FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: Additional studies to investigate mutagenicity further or to pre-screen for carcinogenicity may be required for higher production volumes and/or to conduct or follow-up a risk assessment, and these can be used for a number of purposes: to confirm results obtained in the base set; to investigate end-points not studied in the base set; to initiate or extend in vivo studies.
Finnish: Lisätutkimukset mutageenisuuden tutkimiseksi tarkemmin tai karsinogeenisuuden esiseulomiseksi voivat olla tarpeen suuremmissa tuotantomäärissä ja/tai riskinarvioinnin tai seurannan suorittamista varten. Tällaisia tutkimuksia voidaan käyttää useisiin eri tarkoituksiin: perussarjatulosten vahvistamiseen, perussarjaan kuulumattomien päätemuuttujien tutkimiseen ja in vivo -tutkimusten käynnistämiseen tai laajentamiseen.
English: Conventional laboratory diets may be used with an unlimited supply of dri nking water.
Finnish: Eläimille voidaan antaa tavanomaista koe-eläinravintoa ja juomavettä on oltava kaiken aikaa tarjolla.
English: Animals should be fasted prior to dosing (e.g. overnight for the rat or 3-4 hours for the mouse); water should not be withheld.
Finnish: Eläimiä ei saa ruokkia ennen annostelua (esim. rottaa yli yön tai hiirtä 3-4 tuntiin), mutta juomavettä tulee olla tarjolla.
English: However, the duration of observation should not be fixed rigidly.
Italian: Tuttavia tale durata non deve essere tassativa.
Dutch: De duur van deze observatieperiode moet echter niet streng vastgelegd worden.
Swedish: Observationsperiodens längd bör dock inte fastställas strikt.
Finnish: Havainnointijakson kestoa ei pitäisi kuitenkaan määritellä tiukasti.
Hungarian: Mindazonáltal a megfigyelés tartama nincsen mereven rögzítve,
Slovenian: Vendar trajanje opazovanja ne sme biti strogo določeno.
Bulgarian: Продължителността на наблюдението, обаче, не бива да бъде строго фиксирана.
Estonian: Vaatlusperioodi ei tuleks siiski rangelt kindlaks määrata.
Latvian: Tomēr novērošanas ilgums nav stingri jānosaka.
Lithuanian: Stebėjimo periodas neturėtų būti griežtai fiksuojamas.
English: When at a starting dose of 25 or 200 mg/kg body weight only one animal of the seco nd sex dies, this would normally lead to no further testing.
Finnish: Kun vain yksi toista sukupuolta oleva eläin kuolee alkuannoksella 25 tai 200 mg/kg, jatkokokeita ei normaalisti enää tehdä.
English: The concentration of the test substance used for each induction exposure should be well-tolerated systemically and should be the highest to cause mild-to-moderate s kin irritation.
Finnish: Testiaineen pitoisuus kutakin induktioaltistusta kohti tulee olla hyvin siedetty systeemisesti ja korkein mahdollinen lievän tai kohtalaisen ihoärsytyksen aiheuttamiseksi.
English: The test patch system should be fully loaded with test substance in a suitable vehicle (the choice of the vehicle should be justified; liquid test substances can be applied undiluted, if appropriate).
Finnish: Testilapun tulee olla läpikotaisin kyllästetty sopivaan vehikkeliin (vehikkelin valinta tulee perustella; nestemäisiä testiaineita voidaan käyttää laimentamattomina, jos se on tarkoituksenmukaista) sekoitetulla testiaineella.
Hungarian: Egy tapaszt helyeznek fel, amelyet teljesen telítenek a megfelelő vivőanyagban elegyített vizsgálati anyaggal (a vivőanyag kiválasztását indokolni kell, folyékony vizsgált anyagok felvihetők adott esetben hígítás nélkül is).
English: approximately 24 hours after the 30 hour observation (approximately 54 hours after application of the chall enge patch) skin reactions are again observed and recorded.
Finnish: noin 24 tunnin kuluttua 30 ensimmäisen tunnin jälkeen suoritetusta havannointikerrasta (noin 54 tuntia haastelapun asettamisesta) havainnoidaan ihoreaktioita uudelleen ja tulokset kirjataan.
English: Where a repeated dose study is used as a preliminary to a long term study, a si milar diet should be used in both studies.
Finnish: Silloin kun toistuvan annostelun koetta seuraa pitkäaikaistutkimus, eläimille tulee antaa samanlaista ravintoa molemmissa tutkimuksissa.
English: General clinical observations should be made at least once a day, preferably at the same time(s) each day and considering the peak period of anticipated effects after dosing. The health condition of the animals should be recorded.
Finnish: Eläimistä on tehtävä kliinisiä yleishavaintoja vähintään kerran päivässä meiluiten suurin piirtein samaan aikaan / samoihin aikoihin joka päivä ja ottaen huomioon, että odotettuja vaikutuksia esiintyy eniten annostelun jälkeen.
English: The liver, kidneys, adrenals, testes, epididymides, thymus, spleen, brain and heart of all animals should be trimmed of any adherent tissue, as appro priate, and their wet weight taken as soon as possible after dissection to avoid drying.
Finnish: Jokaisen eläimen maksa, munuaiset, lisämunuaiset, kivekset, lisäkivekset, kateenkorva, perna, aivot ja sydän puhdistetaan kaikista niihin kiinnittyvistä kudoksista tarkoituksenmukaisella tavalla ja elinten märkäpaino punnitaan mahdollisimman pian dissektion jälkeen kuivumisen estämiseksi.
English: The vehicle control group should be treated in a manner iden tical to the treatment group, except that administration of the test substance is omitted.
Finnish: Vehikkeliä saavaa verrokkiryhmää tulee käsitellä täsmälleen samoin kuin koeryhmää testiaineen annostelua lukuun ottamatta.
English: Sections should include cerebellum (mid longitudinal lev el), medulla oblongata, spinal cord and peripheral nerves.
Finnish: Sektiot tulee ottaa pikkuaivoista (keskellä kulkeva pitkittäistaso), ydinjatkeesta, selkäytimestä ja ääreishermoista.
English: The condition will have the clinical character of an allergic reaction. However, immunological mechanisms do not have to be demonstrated.
Finnish: Kliinisesti tila muistuttaa allergista reaktiota, mutta immunologista mekanismia ei tarvitse kuitenkaan osoittaa.
English: data from a positive bronchial challenge test with the substance conducted according to accep ted guidelines for the determination of a specific hypersensitivity reaction
Finnish: tiedot positiivisista keuhkoputken ärsytystesteistä, jotka on tehty aineella erityisestä yliherkästä reaktiosta päättämiseksi hyväksyttyjen suuntaviivojen mukaisesti.
English: whereas in consequence it is necessary to amend the foreword to Annex I so as to include notes relating to the labelling of preparations and a new group of organic substances in table B;whereas the list of dangerous substances in Annex I contains substances for which specific temporary classification and labelling derogations have been granted to Austria and Sweden by the Act of Accession of Austria, Finland and Sweden;
French: qu'il convient donc de modifier l'avant-propos de l'annexe I pour y inclure des notes concernant l'étiquetage des préparations et pour ajouter dans le tableau B un nouveau groupe de substances organiques; considérant que la liste de substances dangereuses de l'annexe I contient des substances pour lesquelles des dérogations provisoires spéciales en matière de classification et d'étiquetage ont été accordées à l'Autriche et à la Suède en vertu de l'acte d'adhésion de l'Autriche, de la Finlande et de la Suède;
English: 'Nota 4Preparations containing these substances have to be classified as harmful with R65 if they meet the criteria in section 3.2.3 in Annex VI.`;
Italian: «Nota 4 I preparati contenenti queste sostanze devono essere classificati come nocivi e caratterizzati dalla frase R 65 se rispondono ai criteri di cui al punto 3.2.3 dell'allegato VI.»
English: the following nota 5 is added:'Nota 5
Italian: La nota 5 seguente viene aggiunta alla prefazione:
English: The actual studies which may be appropriate in a specific instance will depend on numerous factors, including the chemical and physical characteristics of the substance, the results of the initial bacterial and cytogenetic assays, the metabolic profile of the substance,
Italian: La scelta del saggio più appropriato al caso in esame dipende da tutta una serie di fattori, tra cui le caratteristiche fisico-chimiche della sostanza, i risultati dei primi saggi batterici e citogenetici, il profilo metabolico della sostanza,
English: the results of other toxicity studies, and the known uses of the substance.
Italian: i risultati di altri studi di tossicità e gli usi noti della sostanza.
English: Some general principles for the testing strategy are laid down by Dir. 93/67/EEC, but clear testing strategies may be found in the technical guidance document for Risk Assessment, which nevertheless is flexible
Italian: Alcuni principi generali sui metodi di saggio da adottare vengono fissati dalla direttiva 93/67/CEE;il documento tecnico di orientamento sulla valutazione dei rischi definisce invece precise strategie a questo riguardo, pur ammettendo una certa flessibilità
English: and can be adapted as appropriate to specific circumstances.
Italian: e adattabilità in funzione delle circostanze specifiche.
English: There are methods available to measure heritable effects in whole mammals produced by gene (point) mutations, e. g. the mouse specific locus test, to measure germ-cell mutation in the first generation,
Italian: Esistono metodi atti a determinare gli effetti ereditabili indotti nei mammiferi da mutazioni genetiche (puntiformi), come il saggio dei loci specifici nel topo, che consente di misurare la mutazione della cellula germinale nella prima generazione
English: (not included in this Annex), or for chromosome aberrations, e. g. the mouse heritable translocation test, (Method B.25).
Italian: (non illustrato nel presente allegato), o a determinare aberrazioni cromosomiche, come la prova di traslocazione ereditabile nel topo (metodo B.25).
English: Removal of hair is by clipping, shaving or possibly by chemical depilation, depending on the test method used.Care should be taken to avoid abrading the skin.
Italian: In funzione del metodo di saggio utilizzato, il pelo verrà tagliato, rasato o rimosso con una sostanza depilatoria, avendo cura di non danneggiare la cute.
English: Clinical biochemistry determinations to investigate major toxic effects in tissues and, specifically, effects on kidney and liver, should be performed on blood samples obtained of all animals just prior to or as part of the procedure for killing the animals
Italian: Esami biochimico-clinici finalizzati allo studio dei principali effetti tossici sui tessuti ed in particolare sui reni e sul fegato dovranno essere effettuati sui campioni di sangue prelevati da tutti gli animali immediatamente prima o durante la loro soppressione
English: (apart from those found moribund and/or intercurrently killed).
Italian: (eccetto gli animali trovati moribondi e/o soppressi nel corso del saggio).
English: Investigations of plasma or serum shall include sodium, potassium, glucose, total cholesterol, urea, creatinine, total protein and albumin, at least two enzymes indicative of hepatocellular effects
Italian: Le analisi sul plasma o sul siero comprenderanno il sodio, il potassio, il glucosio, il colesterolo totale, l'urea, la creatinina, le proteine totali e l'albumina, almeno due enzimi indicatori degli effetti epatocellulari
English: (such as alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, gamma glutamyl transpeptidase, and sorbitol dehydrogenase).
Italian: (come l'alanina aminotransferasi, l'aspartato aminotransferasi, la fosfatasi alcalina, la gamma-glutamil transpeptidasi e la sorbitol deidrogenasi).
English: The young adult domestic laying hen (Gallus gallus domesticus), aged 8 to 12 months, is recommended. Standard size breeds and strains should be employed and the hens normally should have been reared under conditions which permitted free mobility.
Italian: Si utilizzeranno di preferenza galline domestiche ovaiole (Gallus gallus domesticus), giovani e adulte, di età compresa tra 8 e 12 mesi, appartenenti a razze e a ceppi di taglia standard. Gli animali saranno allevati in condizioni che ne garantiscano la libertà di movimento.
English: Six hens randomly selected from each of the treatment and vehicle control groups, and three hens from the positive control group (when this group is run concurrently), should be killed within a few days after dosing,
Italian: Pochi giorni dopo l'esposizione si sopprimeranno sei galline scelte in modo casuale da ciascuno dei gruppi trattati e di controllo negativo e tre appartenenti al gruppo di controllo positivo (se realizzato).
English: and the brain and lumbar spinal cord prepared and assayed for neuropathy target esterase inhibition activity.
Italian: Il cervello e il midollo spinale lombare saranno quindi preparati e analizzati per identificare un'eventuale attività di inibizione della NTE.
English: If observation of clinical signs of intoxication (this can often be assessed by observation of the time of onset of cholinergic signs) indicates that the toxic agent may be disposed of very slowly then
Italian: Qualora l'osservazione dei segni clinici di intossicazione (spesso valutabili in funzione della comparsa di effetti colinergici) suggerisca che l'eliminazione della sostanza tossica avviene molto lentamente,
English: it may be preferable to sample tissue from three birds at each of two times between 24 and as late as 72 hours after dosing.
Italian: può essere preferibile effettuare altri due prelievi tissutali da tre animali nel periodo compreso tra 24 e non oltre 72 ore dopo la somministrazione.
English: Additionally, all data should be summarized in tabular form, showing for each test group the number of animals at the start of the test, the number of animals showing lesions, behavioural
Italian: Inoltre, tutti i dati dovranno essere riassunti in una tabella indicante, per ogni gruppo, il numero di animali all'inizio del saggio, il numero di animali recanti lesioni, alterazioni del comportamento
English: or biochemical effects, the types and severity of these lesions or effects, and the percentage of animals displaying each type and severity of lesion or effect.
Italian: o effetti biochimici, la natura e la gravità di detti effetti o lesioni e la percentuale di animali per ogni tipo di effetto o lesione e per ogni livello di gravità.
English: Organophosphorus substances include uncharged organophosphorus esters, thioesters or anhydrides of organophosphoric, organophosphonic or organophosphoramidic acids or of related phosphorothioic,
Italian: Le sostanze organofosforiche comprendono esteri, tioesteri o anidridi organofosforici neutri degli acidi organofosforico, organofosfonico o organofosforamidico o dei corrispondenti acidi fosforotioico, fosfonotioico
English: phosphonothioic or phosphorothioamidic acids or other substances that may cause the delayed neurotoxicity sometimes seen in this class of substances.
Italian: o fosforotioamidico, o altre sostanze suscettibili di indurre gli effetti neurotossici ritardati talvolta osservati in questa classe di sostanze.
English: The animals are observed at least daily for behavioural abnormalities, ataxia and paralysis until 14 days after the last dose: Biochemical measurements, in particular neuropathy target esterase inhibition (NTE),
Italian: Gli animali vengono esaminati almeno una volta al giorno al fine di individuare eventuali anomalie del comportamento, atassia e paralisi fino a 14 giorni dopo l'ultima somministrazione.Analisi biochimiche, e in particolare l'inibizione della NTE,
English: are undertaken, on hens randomly selected from each group, normally 24 and 48 hours after the last dose.
Italian: vengono di norma eseguite 24 e 48 ore dopo l'ultima esposizione su galline selezionate da ciascun gruppo secondo un criterio di casualità.
English: Healthy young adult hens free from interfering viral diseases and medication, and without abnormalities of gait should be randomized and assigned to treatment and control groups and acclimatized
Italian: Galline adulte, giovani e sane, che non presentino affezioni virali e non siano trattate con farmaci suscettibili di alterare i risultati del saggio, nonché esenti da turbe della deambulazione, vengono assegnate in modo casuale a gruppi da trattare e di controllo e
English: to the laboratory conditions for at least 5 days prior to the start of the study.
Italian: acclimatate alle condizioni di laboratorio per almeno 5 giorni prima dell'inizio del saggio.
English: Additionally, all data should be summarized in tabular form, showing for each test group the number of animals at the start of the test, the number of animals showing lesions, behavioural or biochemical effects, the types and severity of
Italian: Inoltre, tutti i dati dovranno essere riassunti in una tabella indicante, per ogni gruppo, il numero di animali all'inizio del saggio, il numero di animali recanti lesioni, alterazioni del comportamento o effetti biochimici, la natura e la gravità di detti effetti o
English: these lesions or effects, and the percentage of animals displaying each type and severity of lesion or effect.
Italian: lesioni e la percentuale di animali per ogni tipo di effetto o lesione e per ogni livello di gravità.
English: The condition will have the clinical character of an allergic reaction.However, immunological mechanisms do not have to be demonstrated.
Italian: La condizione osservata si presenterà come una reazione allergica, tuttavia non è necessario dimostrare la presenza di meccanismi immunologici.
English: Propane, butane and liquefied petroleum gas are classified in Annex I. Although preparations containing these substances are classified in accordance with Article 3 of Directive 88/379/EEC,
Italian: Il propano, il butano e il gas di petrolio liquefatto sono classificati nell'allegato I. Benché i preparati contenenti queste sostanze siano classificati conformemente all'articolo 3 della direttiva 88/379/CEE,
English: they do not present a danger to human health when they are placed on the market in closed refillable cylinders or in non-refillable cartridges within the scope on EN 417 as fuel gases which are only released for combustion.
Italian: essa non costituiscono un pericolo per la salute umana quando vengono immesse in commercio, come gas combustibili liberati unicamente in vista della loro combustione, in bombole ricaricabili o in cartucce non ricaricabili disciplinate dalla norma EN 417.
English: The heading of 'Section 9.4 Organic peroxides` is replaced by: '9.5.
Italian: Il titolo della sezione «9.4 perossidi organici», è sostituito da: «9.5.
English: COMMISSION DIRECTIVE 96/54/EC of 30 July 1996 adapting to technical progress for the twenty-second time Council Directive 67/548/EEC on the approximation of the laws, regulations
Italian: DIRETTIVA 96/54/CE DELLA COMMISSIONE del 30 luglio 1996 recante ventiduesimo adeguamento al progresso tecnico della direttiva 67/548/CEE del Consiglio concernente il ravvicinamento delle disposizioni legislative, regolamentari
English: and administrative provisions relating to the classification, packaging and labelling of dangerous substances (Text with EEA relevance)
Italian: e amministrative relative alla classificazione, all'imballaggio e all'etichettatura delle sostanze pericolose (Testo rilevante ai fini del SEE)
English: EN:bromobenzene EN:hexachlorobenzene
Italian: IT:bromobenzene IT:esaclorobenzene
English: Concentration limits,
Italian: Limiti di concentrazione,
English: m -phenylenediamine dihydrochloride [1],
Italian: m -fenilendiamina, dicloridrato [1];
English: EN:1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1 H, 3
Italian: IT:1,3,5-tris(ossiranilmetil)-1,3,5-triazin-2,4,6(1 H, 3
English: ANNEX 4
Italian: ALLEGATO 4
English: Additional studies to investigate mutagenicity further or to pre-screen for carcinogenicity may be required for higher production volumes and/or to conduct or follow-up a risk assessment, and these can be used for a number of purposes: to confirm results obtained in the base set; to initiate or extend in vivo studies.
Dutch: Voor hogere productievolumes en/of met het oog op de uitvoering of nadere uitwerking van een risicobeoordeling, kunnen aanvullende onderzoeken van de mutageniteit en pre-screening op carcinogeniteit nodig zijn. Deze kunnen voor een aantal doelen worden gebruikt: om resultaten van de basistests te bevestigen, om parameters te evalueren die niet in de basistests zijn onderzocht en om in vivo onderzoek op te zetten of uit te breiden.
English: Dosing with the test substance should normally be by the oral route using gavage, gelatine capsules, or a comparable method.Liquids may be given undiluted or dissolved in an appropriate vehicle such as corn oil;
Dutch: Het toedienen van de teststof gebeurt gewoonlijk langs orale weg door middel van een maagsonde, gelatinecapsules of een vergelijkbare methode.Vloeistoffen kunnen onverdund of opgelost in een geschikt vehiculum zoals maïsolie worden toegediend.
English: SPECIAL CASES: substanc
Dutch: SPECIALE GEVALLEN: stoffen
English: ANNEX 6
Dutch: BIJLAGE 6
English: When Member States adopt the provisions referred to in paragraphs 1 and 2, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
Portuguese: As normas referidas nos nºs 1 e 2 adoptadas pelos Estados-membros devem incluir uma referência à presente directiva ou ser acompanhadas dessa referência aquando da sua publicação oficial.As modalidades da referência são adoptadas pelos Estados-membros.
English: Additional studies to investigate mutagenicity further or to pre-screen for carcinogenicity may be required for higher production volumes and/or to conduct or follow-up a risk assessment, and these can be used for a number of purposes: to confirm results obtained in the base set;to investigate end-points not studied in the base set;
Portuguese: No caso de volumes de produção mais elevados e/ou com o objectivo de realizar ou confirmar uma avaliação dos riscos, podem ser necessários estudos complementares de avaliação da mutagenicidade ou pré-despistagem da carcinogenicidade, que podem utilizar-se com diversos fins, nomeadamente a confirmação dos resultados obtidos nos ensaios de base, a investigação de parâmetros não abordados nos mesmos e o início ou prosseguimento de estudos in vivo.
Swedish: I fråga om högre produktionsvolymer kan vidare tester krävas för att undersöka mutagenicitet ytterligare eller för att testa cancerogenicitet och/eller för att utföra eller följa upp en riskutvärdering, och dessa tester kan användas för flera olika syften: För att bekräfta erhållna resultat i grundomgången;
English: to initiate or extend in vivo studies.For these purposes, methods B.15 to B.25 include both in vivo and in vitro eukaryotic systems and an extended range of biological end-points.
Portuguese: Para os fins em causa, os métodos B.15 a B.25 utilizam sistemas eucariotas in vitro e in vivo, abrangendo uma vasta gama de parâmetros biológicos.
English: LITERATURE ¿REF¿ERENCES
Portuguese: ¿REF¿ERÊNCIAS BIBLIOGRÁFICAS
English: Besides, the procedure described in this test method allows for the selection of three additional fixed doses, which could either be used as alternative options at given decision points or as option for further testing.The use of (any of the) additional doses may be considered in case a further refinement may be desirable or necessary.
Portuguese: Além disso, o procedimento descrito no presente método de ensaio permite a selecção de três doses fixas adicionais, que podem ser utilizadas como opções em determinadas fases decisivas ou para a realização de ensaios posteriores, caso se pretendam ou necessitem esclarecimentos complementares.
English: The dose level to be used as the starting dose is selected from one of three fixed levels i.e. 25, 200 and 2 000 mg/kg body weight.The starting dose level should be that which is most likely to produce mortality in at least some of the dosed animals.
Portuguese: A dose de partida é seleccionada entre as três doses fixas, isto é, 25, 200 e 2 000 mg/kg de massa corporal, devendo ser a dose mais susceptível de induzir a morte de, pelo menos, alguns dos animais a que for administrada.