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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The published data are considered as reliable with restrictions.

Data source

Reference
Reference Type:
publication
Title:
Long-term toxicity of Quillaja extract in rats
Author:
J.J.P. Drake et al.
Year:
1982
Bibliographic source:
Food Cosmet. Toxicol., 20, 15-23 (1982)

Materials and methods

Test guideline
Qualifier:
no guideline followed
Guideline:
other: no data
Deviations:
not specified
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
gas under pressure: refrigerated liquefied gas
Details on test material:
spray-dried liquid extract of Quillaja bark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Housing and feeding:
Temperature: 20°C

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
2 years
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 0.3, 1.0 or 3.0% in the diet
Basis:
nominal in diet
No. of animals per sex per dose:
48 male and 48 female animals
Control animals:
yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:
Body weight: 2-monthly intervals
Food and water consumption: 24-hour period prior to body weight determination
Blood (tail veins): week 15, 25 and 52
Blood (aorta): week 108
Urin: week 13, 24, 78
Sacrifice and pathology:
complete autopsy including histological examinations of tissues and organs

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Water consumption and compound intake (if drinking water study):
no effects observed
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Details on results:
Body weight: High-dose male female rats weighed 7-8% lower than controls after 106 weeks.
Food consumption: 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.

Effect levels

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Dose descriptor:
NOAEL
Effect level:
1 175 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male
Dose descriptor:
NOAEL
Effect level:
1 500 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
female

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
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 for females.
Executive summary:

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 for females.