Day 038 - 19 Oct 94 - Page 45


     
     1        high incidence in the control groups, but I have never seen
     2        the comparison explored for historical controls.
     3
     4   MR. JUSTICE BELL:  Can you turn the three per cent or the five
     5        per cent into something which is meaningful so far as
     6        quantity is concerned?  I mean, the five per cent dietary
     7        group, what does that mean, that five per cent of their
     8        daily diet is actually Sunset Yellow?
     9        A.  Indeed it is, which is a very -----
    10
    11   Q.   If I had three soft drinks in a day with Sunset Yellow in
    12        them, I appreciate they appear in cereals, sauces sources
    13        and fish fingers and so on as well, but what percentage of
    14        my diet would the Sunset Yellow and three soft drinks
    15        contain?  Can you give me any idea?
    16        A.  It is difficult to be precise because even when used in
    17        commercial products it is used in dilution, but I would be
    18        surprised if it was anything approaching that level.  It is
    19        likely to be a thousandth of that level or less, would be
    20        my guess, of the total diet.
    21
    22   Q.   That is what I had rather assumed.  I had assumed that if
    23        it was five per cent or three per cent of my daily diet --
    24        I mean, is that by weight or volume?
    25        A.  That is by weight.
    26
    27   Q.   Does that include drink or just -----
    28        A.  No, that includes -- typically in these feeding studies
    29        it would be just the drink.  The animals would be at
    30        liberty to drink as much fluid as they liked, whereas that
    31        would be free of the test compound.
    32
    33   Q.   That is all liquid, is it, their diet?
    34        A.  It varies from study to study.  You will find studies
    35        in which they consume all their intake in a liquid form
    36        but, more commonly, they take solid food with the additive
    37        incorporated into solid food and they take liquid as well.
    38        When you estimate the dose that the rats received, it is a
    39        rather complex calculation because you have to know how
    40        much is present in the food, you have to weigh the amount
    41        of food daily before it is given to the rat.  You weigh how
    42        much is left.  You, therefore, calculate how much they
    43        should have ingested, and you then have to calculate that
    44        as a proportion of the weight that the rat is at that time
    45        in order to estimate the dose in milligrams per unit body
    46        weight that the rat has had.
    47
    48        So, while you have a constant dosing level of the food,
    49        that does not directly correspond to a constant dosing
    50        level of the body weight of the rat.  It is calculated as 
    51        an average over the animal's lifetime. 
    52 
    53   Q.   Since I have interrupted anyway, the other matter is this,
    54        so I can get some idea of what the ADIs mean:  Suppose a
    55        man weighed about 75 kilograms?
    56        A.  Yes.
    57
    58   Q.   I think that is about 11 stone 11, he is going to be ADI
    59        awarded in 1975 -----
    60        A.  2.5 milligrams.

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