Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-05-14 - 2008-07-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Data obtained from a guideline study according to US EPA Guideline - OPPTS 870.2500 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 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
gas under pressure: refrigerated liquefied gas
Details on test material:
QUiLLAJA EXTRACT (QL AGR1) LOTE: 260208-0700
BATCH No: 260208-0700
Product description: brown liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Test system: New Zealand rabbits white rabbits.
Source: DI PAGA Rabbit House - Ruta 8. Km 94 - 2764 Soli's - San Andrés de Giles - Buenos Aires - Argentina
Number of animals for the study: 3 male were used. Additional animals were required to clarify doubtful responses.
Body weight and age at the start of the test: Young adult animals of body weight between 1800 and 2800 g.
Identification. By cage number, by gender and picric acid colour body marking. Acclimatization: The animals were acclimatized to the laboratory conditions 5 days prior to the start of the test. After acclimatization healthy animals were randomized in individual cages.
Housing and feeding: The animals were housed under standard laboratory conditions.
The experimental animals' room was provided with conditioned air, filtered by HEPA filters, with 10 to 15 air changes per hour. The temperature of the animals room were 22 + 3°C and the relative humidity 30-70 per cent, though a higher relative humidity range can be 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.
Food for rabbits from: Ganave, Balanced food for rabbits supplied by Distribuidora Horacio Izaguirre.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Physical state of the test substance: liquid
pH of the test substance: 4.3 (Method : CIPAC MT 75 at 1% in aqueous solution)
Solvent used: None
Application area: Approximately 6 cm^2 of skin.
Application method: On the gauze patch
Contact treatment: By means of a suitable semi-occlusive dressing with gauze patch, which was held in place with non-irritant tape.
Exposure period: 4 hours, at the end of the period the residual substances were removed with water.
Dose: 0.5 ml/animal
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 males
Details on study design:
Around 24 hrs. before the test the dorsal region of the trunk of the animals was shaved in a surface of approximately 10 cm x 10 cm avoiding damage of the skin. Only animals with healthy and intact skin were used. Skin reaction was observed, and the responses were recorded at 60 minutes, and then at 24, 48,and 72 hours after patch removal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 60 min
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 60 min.
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the US EPA Guideline - OPPTS 870.2500 "Acute Dermal Irritation". A single 4-hour, semi-occluded application of the test material to the shaved intact skin of three rabbits produced very slight erythema and very slight oedema (score 1) after 24 hours. The effects were fully reversible within 48 hours. Therefore the test item is considered as non irritant to the skin.
Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the US EPA Guideline - OPPTS 870.2500 "Acute Dermal Irritation". A single 4-hour, semi-occluded application of the test material to the shaved intact skin of three rabbits produced very slight erythema and very slight oedema (score 1) after 24 hours. The effects were fully reversible within 48 hours. Therefore the test item is considered as non irritant to the skin.