Procedure for animal research experiments

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PROCEDURE FOR ANIMAL RESEARCH EXPERIMENTS USING
IONISING RADIATION
General information
A distinction can be made between various types of experiments within the domain of animal
research and these may take place under variable conditions and in different rooms and
buildings on the Randwyck site. The use of radioactive tracers in laboratory animals always
requires additional attention to be paid in relation to radiation hygiene, more so than is the
case with in-vitro experiments. The likelihood of contamination is relatively great, depending
on the behaviour of the animal, while the various components of an experiment may take
place in different rooms.
In addition, the fact that various personnel are involved in animal experiments (such as the
researcher performing the experiment, supporting personnel, biotechnicians, animal
laboratory technicians and the on-site radiation expert) requires thorough consultation
beforehand and effective mutual communication if the experiment is to be successful.
A number of standards types of animal experiments and procedures that are commonly used
are described in the annex.
Justification
An important aspect of the justification for animal experiments is included in the statutory
review of the Animal Experiments Committee (DEC) [Dier Experimenten Commissie] within
the scope of the Laboratory Animals Act [Wet op Proefdieren]. The choice of ionising
radiation emitting devices is usually determined by the greater sensitivity and accuracy with
regard to techniques in which no sources of radiation are used. However, this implies in a
number of cases that the use of radioactive tracers is actually preferable, as the number of
laboratory animals used is reduced as a result. The costs of alternative methods often form a
determining factor when considering the advantages and disadvantages too.
Preconditions
The following general basic rules and preconditions apply when performing animal research
experiments using radioactive sources:
 Activities using radioactive sources may only be performed under the regime of an issued
internal permit (SIT) and within the frameworks of the Randwyck complex permit
 For every new application of ionising radiation, an application must be submitted to
and/or in cooperation with the on-site expert to the Radiation Protection Unit (SBE) in
accordance with the internal permits procedure
 Prior to the research being carried out, the SBE performs a risk analysis of the
application applied for and an internal permit (SIT) is issued on the basis of this. The
maximum activity and dose to be used for individuals and the environment, both under
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normal conditions as well as in the event of incidents and/or unintentional occurrences,
are calculated for each activity, which are described under ‘standard types’.
Before the experiment begins, it must also be approved by the Animal Experiments
Committee (DEC).
The working procedure is laid down on the basis of the described standard types of
experiments.
A consultation must have taken place with the team who are conducting the experiment
prior to the start. The person applying to conduct the experiment sets down details in
writing of which duties are performed by whom and (if possible) when, and distributes this
protocol among the team leaders.
Activities with laboratory animals must be performed by authorised individuals, within the
meaning of Articles 9, 12 or 14 of the Laboratory Animals Act, who have also received
training in radiation hygiene to at least level 5.
The on-site radiation expert supervises the activities in so far as radiation hygiene-related
aspects of the experiment within his/her management unit are concerned. He/she may
exercise his/her powers in cases where this is necessary.
Laboratory animals must be transported in cages that provide sufficient protection to
prevent contamination of the environment and to minimise external radiation
Laboratory animals must only be transported between institutions along the shortest
possible route and in accordance with an internal procedure drawn up for this purpose.
If possible, laboratory animals must be handled in a sedated state.
The animals must only be kept in specially-equipped rooms within the radionuclide
laboratory complex (RNL) in the Faculty of Health, Medicine and Life Sciences building in
cages suitable for this purpose.
The composition of bedding material in cages, both during transportation and when in
accommodation facilities, must be such that it prevents contamination occurring as a
result of particle dispersion.
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ANNEX:
ANIMAL EXPERIMENTS AND PROCEDURES
Standard types of test:
Metabolic studies
Nuclides:
Usual activity:
Laboratory animals:
Accommodation:
Nuclear medicine studies
Nuclides:
Usual activity:
Laboratory animals:
Accommodation:
Transport:
3
H, 14C, 32P, 35S, 125I, 131I
Up to 200 MBq
Rat, mouse, rabbit, piglet
RNL department, rooms 0.134A and 0.127C
99m
Tc, 201Tl, 68Ga, 18F, 123I, 131I
Up to 400 MBq
Rat, mouse, rabbit, piglet
RNL department, rooms 0.134A and 0.127C
Transportation between RNL and Maastricht Academic Hospital
must take place through the basement between the hospital and
the FHML building. Regulations also apply to internal
transportation of radioactive substances.
The table below provides an overview of the most frequent activities and the
accompanying value for the parameter for the likelihood of dissemination, p.
Activity
p-value
Using a pipette from the stock solution
Administration via injection (intravenous, intraperitoneal) local
application or infusion
Use of an animal (sedated)
Use of an animal (non-sedated)
Accommodation
Care
Transport
Blood sample
Collection of urine, faeces and blood samples
Autopsy
Chemical and histological treatments
Taking various readings and autoradiography
Processing biological waste
-1
-2
-2
-3
-1
-1
-1
-2
-2
-1
-1
-1
-1
When calculating the maximum level of activity to be used, the p-value is applied in
accordance with the “Annex – Radionuclide laboratory, May 2002”.
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Radiodiagnostic activities
X-ray equipment:
Up to 150 kV for fixed position and up to 100 kV for mobile equipment
Purpose:
Radiographic examination and X-ray photography for
orthopaedic diagnostic purposes
Monitoring diagnostic operations
Following development processes
(Heart) catheterisation
Laboratory animals: Rabbit, dog, piglet, sheep
These activities are subject to the guidelines that apply to radiodiagnostic rooms (in
accordance with the “Radiation Hygiene Regulation for Randwyck”). The X-ray
Instrumentation group of Maastricht Academic Hospital perform periodic quality control
checks on equipment under the responsibility of the on-site radiation expert.
Radiotherapeutic activities
X-ray equipment: Up to 225 kV for fixed positions
Purpose:
Immunological, oncological and microbiological research
Research for the purpose of applications in therapy
Laboratory animals: Rat, mouse
These activities are subject to the guidelines that apply to the RNL department (in
accordance with the “Radiation Hygiene Regulation for Randwyck”). The IDEE department
(of Maastricht University) and the MAASTRO clinic perform periodic quality control checks
under the responsibility of the on-site radiation expert.
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