WORLD HEALTH ORGANIZATION
WHO Food Additives Series 1972, No. 1
TOXICOLOGICAL EVALUATION OF SOME
ENZYMES, MODIFIED STARCHES AND
CERTAIN OTHER SUBSTANCES
The evaluations contained in this publication were prepared by the
Joint FAO/WHO Expert Committee on Food Additives which met in Rome,
16-24 June 19711
World Health Organization
1 Fifteenth Report of the Joint FAO/WHO Expert Committee on Food
Additives, Wld Hlth Org. techn. Rep. Ser., 1972, No. 488; FAO
Nutrition Meetings Report Series, 1972, No. 50.
The monographs contained in the present volume are also issued by the
Food and Agriculture Organization of the United Nations, Rome, as FAO
Nutrition Meetings Report Series, No. 50A
(c) FAO and WHO 1972
This enzyme preparation is prepared from the species Mucor miehei.
Four groups of 25 male and 25 female rats received in their diet 0,
0.1, 0.5 and 2.5 per cent. of microbial rennin (equivalent to 0, 100,
500 and 2500 units/kg/day) for 1 year. Appearance and behaviour was
normal throughout the experiment. Survival was comparable in all
groups and the few deaths observed were unrelated to the
administration of the test substance. Mean body-weight and food
consumption were similar to controls. Haematology, blood chemistry
and urinalysis showed nothing significant compared with controls.
Relative organ weights, gross and histopathology showed nothing of
note (Gesler, 1970).
Four groups of 5 male and 5 female beagles received by daily gavage 6
times a week for 1 year either 0, 100, 500 or 2500 units/kg
body-weight. Apart from some vomiting early in the study and
occasional vomiting in the highest test group there was no further
difficulty in administration. Behaviour, appearance, food consumption
and mean body-weight did not differ from controls. Haematology, blood
chemistry, blood coagulation studies and urinalysis revealed no
changes due to the administration of the test substance. Mean
relative organ weights, gross and histopathology revealed no changes
different from controls (Gesler, 1970a).
Two studies extending over 1 year in the rat and dog are available for
evaluation and do not reveal any adverse effects at levels up to 2.5
per cent. in the diet of the rat. They are not sufficiently long to
reveal possible chronic effects although the levels used would have
revealed any deleterious effects due to mycotoxins. Because it is
conceivable that undetected chronic effects could occur, further tests
Temporarily not limited.*
Further work required by 1975
Two-year study in rats.
Gesler, R. M. (1970) Unpublished report submitted by Travenol
Gesler, R. M. (1970a) Unpublished report submitted by Travenol
*Except for good manufacturing practice.