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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: 18a. Inventory of Institutions

Notes:

1To avoid any loss in consistency, some concepts were not translated to English: names of institutions, professional degrees and positions.

2According to the tradition in Spain, two surnames are included for each scientist. The first scientist of each group (103) is the contact person.

3IThe following information is included in experimental systems: biological model system, endpoint and endpoint measurement, aim of the study / area of application, and type of assay.

Prefix for tel and fax is 34

Type of Institution: Industrial (pharmaceutical)

Staff:

Total staff involved in alternative methods is 3 people.

Activities / aims: This industrial (pharmaceutical) department is mainly involved in regulatory testing; it performs biochemistry, biokinetics and biotransformation testing on a routine basis. Pharmaceuticals are routinely evaluated. The main use of alternative methods is for complementary and replacement tests.

Model systems: The model systems used are in vitro methods - organ culture (rat liver slices) and cell-free systems (S9 fractions, human recombinant P450).

The endpoints employed in vitro are biotransformation systems (cytochrome P450, nDP- GTM flavine dependent).

Experimental systems (examples):

1 rat liver microsomes, NADP dependent pharmaceutical biotransformation (by HPLC), metabolic profile, complementary test

2 human recombinant cyt P450-NADP dependent pharmaceutical biotransformation, identification of enzymes responsible for the biotransformation process, complementary test

3 liver microsomes from different animal species, pharmaceutical metabolite isolation by HPLC, identification of metabolites, replacement test

4 rat liver microsomes, P450 and UDP-glucuronyl transferase activities, metabolic enzymes induction, complementary test

Work lines: Comparison of the metabolic profiles of new drug candidates in different animal species using liver microsomes and/or S9 fraction. Isolation and identification of drug metabolites produced by liver microsomes. Identification of the enzymes involved in the metabolism of new drugs. Assessment of drug-metabolizing enzyme induction in rats.

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


Type of Institution: Industrial (cosmetics)

Staff:

Total staff involved in alternative methods is 3 people.

Activities / aims: This industrial (cosmetics) department is mainly involved in regulatory testing and method development; it performs toxicology (ocular cytotoxicity, dermal irritation and corrosivity, immunotoxicity and sensitisation, phototoxicity) testing on a routine basis, and cell biology, biochemistry, pharmacology, physiology and culture methodology studies at a research level. Cosmetics and essential oils are routinely evaluated.

The main use of alternative methods is for replacement tests.

Model systems: The model systems used are in vitro methods -- culture of explants, reaggregates, reconstituted organs (skin), primary culture of dispersed cells (fibroblasts) and cell-free systems (physico-chemical models).

The endpoints employed in vitro are cell viability (MTT reduction), cytoskeleton/membranes/enzyme release (IL-1 release).

Experimental systems (examples):

1 human erythrocytes, haemolysis studied by photometry, irritation and phototoxicity, replacement test

2 skin explants, MTT reduction by spectrophotometry, irritation, photoprotection, replacement test

3 skin explants, IL-1alpha by ELISA, irritation and photometry, replacement test

Work lines: Safety evaluation of cosmetic products by alternative methods to animal testing. Evaluation of sun protection factors. Efficacy evaluation.

Quality assurance / Validation programmes: A Quality Assurance Unit is operating inside the facility. The institution applies Good Laboratory Practices rules according to the OECD. The team are available to participate in EU validation programmes in relation to alternative methods to the use of animals.

Type of Institution: society for animal rights

Staff:

Total staff involved in alternative methods is 1 person.

Activities / aims: This society for animal rights is mainly involved in the dissemination of alternatives

Type of Institution: Industrial (pharmaceutical)

Staff:

Total staff involved in alternative methods is 1 person.

Activities / aims: This industrial (pharmaceutical) department is mainly involved in basic research, non-regulated applied research, regulatory testing and alternatives to the use of animals in education; it performs pharmacodynamics, biokinetics and biotransformation, toxicology testing (acute systemic toxicity, neurotoxicity, endocrine disruption) on a routine basis, and biochemistry, pharmacology, physiology, surgery, pathology and production studies at a research level. Hormones, pharmaceuticals, diverse chemical compounds and biomaterials are routinely evaluated.

The main use of alternative methods is for complementary studies.

Model systems: The model systems used are animal models –conventional and transgenics--, in vitro methods -- cell-free systems (microsomes) and education models.

The endpoints employed in vitro are metabolic activity biotransformation systems

Work lines: Standardization of refined methods for dehabituation and desensibilization on animals

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

Others: The supervision of protocols on ethical committees and education related to the 3 Rs

Type of Institution: Private / contract laboratory

Staff:

Total staff involved in alternative methods is 5 people.

Activities / aims: This private / contract laboratory department is mainly involved in non-regulated applied research, regulatory testing, method development and method validation; it performs toxicology (basal cytotoxicity, ocular cytotoxicity, haematoxicity, genotoxicity / mutagenicity) culture methodology and efficacy of new materials testing on a routine basis. Pharmaceuticals, cosmetics, diverse chemical compounds, medical devices, biomaterials and colourings are routinely evaluated; vaccines, hormones, pesticides 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 conventional animal models, embryos (HET-CAM), in vitro methods - - micro-organisms (Salmonella typhimurium, E. coli), culture of explants, reaggregates, reconstituted organs, (human spongy bone explants, BCOP- bovine isolated cornea) and cell lines culture (L929, MG63, SIRC, L1210, Lewis lung carcinoma LI, L51784, human osteoblasts, bovine corneal cells).

The endpoints employed are in vitro morphology (optical microscopy, scanning electronic microscopy), cell viability (MTT reduction, neutral red uptake, LDH, trypan blue exclusion), enzyme release (LDH leakage), cellular proliferation (cell count (chamber, cell counter)), metabolic activity (mitochondrial (MTT)) and organ-specific indicators (osteocalcine, alkaline phosphatase in osteoclasts).

Experimental systems (examples):

1 L929 mouse fibroblasts, MTT reduction, neutral red uptake by photometry, basal cytotoxicity, replacement test

2 Human osteoblasts, cell adhesion and proliferation, MTT reduction, cell number, protein content, alkaline phosphatase (spectrophotometry), osteocalcine (ELISA), morphology (SEM), physiology, osteointegration, replacement test

3 HET-CAM chick embryo chorioalantoid membrane, membrane alteration (visualization), ocular irritation, replacement test

4 BCOP- Isolated bovine cornea, corneal opacity (optical transmission), permeability (photometry), ocular irritation, replacement test

Quality assurance / Validation programmes: A Quality Assurance Unit is operating inside the facility. The institution applies Good Laboratory Practices rules according to the EU, OECD and the FDA. The team have previously been involved in the following validation programmes on alternative methods: EU/ Home Office Validation Study of Ocular Irritation alternative methods. They are is available to participate in EU validation programmes related to validation of alternative methods

Type of Institution: Private research facility

Staff:

Total staff involved in alternative methods is 1 person.

Activities / aims: This private research facility department is mainly involved in basic research; it performs toxicology (neurotoxicity) testing on a routine basis, and biochemistry studies at a research level. Drugs of abuse are routinely evaluated; pharmaceuticals also being occasionally studied.

Model systems: The model system used is human volunteers

Experimental systems (examples):

1 psychopathological questionnaires, drug of abuse consumption, consequences of drug abuse

Work lines: Long-term health consequences of drug abuse in human beings, especially cannabis abusers, and among psychiatric patients.

Quality assurance / Validation programmes: The team are available to participate in EU validation programmes in relation to drugs of abuse screening, and long-term effects. 

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.