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
Geneva
1972
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
MICROBIAL CARBOHYDRASE
Biological data
Source
This enzyme preparation is prepared from some varieties of
Asperigillus niger.
Acute toxicity
Data are available for some commercial preparations.
Animal Route LD50 Reference
(mg/kg body-weight)
mouse oral >3 200 Hunt & Garvin, 1963
>4 000 Hunt & Garvin, 1971
>3 200 Willard & Garvin, 1968
>4 000 Garvin et al., 1966
rat oral 10 000 Gray, 1960
31 600 Kay & Calandra, 1962
>3 200 Willard & Garvin, 1968
>4 000 Garvin et al., 1966
>10 000 Gray, 1960
rabbit oral >4 000 Garvin et al., 1966
dog oral >4 000 Garvin et al., 1966
Short-term studies
Rat
Four groups of 10 male rats received in their diet for 30 days enzyme
at 0, 0.5 and 5 per cent. There were no adverse effects related to
treatment regarding growth, appearance, behaviour, survival, food
consumption, haematology, organ weights and gross pathology (Garvin et
al., 1966).
Two groups of 10 male and 10 female rats received daily for 91 days in
their diet either 0 or 5 per cent. enzyme. There was no difference
from controls regarding appearance, behaviour, survival, weight gain,
haematology, organ weights and gross pathology (Garvin & Merubia,
1959).
Long-term studies
None available.
Special studies
Groups of 5 ducklings received in their diet either 0, 1, 5 or 10 per
cent. of enzyme for 29 days. Growth, feed consumption, survival,
behaviour and mean liver weights were comparable. No gross or
histo-pathological lesions of the liver were seen (F.D.R.L., 1963).
Groups of 5 ducklings received in their diet either 0, 1, 5 or 10 per
cent. of enzyme for 29 days. Growth, feed consumption, behaviour and
development were comparable in all groups. No gross liver lesions
were seen at autopsy and mean liver weights were similar to controls.
Histopathology of the livers was normal. No toxic element was noted
(F.D.R.L., 1963).
Comments
Aspergillus niger is a contaminant of food. The available
information appears to indicate that it is not pathogenic to man.
Duckling tests are available on 2 preparations and 2 inadequate
short-term studies in rats on another 2 preparations using levels up
to 5 per cent. in the diet. These give some reassurance that the
strains used to prepare carbohydrase do not produce aflatoxin or
related mycotoxins.
EVALUATION
Temporarily not limited. *
Further work required by 1972
Adequate 90-day study in rats.
REFERENCES
F.D.R.L. (1963) Unpublished report No. 84600e submitted by Miles Chem.
Co.
F.D.R.L. (1963) Unpublished report No. 84600f submitted by Miles Chem.
Co.
Garvin, P. & Merubia, J. (1959) Unpublished report submitted by Baxter
Laboratories Inc.
*Except for good manufacturing practice.
Garvin, P. J., Willard, R., Merubia, J., Huszar, B., Chiu, E. &
Gilbert, C. (1966) Unpublished report submitted by Baxter Laboratories
Inc.
Gray, E. H. (1960) Unpublished report submitted by Miles Laboratories
Inc.
Hunt, R. F. & Garvin, P. J. (1963) Unpublished report submitted by
Baxter Laboratories Inc.
Hunt, R. F. & Garvin, P. J. (1971) Unpublished report submitted by
Travenol Laboratories Ltd.
Kay, J. H. & Calandra, J. C. (1962) Unpublished report submitted by
Miles Chem. Co.
Phillips, B. M., Hartnagel, R. E. & Thompson, D. (1967) Unpublished
report submitted by Miles Chem. Co.
Willard, R. L. & Garvin, P. J. (1968) Unpublished report submitted by
Travenol Laboratories Ltd.