GLUCOSE ISOMERASE (IMMOBILIZED) FROM ACTINOPLANES MISSOURIENSIS
EXPLANATION
This enzyme preparation has not been previously evaluated by the
Joint FAO/WHO Expert Committee on Food Additives.
BIOLOGICAL DATA
Biochemical aspects
No information available.
Toxicological studies
Special study on reproduction
Rats
Groups of 20 male and 20 female Sprague-Dawley rats were fed
diets containing 0 or 1% whole, non-viable Actinoplanes
missouriensis in the diet. After 60 days on test, males and females
were mated on a 1-to-1 basis. The males were sacrificed after 90 days
on test for organ-weight analysis and gross and microscopic pathology
evaluation. The females were allowed to litter and nurse their young
until weaning at 21 days. Body weights tended to be lower in male rats
given the test compound but did not differ significantly from
controls. Right gonad weights tended to be slightly higher in treated
males and females. No compound-related changes were observed in
haematology, urinalysis, clinical chemistry, or gross or microscopic
pathology, nor were there any effects on reproductive performance of
the offspring (Tisdel & Harris, 1974a).
Acute toxicity
LD50
Species Route (mg/kg b.w.) Reference
Rat (male) Oral (dietary) 40,000 Regel, 1973
Mouse (male) i.v. 1,250 Regel, 1973
Mouse (male) i.v. 875-1,250 Regel, 1973
Rabbit s.c. 1,250 Regel, 1973
Short-term study
Dogs
Groups of 2 male and 2 female beagle dogs were fed for 90 days
diets containing 0 or 1% whole, non-viable cells of Actinoplanes
missouriensis. Body-weight gains and food consumption were less for
the test dogs than controls, but remained in the normal range for dogs
of their age during the course of the study. Results of haematology
and urinalysis were normal for all animals and no compound-related
effects on organ weights or gross and microscopic pathology were
reported (Tisdel & Harris, 1974b).
Long-term studies
No information available.
Observations in man
No information available.
Comments
A well-conducted short-term study in rats, which included a
1-generation reproduction study, showed no significant toxicological
effects. A short-term study in dogs provides additional information on
the lack of toxicity of the preparation.
The studies on the non-immobilized enzyme were considered by the
Committee to be appropriate for evaluating the immobilized form
because the use of gelatin as an entrapping agent does not present a
toxicological problem. The release of free glutaraldehyde from the
enzyme preparation is controlled by the specifications for the
preparation established by the Committee.
EVALUATION
Level causing no toxicological effect
Rat: 1% (10,000 ppm) in the diet, equivalent to 1,000 mg/kg b.w./day.
Estimate of acceptable daily intake for man
Acceptable for use in food processing when used as a component in an
immobilized system.
REFERENCES
Regel, L. (1973). Untitled report on acute toxicity studies.
Unpublished study of the Warf Institute, Inc., Madison, WI, USA.
Submitted to the World Health Organization by Gist-Brocades.
Tisdel, M. & Harris, D. (1974a). 90-Day subacute and reproduction
study - Rat. Unpublished study of the Warf Institute, Inc.,
Madison, WI, USA. Submitted to the World Health Organization by
Gist-Brocades.
Tisdel, M. & Harris, D. (1974b). 90-Day subacute and reproduction
study - Dog. Unpublished study of the Warf Institute, Inc.,
Madison, WI, USA. Submitted to the World Health Organization by
Gist-Brocades.