Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-05-09 - 2008-07-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Data obtained from a guideline study according to EPA OPPTS 870.1100 (Acute Oral Toxicity) and therefore considered reliable without restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
up-and-down procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
gas under pressure: refrigerated liquefied gas
Details on test material:
• QUILLAJA EXTRACT (QL AGRI) LOTE: 260208-0700, BATCH No: 260208-0700
• Product description: brown liquid
• Storage conditions: Room Temperature
• Container: plastic flask with white screw cap

TEST ITEM PREPARATION:
• Physical state of the test substance: Liquid
• Solvent used: Water
• Test substance concentration in the solvent: 50% w/v

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
Test system: Sprague Dawley rats
Origin: Charles River Laboratories
Source: Facultad de Ciencias Vetcrinarias, Universidad de Buenos Aires, Av. Chorroarin 280, C1427CWO - Buenos Aires, Argentina.
Number of the test animals: 3 Animals. The test was conducted using a single sex (females). Females used were nulliparous and non-pregnant.

Age and weight at the start of the test: Young-adult animals of age 8-12 weeks old, 200-300 g
Body weight: The weight variation in animals used in the test didn t exceed 20% per cent of the mean weight.
Identification: Marks on the tail with inerasable ink
Acclimatization: Animals were acclimatized to laboratory conditions for 10 days before to the start of the test. After acclimatization healthy animals were randomized and assigned to treatment group.

Housing and feeding
Animals were housed under standard laboratory conditions. The experimental animals' room was provided with conditioned air filtered by HEPA filters with 10-15 air changes per hour. The temperature of the animals room was between 22 ± 3°C and the relative humidity between 30-70 per cent, although the upper range for humidity may have exceeded during the cleaning of the room.
Animals were provided with photoperiods of 12 hours light- 12 hours dark and placed into individual cages made of steel with litter of wood shavings.
The following diet was provided ad libitum: Balanced food Rat-Mouse Ganave supplied by Distribuidora Horacio Izaguirre.
Tap water dechlorinated by passage through cartridge of activated charcoal was used ad libitum.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Food was withheld the night prior to the administration of the test compound. For the administration of the dose, rigid probes with rounded end were used. The administration volume was 1 ml/100 gr.
After the administration of the test substance, animals were kept unfed for a 3 hour period. Once the substance was administered, observations were made and recorded systematically and individually for each animal.
Doses:
Limit Test 5000 mg/kg bw.
No. of animals per sex per dose:
3
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
none
Body weight:
The body weight was within the range of physiological variability of the test animals.
Gross pathology:
No abnormalities
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral toxicity of the liquid QUILLAJA EXTRACT QL AGRI, LOTE: 260208-0700 was investigated according to US EPA Guideline EPA OPPTS 870.1100. A group of 3 female Sprague Dawley rats were administered a liquid extract of Quillaja saponaria at a single dose of 5000 mg/kg bw by gavage.
No mortality and no clinical signs of toxicity were obeserved. No abnormalities were recorded durcing necropsies. Therefore the acute oral LD50 value was estimated as > 5000 mg/kg bw.
Executive summary:

The acute oral toxicity of the liquid QUILLAJA EXTRACT QL AGRI, LOTE: 260208-0700 was investigated according to US EPA Guideline EPA OPPTS 870.1100. A group of 3 female Sprague Dawley rats were administered a liquid extract of Quillaja saponaria at a single dose of 5000 mg/kg bw by gavage. No mortality and no clinical signs of toxicity were obeserved. No abnormalities were recorded durcing necropsies. Therefore the acute oral LD50 value was estimated as > 5000 mg/kg bw.