natgillin/translations-raw huggingface dataset:
Derudover kan der udtages prøver på andre tidspunkter, hvis det er relevant.
Samples of peripheral blood are taken at least twice, starting not earlier than 36 hours after treatment, with appropriate intervals following the first sample, but not extending beyond 72 hours. When a positive response is recognised at one sampling time, additional sampling is not required. (b) if two or more daily treatments are used (e.g. two or more treatments at 24 hour intervals), samples should be collected once between 18 and 24 hours following the final treatment for the bone marrow and once between 36 and 48 hours following the final treatment for the peripheral blood (12); Other sampling times may be used in addition, when relevant.
Hvis der ved en test med én dosis på mindst 2000 mg p. kg legemsvægt indgivet på én gang eller i to omgange samme dag ikke kan iagttages nogen toksiske virkninger, og hvis man på grundlag af data om strukturnæssigt beslægtede stoffer ikke forventer gentoksicitet, kan en fuldstændig undersøgelse med tre dosisniveauer anses for unødvendig, for længerevarende undersøgelser er grænsedosis på 2000 mg pr. kg legemsvægt pr. dag for behandlinger over højst 14 dage og på 1000 mg pr. kg legemsvægt pr. dag for behandlinger over mere end 14 dage.
If a test at one dose level of at least 2000 mg/kg body weight using a single treatment, or as two treatments on the same day, produces no observable toxic effects, and if genotoxicity would not be expected based upon data from structurally related substances, then a full study using three dose levels may not be considered necessary. For studies of a longer duration, the limit dose is 2000 mg/kg/body weight/day for treatment up to 14 days, and 1000 mg/kg/body weight/day for treatment longer than 14 days.
Et positivt resultat af mikrokernetesten viser, at teststoffet fremkalder mikrokerner, som følge af beskadigelse af kromosomer eller mitoseapparat hos erythroblaster i den undersøgte art. Et negativt resultat viser, at teststoffet under testbetingelserne ikke fremkalder mikrokerner hos umodne erythrocytter i den undersøgte art.
Positive results in the micronucleus test indicate that the substance induces micronuclei which are the result of chromosomal damage or damage to the mitotic apparatus in the erythroblasts of the test species. Negative results indicate that, under the test conditions, the test substance does not produce micronuclei in the immature erythrocytes of the test species.
(1983), Micronuclei in Circulating Erythrocytes: A Rapid Screen for Chromosomal Damage During Routine Toxicity Testing in Mice, in: Developments in Science and Practice of Toxicology, cd.
A.W.
The Collaborative Study Group for the Micronucleus Test (1992). Micronucleus Test with Mouse Peripheral Blood Erythrocytes by Acridine Orange Supravital Staining: The Summary Report of the 5th Collaborative Study by CSGMT/JEMMS.
The Collaborative Study Group for the Micronucleus Test, (1992) Micronucleus Test with Mouse Peripheral Blood Erythrocytes by Acridine Orange Supravital Staining: The Summary Report of the 5th Collaborative Study by CSGMT/JEMMS. MMS.
The Collaborative Study Group for the Micronucleus Test (CSGMT/JEMMS, MMS: The Mammalian Mutagenesis Study Group of the Environmental Mutagen Society of Japan) (1995).
The Collaborative Study Group for the Micronucleus Test (CSGMT/JEMMS. MMS: The Mammalian Mutagenesis Study Group of the Environmental Mutagen Society of Japan), (1995) Protocol recommended for the short-term mouse peripheral blood micronucleus test.
Richold, M., Ashby, J., Bootman, J., Chandley, A., Gatehouse, D.G. and Henderson, L. (1990), In Vivo Cytogenetics Assay, in: D.J.
Richold, M., Ashby, J., Bootman, J., Chandley, A., Gatehouse, D.G. and Henderson, L., (1990) In Vivo Cytogenetics Assay. In: D.J. Kirkland (Ed.)
Kirkland (ed.), Basic Mutagenicity tests.
Basic Mutagenicity tests. UKEMS Recommended Procedures.
UKEMS Recommended Procedures, UKEMS Sub-Committe on Guidelines for Mutagenicity Testing Report, Part 1, revised, Cambridge University Press, Cambridge, New York, Port Chester, Melbourne, Sydney, pp.
UKEMS Sub-Committee on Guidelines for Mutagenicity Testing. Report, Part I, revised.
Lovell, D.P., Anderson, D., Albanese, R., Amphlett, G. E., Clare, G., Ferguson, R., Richold, M., Papworth, D.G. and Savage, J.R.K.
Lovell, D.P., Anderson, D., Albanese, R., Amphlett, G.E., Clare, G., Ferguson, R., Richold, M., Papworth, D.G. and Savage, J.R.K., (1989) Statistical Analysis of In Vivo Cytogenetic Assays. In: D.J.
Kirkland (ed.), Statistical Evaluation of Mutagenicity Test Data.
Kirkland (Ed.) Statistical Evaluation of Mutagenicity Test Data.
Report, Part III, Cambridge University Press, Cambridge, New York, Port Chester, Melbourne, Sydney, pp.
Report, Part III.
For begge metoders vedkommende tælles revertantkolonierne efter to-tre dages inkubation, og der sammenlignes med antallet af spontane revertantkolonier på kontrolpladerne med opløsningsmiddel.
For both techniques, after two or three days of incubation, revertant colonies are counted and compared to the number of spontaneous revertant colonies on solvent control plates. Several procedures for performing the bacterial reverse mutation test have been described.
De er begge acceptable til udførelse af forsøgene både med og uden metabolismeaktivering.
Either of them is acceptable for conducting experiments both with and without metabolic activation. Some substances may be detected more efficiently using the preincubation method.
Følgende »særtilfælde« er konstateret (samt eksempler på fremgangsmåder, der kan benyttes til påvisning): azofarvestoffer og diazoforbindelser (3) (5) (6) (13), gasser og flygtige stoffer (12) (14) (15) (16) og glycosider (17) (18), Afvigelser fra standardmetoden skal begrundes sagligt.
The following ‘special cases’ could be identified (together with examples of procedures that could be used for their detection): azo-dyes and diazo compounds (3)(5)(6)(13), gases and volatile chemicals (12)(14)(15)(16) and glycosides (17)(18). A deviation from the standard procedure needs to be scientifically justified.
typhimurium TA 1535, og
Such substances may be detected by E. coli WP2 strains or S. typhimurium TA102 (19), which have an AT base pair at the primary reversion site. Therefore the recommended combination of strains is:
typhimurium TA 1537, TA97 eller TA97a, og
typhimurium TA1535, and S. typhimurium TA1537 or TA97 or TA97a, and
cyclophosphamidmonohydrat
cyclophosphamide monohydrate
Congo-rødt
Congo Red
2-nitrofluoren
2-nitrofluorene
cumenbydroperoxid
Cumene hydroperoxide
furylfuramid (AF2)
Furylfuramide (AF2)
Norpoth K.H. and Garner, R.C., Springer, Berlin-Heidelberg-New York, pp.
In: Short-term Test Systems for Detecting Carcinogens. Ed.
I.R., Wilcox, P., Callender, R.D. and Foster R. (1980), Bacterial Mutation Assays, in: Basic Mutagenicity Tests: UKEMS Part 1 Revised, ed.
In: Basic Mutagenicity Tests: UKEMS Part 1 Revised.
Kilbey, B. J., Legator, M., Nichols, V. and Ramel, C, Elsevier, Amsterdam-New York-Oxford, pp.
In: Handbook of Mutagenicity Test Procedures. 2nd Edition. Ed.
Mutagen.
Mol.
Tamura, G., Gold, C, Ferro-Luzzi, A. and Arnes, B. N. (1980), Fecalase: A Model for Activation of Dictary Glycosides to Mutagens by Intestinal Flora, Proc.
Tamura, G., Gold, C., Ferro-Luzzi, A. and Ames, B.N., (1980) Fecalase: A Model for Activation of Dietary Glycosides to Mutagens by Intestinal Flora. Proc.
(1989), Analysis of Data from Microbial Colony Assays, in: UKEMS Sub-Committee on Guidelines for Mutagenicity Testing, Part II.
Part II.
Når der testes toksiske stoffer, bør den højeste koncentration ikke reducere overlevelsesgraden til mindre end 5 til 10 %.
For toxic substances, the highest concentration tested should not reduce survival below 5 to 10 %.
Stoffer, som er relativt uopløselige i vand, testes under anvendelse af passende fremgangsmåder op til opløselighedsgrænsen.
Relatively water-insoluble substances should be tested up to their limit of solubility, using appropriate procedures.
Den højeste koncentration af ikke-toksiske teststoffer, som er frit opløselige i vand, fastlægges fra stof til stof.
For freely water-soluble non-toxic substances, the upper concentration should be determined on a case by case basis.
Pladerne inkuberes i fire til syv dage mellem 28 og 30 oC i mørke.
The plates are incubated four to seven days at 28 to 30 oC in the dark.
Spontane mutationsfrekvenser
Spontaneous mutation frequencies
Der anvendes mindst tre parallelle plader for hver koncentration ved bestemmelsen af prototrofer, som er fremkommet ved genmutation, og af cellernes levedygtighed.
At least three replicate plates should be used per concentration for the assay of prototrophs produced by gene mutation and for cell viability.
Alle resultater efterprøves i et uafhængigt forsøg, Evalueringen af data baseres på passende statistiske metoder.
All results should be confirmed in an independent experiment. The dara should be evaluated using appropriate statistical methods.
Sideløbende med testkulturerne dyrkes positive kontrolkulturer, ubehandlede kontrolkulturer og kontrolkulturer med det anvendte opløsningsmiddel.
Use of negative and positive controls Positive, untreated and solvent controls should be performed concurrently.
I alle forsøg medtages der sideløbende både positive og negative (opløsningsmiddel eller bærestof) kontrolprøver, såvel med som uden metabolismeaktivering, Når der benyttes metabolismeaktivering, bør der som positivt kontrolkemikalie anvendes et, der kræver aktivering for at virke mutagent.
Concurrent positive and negative (solvent or vehicle) controls, both with and without metabolic activation should be included in each experiment. When metabolic activation is used, the positive control chemical should be the one that requires activation to give a mutagenic response.
HFRT
HPRT
Chemical Induction of Specific Locus Mutations in Chinese Hamster Cells In Vitro, Proc.
Chemical Induction of Specific Locus Mutations in Chinese Hamster Cells In Vitro, Proc.
Clive, D., Johnson, K.O., Spector, J.F.S., Batson, A.G. and Brown M.M.M.
Clive, D., Johnson, K.O., Spector, J.F.S., Batson, A.G. and Brown M.M.M., (1979) Validation and Characterisation of the L5178Y/TK+/- Mouse Lymphoma Mutagen Assay System. Mutat.
(1982), CHO/HGPRT Mutation Assay: Evaluation of Gases and Volatile Liquids, In: Tice, R.R., Costa, D.L, Schaich, K.M, (eds.), Genotoxic Effects of Airborne Agents, New York, Plenum, pp.
In: Tice, R.R., Costa, D.L., Schaich, K.M. (eds). Genotoxic Effects of Airborne Agents.
Hannerne parres efter doseringen individuelt med en eller to ikke-doserede jomfruelige hunner i på hinanden følgende perioder af passende længde.
Other treatment schedules may be used. Individual males are mated sequentially to one or two untreated virgin females at appropriate intervals after treatment.
Et positivt resultat af en in vivo-test for kromosomaberrationer i spermatogonier hos pattedyr viser, at teststoffet fremkalder strukturelle kromosomaberrationer i kimceller hos den undersøgte art. Et negativt resultat viser, at teststoffet under testbetingelserne ikke fremkalder strukturelle kromosomaberrationer i kimceller hos den undersøgte art.
Positive results from the in vivo spermatogonial chromosome aberration test indicate that the test substance induces structural chromosome aberrations in the germ cells of the species tested. Negative results indicate that, under the test conditions, the test substance does not induce chromosome aberrations in the germ cells of the species tested.
Kirkland (ed.), Basic Mutagenicity Tests, UKEMS Recommended Procedures.
Basic Mutagenicity Tests, UKEMS Recommended Procedures.
Adler, I.D., Shelby, M.D., Bootman, J., Favor, J., Generoso, W., Pacchierotti, F., Shibuya, T, and Tanaka, N. (1994), International Workshop on Standardisation of Genotoxicity Test Procedures.
Adler, I.D., Shelby M.D., Bootman, J., Favor, J., Generoso, W., Pacchierotti, F., Shibuya, T. and Tanaka N., (1994) International Workshop on Standardisation of Genotoxicity Test Procedures. Summary Report of the Working Group on Mammalian Germ Cell Tests.
UKEMS SubCommittee on Guidelines for Mutagenicity Testing, report, Part III, Cambridge University Press, Cambridge, New York, Port Chester, Melbourne, Sydney, pp.
UKEMS Sub-Committee on Guidelines for Mutagenicity Testing, report, Part III.
Efter parringen placeres hunnerne i hver sit bur, Ved fødslen registreres dato, kuldstørrelse og afkommets køn.
At the end of the mating period females are caged individually. When females give birth, the date, litter size and sex of progeny are recorded.
Translokationsbærere identificeres på grundlag af multivalente konfigurationer i primære spermatocytters diakinese-metafase I. Hvis der observeres mindst to celler med multivalente konfigurationer betragtes det som bevist, at forsøgsdyret er translokationsbærer.
Translocation carriers are identified by the presence of multivalent configurations at diakinesis-metaphase I in primary spermatocytes. Observation of at least two cells with multivalent association constitutes the required evidence that the tested animal is a translocation carrier.
Der foretages mikroskopisk undersøgelse af mindst 25 diakinese-metafaser I pr. han.
A minimum of 25 diakinesis-metaphase I cells per male must be scored microscopically.
F1-hanner med små testikler og defekt meiose, som standser før diakinesen, samt F1-hunner, som formodes at være XO-bærere, underkastes undersøgelse af mitotiske metafaser i spermatogonier eller knoglemarv.
Examination of mitotic metaphases, in spermatogonia or bone-marrow, is required in F1 males with small testes and meiotic breakdown before diakinesis or from F1 female XO suspects.
Følgende væv skal præserveres ved hjælp af det mest passende fiksationsmedie både med henblik på vævstypen og den følgende histopatologiske undersøgelse: alle større læsioner, hjernen (repræsentative regioner, inklusive cerebrum, cerebellum og medulla/pons), rygmarven (fra tre niveauer: cervikal, midt-torakal og lumbal), hypofyse, tyreoidea og paratyreoidea, tymus, øsofagus, spytkirtlerne, mavesækken, tynd- og tyktarm, (inklusive de Peyerske plaques) lever, pankreas, nyrer, binyrer, milt, hjerte, luftrør og lunger (bevaret ved indblæsning med fiksativ og påfølgende neddypning), aorta, gonader, uterus, sekundære kønsorganer, brystkirtlerne fra hundyrene, prostata, urinblære, galdeblære (mus), lymfeknuder (helst en lymfeknude, som dækker belastningsvejen, og en anden langt derfra for at dække den systemiske virkning), perifer nerve (ischiadicus eller tibialis) helst nær ved musklen, en sektion af knoglemarven (og/eller frisk knoglemarvsaspirat), hud og øjne (hvis oftalmologisk undersøgelse viste ændringer), Kliniske og andre fund kan foranledige undersøgelse af andet væv.
The following tissues should be preserved in the most appropriate fixation medium for both the type of tissue and the intended subsequent histopathological examination: all gross lesions, brain (representative regions including cerebrum, cerebellum and medulla/pons), spinal cord (at three levels: cervical, mid-thoracic and lumbar), pituitary, thyroid, parathyroid, thymus, oesophagus, salivary glands, stomach, small and large intestines (including Peyer's patches), liver, pancreas, kidneys, adrenals, spleen, heart, trachea and lungs (preserved by inflation with fixative and then immersion), aorta, gonads, uterus, accessory sex organs, female mammary gland, prostate, urinary bladder, gall bladder (mouse), lymph nodes (preferably one lymph node covering the route of administration and another one distant from the route of administration to cover systemic effects), peripheral nerve (sciatic or tibial) preferably in close proximity to the muscle, a section of bone marrow (and/or a fresh bone marrow aspirate), skin and eyes (if changes were observed during ophthalmological examinations). The clinical and other findings may suggest the need to examine additional tissues.
Blandt de fund, der skal noteres (men ikke som de eneste), er ændringer i hud, pels, øjne, slimhinder, forekomst af sekretion og ekskreter og autonom aktivitet (f.eks. tåreflåd, hårrejsning, pupilstørrelse, usædvanligt respirationsmønster).
Signs of toxicity should be carefully recorded, including time of onset, degree and duration. Observations should include, but not be limited to, changes in skin, fur, eyes, mucous membranes, occurrence of secretions and excretions and autonomic activity (e.g. lacrimation, pilo-erection, pupil size, unusual respiratory pattern).
Lever, nyrer, binyrer og testikler vejes så hurtigt som muligt efter dissektion for at undgå udtørring, Følgende væv og organer skal opbevares i et passende medium med henblik på mulig senere histopatologisk undersøgelse: alle væv og organer, som udviser læsioner, hjerne, herunder snit af medulla/pons, den cerebellare og cerebrale cortex, hypofyse, skjoldbrusk/biskjoldbruskkirtel, thymusvæv, (trakea), lunger, hjerte, aorta, spytkirtler, lever, milt, nyrer, binyrer, bugspytkirtel, kønskirtler, uterus, assesoriske kønskirtler, galdeblære (hvis den findes), spiserør, mavesæk, duodenum, jejunum, ileum, coecum, tyktarm, endetarm, urinblære, en repræsentativ lymfeknude, (kvindelig brystkirtel), (lårmuskulatur), perifer nerve, (øjne), (sternum med benmarv), (femur inklusive ledflade), (rygmarv i tre forskellige snit — cervikalt, midt for thorax og lumbalt) og (exorbitale tårekirtler).
The liver, kidneys, adrenals and testes must be weighed wet as soon as possible after dissection to avoid drying. The following organs and tissues should be preserved in a suitable medium for possible future histopathological examination: all gross lesions, brain — including sections of medulla/pons, cerebellar cortex and cerebral cortex, pituitary, thyroid/parathyroid, any thymic tissue, (trachea), lungs, heart, aorta, salivary glands, liver, spleen, kidneys, adrenals, pancreas, gonads, uterus, accessory genital organs, gall bladder (if present), oesophagus, stomach, duodenum, jejunum, ileum, caecum, colon, rectum, urinary bladder, representative lymph node, (female mammary gland), (thigh musculature), peripheral nerve, (eyes), (sternum with bone marrow), (femur — including articular surface), (spinal cord at three levels — cervical, mid-thoracic and lumbar), and (exorbital lachrymal glands).
Data opstilles i tabelform, som for hver gruppe viser antal dyr ved begyndelsen af forsøget, antal dyr med læsioner og for hver type af læsioner den procentdel dyr, der udviser den pågældende læsion, Evaluering af resultaterne skal baseres på en passende statistisk metode.
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 showing lesions, the type of lesions and the percentage of animals displaying each type of lesion. Results should be evaluated by an appropriate statistical method.
Eksposition kan foregå gennem mund-næse, hovedet alene eller ved kamre til hele kroppen. Ved anvendelse af de to første muligheder opnår man, at indtagelse af teststoffet ad andre veje reduceres.
Oro-nasal, head only, or whole body individual chamber exposure may be used; the first two will minimise uptake by other routes.
Følgende bestemmelser kan foreslås: kalcium, fosfor, klorid, natrium, kalium, fasteglukose (fasteperioden vil afhænge af dyrearten), serum alanin aminotransferase (ALAT), serum aspartat aminotransferase (ASAT), ornitin, decarboxylase, gamma glutamyl transpeptidase, urinstof, albumin, blodkreatinin, total bilirubin og total serumprotein.
Suggested determinations are calcium, phosphorus, chloride, sodium, potassium, fasting glucose (with period of fasting appropriate to the species), serum glutamic pyruvic transaminase [4] Now known as serum alanine aminotransferase. , serum glutamic oxaloacetic transaminase [5] Now known as serum aspartate aminotransferase.
Andre bestemmelser, der kan være påkrævede i en adækvat toksikologisk vurdering omfatter lipidanalyser, hormonanalyser, syre/basebalance, methæmoglobin, cholinesteraseaktivitet.
, ornithine decarboxylase, gamma glutamyl transpeptidase, urea nitrogen, albumin, blood creatinine, total bilirubin and total serum protein measurements. Other determinations, which may be necessary for an adequate toxicological evaluation include analyses of lipids, hormones, acid/base balance, methaemoglobin and cholinesterase activity.
Ved benyttelse af andre dyr end gnavere kan der anvendes et mindre antal, dog mindst fire af hvert køn pr. gruppe.
For non-rodents a smaller number of animals, but at least four per sex per group, is acceptable. 1.6.2.3. Dose levels and frequency of exposure
Hvis det er muligt, bør prøverne tages fra de samme rotter hver gang, Fra andre dyr end gnavere bør der tages en prøve, inden forsøget påbegyndes.
If possible, samples should be from the same rats at each interval. In addition, a pre-test sample should be collected from non-rodents.
Der udtages blodprøver til klinisk-kemisk undersøgelse med ca. seks måneders mellemrum under forsøget og ved forsøgets afslutning fra hvert enkelt dyr, såfremt det drejer sig om andre aner end gnavere, og fra ti rotter/køn i alle grupper så vidt muligt fra de samme rotter hver gang.
At approximately six-monthly intervals and at termination, blood samples are drawn for clinical chemistry measurements from all non-rodents and 10 rats/sex of all groups, if possible, from the same rats at each interval. In addition, a pre-test sample should be collected from non-rodents.
Alle dyr inklusive de dyr, som er døde under forsøget, eller som blev aflivet, fordi de var døende, underkastes en fuldstændig makroskopisk vurdering.
Gross necropsy Full gross necropsy should be performed on all animals, including those which died during the experiment or were killed having been found in a moribund condition.
Dyrene i alle forsøgsgrupper skal så vidt muligt være af ensartet vægt og alder, På hvert dosisniveau skal anvendes unge voksne hundyr, som ikke tidligere har født.
The animals of all test groups should, as nearly as practicable, be of uniform weight and age. Young adult nulliparous female animals should be used at each dose level.
Anvendes et vehikel eller andet tilsætningsstof, skal følgende egenskaber tages i betragtning: Indvirkningen på teststoffets absorption, fordeling, metabolisme og retention eller udskillelse; eventuel sådan indvirkning på teststoffets kemiske egenskaber, som kan ændre dets toksiske egenskaber, samt indvirkningen på dyrenes føde- og vandindtagelse eller ernæringstilstand, Vehiklet må hverken være udviklingstoksisk eller påvirke reproduktionen.
If a vehicle or other additive is used to facilitate dosing, consideration should be given to the following characteristics: effects on the absorption, distribution, metabolism, and retention or excretion of the test substance; effects on the chemical properties of the test substance which may alter its toxic characteristics; and effects on the food or water consumption or the nutritional status of the animals. The vehicle should neither be developmentally toxic nor have effects on reproduction.
Det er velkendt, at uhensigtsmæssig behandling eller stress i drægtighedsperioden kan medføre prænatalt tab. For at sikre mod prænatalt tab som følge af ikke-behandlingsrelaterede faktorer skal man undgå unødvendig håndtering af drægtige dyr samt stress forårsaget af ydre faktorer som støj.
It is well known that inappropriate handling or stress during pregnancy can result in prenatal loss. To guard against prenatal loss from factors which are not treatment related, unnecessary handling of pregnant animals as well as stress from outside factors such as noise should be avoided.
Doseringen bør på grundlag af foreliggende data vælges, så man undgår kraftig maternel toksicitet, Konstateres der kraftig toksisk effekt i de behandlede moderdyr, skal disse aflives af humane grunde.
Existing data should be used for dose selection to prevent excess maternal toxicity. However, if excess toxicity is noted in the treated dams, those animals should be humanely killed.
Vægten af den gravide uterus skal ikke bestemmes for dyr, som findes døde i løbet af undersøgelsen.
Gravid uterine weights should not be obtained from animals found dead during the study. The number of corpora lutea should be determined for pregnant animals.