natgillin/translations-raw huggingface dataset:
The skin disc should be fully submerged in the MgSO4 solution.
Kožne ploščice morajo biti popolnoma potopljene v raztopino MgSO4.
As many as 10-15 skin discs can be obtained from a single rat skin.
Iz kože ene podgane je mogoče pridobiti od 10 do 15 kožnih ploščic.
Before testing begins, the electrical resistance of two skin discs is measured as a quality control procedure for each animal skin.
Na dveh kožnih ploščicah iz kože vsake živali se pred začetkom preskušanja za namene kontrole kakovosti izmeri električna upornost.
Both discs should give resistance values greater than 10 kΩ for the remainder of the discs to be used for the test.
Ploščice se lahko uporabijo v preskusu, če je upornost obeh ploščic večja od 10 kΩ.
If the resistance value is less than 10 kΩ, the remaining discs from that skin should be discarded.
Če je upornost manjša od 10 kΩ, je treba preostale ploščice, pripravljene iz iste kože, zavreči.
Application of the test and control substances
Nanos preskušanih in kontrolnih snovi
Concurrent positive and negative controls should be used for each study to ensure adequate performance of the experimental model.
V vsaki študiji je treba uporabiti istočasne pozitivne in negativne kontrole, da se zagotovi ustreznost izvedbe modela poskusa.
Skin discs from a single animal should be used.
Uporabijo se lahko le kožne ploščice ene živali.
The suggested positive and negative control substances are 10 M hydrochloric acid and distilled water, respectively.
Predlagana snov za pozitivno kontrolo je 10-molarna klorovodikova kislina, za negativno kontrolo pa destilirana voda.
Liquid test substances (150 μL) are applied uniformly to the epidermal surface inside the tube.
Tekoče preskušane snovi (150 μL) se nanesejo enakomerno na površino pokožnice v cevi.
When testing solid materials, a sufficient amount of the solid is applied evenly to the disc to ensure that the whole surface of the epidermis is covered.
Pri preskušanju trdnega materiala se na kožno ploščico enakomerno nanese dovolj trdne snovi, da se zagotovi, da je prekrita celotna površina pokožnice.
Deionised water (150 μL) is added on top of the solid and the tube is gently agitated.
Nato se na trdno snov doda deionizirana voda (150 μL), cevka pa se rahlo pretrese.
In order to achieve maximum contact with the skin, solids may need to be warmed to 30 oC to melt or soften the test substance, or ground to produce a granular material or powder.
Za največji stik s kožo bo morda treba trdno snov segrevati do 30 oC, da se preskušana snov stali ali zmehča, ali zmleti, da nastane granulat ali prašek.
The test substance is removed by washing with a jet of tap water at up to 30 oC until no further material can be removed.
Preskušana snov se odstrani tako, da se toliko časa spira s curkom tekoče vode, ki ima do 30 oC, dokler ni več mogoče odstraniti materiala.
TER measurements
Meritve TER
The skin impedance is measured as TER is measured by using a low-voltage, alternating current Wheatstone databridge (13).
Impedanca kože se izmeri kot TER z Wheatstonovim mostičem nizke napetosti in izmeničnega toka (13).
General specifications of the bridge are 1-3 Volt operating voltage, a sinus or rectangular shaped alternating current of 50 – 1000 Hz, and a measuring range of at least 0,1 – 30 kΩ.
Splošne specifikacije za mostič so: delovna napetost 1-3 volte, izmenični tok 50–1000 Hz v obliki sinusa ali pravokotnika in merilno območje najmanj 0,1–30 kΩ.
The databridge used in the validation study measureds inductance, capacitance and resistance up to values of 2000 H, 2000 μF, and 2 MΩ, respectively at frequencies of 100 Hz or 1 kHz, using series or parallel values.
Merilni mostič v validacijski študiji je meril induktivnost do 2000 H, kapacitivnost do 2000 μF in upornost do 2 MΩ pri frekvencah 100 Hz ali 1 kHz v zaporednih ali vzporednih meritvah.
For the purposes of the TER corrosivity assay measurements are recorded in resistance, at a frequency of 100 Hz and using series values.
V preskusu jedkosti TER se meritve beležijo v obliki upornosti pri frekvenci 100 Hz in z zaporednimi vrednostmi.
Prior to measuring the electrical resistance, the surface tension of the skin is reduced by adding a sufficient volume of 70 % ethanol to cover the epidermis.
Pred merjenjem električne upornosti se površinska napetost kože zmanjša, tako da se doda zadostna količina 70-odstotnega etanola, da prekrije pokožnico.
After a few seconds, the ethanol is removed from the tube and the tissue is then hydrated by the addition of 3 mL MgSO4 solution (154 mM).
Po nekaj sekundah se etanol odstrani iz cevi, tkivo pa se nato navlaži s 3 mL raztopine MgSO4 (154 mM).
The databridge electrodes are placed on either side of the skin disc to measure the resistance in kΩ/skin disc (Figure 1).
Za merjenje upornosti v kΩ/kožno ploščico se elektrode merilnega mostiča namestijo na vsako stran kožne ploščice (slika 1).
Electrode dimensions and the length of the electrode exposed below the crocodile clips are shown in Figure 2.
Mere elektrod in dolžina elektrode pod krokodilsko sponko so navedene na sliki 2.
The clip attached to the inner electrode is rested on the top of the PTFE tube during resistance measurement to ensure that a consistent length of electrode is submerged in the MgSO4 solution.
Sponka notranje (debele) elektrode med merjenjem upornosti leži na vrhu PTFE-cevi, s čimer se zagotovi, da je v raztopino MgSO4 ves čas potopljena enaka dolžina elektrode.
The outer electrode is positioned inside the receptor chamber so that it rests on the bottom of the chamber.
Zunanja elektroda je v receptorski komori, in sicer se dotika njenega dna.
The distance between the spring clip and the bottom of the PTFE tube is maintained as a constant (Figure 2), because this distance affects the resistance value obtained.
Razdalja med vzmetno sponko in dnom PTFE-cevi je konstantna (slika 2), saj ta razdalja vpliva na dobljeno vrednost upornosti.
Consequently, the distance between the inner electrode and the skin disc should be constant and minimal (1-2 mm).
Zato mora biti razdalja med notranjo elektrodo in kožno ploščico konstantna in minimalna (1–2 mm).
If the measured resistance value is greater than 20 kΩ, this may be due to the remains of the test substance coating the epidermal surface of the skin disc.
Če je izmerjeni upor večji od 20 kΩ, je to morda posledica tega, da ostanki preskušane snovi prekrivajo površino pokožnice kožne ploščice.
Further removal of this coating can be attempted, for example, by sealing the PTFE tube with a gloved thumb and shaking it for approximately 10 seconds; the MgSO4 solution is discarded and the resistance measurement is repeated with fresh MgSO4.
Za odstranitev te plasti se lahko na primer začepi PTFE-cev z orokavičenim palcem in jo stresa približno 10 sekund; raztopina MgSO4 se zavrže, merjenje upornosti pa se ponovi s svežim MgSO4.
The properties and dimensions of the test apparatus and the experimental procedure used may influence the TER values obtained.
Lastnosti in mere preskusne naprave in uporabljenega poskusnega postopka lahko vplivajo na pridobljene vrednosti TER.
The 5 kΩ corrosive threshold was developed from data obtained with the specific apparatus and procedure described in this method.
Prag za jedkost 5 kΩ je bil ugotovljen na podlagi podatkov, pridobljenih s posebnimi napravami in postopki, opisanimi v tej metodi.
Different threshold and control values may apply if the test conditions are altered or a different apparatus is used.
Če se preskusni pogoji bistveno spremenijo ali če se uporabi drugačna aparatura, lahko veljajo drugačni pragovi in kontrolne vrednosti.
Therefore, it is necessary to calibrate the methodology and resistance threshold values by testing a series of reference standards chosen from the chemicals used in the validation study (4)(5), or from similar chemical classes to the chemicals being investigated.
Zaradi tega je treba metodologijo in prag upornosti obvezno umerjati s preskušanjem vrste referenčnih standardov, ki se izberejo izmed kemikalij, uporabljenih v validacijski študiji (4) (5), ali iz skupin kemikalij, ki so podobne preskušani.
A set of suitable reference chemicals is shown in Table 1.
Nabor primernih referenčnih kemikalij je prikazan v tabeli 1.
Dye binding methods
Metode vezave barvila
Exposure of certain non-corrosive materials can result in a reduction of resistance below the cut-off of 5 kΩ allowing the passage of ions through the stratum corneum, thereby reducing the electrical resistance (5).
Izpostavljenost določenim nejedkim materialom lahko povzroči zmanjšanje upornosti pod prag 5 kΩ, pri čemer je omogočen prehod ionov skozi roženo plast in zmanjšanje električne upornosti (5).
For example, neutral organics and chemicals that have surface-active properties (including detergents, emulsifiers and other surfactants) can remove skin lipids making the barrier more permeable to ions.
Npr. nevtralne organske snovi in kemikalije, ki so površinsko aktivne (med drugim detergenti, emulgatorji in druge površinsko aktivne snovi) lahko odstranjujejo kožne lipide in povzročijo večjo prepustnost ionov.
Thus, if the TER values of test substances are less than or around 5 kΩ in the absence of visual damage, an assessment of dye penetration should be carried out on the control and treated tissues to determine if the TER values obtained were the result of increased skin permeability, or skin corrosion (3)(5).
Zato je treba pri vrednostih TER za preskušano snov pod ali okoli 5 kΩ in brez vidnih poškodb opraviti oceno penetracije barvila na kontrolnih in obdelovanih tkivih, da se ugotovi, ali so vrednosti TER posledica povečane prepustnosti kože ali jedkosti za kožo (3) (5).
In case of the latter where the stratum corneum is disrupted, the dye sulforhodamine B, when applied to the skin surface rapidly penetrates and stains the underlying tissue.
V slednjem primeru barvilo sulforodamin B poruši roženo plast, ki po nanosu na površino kože hitro penetrira in obarva pod njim ležeče tkivo.
This particular dye is stable to a wide range of chemicals and is not affected by the extraction procedure described below.
To specifično barvilo je odporno proti širokemu razponu kemikalij in nanj ne vpliva ekstrakcijski postopek, opisan spodaj.
Sulforhodamine B dye application and removal
Nanos in odstranitev barvila sulforodamin B
Following TER assessment, the magnesium sulfate is discarded from the tube and the skin is carefully examined for obvious damage. If there is no obvious major damage, Sulforhodamine B dye (Acid Red 52; C.I.
Po oceni TER se magnezijev sulfat odstrani iz cevi, kožo pa je treba natančno pregledati za vidne poškodbe.
45100; EINECS Number 222-529-8; CAS number 3520-42-1), 150 μL of a 10 % (w/v) dilution in distilled water, is applied to the epidermal surface of each skin disc for two hours.
Če ni očitnih večjih poškodb, se na površino pokožnice vsake kožne ploščice za 2 uri nanese 150 μl 10-odstotne (m/V) raztopine barvila sulforodamin B (Acid Red 52; C.I. 45100; št. Einecs 222-529-8; št. CAS 3520-42-1) v destilirani vodi.
These skin discs are then washed with tap water at up to room temperature for approximately 10 seconds to remove any excess/unbound dye.
Te kožne ploščice se nato približno 10 sekund spirajo s tekočo vodo pri največ sobni temperaturi, da se odstrani morebitno odvečno/nevezano barvilo.
This rinsing procedure is then repeated, after which the skin discs are removed and placed into vials containing 5 ml of 30 % (w/v) sodium dodecyl sulphate (SDS) in distilled water and are incubated overnight at 60 oC.
Postopek izpiranja se ponovi, nato pa se kožne ploščice odstranijo in prenesejo v viale, ki vsebujejo 5 mL 30-odstotnega (m/V) natrijevega dodecil sulfata (SDS) v destilirani vodi in se v inkubatorju čez noč shranijo pri 60 oC.
The optical density (OD) of the solution is measured at 565 nm.
Optična gostota (OD) raztopine se meri pri 565 nm.
Calculation of dye content
Izračun vsebnosti barvila
The sulforhodamine B dye content per disc is calculated from the OD values (5) (sulforhodamine B dye molar extinction coefficient at 565 nm = 8,7 × 104; molecular weight = 580).
Vsebnost barvila sulforodamin B v ploščici se izračuna iz vrednosti OD (koeficient molarne ekstinkcije barvila sulforodamin B pri 565 nm = 8,7 × 10; molekulska masa = 580).
The dye content is determined for each skin disc by the use of an appropriate calibration curve and a mean dye content is then calculated for the replicates.
Vsebnost barvila se določi za vsako kožno ploščico s pomočjo ustrezne umeritvene krivulje, nato pa se izračuna srednja vrednost vsebnosti barvila za ponovitve.
Resistance values (kΩ) and mean dye content values (μg/disc), where appropriate, for the test material, as well as for positive and negative controls should be reported in tabular form (individual trial data and means ± S.D.), including data for replicates/repeat experiments, mean and individual values.
Vrednosti upornosti (kΩ) in, kadar je primerno, vrednosti vsebnosti barvila (μg/ploščico) za preskušano snov skupaj s podatki pozitivnih in negativnih kontrol, je treba prikazati v obliki razpredelnice (posamezni podatki preskušanja in srednje vrednosti ± standardni odklon), vključno s podatki ponovitev/ponovljenih poskusov, srednjimi vrednostmi in posameznimi vrednostmi.
The mean TER results are accepted if the concurrent positive and negative control values fall within the acceptable ranges for the method in the testing laboratory.
Povprečni rezultati TER se sprejmejo pod pogojem, da so vrednosti istočasne pozitivne in negativne kontrole v mejah sprejemljivosti za to metodo v preskusnem laboratoriju.
The acceptable resistance ranges for the methodology and apparatus described above are given in the following table:
Meje sprejemljivosti za metodologijo in aparaturo, opisani zgoraj, so prikazane v naslednji tabeli:
Resistance range (kΩ)
Mejni upor (kΩ)
Hydrochloric acid
10 M klorovodikova kislina
The mean dye binding results are accepted on condition that concurrent control values fall within the acceptable ranges for the method.
Povprečni rezultati vezanja barvila se sprejmejo pod pogojem, da so vrednosti istočasne kontrole v mejah sprejemljivosti za metodo.
Suggested acceptable dye content ranges for the control substances for the methodology and apparatus described above are given below:
Predlagane sprejemljive meje vsebnosti barvila za kontrolne snovi za opisano metodologijo in napravo so naslednje:
Dye content range (μg/disc)
Meje vsebnosti barvila (μg/košček)
The test substance is considered to be non-corrosive to skin:
Preskušana snov se šteje kot nejedka za kožo:
if the mean TER value obtained for the test substance is greater than 5 kΩ; or
če je srednja vrednost TER, dobljena za preskušano snov, večja od 5 kΩ ali
the mean TER value is less than or equal to 5 kΩ; and
če je srednja vrednost TER manjša ali enaka kot 5 kΩ in
the skin disc is showing no obvious damage, and
na kožni ploščici ni vidnih poškodb in
the mean disc dye content is well below the mean disc dye content of the 10M HCl positive control obtained concurrently.
je srednja vrednost vsebnosti barvila v kožni ploščici veliko manjša od istočasno določene srednje vrednosti vsebnosti barvila v kožni ploščici iz pozitivne kontrol 10-molarno HCl.
The test substance is considered to be corrosive to skin:
Preskušana snov se šteje kot jedka za kožo:
if the mean TER value is less than or equal to 5 kΩ and the skin disk is obviously damaged; or
če je srednja vrednost TER manjša ali enaka kot 5 kΩ in je kožna plošč vidno poškodovana ali
the skin disc is showing no obvious damage, but
na kožni ploščici ni vidnih poškodb, vendar
the mean disc dye content is greater than or equal to the mean disc dye content of the 10M HCl positive control obtained concurrently.
je srednja vrednost vsebnosti barvila v kožni ploščici večja ali enaka istočasno določeni srednji vrednosti vsebnosti barvila v kožni ploščici iz pozitivne kontrole z 10-molarno HCl.
Test and control substances:
Preskušane in kontrolne snovi:
chemical name(s) such as IUPAC or CAS name and CAS number, if known,
kemijsko(-a) ime(-na), npr. IUPAC, ime CAS in številko CAS, če je znana,
purity and composition of the substance or preparation (in percentage(s) by weight) and physical natur,
čistost in sestavo snovi ali pripravka (v utežnih odstotnih vrednostih) in agregatno stanje,
physico-chemical properties such as physical state, pH, stability, water solubility, relevant to the conduct of the study,
fizikalno-kemijske lastnosti pomembne za izvedbo študije, npr. agregatno stanje, pH, stabilnost, topnost v vodi,
treatment of the test/control substances prior to testing, if applicable (e.g. warming, grinding),
obdelava preskušanih/kontrolnih snovi pred preskušanjem, če je smiselno (npr. segrevanje, mletje),
stability, if known.
stabilnost, če je znana.
strain and sex used,
uporabljena linija in spol,
age of the animals when used as donor animals,
starost živali, ko so bile uporabljene kot donorke,
source, housing condition, diet, etc,
vir, pogoji nastanitve, prehrana itd.,
details of the skin preparation.
podrobnosti o pripravi kože.
calibration curves for test apparatus,
umeritvene krivulje za preskusne aparature,
calibration curves for dye binding test performance,
umeritvene krivulje za izvedbo preskusa vezave barvila,
details of the test procedure used for TER measurements,
podrobni podatki o preskusnem postopku uporabljenem za meritve TER,
details of the test procedure used for the dye binding assessment; if appropriate,
podrobni podatki o preskusnem postopku uporabljenem za oceno vezave barvila; če je primerno,
description of any modification of the test procedures,
opis vseh sprememb preskusnih postopkov,
description of evaluation criteria used.
opis uporabljenih kriterijev ocenjevanja.
tabulation of data from the TER and dye binding assay (if appropriate) for individual animals and individual skin samples;
podatki iz poskusa TER in vezave barvila (če je smiselno) za posamezno žival in posamezne vzorce kože v obliki razpredelnice,
description of any effects observed.
opis vseh opaženih učinkov.
OECD (2002) Extended Expert Consultation Meeting on The In Vitro Skin Corrosion Test Guideline Proposal, Berlin, 1st–2nd November 2001, Secretariat's Final Summary Report, 27th March 2002, OECD ENV/EHS, available upon request from the Secretariat.
OECD (2002) Extended Expert Consultation Meeting on The In Vitro Skin Corrosion Test Guideline Proposal, Berlin, 1st –2nd November 2001, Secretariat's Final Summary Report, 27th March 2002, OECD ENV/EHS, available upon request from the Secretariat
Apparatus for the rat skin TER assay
Aparatura za preskus TER s podganjo kožo
inner (thick) electrode
notranja (debela) elektroda
crocodile clip
krokodilska sponka
outer (thin) electrode
zunanja (tanka) elektróda
PTFE tube
PTFE cev
spring clip
vzmetna sponka
receptor chamber (disposable tube)
receptorska komora (za enkratno uporabo)
magnesium sulphate (154 mM)
magnezijev sulfat (154 mM) pokožnica kožné plošice usnjica kožne plošice
Dimensions of the polytetrafluoroethylene (PFTE) and receptor tubes and electrodes used
Mere uporabljenih cevi iz politetrafluoroetilena (PTFE), receptorskih cevi in elektrod
Crocodile clip
krokodilska sponka
Critical factors of the apparatus shown above:
Ključni dejavniki zgoraj prikazane aparature:
the inner diameter of the PTFE tube,
notranji premer PTFE-cevi,
the length of the electrodes relative to the PTFE tube and receptor tube, such that the skin disc is not touched by the electrodes and that a standard length of electrode is in contact with the MgSO4 solution,
dolžina elektrod relativno na PTFE-cev in receptorsko cev, tako ta se kožna ploščica ne dotika elektrod in da je v stiku z raztopino MgSCO4 standardna dolžina elektrode,
the amount of MgSO4 solution in the receptor tube should give a depth of liquid, relative to the level in the PFTE tube, as shown in Figure 1,
višina raztopine MgSCO4 v receptorski cevki mora biti relativna na gladino raztopine v PTFE-cevi, kakor je prikazano v sliki 1,
the skin disk should be fixed well enough to the PFTE tube, such that the electrical resistance is a true measure of the skin properties.
kožna ploščica mora biti v PTFE-cev fiksirana zadostno, da je upor električnega toka resnično merilo lastnosti kože.
This testing method is equivalent to the OECD TG 431 (2004).
Ta preskusna metoda je enakovredna OECD TG 431 (2004).
Skin corrosion refers to the production of irreversible tissue damage in the skin following the application of a test material [as defined by the Globally Harmonised System for the Classification and Labelling of Chemical Substances and Mixtures (GHS)] (1).
Jedkost za kožo pomeni nastanek nepovratnih poškodb kožnega tkiva po nanosu preskušanega materiala [po definiciji iz Globally Harmonised System for the Classification and Labelling of Chemical Substances and Mixtures (GHS)] (1).
This Testing Method does not require the use of live animals or animal tissue for the assessment of skin Corrosivity.
V tej preskusni metodi se ocena jedkosti ne opravlja na živih živalih ali živalskem tkivu.
Concern for the pain and suffering involved with this procedure has been addressed in the revision of testing method B.4 that allows for the determination of skin corrosion by using alternative, in vitro, methods, avoiding pain and suffering of animals.
Zadržki v zvezi z bolečinami in trpljenjem živali, ki je povezano s tem postopkom, je bila upoštevana v reviziji preskusne metode B.4, ki omogoča določevanje jedkosti za kožo z alternativnimi metodami in vitro, pri čemer se prepreči bolečina in trpljenje živali.
Following this, a formal, validation study of in vitro methods for assessing skin corrosion (4)(5) was conducted (6)(7)(8).
Za temi je bila opravljena uradna validacijska študija metod in vitro za oceno jedkosti za kožo (4) (5) (6) (7) (8).
The outcome of these studies and other published literature (9) led to the recommendation that the following tests could be used for the assessment of the in vivo skin corrosivity (10)(11)12)(13): the human skin model test (this method) and the transcutaneous electrical resistance test (see testing method B.40).
Na podlagi izidov teh študij in druge objavljene literature (9) je bilo izdano priporočilo, da se lahko naslednja preskusa uporabita za oceno jedkosti za kožo in vivo (10) (11) (12) (13): preskus z modelom človeške kože (glej metodo) in preskus transkutane električne upornosti (preskusna metoda B.40).
Validation studies have reported that tests employing human skin models (3)(4)(5)(9) are able to reliably discriminate between known skin corrosives and non-corrosives.
V validacijskih študijah so ugotovili, da lahko preskus z modelom človeške kože (3) (4) (5) (9) zanesljivo razlikuje med znanimi snovmi, ki so jedke za kožo, in znanimi snovmi, ki niso jedke.
The test protocol may also provide an indication of the distinction between severe and less severe skin corrosives.
S protokolom preskusa je mogoče pridobiti podatke o tem, ali je preskusna snov močno ali šibko jedka za kožo.
It further allows the identification of non-corrosive substances and mixtures when supported by a weight of evidence determination using other existing information (e.g. pH, structure-activity relationships, human and/or animal data) (1)(2)(13)(14).
Omogoča tudi identifikacijo nejedkih snovi in mešanic, če je podprta z dokazi in ob uporabi drugih obstoječih podatkov (npr. pH, razmerja struktura-aktivnost, podatki o ljudeh in/ali živalih) (1) (2) (13) (14).
It does not normally provide adequate information on skin irritation, nor does it allow the subcategorisation of corrosive substances as permitted in the Globally Harmonised Classification System (GHS) (1).
Običajno pa ne daje zadostnih podatkov o draženju kože niti ne omogoča nadaljnje kategorizacije jedkih snovi, kakor je to dovoljeno v Globally Harmonised Classification System (GHS) (1).
For a full evaluation of local skin effects after single dermal exposure, it is recommended to follow the sequential testing strategy as appended to testing method B.4 (2) and provided in the Globally Harmonised System (GHS) (1).
Za popolno vrednotenje lokalnih učinkov na kožo po enkratni izpostavljenosti se priporoča upoštevanje načrtovanja zaporednega preskušanja, ki je priloženo preskusni metodi B.4 (2) in na voljo v Globally Harmonised System (GHS) (1).