Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-05-09 - 2008-07-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Data obtained from a guideline study according to US EPA Guideline EPA OPPTS 870.1200 (Acute Dermal 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 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose 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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Test system: Sprague Dawley rats
Origin: Charles River Laboratories
Source: Facultad de Ciencias Veterinarias, Universidad de Buenos Aires. Av. Chorroarin 280, C1427CWO - Buenos Aires, Argentina
Number of the test animals: 10, 5 animals of each gender at each dose level. Females were nulliparous and non-pregnant.
Age and weight at the start of the test: Young-adult animals of age 8-12 weeks, with close body weight range. The weight variation in animals used in the test won't exceed ± 20% per cent of the mean weight.
Identification: Marks on the tail with inerasable ink
Acclimatization: Animals were acclimatized to the laboratory conditions during 11 days before to the start of the test. After acclimatization healthy animals were randomized and assigned to treatment I animal per cage.

Housing and feeding:
Animals were housed under standard laboratory conditions. The experimental animals' room was provided with conditioned air 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 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 darkness 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.
Drinking water dechlorinated by passage through cartridge of activated charcoal were used ad libitum.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Approximately 24 hours before treatment, the dorsal area of the trunk of the test animals was shaved, but taking care not to abrade the skin, since it could alter the test. Only healthy animals with intact skin were used.
The test substance was applied uniformly on the shaved area (approximately 10% of the total body surface area) using the graduated syringe.
The dressing was wrapped around the abdomen and was retained in place with non-irritant adhesive tape. The exposure period was 24 hours. Animals were not entirely immobilized. After the exposure period, the residues of the test substance were removed with water.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no
Clinical signs:
none
Body weight:
The body weight was within the range of physiological variability of the test animals.
Gross pathology:
No abnormalities were observed.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal toxicity of a liquid Quillaja saponaria extract was investigated according to US EPA Guideline EPA OPPTS 870.1200 (Acute Dermal Toxicity).
The test item was applied as a single dose of 2000 mg/kg bw to the shaved dorsal area of the trunk of 5 male and 5 female Sprague Dawley rats. The coverage of the exposed area was removed after 24 hours. No mortolatity or clinical signs of toxicity was observed. No abnormalites were recorded durcing necropsy. Therefore the acute dermal LD50 was estimated as > 2000 mg/kg bw.
Executive summary:

The acute dermal toxicity of a liquid Quillaja saponaria extract was investigated according to US EPA Guideline EPA OPPTS 870.1200 (Acute Dermal Toxicity).

The test item was applied as a single dose of 2000 mg/kg bw to the shaved dorsal area of the trunk of 5 male and 5 female Sprague Dawley rats. The coverage of the exposed area was removed after 24 hours. No mortolatity or clinical signs of toxicity was observed. No abnormalites were recorded durcing necropsy. Therefore the acute dermal LD50 was estimated as > 2000 mg/kg bw.