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EC number: 941-809-7
CAS number: -
In a repeated dose study according to OECD guideline 407, GLP, the test
item “Sophorolipids: fermentation products of glucose and fatty acids,
C18-unsatd., esters with glycerol with yeast Candida bombicola,
partially hydrolysed” was administered to male and female Sprague Dawley
rats via gavage for 4 weeks. The following recovery period was 4 weeks.
Initially, the aim of this study was to obtain information on the
possible toxic effects on Sprague Dawley rats of both sexes after
repeated dosing with the test item, as well as any effects of the test
item on male and female reproductive performance, such as gonadal
function, conception,arturition and early lactation of the offspring.
The animals, 10 per sex, were assigned to four groups and administered
orally, via gavage, at dose levels of 100, 300 and 1000 mg/kg/day.
Control animals received the vehicle (softened water by reverse osmosis)
at the same dose volume of 10 mL/kg.
Due to unexpected mortality and overall adverse effects during the first
and the second week of treatment, it seemed evident that pairing and
subsequent gestation and parturition of animals could be affected by the
Therefore, it was decided to reduce the high dose level from 1000
mg/kg/day to 500 mg/kg/day, starting from Day 15 of treatment and to
investigate repeated dose toxicity and recovery from any
treatment-related effects, changing the current study design to a 4 week
oral toxicity study followed by 4 weeks of recovery.
A total of five treated animals were found dead during the study: one
mid-dose female (300 mg/kg/day), one high dose male and three high dose
females (1000 mg/kg/day). Atrophy of spleen, thymus and decreased
cellularity of bone marrow were considered the factor contributory to
the death of the high dose animals. These findings were considered the
response to stress and related to the very high dose, or being
associated with agony of these animals. In the female of the mid-dose
group, the cause of death was due to a mis-dosing.
Dosing Phase: Decreased activity, cyphosis, emaciated and piloerection
were seen in one control male during the last week of treatment. At 100
mg/kg/day, salivation and staining on the neck were seen in single
females. At 300 mg/kg/day salivation, piloerection on occasions in Weeks
1 and 2, hairloss/head in single males and females were seen during the
treatment. At 1000/500 mg/kg/day, salivation, dyspnoea, rales and
swollen/hard abdomen were seen in single animals, with higher incidence
in females while receiving 1000 mg/kg/day. After reduction of dose level
to 500 mg/kg/day, recovery from all signs was seen during the fourth
week of treatment. No relevant signs were seen during the recovery
Neurotoxicity assessment (Functional Tests and Motor activity)
Dosing Phase: Increases in grip strength in all treated groups,
statistically significant in the first trial and in the mean value of
the mid-dose male and high dose female groups, were seen at the end of
treatment. Measurements of motor activity and sensory reaction to
stimuli were comparable between control and treated groups.
Recovery Phase: Similar trend was again seen in the grip strength at the
end of the recovery period (statistical significance limited to second
trial and mean value of low dose females). No relevant differences
between treated and control groups were seen in the motor activity and
sensory reaction to stimuli at the end of the recovery periods.
No relevant changes were seen in treated animals, compared to controls.
Dosing Phase: Slight reduction in food consumption was seen in high dose
females on Days 8 and 15 of the study, during treatment at 1000
mg/kg/day, compared to controls.
Recovery Phase: No relevant changes were seen in treated animals,
compared to controls.
Dosing Phase: Leucocytosis was recorded in a number of males from all
treated groups, in one female dosed at 100 mg/kg/day and one female
receiving 1000/500 mg/kg/day. Compared with mean control data, changes
were with no dose-relation and mainly due to lymphocytosis. No changes
were recorded in the coagulation parameter.
Recovery Phase: Leucocytosis was still present in a number of animals of
both sexes receiving 1000/500 mg/kg/day and in one male receiving 300
Dosing Phase: Compared with mean control data, fluctuations of some
biochemical parameters (glucose, cholesterol, creatinine, calcium)
recorded in a number of animals treated at 300 and 500/1000 mg/kg/day
were not considered to be suggestive of tissue/organ injury.
Recovery Phase: Changes observed were considered unrelated to treatment.
No relevant changes were observed.
Terminal body weight and organ weights
No relevant changes were observed on terminal body weight, absolute and
relative organ weight of treated animals, when compared to the controls.
No remarkable differences were noted at post mortem examination in
treated animals, when compared with controls, either in animals that
completed the treatment or recovery period.
No treatment related changes were observed in treated animals, when
compared to the
controls. Seminiferous tubules were evaluated with respect to their
stage in the spermatogenic cycle
and to the integrity of the various cell types within the different
stages; regular layering in
the germinal epithelium was noted.
Based on the results of the present study, the dose level of 500
mg/kg/day can be considered the NOAEL (No Observed Adverse Effect Level).
This dose level could be used as high dose level for a subsequent OECD
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