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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
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:
Short-term toxicity of Quillaja extracts in rats
Author:
I.F. Gaunt et al.
Year:
1974
Bibliographic source:
Food Cosmet.Toxicol. , 12, 641-650 (1974)

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
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 aqueous extract of quillaja bark

Test animals

Species:
rat
Strain:
other: CFE strain
Sex:
male/female
Details on test animals and environmental conditions:
Test animals:
Body weight: 130 - 170 g

Housing and feeding:
Temperature: 20°C
Humidity: 40 - 50%

Administration / exposure

Route of administration:
oral: feed
Vehicle:
water
Analytical verification of doses or concentrations:
no
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 0.6, 2, 4 %
Basis:
nominal in diet
No. of animals per sex per dose:
15 male and 15 female rats were fed diets containing 0, 0.6, 2 or 4% quillaja extract for 13 weeks. 5 male and 5 female rats received 0, 2, 4 quillaja extract for 2 or 6 weeks.
Control animals:
yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:
Body weight and food intake were measured at the beginning and weekly throughout the study.
Urine was analysed during the final week.
Sacrifice and pathology:
At sacrifice, the absolute and relative organ weights were determined. Tissues and organs of the group given 4% quillaja were examined by histopathology. Blood collected at autopsy was examined for haematological and serum chemical parameters.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
effects observed, treatment-related
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
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

Effect levels

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Dose descriptor:
NOAEL
Effect level:
400 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: see 'Remark'
Dose descriptor:
LOAEL
Effect level:
200 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
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.
Executive summary:

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.