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    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