natgillin/translations-raw huggingface dataset:
Lymfeknuder (både overfladiske og dybe)
lymph nodes (both superficial and deep)
Vesiculae seminales
seminal vesicle
Urinblære
urinary bladder
Brystkirtel (obligatorisk for hundyr og, hvis de er synligt dissekerbare, for handyr)
mammary gland (obligatory for females and, if visibly dissectable, from males)
Skeletmuskel
skeletal muscle
Uterus med cervix
uterus (including cervix)
[Øvre luftveje, herunder næse, muslingeben og paranasale sinusser]
[upper respiratory tract, including nose, turbinates, and paranasal sinuses]
Øje (herunder retina)
eye (including retina)
Øsofagus
oesophagus
Rygmarv (på tre niveauer: (cervikal, midt-torakal og lumbal)
spinal cord (at three levels: cervical, mid-thoracic, and lumbar)
[Femur med led]
[femur with joint]
Milt
spleen
Galdeblære (for andre arter end rotte)
gall bladder (for species other than rat)
Æggestok
ovary
[Sternum]
[sternum],
Sektion af knoglemarven og/eller frisk knoglemarvsaspirat
section of bone marrow and/or a fresh bone marrow aspirate
Harderian-kirtel
Harderian gland
I tilfælde af parrede organer, f.eks. nyrer og binyrer, præserveres begge organer.
In the case of paired organs, e.g. kidney, adrenal, both organs should be preserved.
I forsøg, der omfatter dermal applikation, skal de organer, der er opført på listen over organer til præservation ved oral administration, præserveres, og specifik prøvetagning og præservation af huden fra applikationsstedet skal foretages.
In studies involving the dermal route of administration, the list of organs as set out for the oral route should be preserved, and specific sampling and preservation of the skin from the site of application is essential.
I inhalationsforsøg skal listen over væv, der skal præserveres og undersøges fra luftvejene, følge anbefalingerne i kapitel B.8 i dette bilag (8) og kapitel B.29 i dette bilag (9).
In inhalation studies, the list of preserved and examined tissues from the respiratory tract should follow the recommendations of Chapters B.8 of this Annex (8) and Chapter B.29 of this Annex (9).
For andre organer/væv (og i tillæg til de væv, der specifikt er præserveret fra luftvejene) skal de organer, der er anført for oral administration, undersøges.
For other organs/tissues (and in addition to the specifically preserved tissues from the respiratory tract) the list of organs as set out for the oral route should be examined.
Der foreligger vejledning om bedste praksis i forbindelse med gennemførelsen af toksikologiske patologiforsøg (32).
Guidance is available on best practices in the conduct of toxicological pathology studies (32).
De histopatologiske undersøgelser skal som minimum omfatte:
The minimum histopathological examinations should be:
alle væv fra højdosis- og kontrolgruppen
all tissues from the high dose and control groups;
alle væv fra dyr, som er døde eller aflivet under forsøget
all tissues from animals dying or killed during the study;
alle væv, som udviser makroskopiske abnormiteter
all tissues showing macroscopic abnormalities;
målvæv eller væv, der udviser behandlingsrelaterede forandringer i højdosisgruppen, fra dyr i alle andre dosisgrupper
target tissues, or tissues which showed treatment-related changes in the high dose group, from all animals in all other dose groups;
i tilfælde af parrede organer, f.eks. nyrer og binyrer, præserveres begge organer.
in the case of paired organs, e.g. kidney, adrenal, both organs should be examined.
Der skal fremlægges data for de enkelte dyr for alle evaluerede parametre.
Individual animal data should be provided for all parameters evaluated.
Yderligere skal alle data opsummeres i tabeller, der for hver testgruppe viser antal dyr ved forsøgets begyndelse, antal dyr fundne døde i løbet af testen eller aflivede af humane grunde og tidspunktet for deres død, det antal dyr, der udviser tegn på toksicitet, en beskrivelse af disse tegn, inklusive tidspunktet for deres begyndelse, deres varighed og toksicitetsgraden; det antal dyr, der har læsioner, typen af læsioner og den procentdel af dyrene, der udviser de forskellige typer af læsion.
Additionally, all data should be summarised in tabular form showing for each test group the number of animals at the start of the test, the number of animals found dead during the test or killed for humane reasons and the time of any death or humane kill, the number showing signs of toxicity, a description of the signs of toxicity observed, including time of onset, duration, and severity of any toxic effects, the number of animals showing lesions, the type of lesions and the percentage of animals displaying each type of lesion.
I oversigtstabeller anføres middel- og standardafvigelser (for kontinuerlige testdata) for dyr, der udviser toksiske virkninger eller læsioner, samt gradueringen af læsioner.
Summary data tables should provide the means and standard deviations (for continuous test data) of animals showing toxic effects or lesions, in addition to the grading of lesions.
Historiske kontroldata kan være værdifulde i forbindelse med fortolkningen af forsøgsresultaterne, f.eks. hvis der er tegn på, at data fra de samtidige kontroller er væsentligt afvigende i forhold til nylige data fra kontroldyr fra samme forsøgslaboratorium/koloni.
Historical control data may be valuable in the interpretation of the results of the study, e.g. in the case when there are indications that the data provided by the concurrent controls are substantially out of line when compared to recent data from control animals from the same test facility/colony.
Historiske kontroldata, som evalueres, bør indgives fra samme laboratorium og vedrøre dyr af samme alder og stamme genereret i de fem år forud for det aktuelle forsøg.
Historical control data, if evaluated, should be submitted from the same laboratory and relate to animals of the same age and strain generated during the five years preceding the study in question.
Den statistiske metode og de data, der skal analyseres med den, skal vælges under planlægningen af forsøget (se afsnit 8).
The statistical methods and the data to be analysed should be selected during the design of the study (paragraph 8).
Ved udvælgelse bør der tages behov for evt. justeringer for overlevelse.
Selection should make provision for survival adjustments, if needed.
fysiske egenskaber, renhedsgrad og fysisk-kemiske egenskaber
physical nature, purity, and physicochemical properties;
identifikationsdata
identification data;
testkemikaliets kilde
source of chemical;
batchnummer
batch number;
certifikat for kemisk analyse.
certificate of chemical analysis
begrundelse for valg af vehikel, hvis dette ikke er vand.
justification for choice of vehicle (if other than water).
anvendt art/stamme og begrundelse for anvendelse
species/strain used and justification for choice made;
dyrenes antal, alder og køn ved forsøgsstart
number, age, and sex of animals at start of test;
begrundelse for valg af administrationsvej og dosis
rationale for route of administration and dose selection;
de statistiske metoder, der er anvendt til dataanalyse, hvis relevant
when applicable, the statistical methods used to analyse the data;
oplysninger om formuleringen af testkemikalie/fodertilberedning
details of test chemical formulation/diet preparation;
analysedata om opnået koncentration, stabilitet og homogenitet for tilberedningen
analytical data on achieved concentration, stability and homogeneity of the preparation;
administrationsvej og nærmere oplysninger om administrationen af testkemikaliet
route of administration and details of the administration of the test chemical;
eksponering gennem næsen og helkropseksponering for inhalationsforsøg
for inhalation studies, whether nose only or whole body;
faktiske doser (mg/kg kropsvægt/dag) og omregningsfaktor fra testkemikaliets koncentration i foder/vand (mg/kg eller ppm) til faktisk dosis, hvis muligt
actual doses (mg/kg body weight/day), and conversion factor from diet/drinking water test chemical concentration (mg/kg or ppm) to the actual dose, if applicable;
Resultater (opsummerende data og data for individuelle dyr opstilles i tabelform):
Results (summary tabulated data and individual animal data should be presented):
data om overlevelse
survival data;
foderindtagelse, beregning af foderudnyttelse og indtagelse af vand, hvis muligt
food consumption, calculations of food efficiency, if made, and water consumption if applicable;
art, incidens (og, hvis vurderet sværhedsgrad) og varighed af kliniske symptomer (hvad enten disse er reversible eller ikke)
nature, incidence (and, if scored, severity), and duration of clinical observations ((whether transitory or permanent);
oftalmologisk undersøgelse
ophthalmological examination;
hæmatologiske målinger
haematological tests;
klinisk-biokemiske målinger
clinical biochemistry tests;
urinanalyser
urinalysis tests;
resultat af undersøgelser af neurotoksicitet eller immunotoksicitet
outcome of any investigations of neurotoxicity or immunotoxicity;
kropsvægt ved forsøgets afslutning
terminal body weight;
organvægt (og deres forhold, hvis relevant)
organ weights (and their ratios, if applicable);
en detaljeret beskrivelse af alle behandlingsrelaterede histopatologiske fund
a detailed description of all treatment-related histopathological findings;
Evt. statistisk behandling af resultaterne
Statistical treatment of results, as appropriate
Diskussioner af resultater, herunder:
Discussion of results including:
forhold mellem dosis og respons
Dose: response relationships
overvejelse af oplysninger om virkningsmåde
Consideration of any mode of action information
diskussion af tilgange til modellering
Discussion of any modelling approaches
bestemmelse af BMD, NOAEL eller LOAEL
BMD, NOAEL or LOAEL determination
historiske kontroldata
Historical control data
relevans for mennesker.
Relevance for humans
Kapitel B.27 i dette bilag, Subkronisk oral toksicitetstest — et 90-dages forsøg over gentagne orale dosers toksicitet på ikke-gnavere.
Chapter B.27 of this Annex, Sub-chronic Oral Toxicity Test Repeated Dose 90-day Oral Toxicity Study in Non-Rodents.
Guidance Document on the Design and Conduct of Chronic Toxicity and Carcinogenicity Studies, Supporting Test Guidelines 451, 452 og 453 — Second edition.
Guidance Document on the Design and Conduct of Chronic Toxicity and Carcinogenicity Studies, Supporting Test Guidelines 451, 452 and 453 — Second edition.
Series on Testing and Assessment No. 116, findes på OECD's offentlige websted for Test Guidelines på www.oecd.org/env/testguidelines.
Series on Testing and Assessment No 116, available on the OECD public website for Test Guideline at www.oecd.org/env/testguidelines.
Guidance Document on Acute Inhalation Toxicity Testing, Series on Testing and Assessment No. 39, ENV/JM/MONO(2009)28, OECD, Paris.
Guidance Document on Acute Inhalation Toxicity Testing, Series on Testing and Assessment No 39, ENV/JM/MONO(2009)28, OECD, Paris.
Kapitel B.8 i dette bilag, Subakut toksicitet (inhalation): 28-dages forsøg
Chapter B.8 of this Annex, Subacute Inhalation Toxicity: 28-Day Study.
Kapitel B.29 i dette bilag, Subkronisk toksicitet (inhalation): 90-dages forsøg
Chapter B.29 of this Annex, Subchronic Inhalation Toxicity: 90-Day Study.
Kapitel B.9 i dette bilag, Toksicitet ved gentagen dosering (28 dage, dermal).
Chapter B.9 of this Annex, Repeated Dose (28 Days) Toxicity (Dermal).
Guidance Notes for Analysis and Evaluation of Chronic Toxicity and Carcinogenicity Studies, Series on Testing and Assessment No. 35 and Series on Pesticides No. 14, ENV/JM/MONO(2002)19, OECD, Paris.
Guidance Notes for Analysis and Evaluation of Chronic Toxicity and Carcinogenicity Studies, Series on Testing and Assessment No 35 and Series on Pesticides No 14, ENV/JM/MONO(2002)19, OECD, Paris.
Guidance document on the recognition, assessment and use of clinical signs as humane endpoints for experimental animals used in safety evaluation.
Guidance Document on the recognition, assessment, and use of clinical signs as humane endpoints for experimental animals used in safety evaluation, No 19, ENV/JM/MONO(2000)7, OECD, Paris.
Europa-Parlamentets og Rådets direktiv 2010/63/EU af 22. september 2010 om beskyttelse af dyr, der anvendes til videnskabelige formål (EUT L 276 af 20.10.2010, s. 33).
Directive 2010/63/EU of the European parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
NIH Publication No. 86-23.
NIH Publication No 86-23.
EMEA-dokument (udkast) »Non-clinical guideline on drug-induced hepatotoxicity« (Dok. ref. EMEA/CHMP/SWP/a50115/2006).
EMEA (draft) document “Non-clinical guideline on drug-induced hepatotoxicity” (Doc. Ref. EMEA/CHMP/SWP/a50115/2006).
Kapitel B.32 og B.33 affattes således:
Chapters B.32 and B.33 are replaced by the following:
KARCINOGENICITETSFORSØG
CARCINOGENICITY STUDIES
Denne testmetode svarer til OECD Test Guideline (TG) 451 (2009).
This Test Method is equivalent to OECD Test Guideline (TG) 451 (2009).
Denne testmetode B.32 er opdateret parallelt med revisionen af kapitel B.30 i dette bilag (Forsøg vedrørende kronisk toksicitet) og kapitel B.33 i dette bilag (Kombineret forsøg vedrørende karcinogenicitet/kronisk toksicitet) med det formål at fremskaffe yderligere oplysninger fra de dyr, der bruges i forsøget, og flere oplysninger om dosisvalg.
The updating of this Test Method B.32 has been carried out in parallel with revisions of Chapter B.30 of this Annex, Chronic Toxicity Studies, and Chapter B.33, of this Annex, Combined Chronic ToxicityCarcinogenicity Studies, and with the objective of obtaining additional information from the animals used in the study and providing further detail on dose selection.
Denne testmetode B.32 er designet, så den kan bruges til test af en bred vifte af kemikalier, herunder pesticider og industrikemikalier.
This Test Method B.32 is designed to be used in the testing of a broad range of chemicals, including pesticides and industrial chemicals.
Det skal dog bemærkes, at andre oplysninger og krav kan være gældende for lægemidler (se International Conference on Harmonisation (ICH) Guidance S1B on Testing for Carcinogenicity of Pharmaceuticals).
It should be noted however that some details and requirements may differ for pharmaceuticals (see International Conference on Harmonisation (ICH) Guidance S1B on Testing for Carcinogenicity of Pharmaceuticals).
De fleste karcinogenicitetsforsøg gennemføres ved hjælp af gnaverarter, og det er derfor hensigten, at denne testmetode primært anvendes i forsøg på sådanne arter.
The majority of carcinogenicity studies are carried out in rodent species, and this Test Method is intended therefore to apply primarily to studies carried out in these species.
De tre primære administrationsveje i karcinogenicitetsforsøg er oral indgift, dermal applikation og inhalation.
The three main routes of administration used in carcinogenicity studies are oral, dermal and inhalation.
Yderligere oplysninger om valg af administrationsvej findes i Guidance Document No. 116 (7).
Additional information on choice of route of exposure is provided in Guidance Document No 116 (7).
Denne testmetode fokuserer på oral eksponering, den administrationsvej, der oftest bruges i karcinogenicitetsforsøg.
This Test Method focuses on exposure via the oral route, the route most commonly used in carcinogenicity studies.
Karcinogenicitetsforsøg, der involverer eksponering via inhalation eller dermal applikation, kan også være nødvendige i forbindelse med vurdering af risici for menneskers sundhed og/eller påkrævet i medfør af lovgivningen, men betydelig teknisk kompleksitet er forbundet med begge eksponeringsveje. Sådanne forsøg skal designes i hvert enkelt tilfælde, selv om den testmetode, der er beskrevet her til vurdering og evaluering af karcinogenicitet ved oral administration, kan bruges som udgangspunkt for en protokol for inhalationsforsøg og/eller dermale forsøg, hvad angår anbefalinger vedrørende behandlingsperioder, kliniske og patologiske parametre osv.
While carcinogenicity studies involving exposure via the dermal or inhalation routes may also be necessary for human health risk assessment and/or may be required under certain regulatory regimes, both routes of exposure involve considerable technical complexity.
Der findes OECD-vejledninger om administration af testkemikalier ved hjælp af dermal applikation (7) og inhalation (7) (8).
Such studies will need to be designed on a case-by-case basis, although the Test Method outlined here for the assessment and evaluation of carcinogenicity by oral administration could form the basis of a protocol for inhalation and/or dermal studies, with respect to recommendations for treatment periods, clinical and pathology parameters, etc. OECD Guidance is available on the administration of test chemicals by the dermal (7), and inhalation routes (7) (8).
Kapitel B.8 i dette bilag (9) og kapitel B.29 i dette bilag (10) bør sammen med OECD Guidance Document on Acute Inhalation Testing (8) specifikt anvendes ved design af forsøg med længere varighed, der involverer eksponering via inhalation.
Chapter B.8 of this Annex (9) and Chapter B.29 of this Annex (10), together with the OECD Guidance Document on acute inhalation testing (8), should be specifically consulted in the design of longer term studies involving exposure via the inhalation route.
Kapitel B.9 i dette bilag (11) anvendes, hvis forsøget vedrører dermal applikation.
Chapter B.9 of this Annex (11) should be consulted in the case of testing carried out by the dermal route.
Karcinogenicitetsforsøget skaffer viden om mulige sundhedsfarer, som kan opstå ved gentagen eksponering i løbet af en periode, der kan vare de anvendte arters levetid.
The carcinogenicity study provides information on the possible health hazards likely to arise from repeated exposure for a period lasting up to the entire lifespan of the species used.
Forsøget tilvejebringer oplysninger om de toksiske virkninger af testkemikaliet, herunder potentiel karcinogenicitet, og kan pege på, hvilke organer der rammes, og muligheden for akkumulation.
The study will provide information on the toxic effects of the test chemical including potential carcinogenicity, and may indicate target organs and the possibility of accumulation.
Det kan også give et estimat af niveauet uden observerbare negative effekter (NOAEL) og, i tilfælde af ikke-genotoksiske karcinogener, af tumorrespons, som kan anvendes ved fastsættelse af sikkerhedskriterier for menneskers eksponering.
It can provide an estimate of the no-observed-adverse effect level for toxic effects and, in the case of non-genotoxic carcinogens, for tumour responses, which can be used for establishing safety criteria for human exposure.
De forsøgsformål, der er omfattet af denne testmetode, omfatter:
The objectives of carcinogenicity studies covered by this Test Method include:
identifikation af et testkemikalies karcinogene egenskaber, der fører til en øget incidens af neoplasmer, øget andel af ondartede neoplasmer eller en reduktion i tiden til forekomsten af neoplasmer sammenlignet med samtidige kontrolgrupper
The identification of the carcinogenic properties of a test chemical, resulting in an increased incidence of neoplasms, increased proportion of malignant neoplasms or a reduction in the time to appearance of neoplasms, compared with concurrent control groups;
identifikation af målorganer for karcinogenicitet
The identification of target organ(s) of carcinogenicity;
identifikation af tid til fremkomst af neoplasmer
The identification of the time to appearance of neoplasms;
karakterisering af forholdet mellem dosis-respons og tumor
Characterisation of the tumour dose-response relationship;
ekstrapolering af karcinogene virkninger til eksponeringsniveauer for mennesker ved lav dosis
Extrapolation of carcinogenic effects to low dose human exposure levels;
data til testhypoteser vedrørende virkningsmåde (2) (7) (12) (13) (14) (15).
Provision of data to test hypotheses regarding mode of action (2) (7) (12) (13) (14) (15).
Ved vurderingen og evalueringen af den potentielle karcinogenicitet af et testkemikalie inddrages alle tilgængelige informationer om testkemikaliet af testlaboratoriet inden gennemførelsen af forsøget, således at forsøget fokuseres på effektiv test af potentialet for karcinogenicitet, og således at omfanget af dyreforsøg minimeres.
In the assessment and evaluation of the potential carcinogenicity of a test chemical, all available information on the test chemical should be considered by the testing laboratory prior to conducting the study, in order to focus the design of the study to more efficiently test for carcinogenic potential and to minimise animal usage.
Information om og overvejelse af virkningsmåden for et mistænkt karcinogen (2) (7) (12) (13) (14) (15) er særlig vigtig, fordi det optimale design kan variere, afhængigt af om testkemikaliet er et kendt eller mistænkt genotoksisk karcinogen.
Information on, and consideration of, the mode of action of a suspected carcinogen (2) (7) (12) (13) (14) (15) is particularly important, since the optimal design may differ depending on whether the test chemical is a known or suspected genotoxic carcinogen.
Yderligere vejledning om overvejelser vedrørende virkningsmåde findes i Guidance Document No. 116 (7).
Further guidance on mode of action considerations can be found in Guidance Document No 116 (7).
Informationer, der kan hjælpe med at fastlægge forsøgsdesignet, omfatter testkemikaliets identitet, kemiske struktur og fysisk-kemiske egenskaber, resultater af in vitro- eller in vivo-toksicitetstest, herunder genotoksicitetstest, forventede anvendelser og potentialet for human eksponering, tilgængelige (Q)SAR-data, data om mutagenicitet/genotoksicitet og toksikologiske data vedrørende strukturelt relaterede kemikalier, tilgængelige toksikokinetiske data (kinetiske data ved enkelt og gentagen eksponering) samt data udledt af andre forsøg med gentagen eksponering.
Information that will assist in the study design includes the identity, chemical structure, and physico-chemical properties of the test chemical; results of any in vitro or in vivo toxicity tests including genotoxicity tests; anticipated use(s) and potential for human exposure; available (Q)SAR data, mutagenicity/genotoxicity, carcinogenicity and other toxicological data on structurally-related chemicals; available toxicokinetic data (single dose and also repeat dose kinetics where available) and data derived from other repeated exposure studies.
Vurderingen af karcinogenicitet bør udføres, når indledende informationer om toksicitet er indhentet fra 28-dages eller 90-dages toksicitetstest med gentagen dosering.
Assessment of carcinogenicity should be carried out after initial information on toxicity has been obtained from repeated dose 28-day and/or 90-day toxicity tests.
Kortvarige test med cancerinitiering-/fremme kan også give nyttige oplysninger.
Short-term cancer initiation-promotion tests could also provide useful information.
Det bør overvejes at benytte en faseinddelt testtilgang til karcinogenicitetstest som et led i den overordnede vurdering af de potentielle sundhedsskadelige virkninger af et bestemt testkemikalie (16) (17) (18) (19).
A phased testing approach to carcinogenicity testing should be considered as part of the overall assessment of the potential adverse health effects of a particular test chemical (16) (17) (18) (19).
Det skal bl.a. overvejes, om statistikkerne skal omfatte justering for overlevelse, analyse af kumulative tumorrisici i forhold til overlevelsesvarighed, analyse af tid til tumor og analyse i tilfælde af afslutning af en eller flere grupper før tid.
Issues to consider include whether the statistics should include adjustment for survival, analysis of cumulative tumour risks relative to survival duration, analysis of the time to tumour and analysis in the event of premature termination of one or more groups.
Vejledning om relevante statistiske analyser og nøglereferencer til internationalt anerkendte statistiske metoder findes i Guidance Document No. 116 (7) og Guidance Document No. 35 (20).
Guidance on the appropriate statistical analyses and key references to internationally accepted statistical methods are given in Guidance Document No 116 (7), and also in Guidance Document No 35 on the analysis and evaluation of chronic toxicity and carcinogenicity studies (20).