Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-04-08 - 2002-05-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Data obtained from a guideline study according to OECD guideline 403 and therefore considered reliable without restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed concentration procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Name of the product: Avda. Industrrial 1980 – Quilpué Chile, Quillaja Powder QP, Lot. 051000
Description of the product: Brown fine powder
Vehicle used: Tween 80 at 2% w/v

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Test system: Rat Sprague Dawley, strain Crl: CD®(SD) IGS-BR
Origin: Charles River Laboratories
Source: FUCAL (breeders' of laboratory animals merger). Access North km. 42,5. Del Viso
Number of test animals: 10, 5 males and 5 females. The females were nulliparous and non-pregnant.
Weight and age at the star of the test: young adult rats, weighting 200-300 gr. The weight range within the test animal population did not exceed ± 20 per cent of the mean weight.
Acclimatization: The animals were acclimatized to the laboratory conditions for at least 9 days prior to the test. After the acclimatization, the healthy animals were randomized and assigned to groups of 5 per cage. (the same dosage and the same sex per cage).
HOUSING AND FEEDING CONDITIONS: The animals were housed under standard laboratory conditions.
The experimental animal room was provided with air conditioning, filtered by HEPA filters, with 10 to 15 air changes per hour. The temperature of the animal room was 22  3°C and the relative humidity 30-70 per cent, though the higher relative humidity range can be exceeded during the cleansing 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 disposable diaper of daily replacement. The following diet were provided ad libitum: Ratas y Ratones, supported by Horacio Omar Gilardoni. Av. 25 de Mayo 167. San
Vicente, Buenos Aires, Argentina.
Drinking water dechlorinated by passage though cartridge of activated charcoal was used ad libitum.

Administration / exposure

Route of administration:
other: suspension in Tween 80 at 2% w/v
Type of inhalation exposure:
nose only
Details on inhalation exposure:
The exposure was performed in a 50L nasal chamber built for that Objective. The mixture of air and test substance was generated by a Dysem professional ultrasonic nebulizer (Argentine industry) joined to the inhalation chamber by a plastic tubing, to get 12 air changes per hour.
The extracted air of the chamber, was underwent to a treatment system that consisted on making it bubble in an solution of Sodium Hydroxide at 40%.
Slight negative pressure was maintained inside the inhalation chamber throughout the exposure period, by a compressor of air to diaphragm ENE free of oil (Equipos Neumáticos Especializados). The temperature, and the relative humidity were controled during the exposure.
Volumen of chamber: 50 L
Air changes per hour: 12
Stabilization time (min): 31
Nominal concentration (mg/L): 0.45
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
4 h
Concentrations:
The size of the particles was determined by a laser counter (Hand-Held Airborne particle counter- ABACUS 301).
The total amount of test substance (in mg) was divided by the total volume of air that flowed through the chamber to calculate the
nominal concentration of the test substance. 0.45 mg/l was the highest technical achievable concentration.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
A group of 5 males and 5 females received nasal only exposure to aerosol concentrations of the test substance during 4 hours. After exposure, the residual test substance was removed from the face of each animal. Then they were returned to their corresponding cages, and food and water were not withheld.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.45 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
no
Clinical signs:
none
Body weight:
The body weight was within the range of physiological variability of the test system.
Gross pathology:
No abnormalities were observed during necropsy.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute toxicity by the the inhalation route of Quillaja saponaria powder was examined according to OECD Guideline 403. A limit test with an exposition of 0.45 mg/L as a nominal concentration was performed due to the physical-chemical properties of the test substance. This was the highest technical achievable concentration.
A group of 5 males and 5 females received nasal only exposure to aerosol concentrations of the test substance during 4 hours. No mortality and clinical sign of toxicity were observed. No abnormalities were recorded during necropsy.
Therefore the acute LC50 value of Quillaja saponaria powder can be stated as > 0.45 mg/l.
Executive summary:

The acute toxicity by the the inhalation route of Quillaja saponaria powder was examined according to OECD Guideline 403. A limit test with an exposition of 0.45 mg/L as a nominal concentration was performed due to the physical-chemical properties of the test substance. This was the highest technical achievable concentration. A group of 5 males and 5 females received nasal only exposure to aerosol concentrations of the test substance during 4 hours. No mortality and clinical sign of toxicity were observed. No abnormalities were recorded during necropsy. Therefore the acute LC50 value of Quillaja saponaria powder can be stated as > 0.45 mg/l.