Chronic toxicity and carcinogenicity of modified starch

No data were available for oxidised starch (E 1404), monostarch phosphate (E 1410), distarch phosphate (E 1412), hydroxypropyl starch (E 1440), acetylated oxidised starch (E 1451) and starch aluminium octenyl succinate (E 1452).

Phosphated distarch phosphate (E 1413)


In an experiment, groups of male and female rats were fed different levels of phosphated distarch phosphate, a modified starch, for 104 weeks. The rats did not show any negative effects on their appearance, behavior, or mortality. The treated rats had similar food intake, growth rate, and food efficiency compared to the control rats. Tests on the rats’ blood, urine, and organs did not show any significant differences. The study did not reveal any signs of cancer. However, the male rats fed the highest level of the modified starch showed a slightly increased occurrence of a specific kidney issue.

Acetylated distarch phosphate (E 1414)


In this study, 30 male and 30 female rats were fed acetylated distarch phosphate at different levels for 104 weeks. The results showed no significant differences in appearance, behavior, or mortality. The rats’ food intake, growth rate, and food efficiency were similar to the control group, but the final body weight was slightly lower. The rats also showed no consistent differences in blood, urine, or organ function, except for an increase in adrenal weight in females and caecal weight in both sexes at higher levels. The kidney lesion was the only treatment-related effect found, but it was not linked to cancer.

A study looked at kidney lesions caused by modified starch in rats. Female rats were fed diets with 30% acetylated distarch phosphate or unmodified starch for one year in weanling rats (Experiment I) and for nine months in 9-month-old rats (Experiment II). No differences were observed between the two groups in terms of body weight, food consumption, urine volume, urine pH, or crystal content. Caecal weight was significantly increased, but no other treatment-related effects on relative organ weights were observed. Histopathological examination showed treatment-related pelvic nephrocalcinosis, which was correlated with increased accumulation of calcium in the kidney and increased urinary excretion of calcium.

In 1977, an expert reviewed how minerals build up in the renal pelvis of rats. They found that certain mineral imbalances can cause kidney problems, like pelvic nephrocalcinosis and calculus formation. These issues are common in untreated laboratory rats, especially in older ones. The Panel agreed with this conclusion.

Acetylated starch (E 1420)


A study was conducted on groups of 30 male and 30 female rats. They were fed different levels of starch acetate for 104 weeks. The results showed that there were no significant effects on the rats’ general appearance, behavior, or mortality. The food intake, growth rate, and efficiency of treated animals were the same as the controls. There was an increase in caecal weight in both sexes at the highest level, but only in males at the medium level, which was attributed to an adaptive response. Other organ weights showed no changes. The only observed effect was a kidney lesion in high-dose males, which was identified as the NOAEL. No treatment-related effect was found on neoplasm development.

Acetylated distarch adipate (E 1422)


A study was done on rats, where groups of 30 male and female rats were fed either acetylated distarch adipate or unmodified starch (control) for 104 weeks. The acetylated distarch adipate group had a lower body weight, but no significant differences in skeletal growth or organ weights were observed. No significant differences were found in haematology, serum biochemical analyses, bacteriological examinations or organ weight determinations between the two groups. The histological examination showed no significant differences between the two groups, and the authors did not consider the observed effects to be treatment-related. However, independent reviewers concluded that the incidence of epithelial hyperplasia was greater in female rats fed modified starch. The Panel agreed with the independent reviewers’ conclusions.

In a study, 25 female rats were given either a diet with acetylated distarch adipate (equivalent to 15,000 mg/kg bw per day) or an unmodified starch diet for one year (Experiment I) and a separate nine-month study (Experiment II). The rats on the test diet showed an increase in urinary calcium concentration and total daily output, but there were no significant effects on body weight, food consumption, and other minerals in urine or feces. The only notable effect was pelvic nephrocalcinosis in the kidneys, which was correlated with increased calcium accumulation and excretion in urine. No other differences were observed in organ weights or histopathology.

Hydroxypropyl distarch phosphate (E 1442)


A group of 75 male and 75 female Swiss albino SPF mice were fed a diet with a chemical called hydroxypropyl distarch phosphate (equal to 27,500 mg/kg bw per day) or a control diet with pregelatinised potato starch for 89 weeks. They monitored the mice’s growth, appearance, blood, urine, organ weights, mortality, and health of the kidney and bladder. At week 80, 10 mice of each sex from each group were examined, and the rest were examined after 89 weeks.

In a study with mice, some were given a diet containing hydroxypropyl distarch phosphate while others were given a control diet with pregelatinised potato starch. The mice on the test diet experienced loose stools and slight diarrhea more frequently than the control group. Male control mice also lost more body weight before death than those on the test diet. The test group drank more water, and their caecum and colon were heavier than the control group. The kidneys of both male and female mice on the test diet showed an increase in intratubular mineralization, but no evidence of carcinogenicity was found.

Starch sodium octenyl succinate (E 1450)


Rats were fed different amounts of OSA-modified starch for 120 or 116 weeks, depending on their sex. The rats’ body weight gain was not affected, and no change in feed intake or efficiency was observed. The only notable change was the increase in pituitary gland size in male rats fed the highest dose, which is common in rats of this age and strain. The study concluded that OSA-modified starch is not carcinogenic or toxic when fed to rats at concentrations of up to 30% in the diet, equivalent to 17,000 mg/kg bw per day.


Two studies lasting 52 weeks looked at acetylated distarch phosphate (E 1414) and acetylated distarch adipate (E 1422). At the end, organs weights were similar except for caecal enlargement. Kidney examination showed pelvic nephrocalcinosis related to the treatments. More calcium was found in the kidney and urine of rats with increased incidence of pelvic nephrocalcinosis.

A study looked at whether hydroxypropyl distarch phosphate (E 1442) causes cancer in mice over 89 weeks. The study found no evidence of cancer. However, the mice did have some kidney changes that were not harmful to humans.

Studies on rats showed no evidence of carcinogenicity for several types of distarch phosphates and starch sodium octenyl succinate. Long-term studies also found no significant effects except for an enlarged caecum, which was not considered toxicologically significant for humans.

Rats fed high levels of certain food additives including phosphated distarch phosphate (E 1413), acetylated distarch phosphate (E 1414), acetylated starch (E 1420), acetylated distarch adipate (E 1422), and hydroxypropyl distarch phosphate (E 1442) showed kidney lesions (pelvic and corticomedullary mineralisation). This was believed to be due to an imbalance of certain nutrients in the diet. However, the effect was only observed in rats and not other animals. Therefore, it is not considered a risk to human health. No renal changes were observed in rats fed starch sodium octenyl succinate (E 1450).

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