Saponins

Repeated dose toxicity: oral

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

Guideline:

OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)

Deviations:

not specified

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Saponins

EC Number:

232-462-6

EC Name:

Saponins

Cas Number:

8047-15-2

Molecular formula:

not applicable UVCB

IUPAC Name:

Saponin

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 or test system 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

1

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'

2

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.