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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: 18c. Inventory of Institutions

Type of Institution: Private research facility

Staff:

Ainhoa Eguizabal Luzuriaga, Email: aeguiza@inasmet.es, Ld Ciencias Biológicas.
Nerea Garagorri Gantxegi, Ld Farmacia.
Ainara Gordóbil Goñi, Ld Ciencias Biológicas.
Iñaki Alava Marquínez, Dr Ciencias Químicas.

Total staff involved in alternative methods is 4 people.

Activities / aims: This private research facility department is mainly involved in regulatory testing; it performs toxicology (basal cytotoxicity, ocular cytotoxicity, dermal irritation and corrosivity, genotoxicity / mutagenicity, ecotoxicity) testing on a routine basis. Diverse chemical compounds, environmental pollutants and wastes are routinely evaluated; medical devices and biomaterials also being occasionally studied.

Model systems: The model systems used are conventional animal models and in vitro methods -- micro-organisms (Salmonella thyphymurium, E. coli.) and cell lines culture (Hela).

Work lines: INASMET is a technological centre whose main areas of activity are "environment" and "materials". The toxicological characterization of industrial wastes and biomaterials is a working tool which makes it possible. It is essential to decide the best way to recover, treat, evaluate and manage industrial wastes and to study the biocompatibility of different materials.

Quality assurance / Validation programmes: The institution applies Good Laboratory Practices rules according to CA-G0-000, EN 45001, ISO 90001. The team have previously been involved in the following alternative method validation programmes: MAT Programme project Nº 254: Certification of Reference Material for short term mutagenicity tests (1996). Programme BCR measurement analysis: Intercomparison of leach test for stabilized wastes (1993). Several national programmes. They are available to participate in EU validation programmes. The centre performs regulatory in vivo and in vitro tests and is open to collaboration on the validation of alternative methods.

Sources of financing: Public contracts, industrial contracts, European projects: Brite, Euram, Environment, Craft, Adapt, Ceca, Innovation, SMT, MAT, Leonardo, BCR.

Others: In the Technological materials centre, the department of Environmental Adaptation and Chemical Technology is working on industrial waste recovery, treatment, evaluation, analysis, toxicology, reuse, etc. The Toxicology Unit performs toxicity, ecotoxicity and mutagenicity assays. The Unit of Biomaterials is also involved on the evaluation of the biocompatibility of dental and medical biomaterials according to UNE-EN 30993-1.

Type of Institution: Private research facility 

Staff:

Consuelo Guerri Sirera, Email: guerri@ochoa.fib.es, Dr Ciencias Biológicas.

Total staff involved in alternative methods is 1 person.

Activities / aims: This private research facility department is mainly involved in basic research; it performs cell biology, molecular biology, biochemistry, toxicology (mechanisms of toxicity, chronic toxicity), pathology and culture methodology studies on a routine basis. Drugs of abuse are routinely evaluated.

Model systems: The model systems used are embryos (rat), and in vitro methods -- primary culture of dispersed cells (rat cortical astrocytes and neurones).

The endpoints employed in vitro are cytoskeleton/membranes/enzyme release, cellular proliferation, cell signalling, nucleic acids and organ-specific indicators.

Experimental systems (examples):

1 primary culture of astrocytes and neurones, cell proliferation, DNA synthesis, MTT reduction, cytotoxicity, ethanol and other chemicals neurotoxicity

2 primary culture of astrocytes and neurones, DNA fragmentation, cell death by necrosis or apoptosis by 3 DIG-dUTP

3 primary culture of neurones, cytoskeleton proteins, cytoskeleton alterations studied by immunofluorescence and immunotransference

Work lines: Teratogenic effects of ethanol. Toxic effects of alcohol on astroglia development. Cellular and molecular mechanisms of ethanol toxicity. The use of primary cultures of neural cells to study the effects of ethanol on central nervous system development.

Quality assurance / Validation programmes: The institution applies Good Laboratory Practices rules according to the EU and FDA. The team are available to participate in EU validation programmes.

Sources of financing: Comisión Interministerial de Ciencia y Tecnología, Dirección General de Enseñanza Superior e Investigación Científica, Fondo de Investigaciones Sanitarias de la Seguridad Social, Generalitat Valenciana, Conselleria de Cultura, Educació i ciència, Fundación Ramón Areces.

Type of Institution: Private research facility

Staff:

Manuel Blanco Pérez, Email: blanco@ochoa.fib.es, Dr. Ing. Agrónomo, Jefe de Departamento, 100 % time devoted to altern. meth.
Amparo Urios Lluch, Email: urios@ochoa.fib.es, Dra. Ciencias Biológicas, Investigadora, 100 % time devoted to altern. meth.
Alicia Martínez Romero, Email: martinez@ochoa.fib.es, Ld. Biología, Investigadora, 100 % time devoted to altern. meth.
Carmen Navarro Rey, Técnico, Ayudante de Laboratorio, 10 % time devoted to altern. meth.

Total staff involved in alternative methods is 4 people.

Activities / aims: This private research facility department is mainly involved in basic research, non-regulated applied research, method development and method validation; it performs toxicology (genotoxicity / mutagenicity) testing on a routine basis. Pharmaceuticals and diverse chemical compounds are routinely evaluated.

The main use of alternative methods is for screening.

Model systems: The model systems used are in vitro methods --micro-organisms (Salmonella typhimurium, E. coli) and cell-free systems (postmitochondrial fractions (liver, kidney, brain)).

The endpoints employed in vitro are nucleic acids (mutations), and biotransformation systems (xenobiotic activation, detoxification, antioxidative systems).

Experimental systems (examples):

1 E coli oxyR-/oxyR+, mutation, mutagenicity induced by oxidative stress

2 postmitochondrial fractions (liver, kidney, brain), mutation, biotransformation / detoxification

Work lines: Development of MUTOXITEST, a bacterial reversion assay specific for oxidative mutagens. The Mutoxitest is based on the use of new Escherichia coli tester strains developed as additions to the WP2 mutagenicity test: strain IC203, deficient in the OxyR function; strain IC206, deficient in the MutY DNA glycosylase. Validation of Mutoxitest. Evaluation of the mutagenicity, resulting from oxidative DNA lesions, of new pharmaceuticals. Prevention of oxidative mutagenesis by chemicals and natural products. Evaluation of antioxidant defenses in fractions from rat liver, kidney or brain.

Quality assurance / Validation programmes: A Quality Assurance Unit is operating inside the facility. The institution applies Good Laboratory Practices rules according to the EU. The team have previously been involved in the following alternative method validation programmes: Societé Française de Toxicologie Génetique 1986. They are available to participate in EU validation programmes, in relation to mutagenicity tests directed to the detection of oxidative mutagenesis. Study of antioxidants used as antimutagens.

Sources of financing: "Desarrollo de nuevos ensayos para la detección y estudio del mecanismo de acción de agentes carcinogénicos", CICYT, I+D, 1993-1996; "Desarrollo de nuevas estrategias para el control de la genotoxicidad de fármacos y para el estudio de su relación con el estrés oxidativo", CICYT, I+D, 1997-2000; "Desarrollo de ensayos bacterianos,basados en la utilización de la citometría de flujo, para el control de la genotoxicidad originada por el estrés oxidativo" Generalitat Valenciana, I+D.

Type of Institution: Private research facility

Staff:

Ana Mª Alejandro Vadillo, Email: alejandro@gaiker.es, Ld Cc Biológicas, Dtora. de proyecto, 100 % time devoted to altern. meth., duties related to altern. meth.: Responsable toxicology
Mª Isabel Rodríguez Llopis, Email: Rodríguez@gaiker.es, Ld Cc Químicas, Dtora. de Proyecto, 35 % time devoted to altern. meth., duties related to altern. meth.: Project responsible
Francisco Javier Vergara, Email: vergara@gaiker.es, Ingeniero industrial, Dtor. Area de Actividad, 5 % time devoted to altern. meth., duties related to altern. meth.: Director de Laboratorio de Toxicología
Ainhoa Eguskiza, Email: eguskiza@gaiker.es, Ld Ciencias Biológicas, Analista, 100 % time devoted to altern. meth., duties related to altern. meth.: Analista
Iñaki Gorostiza, Email: gorostiza@gaiker.es, Ld Ciencias Biológicas, Jefe Unidad Bioprocesos, 15 % time devoted to altern. meth., duties related to altern. meth.: Dtor. Técnico de Laboratorio
Francisco Javier Ereño, Email: ereño@gaiker.es, Ld Ciencias Químicas, Investigador del Area de Calidad y Progreso, 40 % time devoted to altern. meth., duties related to altern. meth.: Responsable de la UGC

Total staff involved in alternative methods is 6 people.

Activities / aims: This private research facility department is mainly involved in non-regulated applied research, regulatory testing, method development, method validation and alternatives to animals in education; it performs toxicology (basal cytotoxicity, ocular cytotoxicity, dermal irritation and corrosivity, nephrotoxicity, haematoxicity, genotoxicity / mutagenicity, ecotoxicity) testing on a routine basis and monitoring --chemical, biological-- studies at a research level. Pharmaceuticals, cosmetics, medical devices, environmental pollutants and wastes are routinely evaluated; diverse chemical compounds and food additives also being occasionally studied.

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

Model systems: The model systems used are vegetables (seeds) and in vitro methods -- micro-organisms (Salmonella typhimurium, E. coli), primary culture of dispersed cells (mice, rat and human tubular and mesangial cells), cell lines culture (3T3, CHO, L929, MCF-7) and proteins: zeine; RBC.

The endpoints employed in vitro are cell morphology (microscopy), cell viability (neutral red uptake, MTT reduction), cytoskeleton/membranes/enzyme release, cellular proliferation (total protein content, colony formation), haemolysis and protein solubilization (zeine).

Experimental systems (examples):

1 3T3 fibroblasts, neutral red uptake, total protein, MTT reduction by spectrophotometry, ocular irritation, screening
2 L929, neutral red uptake, by spectrophotometry, biocompatibility of materials, replacement test
3 L929, protein, microscopy, biocompatibility of materials, replacement test
4 kidney tubular cell culture, neutral red uptake, by spectrophotometry, nefrotoxicity, complementary test
5 Salmonella typhimurium, reversion of mutation, mutagenicity, replacement test
6 red blood cells, haemolysis, by spectrophotometry, haemocompatibility, ocular irritation replacement test
7 zeine protein, protein solubility, dermal irritation, screening
8 CHO fibroblasts, colony formation, mutagenicity, replacement test

Work lines: The main lines of the Unit are: in vitro toxicology, including different cell lines and primary cell cultures for different applications: dermal and ocular irritation, nephrotoxicity and new materials biocompatibility. Mutagenicity and hepatotoxicity tests, as well as assay for environmental toxicology. The introduction of different in vitro assays in the industry for screening and / or regulatory purposes. Co-operation with the following industrial sectors: cosmetics, pharmaceuticals, medical devices, environment. Interest in developing and applying methods that will comply with the 3R´s.

Quality assurance / Validation programmes: A Quality Assurance Unit is operating inside the facility. The institution applies Good Laboratory Practices rules according to the EU; EN 45001. The team are available to participate in EU validation programmes (all types)

Sources of financing: Gobierno Vasco, CICYT, ATYCA, Private industries AAIR, FAIR, BRITE-EURAM, INNOVATION ENVIRONMENT AND CLIMATE, INCO, EUREKA, AVICENA, SMT, BIOTECHNOLOY, CRAFT, ESPRIT, STEP.

Others:- Acreditación en BLP emitida por el ministerio de Sanidad y Consumo para el laboratorio de Toxicología

- Acreditación ENAC (Entidad Nacional de Acreditación) por la norma Europea EN 45001 (Criterios generales para el funcionamieto de los laboratorios de ensayo) a una de las divisiones actuales del Centro, estando las restantes en camino a su reconocimiento por dicho organismo, pero ya trabajando bajo dicha norma.
- Empresa contratista con las Administraciones Públicas.
- Título de idoneidad como Empresa Colaboradora de Verditos del Grupo Tercero.
- Socio del "Grupo de Cromatografía y Técnicas Afines". Real Sociedad Española de Química.
- Socio del "Grupo Espectroquímico". Reales Sociedades Españolas de Física y Química
- Participante en el subcomité de métodos horizontales de análisis de alimentos (SC-4), dentro del Comité Técnico de productos alimenticios (CT-34) de AENOR
- Miembro de la "Water Environment Federation". Sección española ADECAGUA.
- Miembro de la "International Association on Water Quality"
- Miembro del la Asociación para la Revitalización del Bilbao Metropolitano Metrópoli-30.
- Socio del Centro de Cooperación Medioambiental. Fundación Universidad-Empresa. Comisión Europea-Dirección General I Programa ECIIP
- Representante de EITE en el ACLIMA (Agrupación Cluster de Industrias de Medio Ambiente de la CAPV) en calidad de socios de Honor
- Representante del EITE en CEMA (Centro de Empresas de Medio Ambiente de la CAPV), en calidad de socios fundadores
- Miembro Fundador del Centro de Innovación Tecnológica en Medio Ambiente (CITMA)

Type of Institution: Industrial (pharmaceutical) 

Staff:

Santiago Ferrer Bazaga, Email: sfb44640@GlaxoWellcome.co.uk, Dr Biología, Responsable Centro Investigación Farmacológica, 25 % time devoted to altern. meth.
John Sparrowe Gil del Real, Email: js28076@GlaxoWellcome.co.uk, Diplomado en Veterinaria, Ayudante de Investigación, 25 % time devoted to altern. meth.
Carmen Bravo Jara, FPII, Ayudante de Laboratorio , 25 % time devoted to altern. meth.
Magdalena Jiménez Vaquero, FPII, Ayudante de Laboratorio , 25 % time devoted to altern. meth.
Angeles Talavante Sarro, FPII, Ayudante de Laboratorio, 25 % time devoted to altern. meth.

Total staff involved in alternative methods is 5 people.

Activities / aims: This industrial (pharmaceutical) department is mainly involved in basic research and non-regulated applied research; it performs pathology testing on a routine basis and diagnostic studies at a research level. Pharmaceuticals and antifungal medicaments are routinely evaluated.

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

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

Work lines: Development of new animal models in fungal infections

Quality assurance / Validation programmes: The team are available to participate in EU validation programmes.

Type of Institution: Industrial (pharmaceutical) 

Staff:

Pablo M. Aviles, Email: pa27487@glaxowellcome.co.uk, Ld Farmacia, Investigador, 20 % time devoted to altern. meth.
Rosaura Sanroman, T, Ayudante, 10 % time devoted to altern. meth.
Mª Jose Guillen, Email: mjg68314@glaxowellcome.co.uk, Ld Química, Ayudante, 60 % time devoted to altern. meth.

Total staff involved in alternative methods is 3 people.

Activities / aims: This industrial (pharmaceutical) department is mainly involved in basic research; it performs pharmacodynamics (antimycotic drugs), pharmacology (antimycotic drugs), biokinetics and biotransformation testing on a routine basis, and surgery studies at a research level. Pharmaceuticals and diverse chemical compounds are routinely evaluated.

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

Model systems: The model systems used are conventional animal models, in vitro methods -- micro-organisms (fungi)--, and mathematical modelling.

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

Type of Institution: Industrial (pharmaceutical) 

Staff:

Domingo Gargallo, Email: dgv28867@glaxowellcome.co.uk, Dr Biología, Jefe de Laboratorio, 20 % time devoted to altern. meth., duties related to altern. meth.: Miembro Comisión Promotora de REMA

Total staff involved in alternative methods is 1 person.

Activities / aims: This industrial (pharmaceutical) department is mainly involved in basic research; it cell biology, toxicology (basal cytotoxicity, acute systemic toxicity, nephrotoxicity, haematoxicity, genotoxicity / mutagenicity, hepatotoxicity) testing performs on a routine basis, and surgery and pathology studies at a research level. Pharmaceutical antifungal drugs are routinely evaluated.

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

Model systems: The model systems used are conventional animal models and in vitro methods --micro-organisms (fungi) and primary culture of dispersed cells and cell lines culture.

The endpoints employed are in vitro morphology, cell viability, enzyme release, cellular proliferation, metabolic activity and nucleic acids.

Experimental systems (examples):

1 Salmonella, mutation reversion, genotoxicity tests
2 Caco2
3 rat hepatocytes
4 HepG2

Quality assurance / Validation programmes: A Quality Assurance Unit is operating inside the facility. The team have previously been involved in alternative method validation programmes. They are available to participate in EU validation programmes.

Type of Institution: Industrial (pharmaceutical)

Staff:

Esperanza Herreros Avilés, Email: eh13868@glaxowelcome.co.uk, Dr Farmacia, Investigador Responsable de Toxicología In Vitro , 70 % time devoted to altern. meth.
María Jesus Almela Armendari, Email: mja27315@glaxowelcome.co.uk, Diplomada en Ciencias Biológicas, Técnico de Laboratorio, 100 % time devoted to altern. meth.
Sonia Lozano Arias, Email: sl25656@glaxowelcome.co.uk, Auxiliar de Laboratorio, Ayudante de Laboratorio, 50 % time devoted to altern. meth.
Mireya Martínez, Email: cmm9164@glaxowelcome.co.uk Técnico de Laboratorio, Ayudante de Laboratorio, 50 % time devoted to altern. meth.

Total staff involved in alternative methods is 4 people.

Activities / aims: This industrial (pharmaceutical) department is mainly involved in non-regulated applied research; it performs cell biology, toxicology (basal cytotoxicity, hepatotoxicity) testing on a routine basis, and biokinetics and biotransformation studies at a research level. Pharmaceuticals are routinely evaluated.

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

Model systems: The model systems used are in vitro methods --micro-organisms (yeast, Salmonella typhimurium), primary culture of dispersed cells (rat hepatocytes) and cell lines culture (3-4 cell lines per tissue, C6, MDCK, Caco2, HepG2, L6).

The endpoints employed are in vitro morphology (microscopic observation), cell viability (neutral red uptake, CVDE, crystal violet), cytoskeleton/membranes/enzyme release (LDH), cellular proliferation (Tyd uptake, Mty), metabolic activity (MTT, alamar blue, ATP) and nucleic acids (DNA content).

Experimental systems (examples):

1 primary culture of rat hepatocytes, intracellular LDH, induction of hepatotoxicity and biotransformation enzymes, metabolism studies, complementary test
2 HepG2 human hepatoma, Mety incorporation, basal cytotoxicity, complementary test, screening
3 Salmonella tyhimurium, reversion of mutation by spectrophotometry, genotoxicity, complementary test
4 Caco cells, HPLC, intestinal absorption

Work lines: Development of new antifungal agents active against systemic infections of Candida albicans, other Candida spp., Aspergillus fumigatus and Pneumocystis Carinii, with cidal activity and suitable for oral administration

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

Sources of financing: Private industry

Type of Institution: Industrial (pharmaceutical)

Staff:

Antonio Martínez Escandell, Email: am17735@glaxowellcome.co.uk, Dr Veterinaria, Investigador, 20 % time devoted to altern. meth.
Elena Jiménez Navarro, Email: ej15128@glaxowellcome.co.uk, Ld, Investigador, 40 % time devoted to altern. meth.
Jesus Caballero de Toro, Email: ezz63063@glaxowellcome.co.uk, Ld, Becario Investigación, 30 % time devoted to altern. meth.

Total staff involved in alternative methods is 3 people.

Activities / aims: This industrial (pharmaceutical) department is mainly involved in basic research; it performs toxicology (acute systemic toxicity, nephrotoxicity, haematoxicity, hepatotoxicity) testing on a routine basis, and pharmacodynamics, surgery, pathology and diagnostics studies at a research level. Pharmaceuticals and antimycotic agents are routinely evaluated.

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

Model systems: The model systems used are conventional animal models and in vitro methods --micro-organisms (fungi).

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

Type of Institution: Industrial (pharmaceutical) 

Staff:

Alfonso Romero Vidal, Email: research@ferrer-int-grupo.es, Dr Biología, Director Departamento, 10 % time devoted to altern. meth.
Francisca Gómez Marin, Ld Biología y Veterinaria, Técnico Superior, 40 % time devoted to altern. meth.
Josefa Torres Zurano, Técnico de Laboratorio, Laborante, 20 % time devoted to altern. meth.

Total staff involved in alternative methods is 3 people.

Activities / aims: This industrial (pharmaceutical) department is mainly involved in regulatory testing; it performs toxicology (carcinogenicity, hepatotoxicity, integrated test strategies) testing on a routine basis. Pharmaceuticals are routinely evaluated.

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

Model systems: The model systems used are animal models -- transgenics (mmTVu-Ha-ras mice; zetaglobin/v-Ha-ras) and in vitro methods -- primary culture of dispersed cells (rat hepatocytes) and cell-free systems (microsomes).

The endpoints employed in vivo are tumoral frequency; 20 general parameters of general toxicity and in vitro cell viability, cellular proliferation and metabolic activity (gluthation, gamma-GT, FA, ALT, AST, glucose, etc).

Experimental systems (examples):

1 primary culture of adult rats, MTT reduction and others, toxicity of chemicals, screening and complementary test.
2 hepatocytes, (pharmaceuticals) compararison of effects, replacement test.

Work lines: Rat hepatocyte primary cultures for the toxicological screening of a new chemical substance series. Verification or research on the mechanistic systems of the toxic effects detected or suggested by in vivo toxicological studies.

Quality assurance / Validation programmes: A Quality Assurance Unit is operating inside the facility. The institution applies Good Laboratory Practices rules according to the EU

Sources of financing: Self financing

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.