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EC number: 941-809-7
CAS number: -
Tissues which were prepared for microscopic examination and weighed:
Organs / tissues
Fixation / Preservation
Bone marrow (from sternum), only satellite groups
Brain (cerebrum, cerebellum,
Mammary gland - Females
Mammary gland - males
Ovaries with oviducts
Parathyroid glands, weighed and preserved with thyroid gland
Prostate gland (dorsolateral and ventral)
Seminal vesicles with coagulating glands
Spleen, only satellite groups
Thymus, where present, only in satellite groups
Uterus – cervix
In this study according to OECD guideline 421, GLP, the toxicity as well
as any possible effects of “Sophorolipids: fermentation products of
glucose and fatty acids, C18-unsatd., esters with glycerol with yeast Candida
bombicola, partially hydrolysed” on male and female reproductive
performance such as gonadal function, mating behaviour, conception,
development of conceptus and parturition, were investigated (main
groups). Two satellite groups (control and high dose) sacrificed after 4
weeks of treatment were included for specific histopathology
investigations of spleen, thymus and bone marrow.
The dosages used were 100, 300 and 500 mg/kg/day. For parental main
groups animals, no adverse effects were found on oestrous cycle,
copulation, fertility, delivery or lactation gestation length, number of
corpora lutea or implantation sites.
No adverse effects were found in anogenital distance, pup sex ratios,
pup weight, pup viability and no treatment related findings were noted
at necropsy. Thyroid weights of the parental animals and of pups on Day
14 post partum were comparable to the control group.
Macroscopic observation and organ weight were unaffected by treatment.
No treatment related changes were described following histopathology
evaluation in main and satellite groups, including spermatogenic cycle.
Slight changes noted in thyroid hormone levels were considered not
related to treatment.
The histopathological examination performed in satellite group animals
did not show any changes related to treatment.
The No Observed Adverse Effects Level (NOAEL) for reproductive and
developmental toxicity including satellite group animals was considered
to be 500 mg/kg/day for both parental animals and offspring, this
being the highest dose investigated.
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