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EC number: 290-476-8 | CAS number: 90170-43-7
[Extracted from test report]
Mild signs of local irritation / taste in top group. Food consumption during the pre-mating period was decreased in males and females (19% and 16% below control value, respectively) at 600 mg/kg/day. No other treatment-related effects on food consumption, body weight or body weight gain were observed during the post-mating, gestation and lactation periods. Locomotor activity was not affected by treatment. The reproduction parameters were unaffected by treatment.
Body weight gain was decreased at 160 and 600 mg/kg/day in males (23% and 51% below control value, respectively) and in females (37% and 56% below control value, respectively).
No treatment-related hematology parameters were observed.
In males at 600 mg/kg/day, urea and potassium concentrations were statistically significantly increased (24% and 15% above control value, respectively). The changes correlated with the histopathological findings in the kidney. No treatment-related effects on clinical chemistry parameters were observed in females.
Mean absolute liver weight was slightly increased (12% above control value) and mean relative liver and kidney weights were statistically significantly increased in males at 600 mg/kg/day (18% and 11% above control value, respectively). Mean absolute and relative liver weights were significantly increased in females at 600 mg/kg/day (19% and 24% above control value, respectively).
No treatment-related macroscopic findings in treated males were observed, except possibly enlarged liver in one male at 600 mg/kg/day. At 600 mg/kg/day, dark red foci in the stomach of a female were observed. Since changes in the stomach were noted on histopathological examination, this finding could be treatment-related. On microscopic examination, the incidence of the following findings was increased in the high-dose group: diffuse hypertrophy of the liver in males and females; tubular degeneration/regeneration and hyaline droplets/granulation of the kidneys in males; follicular hypertrophy of the thyroid in males and females; acanthosis of the non-glandular stomach in males and females; inflammation of the non-glandular stomach in males; and congestion, thrombosis and inflammation of the glandular stomach in females. The severity of hyaline droplets/granulation in males and thyroid follicular cell hypertrophy in males and females was also increased. The increased thyroid follicular cell hypertrophy may have been secondary to the enhanced liver cell metabolism. The incidence of splenic congestion was increased in males at 600 mg/kg/day. In females, hematopoiesis was reported in all animals, including the control; the severity was slightly increased in females at 600 mg/kg/day. In females, the incidence of thymus atrophy was slightly increased (3/5 vs. 2/5 in control group), but there was no effect in severity. At 160 mg/kg/day, the incidence of the following was increased: hypertrophy in the liver in males, tubular degeneration/ regeneration and hyaline droplets/granulation of the kidneys in males, and congestion and inflammation of the glandular plus non-glandular stomachs in females.
The changes in the liver of males and females at the mid and high doses are considered adaptive in nature and not toxicologically significant.
The test report concludes :
The parental systemic LOAEL for Sodium coco β-iminodipropionate in rats is 160 mg/kg bw/day, based on decreased body weight gain in males and females during the pre-mating period, and an increased incidence of microscopic lesions in the kidneys of males and glandular and acanthosis of the non-glandular stomach of females. The parental systemic NOAEL is 43 mg/kg bw/day.
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