Reproductive and developmental toxicity of modified starch

No data were available for oxidised starch (E 1404), monostarch phosphate (E 1410), distarch phosphate (E 1412), hydroxypropyl starch (E 1440), hydroxypropyl distarch phosphate (E 1442), acetylated oxidised starch (E 1451) and starch aluminium octenyl succinate (E 1452).

Phosphated distarch phosphate (E 1413)

Reproductive toxicity studies: A study was conducted on rats over three generations to investigate the effect of phosphated distarch phosphate (a type of modified starch) on reproduction. Rats were fed a diet containing 10% of the starch, which is equivalent to 5,000 mg/kg body weight per day. No harmful effects were observed in terms of the rats’ appearance, behavior, body weight, fertility, litter size, resorption quotient, weights of pups, or mortality. The only significant finding was an increased spleen weight in female rats of the third generation. The study concluded that the starch did not cause any histopathological changes.

Acetylated distarch phosphate (E 1414)

Reproductive toxicity studies: A study was done to see if a modified potato starch called acetylated distarch phosphate would affect rat reproduction. Three generations of rats were used in the study, and no negative effects were seen in the rats’ health, growth, or reproduction. There was a slight increase in caecum weight in female rats and a decrease in relative thyroid weight in male rats. However, these changes were not considered to be related to the modified starch.

Developmental toxicity: No studies available.

Acetylated starch (E 1420)

Reproductive toxicity studies: A study was conducted with rats to assess the effects of a modified potato starch called starch acetate. Three generations of rats were studied, with each generation producing two successive litters. The starch was given to the rats at a rate of 10% of their diet, and no adverse effects were observed in terms of their health, behavior, fertility, or growth. However, the relative caecum weight was increased in female rats of the P and F2 generations, and the male rats of the F3 generation had a slightly increased kidney and caecum weight. No treatment-related changes were observed during histopathological examination.

Developmental toxicity: No studies available.

Acetylated distarch adipate (E 1422)

Reproductive toxicity studies: In a study, 10 male and 10 female rats were randomly selected from a 2-year chronic toxicity study and were fed acetylated distarch adipate (modified maize starch) or unmodified starch at 62% in their diet. They were then bred to produce several generations of offspring. Offspring were sacrificed at different stages to evaluate their health, growth, and other characteristics. Although preweaning deaths were slightly elevated in the F2b generation, other parameters were similar in treated and control animals, and terminal studies did not reveal any anomalies. No further details from the histopathological exams were given.

Developmental toxicity: No studies available.

Starch sodium octenyl succinate (E 1450)

There are no studies that show whether starch sodium octenyl succinate (E 1450) causes reproductive or developmental harm. However, a study was conducted on Fischer 344 rats to test short-term toxicity. The rats were fed OSA-modified starch from weaning and throughout mating, gestation, and lactation, and their offspring were fed the same diet as their dams. The study didn’t report any effects on the offspring (Buttolph and Newberne, 1980).

Summary

In studies with rats, no negative effects were seen on reproduction or development after consuming E 1413, E 1414, E 1420, and E 1422. The studies used up to 62% of these substances in the rats’ diets, which is equivalent to 31,000 mg/kg body weight per day. However, there were no studies specifically examining the substances’ effects on prenatal development.

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