Day 040 - 21 Oct 94 - Page 17

     
     1   Q.   Were given -- it went up to 1,250 milligrams of Amaranth
     2        per kilogram of body weight, did they not?
     3        A.  Yes.
     4
     5   Q.   You see in the middle of the page -----
     6
     7   MR. JUSTICE BELL:  Please say "yes" or "no".
     8
     9   MR. RAMPTON:  Do you see in the middle of page 171 there is a
    10        paragraph which reads:  "It was concluded that the exposure
    11        of rats to doses of up to 1250 mg of Amaranth/kg body
    12        weight and during pregnancy and lactation followed by
    13        exposure of the offspring for over 2 years did not lead to
    14        any carcinogenic effect".  Do you see that?
    15        A.  I see it and that is what they state.
    16
    17   Q.   You would say, no doubt, one cannot draw any conclusion
    18        from that whatsoever; is that right?
    19        A.  No, that is not how I would put it.
    20
    Q.   Tell us how you would put it, please?
    22        A.  If you look to the paragraph above, it says:  "At all
    23        dose levels, there was an increase in the number of female
    24        rats with calcification of the kidneys and a pelvic
    25        epithelial hyperplasia but no significant differences were
    26        observed in the incidence of these lesions in males even at
    27        the highest dose".
    28
    29        Now, it seems to me that what we find is that in these
    30        rats, particularly in the females, there were no full blown
    31        tumours.  There were, however, signs at all dose levels of
    32        epithelial hyperplasia, which I read as the kind of lesion
    33        which may indicate the likelihood of the development of
    34        cancer.
    35
    36   MR. JUSTICE BELL:  I have to say that it seems to me that JECFA
    37        are not saying that because, having just written what they
    38        have in the paragraph you have referred to, they say:  "It
    39        did not lead to any carcinogenic effect".  "Carcinogenic",
    40        I would have thought (unless you tell me differently),
         means must include anything which they might see as the
    42        beginnings of tumour or cancer.
    43        A.  That may well be the sense in which they use it, but it
    44        is not that uncommon for the Scientific Committee for Food
    45        on the one hand and the Joint Expert Committee on the other
    46        to look at similar data and interpret them differently.
    47
    48   Q.   They seem to me to be saying there were changes.
    49        A.  Yes.
    50 
    51   Q.   But it got no further, just to put it in ordinary 
    52        language. 
    53        A.  Yes, within the lifetime of those rats.
    54
    55   Q.   And their offspring?
    56        A.  Yes.
    57
    58   MR. RAMPTON:  Of the female rats only?
    59        A.  The female rats only -- female lives are no less
    60        important than male -- and they say, of course, it was not