T E C H N I C A L E X C H A N G E M E E T I N G
BIOLOGICAL
How best can we ensure that future Group products
have the
lowest possible activity?
Biological testing should include the following
aspects:
Objectives
(1) To establish BAT products in a favou-gable
position compared
to competitors.
(2) To produce cigarettes of low biological
activity, including a
medium-delivery low-biological activity product.
Although
the reductions in total biological activity so far
rely mainly
on reductions in delivery, such a product has some
attractions,
especially in the areas of consumer satisfaction,
product
differentiation and in combatting quitting.
Long-term Tests
skin-painting
Although there were no immediate plans for
re-starting this
programme, this should be reviewed if
skin-painting is required to
further validate other testse particularly the
Ames Test.
Inhalation Toxicity
The possibility of carrying out a further
long-term study,
using another rodent (probably hamster) was
discussed. As it was
still not certain that a satisfactory biological
end-point could
be achieved in such studies, a positive
recommendation that such
work be undertaken could not yet be made.
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BATCo document for Province of BritiSh Columbia 8
November 1999


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Short-term Tests
Test Batteries
It was agreed that diseases other than lung cancer
should be
considered as the basis for tests. It was also
agreed that a
battery of tests (for example as used by BAT
Germany) would be
required in meeting or anticipating legislation
and encouragement
was given for the further extension and definition
of the required
battery. It was likely that the Ames test and a
chromosome-damage
test would be the essential minimum features of
any battery.
However, as this is a notoriously difficult area
rapid progress
was not expected. The literature and external
research in the
health area largely determine the success and rate
of introduction
of 'new' tests, particularly those thought to be
related to specific
human diseases.
Ames Test
This should be standardized as far as possible
among the three
laboratories now using the test. It has the
potential of becoming
an index for comparing products and is likely to
have wide acceptance
in spite of its shortcomings.
Additives
For volatile additives existing information is
usually sufficient
to obtain clearance from regulatory authorities.
However, in some
European countries food regulations now apply to
the tobacco industry,
and may be symptomatic of a trend to increased
legislation. Additives
which are pyrolysed might require adequate
toxicological testing before
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being accepted by regulatory authorities and we
must be in a position
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BATCo document for Province of BritiSh Columbia 8
November 1999


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Interpretation and Understanding of Results
Understanding of the importance of the tests and
how the
results are interpreted was essential if the
results were to be
used correctly, for example in product design.
Biological tests
rarely give unequivocal yes-no answers.
Effects on the Foetus
This is an emotional area and it was agreed that
it was one
that we could not ignore.
It was agreed that teratology studies were
required for the
toxicological evaluation of new additives.
In the human area a collaborative study into the
effects of
low tar versus medium tar cigarettes on birth
weights was being
discussed in the UK. However, it was not at all
clear if the
effects of smoking could be dissociated from other
factors affecting
birthweight. In addition, animal studies were
underway in Canada
involving the induction of the enzyme AHH in the
foetus.
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BATCo document for Province of British Columbia 8
November 1999