FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: Any available information on the mechanism by which the micro-organisms regulate the production of the(se) metabolite(s) shall be provided. Any available information on the influence of the produced metabolites on the micro-organism’s mode of action shall be provided.
French: Toutes les informations disponibles sur le mécanisme de régulation de la production des métabolites ainsi que l’influence des métabolites produits sur le mode d’action du micro-organisme doivent être fournies.
English: specify appropriate conditions or restrictions to be associated with any approval, specify risk and safety phrases (once introduced) for the protection of man, animals and the environment to be included on packaging (containers),
French: permettre la définition des mentions relatives à la nature des risques et aux conseils de prudence (une fois introduites) pour la protection de l’être humain, des animaux et de l’environnement à faire figurer sur les emballages (récipients),
English: If the micro-organism produces exotoxins in accordance with point 2.8, then these toxins and any other relevant metabolites in the culture medium must also be tested for genotoxicity. Such tests on toxins and metabolites shall be performed using the purified chemical if possible.
French: Si le micro-organisme produit des exotoxines au sens du point 2.8, ces toxines et tout autre métabolite pertinent présents dans le milieu de culture doivent aussi être soumis à des essais de génotoxicité pratiqués, si possible, sur une forme purifiée de la substance chimique.
English: Furthermore, for proper risk assessment the toxicity after repeated exposure to contaminants, growth medium, co-formulants and the micro-organism needs to be addressed. It should be kept in mind that the co-formulants in the plant protection product can influence the toxicity and infectiveness of a micro-organism.
French: En outre, pour une bonne évaluation des risques, il convient d’étudier la toxicité après exposition répétée aux contaminants, au milieu de croissance, aux coformulants et au micro-organisme, sans oublier que les coformulants contenus dans le produit phytopharmaceutique peuvent influer sur la toxicité et l’infectiosité d’un micro-organisme.
English: Information based on practical experience, where it exists and is available, in other cases on theoretical grounds, as to the effectiveness of alternative treatment regimes, where relevant, must be provided. Information on resistance to antibiotics must be provided.
French: Des informations relatives à l’efficacité de régimes thérapeutiques de substitution fondées sur l’expérience pratique ou, à défaut, sur des considérations théoriques, doivent être fournies, de même que des informations sur la résistance aux antibiotiques.
English: Where relevant, appropriate information on the persistence and multiplication of the micro-organism, in all environmental compartments has to be given, unless it can be justified that exposure of the particular environmental compartment to the micro-organism is unlikely to occur. Special attention shall be given to:
French: Il convient de fournir, si nécessaire, des informations pertinentes sur la persistance et la multiplication du micro-organisme dans tous les milieux environnementaux, sauf s’il peut être démontré que toute exposition des différents milieux considérés au micro-organisme est improbable, en accordant une attention particulière:
English: In order to make it possible to correctly interpret the obtained results, it is of greatest importance that the suggested test methods are relevant regarding species sensitivity, administration route, etc. and relevant from a biological and toxicological point of view. The way of administration of the test micro-organism depends on the main exposure routes to humans.
Hungarian: A kapott eredmények helyes értelmezése érdekében különösen fontos, hogy a javasolt vizsgálati módszerek relevánsak legyenek a faj érzékenységét, a bejuttatás módját stb. illetően, valamint biológiai és toxikológiai szempontból.
English: Fate and behaviour in the environment Introduction
Hungarian: A mikroorganizmus sorsa és viselkedése a környezetben
English: Information on the origin, the properties, and the survival of the micro-organism and its residual metabolites as well as its intended use form the basis for an assessment of environmental fate and behaviour. Experimental data are normally required unless it can be justified that an assessment of its fate and behaviour in the environment can be performed with the information already available.
Hungarian: Bevezetés
English: In certain specified instances, tests must be conducted using purified active substance of stated specification. In such cases the principles of the method(s) of purification must be reported.
Italian: Talvolta è necessario eseguire prove usando sostanze attive di specifica già stabilita; in questi casi devono essere riferiti i principi del metodo (o dei metodi) di purificazione.
English: The identity of hydrolysis products formed and the rate constantly observed, must be reported. The estimated DT50 value must also be reported.
Italian: È necessario indicare l’identità dei prodotti di idrolisi formatisi, la costante di velocità di reazione osservata e il valore stimato TD50.
English: The studies, data and information submitted, together with other relevant studies, data and information, must both specify and justify the methods and precautions to be followed in the event of fire. The possible products of combustion in the event of fire shall be estimated, based on the chemical structure and the chemical and physical properties of the active substance.
Italian: Gli studi, i dati e le informazioni presentati, con il supporto di altri opportuni studi, dati ed informazioni connessi, devono specificare e giustificare i metodi e le precauzioni da seguire in caso di incendio; devono essere previsti, sempre in caso di incendio, gli eventuali prodotti di combustione, sulla base della struttura chimica e delle proprietà fisico-chimiche della sostanza attiva.
English: Protected crops Amenity
Italian: impiego in aree di svago (parchi pubblici, ecc.),
English: Other methods to dispose of the active substance, contaminated packaging and contaminated materials, where proposed, must be fully described. Data must be provided for such methods, to establish their effectiveness and safety.
Italian: È necessario descrivere accuratamente altri metodi per lo smaltimento di sostanze attive, imballaggi e materiali contaminati, e fornire dati atti a determinare l’efficacia e la sicurezza di siffatti metodi.
English: If all the results of the in vitro studies are negative further testing must be done with consideration of other relevant information available (including toxicokinetic, toxicodynamic and physico-chemical data and data on analogous substances). The test can be an in vivo study or an in vitro study using a different metabolising system from that/those previously used.
Italian: Se tutti i risultati dei test in vitro sono negativi, dev’essere effettuata un’ulteriore sperimentazione prendendo in considerazione altri dati pertinenti disponibili (ivi compresi dati tossicocinetici, tossicodinamici e chimico-fisici, nonché dati su sostanze analoghe); la prova può consistere in uno studio in vivo o in vitro, effettuato utilizzando un sistema con metabolismo differente da quello/quelli utilizzato/i precedentemente.
English: Such reports shall, where feasible, include data relevant to the mechanism of action of the active substance. These reports shall, where available, include data from persons exposed in manufacturing plants or after application of the active substance (e.g. in efficacy trials).
Italian: Tali relazioni devono contenere, ove possibile, dati sul meccanismo d’azione della sostanza attiva e devono riportare dati, se disponibili, relativi a persone esposte negli impianti di fabbricazione o dopo l’applicazione della sostanza attiva (ad esempio in prove di efficacia).
English: Available information on the sensitisation including allergenic response of workers and others exposed to the active substance, must be provided, and include where relevant details of any incidence of hypersensitivity. The information provided shall include details of frequency, level and duration of exposure, symptoms observed and other relevant clinical information.
Italian: Devono essere fornite le informazioni disponibili sulla sensibilizzazione e sulla risposta allergenica di lavoratori e di altre persone esposte alla sostanza attiva; se del caso, queste informazioni devono contenere dettagli sull’eventuale incidenza di casi di ipersensibilità, nonché sulla frequenza, sul livello e sulla durata dell’esposizione, i sintomi osservati ed altre informazioni cliniche pertinenti.
English: The principal mode of action shall be indicated. In connection with the mode of action it shall also be stated if the micro-organism produces a toxin with a residual effect on the target organism.
Italian: Occorre indicare il principale meccanismo d’azione, specificando inoltre a tale riguardo se il microrganismo produce una tossina avente un effetto residuo sull’organismo bersaglio.
Swedish: Det huvudsakliga verkningssättet ska beskrivas, bland annat ska det framgå om mikroorganismen producerar något toxin som har en kvarstående effekt på målorganismen.
English: Available information on the possible occurrence of the development of resistance or cross-resistance of the target organism(s) must be provided. Where possible, appropriate management strategies shall be described.
Italian: È necessario fornire informazioni sull’eventuale sviluppo di resistenza o resistenza incrociata dell’organismo o degli organismi bersaglio, descrivendo, ove possibile, opportune strategie di prevenzione.
English: three segment designs, dominant lethal assay for male fertility,
Dutch: onderzoek naar de dominante letale oorzaak van onvruchtbaarheid bij mannelijke dieren,
English: Summary of mammalian toxicity and overall evaluation A summary of all data and information provided under paragraphs 5.1 through 5.10, must be submitted, and include a detailed and critical assessment of those data in the context of relevant evaluative and decision making criteria and guidelines, with particular reference to the risks for man and animals that may or do arise, and the extent, quality and reliability of the data base.
Portuguese: Resumo da toxicidade em mamíferos e avaliação global
English: antifoaming agent, antifreeze,
Slovak: prostriedok proti zamrznutiu,
English: In such cases the principles of the method(s) of purification must be reported. The purity of such test material, which must be as high as can be achieved using the best available technology, must be reported.
Slovenian: V takih primerih je treba navesti postopke čiščenja in čistost testne snovi, ki mora biti najvišja možna, ki jo je mogoče doseči z najboljšo razpoložljivo tehnologijo.
English: the relationship between dose and adverse effects, toxicity of the active substance including where possible the Noael,
Slovenian: toksičnosti aktivne snovi vključno s količinami, pri katerih škodljivi učinki niso bili opaženi, kadar je to mogoče,
English: The test must be conducted on juvenile rainbow trout, following exposure of 28 days to the active substance. Data on the effects on growth and behaviour must be generated.
Swedish: Testet ska utföras på ung regnbåge efter utsträckt exponering för det verksamma ämnet (28 dygn) och ska ge uppgifter om effekter på tillväxt och beteende.
English: The persistence of viable residues needs special attention if infectiveness or pathogenicity to mammals have been found in points 2.3 and 2.5 or in Section 5 and/or if any other information suggests a hazard to consumers and/or workers. In this case the competent authorities may require studies similar to those provided for in Part A.
Swedish: Persistensen av rester av viabla mikroorganismer ska ägnas särskild uppmärksamhet om infektionsförmåga eller patogenicitet för däggdjur har påvisats enligt punkterna 2.3, 2.5 eller avsnitt 5 och/eller om andra uppgifter tyder på att en risk föreligger för konsumenter och/eller arbetstagare.