By the application of continuing improvements in science and study design and the implementation of replacement methods in animal testing SafePharm ensure that the number of animals used is reduced to a minimum, without compromising the reliability of the results.

The General Toxicology Department provides for the safety evaluation of industrial chemicals, agrochemicals and pharmaceuticals. The team of operational study directors and experienced technicians provide a rapid, competent and competitively priced service. Good communication and a high degree of flexibility ensures the individual requirements of each sponsor are met. All studies are conducted in compliance with GLP.

• Purpose built, barrier maintained, animal unit – fully refurbished in 2001
• 19 multifunctional animal rooms
• Dedicated necropsy facilities
• Radio isotope laboratory for Local Lymph Node Assay
• State-of-the-art environmental control with remote monitoring
• Total commitment to the highest standards of animal welfare and development of alternative methods

A full range of acute toxicity studies, mainly conducted according to OECD protocols, but also to EPA/OPPTS and Japanese guidelines. Additionally, client specific methods can also be accomodated if required. These include (but are not limted to):

• Acute mammalian toxicity-oral, dermal and intravenous administration
• Local tolerance-skin and eye irritation-single and repeat exposure
• Skin sensitisation – adjuvant and non-adjuvant methods
• Local Lymph Node Assay
• Photosensitisation
• ISO 10993 Biocompatibility studies for safety of medical devices and plastics
• Quality control pyrogen/abnormal toxicity tests

Facilities:

• Modern barrier maintained animal unit
• Capacity for 18 repeated dose toxicity studies to run simultaneously
• Full, dedicated neurotoxicity functional observation battery facilities
• State-of-the-art environmental control to animal rooms
• Total commitment to the highest standards of animal welfare
• Self-contained laboratory facility including animal unit, ancillary laboratories and staff offices.

Study Types – The department conducts a wide range of studies including:

• 7-Day, 14-Day, 28-Day, 90-Day, 26-Week and 52-Week studies.
• Carcinogenicity
• Oral gavage, dietary, intravenous, intramuscular, subcutaneous, intranasal, intravaginal and inhalation routes.

Our technical team is specialised in the conduct of the detailed clinical observations required in repeated dose studies, including the open field observations and functional performance measurements of the neurotoxicity functional observation battery.

Sensory reactivity: Quantitative and qualitative measurements of auditory, visual and proprioceptive responses.

Grip strength: quantitative assessment by grip-strength, force meter.

Motor activity assessment: fully automated battery of photobeam activity monitors capable of activity measurements in 20 animals simultaneously.

• A dedicated necropsy facility attached to the animal unit
• On-site independent consultant pathologist
• Rapid throughput guaranteed by use of two large independent histology laboratories for slide processing

Japanese Chemical Substance Control Law studies – we have conducted more 28-Day studies for chemical notification in Japan than any other non-Japanese laboratory.

Oral gavage studies – the large number of these studies conducted in the department gives us special expertise with a mal-dose rate of less than 0.005%.

Unusual exposure routes – for example, we have developed techniques for intranasal and intravaginal administration in rats and rabbits.