natgillin/translations-raw huggingface dataset:
Investigators could consider using this test method for all types of chemicals, whereby a negative result (IVIS ≤ 3) should be accepted as indicative that no classification is required (UN GHS No Category).
Iga katseprooviga saadud andmete tabel (näiteks hägususe ja OD490 väärtused ning uuritava kemikaali ja positiivse kontrolli, negatiivse kontrolli ning [võimaluse korral] võrdluskemikaali kontrolli jaoks arvutatud IVISe väärtused tabelina, sealhulgas vajaduse korral paralleelkorduskatsete tulemused, iga katse keskväärtused ± standardhälve);
Since the BCOP test method can only identify correctly 31 % of the chemicals that do not require classification for eye irritation or serious eye damage, this test method should not be the first choice to initiate a Bottom-Up approach (5), if other validated and accepted in vitro methods with similar high sensitivity but higher specificity are available.
muude täheldatud toimete kirjeldus.
The BCOP test method is therefore considered applicable to the testing of both substances and mixtures.
in vitro määratud ÜRO GHSi klassifikatsioon, kui see on asjakohane.
The BCOP test method is not recommended for the identification of test chemicals that should be classified as irritating to eyes (UN GHS Category 2 or Category 2A) or test chemicals that should be classified as mildly irritating to eyes (UN GHS Category 2B) due to the considerable number of UN GHS Category 1 chemicals underclassified as UN GHS Category 2, 2A or 2B and UN GHS No Category chemicals overclassifed as UN GHS Category 2, 2A or 2B (2)(3).
Tulemuste arutelu
For this purpose, further testing with another suitable method may be required.
Kättesaadav aadressil: http://iccvam.niehs.nih.gov/methods/ocutox/ivocutox/ocu_tmer.htm.
All procedures with bovine eyes and bovine corneas should follow the testing facility's applicable regulations and procedures for handling animal-derived materials, which include, but are not limited to, tissues and tissue fluids.
Research Triangle Park, NC:National Institute of Environmental Health Sciences.
Universal laboratory precautions are recommended (11).
Kättesaadav aadressil: http://iccvam.niehs.nih.gov/methods/ocutox/MildMod-TMER.htm.
Whilst the BCOP test method does not consider conjunctival and iridal injuries, it addresses corneal effects, which are the major driver of classification in vivo when considering the UN GHS classification.
Kättesaadav aadressil: http://www.unece.org/trans/danger/publi/ghs/ghs_rev04/04files_e.html.
The reversibility of corneal lesions cannot be evaluated per se in the BCOP test method.
Kättesaadav aadressil: [http://www.cdc.gov/ncidod/dhqp/pdf].
It has been proposed, based on rabbit eye studies, that an assessment of the initial depth of corneal injury may be used to identify some types of irreversible effects (12).
Series on Testing and Assessment, No.160.
However, further scientific knowledge is required to understand how irreversible effects not linked with initial high level injury occur.
Käesoleva lisa peatükk B.5 „Äge mürgisus: silmade ärritus/söövitus“.
Finally, the BCOP test method does not allow for an assessment of the potential for systemic toxicity associated with ocular exposure.
Kättesaadav aadressil: [http://iccvam.niehs.nih.gov/methods/ocutox/ivocutox/ocu_brd_bcop.htm].
This test method will be updated periodically as new information and data are considered.
Series on Good Laboratory Practice and Compliance Monitoring.
For example, histopathology may be potentially useful when a more complete characterisation of corneal damage is needed.
No.
As outlined in OECD Guidance Document No. 160 (13), users are encouraged to preserve corneas and prepare histopathology specimens that can be used to develop a database and decision criteria that may further improve the accuracy of this test method.
1: „OECD Principles on Good Laboratory Practice“ (läbi vaadatud 1997. a).
For any laboratory initially establishing this test method, the proficiency chemicals provided in Appendix 3 should be used.
Kättesaadav aadressil: http://www.oecd.org/document/63/0,3343,en_2649_34381_2346175_1_1_1_1,00.html
A laboratory can use these chemicals to demonstrate their technical competence in performing the BCOP test method prior to submitting BCOP test method data for regulatory hazard classification purposes.
Asjakohasus
The BCOP test method is an organotypic model that provides short-term maintenance of normal physiological and biochemical function of the bovine cornea in vitro.
huvipakkuva toime ja katse vahelise seose kirjeldus, millest nähtub, kas see seos on tähenduslik ning kasulik konkreetse eesmärgi puhul.
In this test method, damage by the test chemical is assessed by quantitative measurements of changes in corneal opacity and permeability with an opacitometer and a visible light spectrophotometer, respectively.
See on ulatus, mille piires saab katsemeetodiga õigesti mõõta või prognoosida huvipakkuvat bioloogilist toimet.
Both measurements are used to calculate an IVIS, which is used to assign an in vitro irritancy hazard classification category for prediction of the in vivo ocular irritation potential of a test chemical (see Decision Criteria in paragraph 48).
Asjakohasusega seoses võetakse arvesse ka katsemeetodi täpsust (kordustäpsust) (8).
The BCOP test method uses isolated corneas from the eyes of freshly slaughtered cattle.
Astmelise katsetamise strateegia
Corneal opacity is measured quantitatively as the amount of light transmission through the cornea.
MÕISTED
Permeability is measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea, as detected in the medium in the posterior chamber.
Aine
Test chemicals are applied to the epithelial surface of the cornea by addition to the anterior chamber of the corneal holder.
ooduslikud või mis tahes meetodi abil toodetud keemilised elemendid ja nende ühendid, mis võivad sisaldada toote stabiliseerimiseks vajalikke lisaaineid või tootmismeetodist tingitud lisandeid, kuid ei tohi sisaldada ühtki lahustit, mida on võimalik kemikaali stabiilsust vähendamata ja selle koostist muutmata eraldada (4);
Appendix 4 provides a description and a diagram of a corneal holder used in the BCOP test method.
Kui olemasoleva teabe põhjal saab uuritava kemikaali ärritava toime potentsiaali kohta otsuse teha, ei ole edasisi katseid vaja teha.
Corneal holders can be obtained commercially from different sources or can be constructed.
Kui olemasoleva teabe põhjal ei saa otsustada uuritava kemikaali ärritava toime potentsiaali üle, jätkatakse järjestikuste loomkatsete etapiti tegemist, kuni kemikaali saab üheselt klassifitseerida.
Source and Age of Bovine Eyes and Selection of Animal Species
Biomikroskoop
Cattle sent to slaughterhouses are typically killed either for human consumption or for other commercial uses.
seade, mida kasutatakse silma vahetuks uurimiseks- binokulaarmikroskoobiga, mille abil saadakse suurendatud vertikaalne stereoskoopiline kujutis.
Only healthy animals considered suitable for entry into the human food chain are used as a source of corneas for use in the BCOP test method.
ICE-katses kasutatakse seda seadet kanasilma eesmiste struktuuride vaatlemiseks, samuti sarvkesta paksuse objektiivseks mõõtmiseks, kasutades lisaseadet – pahhümeetrit.
Because cattle have a wide range of weights, depending on breed, age, and sex, there is no recommended weight for the animal at the time of slaughter.
Fluorestseiini peetumine
Variations in corneal dimensions can result when using eyes from animals of different ages.
Klassifitseerimata
Corneas with a horizontal diameter > 30,5 mm and central corneal thickness (CCT) values ≥ 1100 μm are generally obtained from cattle older than eight years, while those with a horizontal diameter < 28,5 mm and CCT < 900 μm are generally obtained from cattle less than five years old (14).
kemikaalid, mida ei klassifitseerita seoses silmaärritusega (ÜRO GHSi 2. kategooria) või raske silmakahjustusega (ÜRO GHSi 1. kategooria).
For this reason, eyes from cattle greater than 60 months old are not typically used.
Samatähenduslik mõistega „ÜRO GHSi kategooriata“.
Eyes from cattle less than 12 months of age have not traditionally been used since the eyes are still developing and the corneal thickness and corneal diameter are considerably smaller than that reported for eyes from adult cattle.
Lahusti/vehiikuli kontroll
However, the use of corneas from young animals (i.e., 6 to 12 months old) is permissible since there are some advantages, such as increased availability, a narrow age range, and decreased hazards related to potential worker exposure to Bovine Spongiform Encephalopathy (15).
uuritava kemikaaliga töötlemata proov, mis sisaldab kõiki katsesüsteemi komponente, sealhulgas lahustit või vehiikulit; sellist proovi töödeldakse samamoodi uuritava kemikaaliga töödeldud proovidele ja muudele kontrolli proovidele, et määrata kindlaks samas lahustis või vehiikulis lahustatud uuritava kemikaaliga töödeldud proovide tekitatud reaktsiooni lähtetase.
As further evaluation of the effect of corneal size or thickness on responsiveness to corrosive and irritant chemicals would be useful, users are encouraged to report the estimated age and/or weight of the animals providing the corneas used in a study.
Kui paralleelselt uuritakse negatiivse kontrolli proovi, siis näitab lahusti/vehiikuli proov ka seda, kas lahusti või vehiikul reageerib katsesüsteemiga.
Collection and Transport of Eyes to the Laboratory
Negatiivne kontroll
Eyes are collected by slaughterhouse employees.
uuritava ainega töötlemata paralleelproov, mis sisaldab kõiki katsesüsteemi komponente.
To minimise mechanical and other types of damage to the eyes, the eyes should be enucleated as soon as possible after death and cooled immediately after enucleation and during transport.
Sellist proovi töödeldakse koos proovidega, mida mõjutatakse uuritava kemikaaliga, ja koos muude kontrolli proovidega, et kontrollida, kas lahusti reageerib katsesüsteemiga.
To prevent exposure of the eyes to potentially irritant chemicals, the slaughterhouse employees should not use detergent when rinsing the head of the animal.
Halogeenlambi valgus suunatakse läbi võrdlusruumi (tühi kamber, millel ei ole aknaid ja milles ei ole vedelikku) fotoelemendile ja võrreldakse valgusega, mis on fotoelemendile suunatud läbi uuritava sarvkestaga ruumi.
Eyes should be immersed completely in cooled Hanks' Balanced Salt Solution (HBSS) in a suitably sized container, and transported to the laboratory in such a manner as to minimise deterioration and/or bacterial contamination.
Fotoelementide andmete võrdlemisest saadakse valgusläbilaskvuse erinevus ja hägususe numbriline väärtus esitatakse digitaalsel näidikul.
Because the eyes are collected during the slaughter process, they might be exposed to blood and other biological materials, including bacteria and other microorganisms.
In vitro ärritava toime hinne (In Vitro Irritancy Score, IVIS)
Therefore, it is important to ensure that the risk of contamination is minimised (e.g., by keeping the container containing the eyes on wet ice during collection and transportation and by adding antibiotics to the HBSS used to store the eyes during transport [e.g. penicillin at 100 IU/ml and streptomycin at 100 μg/ml]).
BCOP-katses kasutatav empiiriliselt tuletatud valem, millega iga katserühma keskmise hägususe ja keskmise läbilaskvuse väärtused ühendatakse üheks kõnealusele katserühmale avaldatud mõju iseloomustavaks in vitro-hindeks (punktisummaks).
The time interval between collection of the eyes and use of corneas in the BCOP test method should be minimised (typically collected and used on the same day) and should be demonstrated to not compromise the assay results.
IVIS = keskmine hägususe väärtus + (15 × keskmine läbilaskvuse väärtus) Kemikaal
These results are based on the selection criteria for the eyes, as well as the positive and negative control responses.
aine või segu.
All eyes used in the assay should be from the same group of eyes collected on a specific day.
Klassifitseerimata
Selection Criteria for Eyes Used in the BCOP Test Method
Sarvkest
The eyes, once they arrive at the laboratory, are carefully examined for defects including increased opacity, scratches, and neovascularisation.
Sarvkesta suurenenud hägusus näitab sarvkesta kahjustust.
Only corneas from eyes free of such defects are to be used.
Sarvkesta hägusus
The quality of each cornea is also evaluated at later steps in the assay.
suurus, millega väljendatakse pärast kokkupuudet uuritava kemikaaliga toimunud sarvkesta hägustumise ulatust.
Corneas that have opacity greater than seven opacity units or equivalent for the opacitometer and cornea holders used after an initial one hour equilibration period are to be discarded (NOTE: the opacitometer should be calibrated with opacity standards that are used to establish the opacity units, see Appendix 4).
Imax
Each treatment group (test chemical, concurrent negative and positive controls) consists of a minimum of three eyes.
lutsiferaasi aktiivsuse maksimaalne induktsioonitegur, võrreldes lahusti (negatiivse) kontrolliga ja mõõdetuna ükskõik millisel uuritava kemikaali kontsentratsioonil.
Three corneas should be used for the negative control corneas in the BCOP test method.
Kahjuliku toime rada (Adverse Outcome Pathway, AOP)
Since all corneas are excised from the whole globe, and mounted in the corneal chambers, there is potential for artifacts from handling upon individual corneal opacity and permeability values (including negative control).
Negatiivne kontroll
Furthermore, the opacity and permeability values from the negative control corneas are used to correct the test chemical-treated and positive control-treated corneal opacity and permeability values in the IVIS calculations.
uuritava ainega töötlemata paralleelproov, mis sisaldab kõiki katsesüsteemi komponente.
Preparation of the Eyes
Sellist proovi töödeldakse koos proovidega, mida mõjutatakse uuritava kemikaaliga, ja koos muude kontrolli proovidega, et kontrollida, ega lahusti ei mõjuta katsesüsteemi.
Corneas, free of defects, are dissected with a 2 to 3 mm rim of sclera remaining to assist in subsequent handling, with care taken to avoid damage to the corneal epithelium and endothelium.
Ohtlikkus
Isolated corneas are mounted in specially designed corneal holders that consist of anterior and posterior compartments, which interface with the epithelial and endothelial sides of the cornea, respectively.
mõjuri või olukorra iseloomulik omadus, millel võib olla kahjulik toime, kui organism, süsteem või (ala-)populatsioon selle mõjuriga kokku puutub.
Both chambers are filled to excess with pre-warmed phenol red free Eagle's Minimum Essential Medium (EMEM) (posterior chamber first), ensuring that no bubbles are formed.
vt „Raske silmakahjustus“.
The device is then equilibrated at 32 ± 1 °C for at least one hour to allow the corneas to equilibrate with the medium and to achieve normal metabolic activity, to the extent possible (the approximate temperature of the corneal surface in vivo is 32 °C).
Lahusti/vehiikuli kontroll
Following the equilibration period, fresh pre-warmed phenol red free EMEM is added to both chambers and baseline opacity readings are taken for each cornea.
Pindaktiivset ainet sisaldav segu
Any corneas that show macroscopic tissue damage (e.g, scratches, pigmentation, neovascularisation) or an opacity greater than seven opacity units or equivalent for the opacitometer and cornea holders used are discarded.
käesoleva katsemeetodi kontekstis segu, mis sisaldab ühte või mitut pindaktiivset ainet lõplikus kontsentratsioonis > 5 %.
A minimum of three corneas are selected as negative (or solvent) control corneas.
klassifitseerimata
The remaining corneas are then distributed into treatment and positive control groups.
Selleks et oleks võimalik hinnata ka positiivse kontrolli kemikaali mõju sõltuvust ajast, ei tohiks mõju olla ülemäära suur.
Because the heat capacity of water is higher than that of air, water provides more stable temperature conditions for incubation.
Pöördumatu toime silmale
Therefore, the use a water bath for maintaining the corneal holder and its contents at 32 ± 1 °C is recommended.
vt „Raske silmakahjustus“.
However, air incubators might also be used, assuming precaution to maintain temperature stability (e.g. by pre-warming of holders and media).
Pöörduv toime silmale
Application of the Test Chemical
vt „Silmade ärritus“.
Two different treatment protocols are used, one for liquids and surfactants (solids or liquids), and one for non-surfactant solids.
Raske silmakahjustus
Liquids are tested undiluted.
koekahjustuse tekkimine silmas või tugev füüsiline nägemislangus pärast seda, kui uuritavat kemikaali on kantud silma eespoolsele pinnale ja mõju ei ole täielikult pöörduv 21 päeva jooksul pärast aine pealekandmist.
Semi-solids, creams, and waxes are typically tested as liquids.
Samatähenduslik mõistetega „Pöördumatu toime silmale“ ja „ÜRO GHSi 1. kategooria“ (4).
Neat surfactant substances are tested at a concentration of 10 % w/v in a 0,9 % sodium chloride solution, distilled water, or other solvent that has been demonstrated to have no adverse effects on the test system.
Fotoelementide andmete võrdlemisest saadakse valgusläbilaskvuse erinevus ja hägususe numbriline väärtus esitatakse digitaalsel näidikul.
Appropriate justification should be provided for alternative dilution concentrations.
Ohtlikkus
Mixtures containing surfactants may be tested undiluted or diluted to an appropriate concentration depending on the relevant exposure scenario in vivo.
suurus, millega väljendatakse pärast kokkupuudet uuritava kemikaaliga toimunud sarvkesta hägustumise ulatust.
Appropriate justification should be provided for the concentration tested.
Positiivne kontroll
Corneas are exposed to liquids and surfactants for 10 minutes.
Hägusust võib hinnata subjektiivselt, nagu tehakse Draize'i katses küülikusilmaga, või objektiivselt aparaadiga, näiteks hägususmõõtjaga.
Use of other exposure times should be accompanied by adequate scientific rationale.
vt „Silmade ärritus“.
Please see Appendix 1 for a definition of surfactant and surfactant-containing mixture.
Spetsiifilisus
Non-surfactant solids are typically tested as solutions or suspensions at 20 % w/v concentration in a 0,9 % sodium chloride solution, distilled water, or other solvent that has been demonstrated to have no adverse effects on the test system.
kõikide negatiivsete / inaktiivsete kemikaalide osakaal, mis katsemeetodi alusel klassifitseeritakse õigesti.
In certain circumstances and with proper scientific justification, solids may also be tested neat by direct application onto the corneal surface using the open chamber method (see paragraph 32).
Segu segu või lahus, mis koosneb kahest või enamast ainest, mis omavahel ei reageeri (4).
Corneas are exposed to solids for four hours, but as with liquids and surfactants, alternative exposure times may be used with appropriate scientific rationale.
Silmade ärritus
Different treatment methods can be used, depending on the physical nature and chemical characteristics (e.g. solids, liquids, viscous vs. non-viscous liquids) of the test chemical.
selliste muutuste tekkimine silmas pärast seda, kui uuritavat kemikaali on manustatud silma eespinnale, mis on täielikult pöörduvad 21 päeva jooksul pärast manustamist.
The critical factor is ensuring that the test chemical adequately covers the epithelial surface and that it is adequately removed during the rinsing steps.
katsemeetodiga aja jooksul saadud tulemuste laborisisese ja laboritevahelise korratavuse ulatuse mõõt, kui katset tehakse sama metoodikaga.
A closed-chamber method is typically used for non-viscous to slightly viscous liquid test chemicals, while an open-chamber method is typically used for semi-viscous and viscous liquid test chemicals and for neat solids.
katsemeetodi tulemuste lähedus kokkulangemisele kinnitatud võrdlusväärtustega.
In the closed-chamber method, sufficient test chemical (750 μl) to cover the epithelial side of the cornea is introduced into the anterior chamber through the dosing holes on the top surface of the chamber, and the holes are subsequently sealed with the chamber plugs during the exposure.
Täpsusega mõõdetakse katsemeetodi toimivust ja see on üks asjakohasuse aspektidest.
It is important to ensure that each cornea is exposed to a test chemical for the appropriate time interval.
Uuritav kemikaal
In the open-chamber method, the window-locking ring and glass window from the anterior chamber are removed prior to treatment.
Usaldusväärsus –
The control or test chemical (750 μl, or enough test chemical to completely cover the cornea) is applied directly to the epithelial surface of the cornea using a micro-pipet.
katsemeetodiga aja jooksul saadud tulemuste laborisisese ja laboritevahelise korratavuse ulatuse mõõt, kui katset tehakse sama katse-eeskirja alusel.
If a test chemical is difficult to pipet, the test chemical can be pressure-loaded into a positive displacement pipet to aid in dosing.
Seda hinnatakse laborisisese ja laboritevahelise korratavuse ja laborisisese korduvuse arvutamisega.
The pipet tip of the positive displacement pipet is inserted into the dispensing tip of the syringe so that the material can be loaded into the displacement tip under pressure.
Uuritav kemikaal
Simultaneously, the syringe plunger is depressed as the pipet piston is drawn upwards.
iga aine või segu, mida uuritakse käesoleva katsemeetodi abil.
If air bubbles appear in the pipet tip, the test chemical is removed (expelled) and the process repeated until the tip is filled without air bubbles.
Valenegatiivsete tulemuste määr kõikide selliste positiivsete kemikaalide osakaal, mis on katsemeetodi alusel ekslikult tunnistatud negatiivseks.
If necessary, a normal syringe (without a needle) can be used since it permits measuring an accurate volume of test chemical and an easier application to the epithelial surface of the cornea.
Uuritav kemikaal iga aine või segu, mida uuritakse käesoleva katsemeetodi abil.
After dosing, the glass window is replaced on the anterior chamber to recreate a closed system.
Valenegatiivsete tulemuste määr kõikide selliste positiivsete kemikaalide osakaal, mis on katsemeetodi alusel ekslikult tunnistatud negatiivseks.
Post-Exposure Incubation
See on katsemeetodi toimivuse üks näitajaid.
After the exposure period, the test chemical, the negative control, or the positive control chemical is removed from the anterior chamber and the epithelium washed at least three times (or until no visual evidence of test chemical can be observed) with EMEM (containing phenol red).
Valepositiivsete tulemuste määr kõikide selliste negatiivsete kemikaalide osakaal, mis katsemeetodi alusel on ekslikult tunnistatud positiivseks.
Phenol red- containing medium is used for rinsing since a colour change in the phenol red may be monitored to determine the effectiveness of rinsing acidic or alkaline test chemicals.
Valideeritud katsemeetod
The corneas are washed more than three times if the phenol red is still discoloured (yellow or purple), or the test chemical is still visible.
katsemeetod, mille valideerimisuuringud on lõpule viidud, st on määratud selle asjakohasus (sealhulgas täpsus) ja usaldusväärsus konkreetse eesmärgi suhtes.
Once the medium is free of test chemical, the corneas are given a final rinse with EMEM (without phenol red).
Oluline on märkida, et valideeritud katsemeetod ei tarvitse olla piisavalt kasutuskõlblik täpsuse ja usaldusväärsuse poolest, et seda saaks lugeda vastuvõetavaks konkreetse eesmärgi saavutamise seisukohast.
The EMEM (without phenol red) is used as a final rinse to ensure removal of the phenol red from the anterior chamber prior to the opacity measurement.
Võrdluskemikaal
The anterior chamber is then refilled with fresh EMEM without phenol red.
Ühinenud Rahvaste Organisatsiooni ühtne ülemaailmne kemikaalide klassifitseerimise ja märgistamise süsteem (ÜRO GHS (Globally Harmonized System))