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EC number: 273-620-4
CAS number: 68990-67-0
Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Quillaja saponaria, Rosaceae.
Groups of 48 male and 48 female rats were fed a diet containing 0, 0.3,
1.0 or 3.0% Quillaja extract for 108 weeks. Haematological examinations
were made at week 15, 25, 52 and 108. Urinanalysis were carried out at
week 13, 24 and 78. At sacrifice a complete autopsy including
histological examination was performed. High-dose male female rats
weighed 7-8% lower than controls after 106 weeks and food consumption
was 1-10% lower in all treated groups. No other treatment related
effects were observed. The incidence of benign tumors and carcinomas of
the thyroid, pituitary and peritoneal cavity were not statistically
different from controls or fell within the spontaneous incidence rate of
the Wistar rat. The NOAEL was 1175 mg/kg bw for males and 1500 mg/kg bw
In a repeated dose study 15 male and 15 female CFE rats were fed diets
containing 0, 0.6, 2 and 4% quillaja extract for 13 weeks. No
abnormalities of behaviour or condition were seen. Bodyweight gain was
reduced in the group receiving 4%. Food and water consumption were
reduced in animals of each sex at all dietary levels but at the end of
the study the weights of treated rats did not differ significantly from
those of the controls.The relative liver weights of male rats given 2 or
4% quillaja was reduced and the stomach weight was increased in both sex
at the same dose levels.
No effects on haematological parameters and clinical were noted.
Histopathology revealed no abnormal changes. Therefore the No Observed
Effect Level was estimated as 400 mg/kg in male and female rats.
15 male and 15 female CFE rats were fed diets containing 0, 360, 1180 or
2470 mg/kg bw quillaja extract for males and 0,440, 1370 or 3030 mg/kg
bw for females for 13 weeks.
No treatment-related effects on mortality, clinical signd, haematology,
clinical chemistry, uirinanalysis gross pathology or histologic
pathology were seen.
High-dose males and mid- and high-doese females had statistically
significant lower body weight than those of controls. Food and water
consumption was decreased in high- and mid-dose rats of both sexes.
Liver weights were decreased in males at the 2.0 and 4.0& level, but
since this was not correlated with changes in clinical chemistry the
effects are considered as not resulting from toxicity of the test
material. In addition, no related histopathological abnormalities were
Therefore the No Observed Effect Level was estimated as 2470 mg/kg bw in
male and 3030 mg/kg bw female rats.
Groups of 48 male and 48 female mice were fed a diet containing 0, 0.1,
0.5 or 1.5% Quillaja extract for 84 weeks. Abnormal behaviour and
condition were observed regularly and the body weight was determined at
intervals. After 24, 56 and 84 weeks haematological parameters were
No effects on mortality or clinical signs were observed. The body
weights of the high-dose male animals were reduced. No changes in
haematology were detected. The detailed autopsy and histopathology
revealed no treatment-related abnormalities.
The No Observed Adverse Effect Levels was 700 mg/kg bw.
conclusion, the results of the available data on repeated dose toxicity
indicate that Quillaja saponaria ext. does not need to be classified for
repeated dose toxicity according to the CLP-Regulation (Regulation
1272/2008/EC) and therefore labelling is not necessary.
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