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Inventory of the Spanish Institutions and Scientists Involved in Alternatives to the use of Laboratory Animals (Refinement, Reduction or Replacement)+

Inventory: 18l. Inventory of Institutions

OTHER COUNTRIES:

ARGENTINA

Type of Institution: Industrial (pharmaceutical, Asoc. Banco Argentino de Células)

Staff:

Susana García Franco, Email: susa@fartox.edu.ar, Dr Químico Biólogo, Jefe de Toxicología Genética, 50 % time devoted to altern. meth., duties related to altern. meth.: Jefe Toxicología In Vitro
Baltasar Serrano, Email: bos@fartox.edu.ar, Técnico Químico y Farmaceútico.

Total staff involved in alternative methods is 4 people.

Activities / aims: This industrial department (pharmaceutical, Asoc. Banco Argentino de Células) is mainly involved in basic research, regulatory testing and method development; it performs pharmacodynamics, pharmacology, toxicology (basal cytotoxicity, acute systemic toxicity, genotoxicity / mutagenicity, hepatotoxicity, chronic toxicity), quality control, and culture methodology studies on a routine basis. Pharmaceuticals and medical devices are routinely evaluated; cosmetics, diverse chemical compounds, pesticides, biomaterials, food additives and environmental pollutants also being occasionally studied.

The main use of alternative methods is for screening, complementary and replacement studies.

Model systems: The model systems used are conventional animal models (rat, mice, dog) and in vitro methods - micro-organisms (Salmonella typhimurium (Ames test)), primary culture of dispersed cells (lymphocytes), cell lines culture (CHO, L929,3T3, wish) and cell-free systems (liver microsomes).

The endpoints employed in vitro are morphology (microscopical examination), cell viability (trypan blue exclusion, crystal violet), cytoskeleton/membranes/enzyme release (MTT), cellular proliferation (clonogenicity) and nucleic acids.

Experimental systems (examples):

1 L 929, cytotoxicity in agar overlay, cytotoxicity, replacement test
2 CHO, cell viability by count, cytotoxicity, replacement test
3 CHO, cell proliferation by clonogenicity, cytotoxicity, complementary test
4 CHO, enzyme release, characterisation, complementary test

Work lines: The centre is devoted to the pharmacological and toxicological screening of chemicals and medical devices, and interested in improving the enzymatic preparation, by using any other alternative than rat liver. Besides, the group is seeking for replace some of the in vivo techniques used nowadays by others already validated in vitro ones. It plans to incorporate some ecotoxicology in vitro techniques for research purposes in the University.

Quality assurance / Validation programmes: A Quality Assurance Unit is operating inside the facility. The institution is implementing Good Laboratory Practices rules according to the FDA. The team have previously been involved in the following alternative method validation programme: Regional patron of measles vaccine. They are available to participate in EU validation programmes in relation to collaborative studies

Sources of financing: Self financing

Others: Organization of scientific meetings on the use of in vitro techniques as alternatives to laboratory animals.

CHILE

Type of Institution: University

Staff:

Carlos Barrios Guerra, Email: cbarrios@udec.cl, Dr, Profesor Titular.
Gisella Rios, Email: grios@udec.cl, MSc, Instructor, 20 % time devoted to altern. meth.

Total staff involved in alternative methods is 2 people.

Activities / aims: This university department is mainly involved in alternatives to animals in education; it performs toxicology (acute systemic toxicity) testing on a routine basis. Environmental pollutants are routinely evaluated.

The main use of alternative methods is for screening.

Model systems: The model systems used are conventional invertebrate animal models.

The endpoints employed are in vitro organ-specific indicators.

Work lines: The Laboratory of Toxicology (LTOX) is an academic organization. The main objetive of LTOX is to perform and stimulate research in the area of academic and occupational toxicology. Academic and occupational toxicology have changed considerably in the past decade. In both the emphasis has shifted from attention to scientific content, and process regulation plays an important role.

Sources of financing: Dirección de Investigación Universidad de Concepción, CONICYT; IAEA

CUBA

Type of institutions: Governmental, Industrial (pharmaceutical)

Staff:

Gastón García Simón, Email: calidad@liorad.sld.cu, Ld. Ciencias Biológicas, Especialista principal de control biológico y Experto Nacional de Toxicología, 20 % time devoted to altern. meth., Duties related to AM: J´Grupo de estudios Toxicológicos Alternativos de Cuba. Laboratorios Liorad.
Mª Julia Martínez Guerra, Email: moron@fcmsa.sld.cu, Especialista en Toxicología, 25 % time devoted to altern. meth., Duties related to AM: J´Grupo de Toxicología del Hosp. Salvador Allende
Niurka León, Email: cebiomar@unepnet.inf.cu, Ld Ciencias Farmaceúticas, Especialista en Toxicología, 25 % time devoted to altern. meth., Duties related to AM: J´Grupo Toxicología Alternativa del Centro de Bioactivos Marinos. CEBIMAR
Emilio Monteagudo Jimenez, Email: emilio@utex.vcl., Dr en Medicina Veterinaria, Especialista en Toxicología, 15 % time devoted to altern. meth., Duties related to AM: J´Grupo Toxicología Alternativa Unidad de Toxicología Experimental Fac. Ciencias
Caridad Rodríguez Torres, Ld Ciencias Farmaceúticas, Especialista en Toxicología, 20 % time devoted to altern. meth., Duties related to AM: J´Grupo Toxicología Experimental Laboratorios LABIOFAM
Aridne Gutierrez Martínez, Email: bioensa@triton.cigb.edu.cu, Ld Ciencias Farmaceúticas, Especialista en Toxicología, 20 % time devoted to altern. meth., Duties related to AM: J´Grupo Toxicología Alternativa. Centro de Ingieneria Genética y Biotecnología CIGB
Ulpiano Perez Marquez, Email: toxi@gies.scu.sld.cu, Dr Ciencias Médicas, Especialista en Toxicología, 20 % time devoted to altern. meth., Duties related to AM: J´Grupo Toxicologicos Alternativos del Centro de Toxicología y Biomedicina TOXIMED
Marcia Freeman Perez Ld en Ciencias Biológicas, J´Grupo de Teratogénesis, 20 % time devoted to altern. meth., Duties related to AM: J´Grupo de estudios Toxicológicos Alternativos del Centro Nacional de Toxicología
Raiza Vega Montalvo, Email: mercolo@infomed.sld.cu, Ld Ciencias Farmaceúticas, Especialista en Toxicología, 20 % time devoted to altern. meth. Duties related to AM: J´Grupo de Toxicología Alternativa del Centro de Investigación y Desarrollo de Medicamentos. CIDEM
Niurka Figueredo Castro, Email: chema@infomed.sld.cu, Ld. Ciencias Biológicas, Especialista en Toxicología de Cosméticos, 20 % time devoted to altern. meth., Duties related to AM: Instituto de Nutrición e Higiene INHA
Lisseth García García, Email: ovidio@censa.edu.cu Ld Ciencias Farmaceúticas, Especialista en Toxicología, 40 % time devoted to altern. meth., Duties related to AM: J´Grupo de Toxicología Alternativa del Centro Nacional de Sanidad Animal CENSA

Total staff involved in alternative methods is about 11 persons.

Activities / aims: This group of industrial (Pharmaceutical) departments are mainly involved in basic research, regulatory testing, methods development and methods validation; they performs toxicology (mecanisms of toxicity, acute systemic toxicity, ocular cytotoxicity, dermal irritation and corrosivity, immunotoxicity and sensitisation, genotoxicity / mutagenicity) and quality control studies on a routine basis, and culture methodology studies at a research level. Vaccines, hormones, pharmaceuticals, cosmetics, diverse chemical compounds, pesticides, medical devices and biomaterials are routinely evaluated, being colourings, environmental pollutants and wastes also occasionally studied.

Model systems: The model systems used are conventional animal models (CTA, FDP, OECD), invertebrates (Artemia Salina MEIC.), embryos (hen) and in vitro methods -- primary culture of dispersed cells (L-929).

Experimental systems (examples):

1 L-929 cell line, cytotoxicity of lids and flasks used for pharmaceuticals, USP XXIII, replacement test
2 dog and rat red blood cells, lysis and coagulation, ocular irritation of surfactants (Invittox 37), replacement test
3 chick embryo chorioalantoid membrane, lysis and coagulation, ocular irritation (Invittox 96), replacement test
4 rat, acute toxicity, classification according to EU, reduction test

Work lines: RBC Invittox protocol 37, ATC protocol OECD, the shrimps larvae for the study of the biological activity of natural plants (MEIC), HET-CAM test (Invittox protocol 96), cell culture phototoxicity test (44), 3T3 NRU phototoxicity (78).

Quality assurance / Validation programmes: A Quality Assurance Unit is operanting inside the facilities. The institutions applies Good Laboratory Practices rules according to the UE, OECD, FDA, CECMED and CCEM. The teams have been previously involved in alternatives methods validation programmes. They are available to participate in EU validation programmes related to inter and intralaboratory ring tests. 

Others: Financing for preclinical toxicological studies

Type of Institution: University

Staff:

Liseth García García, Email: jesus@censa.edu.cu, Ld Ciencias Farmaceuticas, Responsable del Desarrollo de Métodos Alternativos, 70 % time devoted to altern. meth.
Ovidio Figueroa Hernández, Email: ovidio@censa.edu.cu, Dr Medicina Veterinaria, Investigador Agregado, 60 % time devoted to altern. meth.
Evangelina Marrero Faz, Email: jesus@censa.edu.cu, Dra Medicina Humana PhD Medicina Veterinaria, Investigador Titular. Jefe de la Division de Investigación y Desarrollo de medicamentos, 40 % time devoted to altern. meth.
Gleybis Melchor Orta, Email: jesus@censa.edu.es, Ld Ciencias Farmaceúticas, Aspirante a Investigador, 60 % time devoted to altern. meth.

Total staff involved in alternative methods is 6 people.

Activities / aims: This university department is mainly involved in basic research, regulatory testing, method development, method validation and alternatives to animals in education; it performs pharmacodynamics, toxicology (mechanisms of toxicity, acute systemic toxicity, ocular cytotoxicity, genotoxicity / mutagenicity), surgery and culture methodology studies on a routine basis. Vaccines, pharmaceuticals, cosmetics and wastes are routinely evaluated; diverse chemical compounds, pesticides, toxins, food additives and environmental pollutants also being occasionally studied.

The main use of alternative methods is for screening, complementary studies.

Model systems: The model systems used are conventional animal models (respiratory distress S, pulmonary surfactants test) and in vitro methods -- organ culture (isolated lung).

Experimental systems (examples):

1 red blood cells, haemolysis, by spectrophotometry, ocular irritation, replacement test
2 chick embryo chorioallantoic membrane assay, morphological observation staining and, ocular irritation, replacement test

Work lines: To prevent and contribute to the health of plants and animals including the human beings. Different drugs and food are evaluated before animal consumption. Evaluation Toxicology Department. The principal tests are focused on toxicology and ecotoxicology. Accredited by the main authority in Cuba, CECMED.

Quality assurance / Validation programmes: A Quality Assurance Unit is operating inside the facility. The institution applies Good Laboratory Practices rules according to OECD, FDA. The team have previously been involved in the following alternative method validation programmes: Validation of homeless test as alternative to Draize assay, and acute toxic class, and Het-CAM, in a ring test in Cuba. They are available to participate in EU validation programmes in relation to alternative methods on ocular irritation using cell cultures; phototoxicity tests, etc.

Sources of financing: Self financing, Programa Intercampus (AECI) for the development of a course on alternatives in toxicology and ocular Irritation (Univ Barcelona)

SWITZERLAND

Type of Institution: Industrial (pharmaceutical)

Staff:

Jesús Medina Alonso, Email: jesus.medinaalonso@pharma.novartis, Dr Farmacia (Fisiología), Lab Head-Scientific Investigator, 50 % time devoted to altern. meth.

Total staff involved in alternative methods is 1 person.

Activities / aims: This industrial (pharmaceutical) department is mainly involved in regulatory testing; it performs toxicology (mechanisms of toxicity, dermal irritation and corrosivity, immunotoxicity and sensitisation, phototoxicity) testing on a routine basis, and cell biology and molecular biology studies at a research level. Pharmaceuticals are routinely evaluated; diverse chemical compounds also being occasionally studied.

The main use of alternative methods is for screening and complementary studies.

Model systems: The model systems used are conventional animal models (popliteal lymph node assay) and in vitro methods -- culture of explants, reaggregates, reconstituted organs, (human reconstituted skin (SkinEthic)), primary culture of dispersed cells (human keratinocytes, endothelial, epithelial, lanh) and cell lines culture (Hela T).

The endpoints employed are in vivo (lymph node assay: weight, proliferation, surface markers (FACS), cytokines (ELISA, PCR)) and in vitro cell morphology, cell viability (LDH, MTT reduction), cytoskeleton/membranes/enzyme release (LDH leakage), cellular proliferation (BrdU, 3H-Thy), metabolic activity (MTT reduction), cell signalling (cytokines) and nucleic acids (gene expression).

Experimental systems (examples):

1 Skin Ethic, LDH, morphology, cytokines, dermal irritation, complementary test
2 Murine popliteal lymph node assay, proliferation, weight, immunoactivation, replacement test

Work lines: Safety assessment of compounds and formulations in development regarding their irritant and /or phototoxic potential and / or sensitizing potential. Investigation of immunoactivation / immunotoxicity effects of compounds in development.

Quality assurance / Validation programmes: A Quality Assurance Unit is operating inside the facility. The team are available to participate in EU validation programmes in relation to immunotoxicity and dermatotoxicity.

Fuente / Source: Guillermo Repetto, Ana del Peso, Manuel Salguero, Manuel Repetto (1999) Inventory of the Spanish Institutions and Scientists Involved in Alternatives to the use of Laboratory Animals (Refinement, Reduction or Replacement) Revista de Toxicología 16: 50-127.