any decision to adapt the standard information under the appropriate headings in the registration dossier referring to the appropriate specific rule(s) in column 2 or in Annexes IX or X Note: conditions for not requiring a specific test that are set out in the appropriate test methods in Annex X itself that are not repeated in column 2, also apply.
Kadar za določene končne točke podatki niso zagotovljeni zaradi drugih razlogov kakor tistih iz stolpca 2 te priloge ali iz Priloge IX, je treba jasno navesti tudi to dejstvo in razloge.
When, for certain endpoints, information is not provided for other reasons than those mentioned in column 2 of this Annex or in Annex IX, this fact and the reasons shall also be clearly stated.
Treba se je izogibati preskušanju
TOXICOLOGICAL INFORMATION
Draženje kože
Skin irritation
do dražilna za kožo na podlagi ocene končne točke v skladu s Prilogo V
to the skin/irritant on the basis of the assessment of the endpoint according to Annex V
– je snov vnetljiva na zraku pri sobni temperaturi; ali
– the substance is flammable in air at room temperature; or
zelo strupena pri stiku s kožo; ali
very toxic in contact with skin; or
– dermalna študija akutne strupenosti ne pokaže draženja kože do mejne ravni odmerka (2000 mg/kg
– the acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2000 mg/kg
telesne mase).
body weight).
je snov razvrščena kot dražilna za oči s tveganjem za resno poškodbo oči na podlagi ocene končne točke v skladu s Prilogo V; ali
the substance is classified as irritating to eyes with risk of serious damage to eyes on the basis of the assessment of the endpoint according to Annex V; or
za kožo in če registracijski zavezanec razvrsti snov kot dražilno za oči
to the skin, provided that the registrant has classified the substance as eye irritant
ali študija in vitro micronucleus
or in vitro micronucleus study
preskusa in
data from an in
- če je znano, da sodi snov v kategorijo rakotvornosti 1 ali 2
– the substance is known to be carcinogenic category 1 or 2
ocenjevanje kemijske varnosti v skladu s Prilogo I kaže, da tveganje za zdravje/okolje v zvezi z izpostavljenostjo pri navedenih uporabah ni pomembno ali je zadostno nadzorovano ob upoštevanju ukrepov za obvladovanje tveganja.
the chemical safety assessment pursuant to Annex I indicates that the risk to health/environment with regard to exposure for the identified uses is not relevant or is adequately controlled, taking into account risk management measures.
Uporablja se Priloga IX.3.
Section 3 of Annex IX shall apply.
Način uporabe temelji na predvideni uporabi snovi ali pripravka, ki vsebuje snov, in v zvezi s tem povezano izpostavljenostjo.
The route of application shall be based on the intended use of the substance or the prepration containing the substance and the related exposure.
Drug način uporabe za akutno strupenost se testira, le če podatkov ni mogoče dobiti iz drugih podatkov, ki so na voljo.
The second route for acute toxicity shall only be tested if the information cannot be derived from the other available information.
Študij(-e) ni treba izvesti, če:
The study/ies do(es) not need to be conducted if:
– ni mogoče dajati natančnih odmerkov snovi zaradi njenih kemijskih ali fizikalnih lastnosti; ali
– precise doses of the substance cannot be administered due to the chemical or physical properties of the substance; or
za kožo
to the skin
Za snovi, ki niso plini, je treba podatke iz točk od 6.5.1. do 6.5.3. zagotoviti za vsaj dva načina preskušanja, od katerih je eden oralen.
For substances other than gases, the information mentioned under 6.5.1. to 6.5.3. shall be provided for at least two routes, one of which the oral route.
Izbira drugega načina bo odvisna od lastnosti snovi in verjetnega načina izpostavljenosti človeka.
The choice for the second route will depend on the nature of the substance and the likely route of human exposure.
Če je samo en način izpostavljenosti, je treba zagotoviti podatke zgolj za ta način.
If there is only one route of exposure, information for only that route need be provided.
Ustrezen drug način se izbere na podlagi naslednjega:
The appropriate second route shall be chosen on the following basis:
Če ni določeno v Prilogi V.
If not provided for in Annex V
Z vdihavanjem
By inhalation
Dermalno preskušanje je ustrezno, če:
Testing by the dermal route is appropriate if:
(1) ni verjetno vdihavanje snovi; in
(1) inhalation of the substance is unlikely; and
in toksikološke
and toxicological
lastnosti kažejo na
properties suggest
potencial za
potential for
Študija kratkoročne strupenosti pri ponovljenih odmerkih (28 dni), ena vrsta, moškega in ženskega spola, najprimernejši način dajanja, ob upoštevanju verjetnega načina izpostavljenosti človeka.
Short-term repeated dose toxicity study (28 days), one species, male and female, most appropriate route of administration, having regard to the likely route of human exposure.
Študije kratkoročne strupenosti (28 dni) ni treba izvesti, če:
The short-term toxicity study (28 days) does not need to be conducted if:
– je na voljo zanesljiva raziskava subkronične (90 dni) ali kronične strupenosti, če so bile uporabljene primerne vrste
– a reliable sub-chronic (90 days) or chronic toxicity study is available, provided that an appropriate species
in načini dajanja; ali
and route of administration were used; or
– kadar je snov podvržena takojšnjemu razpadanju in obstaja dovolj podatkov o proizvodih njenega razkroja; ali
– where a substance undergoes immediate disintegration and there are sufficient data on the cleavage products; or