ABSTRACT
La meningitis meningocóccica continua siendo un problema de salud en diferentes países y para la prevención de esta enfermedad se han obtenido diferentes vacunas. La vacuna VA-MENGOC-BC® ha constituido ser eficaz y segura en la prevención de la meningitis meningocóccica contra los serogrupos B y C. Esta ha demostrado buena estabilidad en el tiempo sin cambiar su calidad como producto; fue conservada a estante durante 24 y 36 meses a temperaturas de 4 a 8 °C. Se evaluó su posible potencial toxicológico a través de un estudio de tolerancia local en ratas Sprague Dawley para extender su vida útil. Los animales inmunizados se observaron diariamente para evaluar síntomas locales y sistémicos de toxicidad. Se realizaron evaluaciones del peso corporal, consumo de agua y alimento, termometría, musculometría e irritabilidad dérmica por el método de Draize. Se realizaron estudios anatomopatológicos periódicos para observar posibles efectos adversos. No se observaron síntomas de toxicidad ni muertes. No se encontraron diferencias entre los grupos experimentales en cuanto al peso corporal, el consumo de agua y de alimentos, no se evidenció fiebre, ni irritabilidad local. Anatomopatológicamente a nivel del punto de inoculación se observaron procesos granulomatosos de tipo macrofágicos característicos en las vacunas que contienen hidróxido de aluminio. Estos resultados permitieron concluir que la vacuna VA-MENGOC-BC® que permaneció en estante durante 24 y 36 meses no evidenció efectos adversos locales, ni sistémicos en las ratas(AU)
Meningococcal meningitis continues to be a health problem in different countries and different vaccines have been obtained for the prevention of this disease. VA-MENGOC-BC® vaccine has been effective and safe in the prevention of meningococcal meningitis against serogroups B and C. This has shown good stability over time without changing its quality as a product; it was stored on a shelf for 24 and 36 months at temperatures of 4 to 8 °C. Their possible toxicological potential was evaluated through a local tolerance study in Sprague Dawley rats. Immunized animals were observed daily to evaluate local and systemic toxicity symptoms. Body weight, water and feed intake, thermometry, musculometry were performed and dermal irritability by the Draize method. Anatomopathological studies to observe possible adverse effects were made. No symptoms of toxicity or deaths were observed. No differences were found between the experimental groups in terms of body weight, water and food consumption, no fever or local irritability was evident. Anatomopathologically no lesions of diagnostic value were observed, at the site of inoculation, granulomatous processes of macrophagic type characteristic in vaccines containing aluminum hydroxide were observed. These results allowed us to conclude that the VA-MENGOC-BC® vaccine that remained on the shelf for 24 and 36 months did not show any local or systemic effects in rats(AU)
Subject(s)
Animals , Rats , Meningococcal Vaccines/therapeutic use , Reference Drugs , Meningitis, Meningococcal/prevention & controlABSTRACT
Objetivo: prever el riesgo potencial de irritabilidad dérmica de una crema y una loción para bebés, con el fin de obtener el registro sanitario y disminuir la eventualidad de riesgo para la salud. Métodos: se realizó el bioanálisis predictivo de tolerancia dérmica in vivo en conejos, a través de un estudio de tipo exploratorio clínico cualitativo e histopatológico, basado en el enfoque de la ley del Arte para explicar el riesgo/efectividad comparable en humanos. Se aplicó la técnica de exposición aguda simple (prueba parche oclusivo) en seis conejos, por cada producto. Se estimaron los efectos dérmicos mediante una escala de valores que define la probabilidad de inseguridad atribuible por la exposición al cosmético, según prueba de toxicidad dérmica de la Organización para la Cooperación Económica y Desarrollo 2004 (OCED), con ciertas modificaciones por los autores. Resultados: en el bioanálisis se encontró cierta irritabilidad dérmica en la piel de los conejos al aplicarles el cosmético en una dosis única por 92 días. El estudio clínico se complementó con el análisis histopatológico de una muestra de piel irritada y no mostró cambios significativos a los observados. Conclusiones: el bioanálisis clínico e histopatológico permite inferir una irritabilidad dérmica entre insignificante y leve, lo que sugiere la necesidad de mejorar la formulación de los cosméticos estudiados para obtener el registro sanitario, y así alertar tempranamente al productor y a la comunidad de la seguridad y eficacia de los productos(AU)
Objective: to prevent the potential risk of dermal irritability from a cream and a lotion for babies, in order to obtain health registration and to reduce possible health risks. Methods: in vivo predictive bioanalysis of dermal tolerance carried out in rabbits through a qualitative and histopathological clinical exploratory-type study, based on the Lex Artis approach to explain the comparable risk/effectiveness in humans. There was applied the single acute exposure technique (occlusive patch test) in six rabbits to test each product. Dermal effects were then measured in a value scale defining the cosmetic exposure-attributed unsafeness probabilities, according to the dermal toxicity test of the Organization for Economic Cooperation and Development, with some modifications by the authors. Results: the bioanalysis found some dermal irritability in the rabbits' skin after using the single dose of cosmetic for 92 days. The clinical study was supplemented with the histopathological analysis of a sample of irritated skin, without significant changes other than those observed. Conclusions: the clinical and hisopathological analysis showed mild to negligible dermal irritability, which indicates the need for improvements to the formulation of the studied cosmetics in order to obtain the health registration and thus to early advise the manufacturer and the community about the safety and efficacy of products(AU)
Subject(s)
Rabbits , Skin Irritancy Tests/methods , Epidemiology, Descriptive , CosmeticsABSTRACT
In this study, 602 samples were tested by the following assays performed at the animal facilities (Cedeme) of the Federal University of São Paulo (UNIFESP): 385 for dermal irritability, 90 for ocular irritability (discontinued in 1995), 31 for systemic toxicity by injection, 26 for oral acute toxicity, 15 for toxicity by intracutaneous injection, 15 for skin sensitization, 15 for toxicity of serum and vaccines for human use, 14 for toxicity by intramuscular implantation, 7 for pyrogens, 2 for acute dermal toxicity, and 2 for irritation of mucous membrane. The following agents were tested: cosmetics and related substances (42.0 percent), chemicals used in industry (32.9 percent), plastics, rubber, and other polymers (15.9 percent), agrotoxics (4.0 percent), medicines (2.7 percent), and vaccines (2.5 percent). In the present description, emphasis was given to tests of dermal irritability and sensitization. This work was conducted entirely in animal facilities, according to our general belief that animal facilities at universities, while considering ethic principles and sanitary, genetic, nutritional, and pathophysiological controls, also require laboratories specialized in areas such as transgenics, cryopreservation, ambiental physiology, functional genomics, alternative models, and mainly activities and research on methods in toxicology, as focused in this study.
Descrevemos os testes usados em ensaios biológicos de curta duração para estudo de toxicidade e inocuidade de cosméticos, fármacos e outras substâncias químicas, feitos no Biotério Central/Cedeme da Unifesp, de 1986 a 2000. Testamos 602 amostras nos seguintes ensaios: 385 de irritação cutânea, 90 de irritação ocular (até 1995), 31 de toxicidade sistêmica por injeção, 26 de toxicidade oral aguda, 15 de toxicidade por aplicação intracutânea, 15 de sensibilização da pele, 15 de toxicidade de soros e vacinas de uso humano, 14 de toxicidade por implantação intramuscular, 7 de pirogênio, 2 de toxicidade dérmica aguda e 2 de irritação da mucosa. Os agentes testados foram: cosméticos e suas matérias-primas (42,0 por cento), substâncias químicas industriais (32,9 por cento), plásticos, borrachas e outros polímeros (15,9 por cento), defensivos agrícolas (4,0 por cento), medicamentos (2,7 por cento) e vacinas (2,5 por cento). Aqui daremos ênfase aos ensaios de irritação e sensibilização cutânea. Este trabalho foi feito inteiramente em biotério, em consonância com a idéia de que os biotérios em universidades, sem deixar de considerar os princípios éticos pertinentes e sem desconsiderar a presença de laboratórios para controles sanitário, genético, nutricional e fisiopatológico, devem ter também laboratórios para pesquisa em transgênicos, criopreservação, fisiologia ambiental, genômica funcional, modelos alternativos e fundamentalmente toxicologia, entre outros.
Subject(s)
Animals , Guinea Pigs , Biological Assay , Chemical Compounds , Drug-Related Side Effects and Adverse Reactions , Toxicity Tests, Acute , Cosmetics , Clinical TrialABSTRACT
Objective To analyze the dermal irritation characteristics of 8 types of cosmetics.Methods The selected 917 cosmetics samples of 8 types,which were underwent the health safety test in China during 2005-2007,were assessed in the acute dermal irritation according to the related standards and the data were statistically analyzed using CMH method.Results The dermal-irritant samples were detected in different levels in 8 types of cosmetics.In terms of the irritation of cosmetics and the dermal damage caused by cosmetics,the cosmetics for hair,for face clean and for bath showed a significant higher proportion compared with the other types of cosmetics and the dermal damage could last for more than 14 days.Conclusion The acute dermal-irritability is different in 8 types of cosmetics,the cosmetics for hair,for face clean and for bath can cause the irritation and damage in the skin in degrees.