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ABSTRACT: The objective of this letter to the editor went to give and to know three procedures to keep in mind in the fertility, peri and postnatal toxicology studies. These procedures are the preparation of exudates vaginal to verify the mating, steps to continue the day of the birth assuming as 0 day the date of the mating and the guide to check if the breedings are suckling. We think that this work can serve as support material for those investigators that carry out to its products this type of studies.
RETEL : Revista de Toxicología en Línea. 01/2010;
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ABSTRACT: The toxicologics studies of novel adjuvants vaccine, they should be carried out according to the recommendations of the lines guidelines of the Organization for the Cooperation and Development (OECD) and European Medicines Agency (EMEA). In our days its stands out the adjuvants use in most of the vaccine candidates, as enhancers of the immune response, but in general the adjuvants existen, presents adverse and undesirable effects, mainly of toxic nature, results that they have been good to affirm for several experts and studious of this matter that for them the ideal adjuvant doesn't exist. This review has as objective to carry out a design for the toxicological evaluations required in a novel vaccine adjuvant. We kept in mind the assays to determine the toxicity for unique dose, for repeated dose, local tolerance, evaluations of reproduction toxicology, special toxicology which includes genotoxicity and mutagenesis, and lastly the pyrogen assay. They are numerous the evaluations to carry out to be able to register and to validate a novel adjuvant, which allow determining the toxic effect at all the possible levels, this to our approach has been to diminish the risk to undesirable effects of the vaccines used in human and animals.
RETEL : Revista de Toxicología en Línea. 01/2010;
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ABSTRACT: The aim of this work was to describe the methods and technical for sacrifice the mothers and to evaluate the possible toxic effect on the fetuses. We kept in mind the local, required personnel, previous condition, equipment, dissection procedure, variables analyzed, sexing of the fetuses, fetuses weight, technique for the tint with alizarin of the rat fetuses and evaluation of the rat fetuses fixed in Bouin. We think that this work is useful for the journal readers as well as for the scientific community in general
RETEL : Revista de Toxicología en Línea. 01/2010;
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ABSTRACT: The behavior constitutes one of the appraisable parameters of more importance in the reproduction toxicology studies, linked mainly to the postnatal stage of the new breeding in one generation and multigenerational studies. In this article we had for objective to offer the procedures to carry out the evaluation of the open field exploratory activity, active and passive avoidance test in mice, evaluation of the orientation movement in inclined plane, evaluation of the response to the hot plate test and lastly the procedure for the evaluation of the response to the rotating rod test. The authors group hopes that this article is since of great utility for the toxicologists that visit the Journal, in this document we highlight the procedures eminently of animal behavior, very useful in the toxicology reproduction studies, where it is thoroughly explained the principle of each one of these tests and as carrying out it. It concerns the researchers to give a scientific explanation to the results that they obtain in each one from these tests when evaluating yours products.
RETEL : Revista de Toxicología en Línea. 01/2010;
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Sergio Sifontes-Rodríguez,
Juan Francisco Infante-Bourzac,
Daiyana Díaz-Rivero, Yulieé López-Feria,
Merlin Pérez-Pérez,
Eligio Sosa-Roble,
Viviana Pérez-Amat,
Yamilé López-Hernández,
Eduardo Alvarez-Figueredo,
Juan Carlos Martínez-Rodríguez,
Mildrey Fariñas-Medina,
Tamara Hernández-Salazar,
Yolexis Tamayo-García,
Yolanda Valdés-Abreu,
Adriana Ponce-Collera,
Niurka Rodríguez-Pérez
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ABSTRACT: A live attenuated vaccine candidate against human cholera has been developed from the genetically modified Vibrio cholerae O1, biotype El Tor, serotype Ogawa, 638 strain. Previous single dose toxicity and local tolerance studies have demonstrated that the product is innocuous in Sprague Dawley rats by oral route and single dose. The present paper describes a repeated dose toxicity study using a further dose compared to the proposed clinical schedule.
Sprague Dawley rats (140-180g) were treated with two doses of the vaccine candidate with a dedicated placebo formulation or were not treated at all (controls). The test products were inoculated at a 21-day interval. Animals were observed daily, body weight was determined weekly and food and water intakes were measured every other day. Three and 14 days after the last inoculation, groups of rats were humanely sacrificed, bled and macroscopically examined. Blood samples were taken for hematology, serum biochemistry and to determine the vibriocide antibody titers. A comprehensive list of tissue and organ samples was taken for microscopic studies.
There was no mortality and no animal showed any clinical symptoms. Food and water intake, body weight, and hematological and biochemical variables did not show differences of toxicological and/or statistical relevance among the experimental groups. Macroscopic examination did not demonstrate any alterations and there were no histological findings of toxicological significance.
The vaccine was considered potentially safe for human use as indicated by the results in Sprague Dawley rats.
Archives of medical research 10/2009; 40(7):527-35. · 1.88 Impact Factor
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ABSTRACT: In our days its stands out the adjuvants use in most of the vaccine candidates, as enhancers of the immune response, but in general the adjuvants existen, presents adverse and undesirable effects, mainly of toxic nature, results that they have been good to affirm for several experts and studious of this matter that for them the ideal adjuvant doesn't exist. This revision has as objective to give some considerations on the inmunotoxicology studies required in a novel vaccine adjuvant. We kept in mind the values that determine general toxicity in the immune system. Studies that can be included in a general way in the registration of the novel vaccine adjuvant, general components and specific components which includes hematology and clinical chemistry, anatomopatologic analysis of all the organs and the lymphoid organs weight , histopatoligic exam, T dependent antibodies response, immunophenotyping, as well as the cellular activity of the natural killer (NK) cells activity assays, macrophage/neutrophil function and lastly the assays to measure cells-mediated immunity. They are numerous the evaluations to carry out to be able to register and to validate a novel adjuvant, where the inmunotoxicologic component has a great importance, which allow determining the toxic effect at all the possible levels, this to our approach has been to diminish the risk to undesirable effects of the vaccines used in human and animals.
RETEL : Revista de Toxicología en Línea. 01/2009;
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ABSTRACT: The preclinic studies achieve the approval of the clinical assays. Some vaccines conceive a toxicity assay for unique dose, for repeated dose and local tolerance, as well as studies of reproduction toxicology. These studies constitute a fundamental link in the chain of regulatory requirements of the preclinic toxicologic studies since they allow to make an through the animals behaviour during a time predetermined to register the generated lesions by the vaccine composition of the chronologically where the adjuvant and the preserve many times they carry out the toxic effect of the same one or for their reaction with the immune system, giving a better information with respect to the products in the preclinic phase of their development. The rats, and in particular those of the Sprague Dawley line, is the species used in the toxicologic assays. To consider an excellent animal model for the preclinical toxicologic evaluation of vaccines it is indispensable that it is sensitive inmunological to the assay product. The objective of the present work is to know the experimental designs for the studies of candidates' preclinic toxicology of the vaccine or vaccine candidates to study that allow a better evaluation of the possible adverse effects provoked and evolution of these in the Finlay Institute.
RETEL : Revista de Toxicología en Línea. 01/2009;
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ABSTRACT: ResumenEl agua y los electrolitos son elementos vitales para la vida, debenmantenerse en constante equilibrio en el interior del organismo, dentro de límites de variación muy estrechos. Para ello los mamíferos poseen mecanismos que compensan las agresiones del medio, que tienden a romper este equilibrio. Estos reciben el nombre de mecanismos reguladores (el riñón, la hormona antidiurética y la aldosterona). Las alteraciones patológicas del equilibrio hidrosalino o lo que es igual, el equilibrio del agua y del sodio, se conocen como contracciones y expansiones del volumen del espacio extracelular. Una de las causas fundamentales de disminución de peso, la aparición de animales con anemia y desfavorable estado físico en los perrosde la raza beagle lo constituyen los cuadros de diarreas, vómitos einapetencia por otras enfermedades sobre todo en la etapa de cuarentena o durante nuestras investigaciones biomédicas las cuales impiden que se utilicen animales aptos y sanos para dicho fin. En el presente trabajo tenemos como objetivo realizar una guía práctica sobre como clasificar, diagnosticar y tratar la deshidratación en perros beagle, para de esta forma llegar al final delos estudios con la mayor calidad y cantidad de animales requeridos,asegurando la rapidez con la cual contrarrestar los efectos desfavorables que ocasiona la deshidratación. Para un buen diagnóstico, pronóstico y tratamiento es fundamental saber el tipo de deshidratación, cantidad de líquido perdido, estado de salud integral del animal y fluidos con los que contamos.SummaryThe water and electrolytes are vital elements for the life; they should be stay in constant balance inside the organism, among limits of very narrow variation. For it the mammals possess mechanisms that compensate the aggressions of the environment that spread to break this balance. These receive the name of mechanisms regulators (the kidney, antidiuretic hormone and the aldosterone). The pathological alterations of the hydrosaline balance, the water and sodium balance, they are known as contractions and expansions of the extracellular space volume. One of the fundamental causes of weight decrease, the appearance of animals with anemia and unfavorable physical state in the dogs of the beagle breed constitutes of diarrheas, vomits, inappetence for other illnesses mainly in the quarantine stage orduring our biomedical research which prevent that are used capable andhealthy animals. The aim of this work is to carry out a practical guide to classify, to diagnose and to treat the dogs beagle dehydration, for to arrive at the final studies with the biggest quality and quantity of animals required, assuring the speed with to counteract it cause the unfavorable dehydration effects. For a good diagnosis, prognosis and treatment is fundamental to know the dehydration type, quantity of lost liquid, state of integral health ofthe animal and existent fluids.
REDVET. 01/2009;
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ABSTRACT: At the present time it is known that the cancer is a process with multiple stadiums, product of the accumulation, in a cell, of genetic and epigenetic events. These stadiums or phases are: initiation, promotion, progression and invasion, that which brings gets the tumor development. Inside the biodiversity of our world, the vascular plants contain an enormous potentiality of compounds that they can be useful in the quimioprevention of illnesses related with the mutations. The plants being continue broadly used by their properties healing and preventive in the traditional medicine, that which represents the habitual practice of the world population's 79% approximately. Additionally the plants have been source of useful bioproducts in the treatment of illnesses like in their prevention. The natural antimutagens present in the diet constitutes an important option as agents quimiopreventive against the cancer and other sufferings of risk, since most of the mutagenesis inhibitors of the coming from other sources can cause adverse effects. Keeping in mind these antecedents, we outline as objective of this work to carry out a search current on the plants like source of the antimutagenic and quimiopreventive agents.
RETEL : Revista de Toxicología en Línea. 01/2009;
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ABSTRACT: The acute toxicity refers to the quick development of symptoms and effects after the application of a relatively high unique dose or it commonly is related with the immediate damages generated by sufficiently big unique dose. The animals observation is carried out after the administration of the substance and it lasts up to 14 days, after which the animals are sacrificed and anatomopatological analyzed. To fulfill 3 " R " principles they have been approved the three reduction methods and refinement of the acute toxicity: the fixed dose, the acute toxic class and the up/down method. Keeping in mind these antecedents, we trace ourselves as objective of this work to give some current considerations on the determination of the acute toxicity of a substance, according to the principle before mentioned. For that which we include the types of data, types of damages caused by the toxic materials, objectives of the acute toxicity, their importance, classification of the acute evaluations, general toxic effects, median lethal dose determination (DL50), 3 “R” principles (Replacement, Reduction and Refinement), classic and alternative methods and lastly like the acute toxicity of a substance should be measured
RETEL : Revista de Toxicología en Línea. 01/2009;
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ABSTRACT: The three studies design that they embrace of direct or indirect form all the stage of the reproduction process, is considered that it is the most appropriate for the evaluation of most medicinal products and vaccine. They should be kept in mind all the pharmacological, kinetic data, and toxicologics to decide which of the studies they will be carried out. The most probable option is the studies combination of, fertility and the early embryonic development, prenatal and postnatal development including the reproductive function and the embriofetal development. The study of prenatal and postnatal effects on the development which is of the one that concerns us to speak, in this article detects the toxic effects in the female during the pregnancy and the lactation and that taken place in the breedings by the exhibition of the mothers from the implantation until the wean. This study is carried out at one species, preferably the rat. These procedures are applied to determine the effects on the breedings of the treatments given to their parents. In the same one is detailed a methodology to evaluate the physical and functional development of rodents from the birth until the wean. The different parameters that are described in this work, it refers to the physical development, sensorial and motor development and the behavior, in rat. Each one of the described parameters, usually appears in rat at a concrete age margin, for what varies the observation moment.
RETEL : Revista de Toxicología en Línea. 01/2009;
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ABSTRACT: he Inmunotoxicology was born with the objective of research the well founded suspicions of the existence of a relationship cause-effect among the exponential increase in the environmental chemical toxicity taken place in the last decades and the parallel increment in the allergic illnesses incidence and autoinmune base illnesses in our environment. The aim of this work is to give a bring up to date in a schematic way of the general immune answer to toxic, carrying out an analysis with depth on the hypersensibility types and its mechanisms, for this way to facilitate the summary and understanding of such an extensive content and with great variety of opinions, since it is necessary a knowledge basic but in turn wide envelope the topic.
RETEL : Revista de Toxicología en Línea. 01/2009;
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ABSTRACT: The in vivo citogenetic assay is a short term mutagenicity assay, of great sensibility, useful to detect structural chromosomal aberrations fundamentally under conditions that they involve the answer the in vivo response, they can vary according to the species and the tissue, they are generally evaluated during the first serial mitosis to the treatment. In this method, are used cells of bone marrow of mammals to be more vascularisated and to contain a cells population of short cycle that they can be isolated and to easiness. In this article is reported the basal frequency of appearance of chromosomal aberrations in of the bone marrow cells of NMRI and Balb-C mice of both sexes, as well as the induced frequency of events, after the cyclophosphamide (CF) administration for intraperitoneal route, reference mutagen used as positive control. You could conclude that the NMRI and Balb-C mice, constitute a good model to use in the genotoxicologic studies, given the spontaneous drop frequency of structural type of aberrations, the mitotic index and the number of polyploidy cells, as well as we stood out the sensibility to the cyclophosphamide action of the administered in dose of 50 mg/kg for intraperitoneal route at the 48 and 24 hours before the sacrifice.
RETEL : Revista de Toxicología en Línea. 01/2009;
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ABSTRACT: Teratology is the scientific discipline that, inside the veterinary and the medicine, its studies the unsightly creatures, those natural creations in a species that don't respond to the common pattern. At the present time standardized experimental protocols are used that they are considered acceptable and solid evaluations of the embrio-fetal development. With them it is possible to evaluate the effect of a substance given on practically all the reproductive process phases. However, the great number of chemical substances that should be evaluated with these methods has taken to the development of in vitro systems that could be used to establish priorities in the animals tests, but these systems have not been able to even this way to replace the tests in animals, being even necessary these in vivo assays, which manifest with more truthfulness the teratogenic effect or not of x product to evaluate. For that the objective of this small work is to give a current panoramic about some considerations to keep in mind in the teratogenesis assays in rodents and non rodent species it is the case of the rabbit, as this established one according to the Organisation for Economic Co-operation and Development (OECD) and International Conference on Harmonization (ICH) regulations, will be useful for experimental toxicology researchers, in the toxicology reproduction branch. We kept in mind the experimental design that should be complete when using rats or rabbits, as well as the variables that should be measured and analyzed.
RETEL : Revista de Toxicología en Línea. 01/2009;
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Eligio Sosa Roble,
Sergio Sifontes Rodríguez,
Juan Francisco Infante Bourzac,
Daiyana Díaz Rivero, Yulieé López Feria,
Viviana Pérez Amat,
Tamara Hernández Salazar,
Luis Riverón Martínez,
Yolanda Valdés Abreu,
Isabel García Riva,
Mildrey Fariñas Medina,
Elina Parajón Góngora,
Niurka Rodríguez González
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ABSTRACT: La vacuna antitifoídica vax-TyVi® consiste en una preparación de polisacárido capsular Vi de Salmonella typhi, el cual es diluido en una solución buffer isotónica solución amortiguador, a laque se le añade fenol como preservo. Cada dosis de 0,5 mL contiene 25 μg de polisacárido como sustancia activa. En nuestro país el esquema de vacunación contra la fiebre tifoidea con vax-TyVi® se aplica a los alumnos de 9-10 años (5to grado), una 2da dosis a la edad de 12-13 años (8vo grado) y una 3ra dosis a la edad de 16-17 años (11no grado). Además, es vacunado el personal de riesgo de Salud Pública y el personal que manipula alimentos. En el presente trabajose describe el ensayo de tolerancia local llevado a cabo con la vacuna vax-TyVi® durante su fase de estudios preclínicos, actualmente utilizada en la vacunación contra la fiebre tifoidea en Cuba.Se empleó un total de 170 ratas que fueron tratadas con la vacuna, su placebo (todos los componentes, excepto la materia prima activa), o que no recibieron tratamiento alguno (controles). Se realizaron observaciones clínicas diarias durante todo el ensayo, se determinó el consumo de agua y alimentos y se realizaron investigaciones anatomopatológicas a animales sacrificados 3, 7, 14, 21, 28, 35 y 42 días después de la inoculación. No se observaron muertes ni síntomas de toxicidad; no se encontraron diferencias estadísticamente significativas entre los pesos vivos, el consumo de agua ni el de alimentos entre los grupos del ensayo. Tampoco se observaron lesiones anatomopatológicas que indicaran toxicidad por parte del producto inoculado. Los resultados permitieron concluir que la potencialidad de la vacuna vax-TyVi® para producir efectos adversos locales es baja.
VacciMonitor. 01/2005;
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