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 Endothia
Data are available for some commercial preparations.
Animal Route LD50 Reference
mouse oral >5 000 Delahunt & Stebbins, 1965
I.v. 820 Delahunt & Stebbins, 1965
rat oral >2 000 Delahunt & Stebbins, 1965
I.v. 544 Delahunt & Stebbins, 1965
Four groups of 10 male and 10 female rats received daily in their diet
for one year either 0, 8, 16 or 40 mg/kg body-weight of microbial
rennin. No adverse effects compared with controls were noted with
regard to survival, appearance, growth rate, food consumption,
haematology, urinalysis, serum chemistry, liver triglycerides, organ
weights, gross and histopathology (Delahunt & Stebbins, 1965).
Four groups of 3 male and 3 female beagles received daily for one year
an oral capsule with 0, 8, 16 or 40 mg/kg body-weight of microbial
rennin. There was no difference between controls and test groups
related to the administration of the test compound as regards
survival, appearance, behaviour, body-weight, haematology, urinalysis,
serum chemistry, serum electrophoresis, neurological and
ophthalmological examination, organ weights, gross and histopathology
(Delahunt & Stebbins, 1965).
The 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 40
mg/kg body-weight. 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 are necessary.
Temporarily not limited.*
Further work required by 1974
Two year study in rats.
Delahunt, C. S. & Stebbins, -. (1965) Unpublished report
*Except for good manufacturing practice.