STARCH SODIUM OCTENYL SUCCINATE
Explanation
This compound was previously evaluated for an ADI for man by the
Joint FAO/WHO Expert Committee on Food Additives in 1969 (Annex I,
Ref. 19). No toxicological monograph was prepared.
Introduction
Modification is carried out by treating a slurry of the starch
with octenyl succinic anhydride. The finished product has a degree of
substitution of 0.02.
BIOLOGICAL DATA
BIOCHEMICAL ASPECTS
In a caloric utilization study, groups each of 10 male albino
rats, 20 to 22 days old, were fed either 2.74 g of a basal diet, or
the basal diet supplemented with 1.5 or 3.0 g of cornstarch or 1.5 or
3.0 g of the starch sodium octenyl succinate (O.S.), or with 0.75,
1.5, 3.0 or 4.5 g of sucrose for a period of 4 weeks. No adverse
effects were noted during the test period. The weight gains of the
test group fed starch or substitutes were similar to the sucrose
group. The caloric value of the substituted cornstarch (O.S.) was
similar to cornstarch (Anon., 1960).
TOXICOLOGICAL STUDIES
Short-term studies
Rat
Groups each of 12 weanling albino rats (equally divided by sex)
were maintained on diets containing 64% carbohydrate ingredients
consisting of 29% cellulose and the remaining 35% consisting of
cornstarch, or starch sodium octenyl succinate (O.S.). Rats fed the
substituted starch showed a slightly slower growth rate than control
rats fed cornstarch. The decreased growth rate was associated with
decreased food consumption. Efficiency of food utilization was not
affected by the test compound (Anon., 1950).
In another study, rats (Charles River) maintained on diets
containing 6%, 12% or 30% of O.S. (plus cornstarch to 30% of the diet)
or 30% cornstarch were bred twice. The F1b generation was maintained
on the same test diet as the parents and used for the study. One
hundred weanling rats (equally divided by sex) were used for the 6%
and 12% groups, and 120 weanling rats (equally divided by sex) were
used for the 30% O.S. group and 30% cornstarch group. Twenty animals
from the 30% O.S. and control groups were killed at 30 days post-
weaning, and the remainder of the animals killed 90 days post-weaning.
Body weights and food intake were measured during the course of the
study. Clinical chemistry (sodium, potassium, chloride, glucose, BUN,
magnesium, alkaline phosphate, SGOT, SGPT, calcium, phosphates, total
protein and albumin), haematology (RBC, WBC, haematocrit, haemoglobin,
total protein and differential blood count) and urinalysis (pH, total
protein, glucose, ketone, occult blood, sodium, potassium, creatinine,
calcium and magnesium) was carried out on select animals at the
termination of the study. All animals that were killed at interval or
at the termination of the study were subjected to complete necropsy.
Relative and absolute weights of organs (kidneys, liver, spleen,
brain, thymus, testes or uterus) were determined, and a complete
histological evaluation was made of the principal organs and tissues.
There was no significant effect on growth rate. Serum chemistry and
haematology were within normal levels and showed no compound-related
effects. Urine chemistry showed higher concentrations of urinary
calcium and magnesium in the females but not in the males. Relative
organ weight data showed a trend for increased liver and kidney weight
with increased concentration of the substituted starch. There was an
increased caecal weight after 30 days on the 30% O.S. starch in both
sexes, but this was only observed in the females after 90 days on the
test diet. The only significant histological finding was an incidence
of kidney pathology, consisting of corticomedullary mineralization.
The effect was more severe in the female than in the male, and
occurred in animals fed either the modified or unmodified starch. The
occurrence of corticomedullary mineralization was considered to result
from a marginal deficiency of dietary magnesium when carbohydrate
comprises a major proportion of the diet (Newberne & Buttolph, 1979).
Comments
The available data from short-term feeding studies in the
rat, indicate that the only significant lesion observed was
corticomedullary mineralization of the kidney. This contrasts with
reports of calcification of the kidney in other studies with phosphate
modified starches where the lesion was located in the pelvic region of
the kidney. The effect was more severe in females than in the males,
and occurred in animals fed either modified or unmodified starch. The
occurrence of the lesion was associated with increased urinary
excretion of magnesium, and the effect may be related to a marginal
magnesium deficiency when carbohydrate comprises a major proportion of
the diet.
EVALUATION
Estimate of acceptable daily intake for man
Not specified.*
* The statement "ADI not specified" means that, on the basis of the
available data (toxicological, biochemical, and other), the total
daily intake of the substance, arising from its use or uses at
the levels necessary to achieve the desired effect and from its
acceptable background in food, does not, in the opinion of the
Committee, represent a hazard to health. For this reason, and for
the reasons stated in individual evaluations, the establishment
of an acceptable daily intake (ADI) in mg/kg bw is not deemed
necessary.
REFERENCES
Anon. (1950) Toxicological studies of certain starch products.
Unpublished report of Food Research Laboratories, Inc. (Report
No. 58380-1). Submitted to the World Health Organization by the
National Starch and Chemical Corporation, Bridgewater, New
Jersey, USA
Anon. (1960) Caloric evaluation of RX12XI and cornstarch.
Unpublished report of Food Research Laboratories, Inc. (Report
No. 80878b-e). Submitted to the World Health Organization by the
National Starch and Chemical Corporation, Bridgewater, New
Jersey, USA
Newberne, P. M. & Buttolph, M. L. (1979) 90-day in utero feeding
study on rats. Unpublished report prepared for National Starch
and Chemical Corporation. Submitted to the World Health
Organization by the National Starch and Chemical Corporation,
Bridgewater, New Jersey, USA
See Also:
Toxicological Abbreviations