Registration Dossier

Administrative data

Description of key information

In vivo skin irritation:
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.
In vivo eye irritation:
The acutc eye irritation/corrosion of a liquid Quillaja saponaria extract was tested in three albino rabbits according to US EPA Guideline EPA OPPTS 870.2400 . The test item was instilled as the original substance at a single dose of 0.1 ml to one of the eyes in each animal. The untreated eye was used as control.
The animals were examined for clinical signs and the eyes were examined for lesions of the conjunctivae, cornea and iris 60 minutes, 24, 48, 72 hours, 7 days and 14 days after instillation of the test item. The grades for ocular lesions were recorded in accordance with the Guideline.
Well defined signs of irritation were observed on the treated eyes. All effects were fully reversible within 14 days.
None of the animals died or showed clinical signs during the course of testing.
Based on the respective mean scores classification of the test item as causing serious eye irritation (Cat. 2) is required according to CLP; EU GHS (Regulation (EC) No 1272/2008).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
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.
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.
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007-06-27 - 2007-07-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Data obtained from a guideline study according to US EPA Guideline 870.2400 and therefore considered reliable without restrictions.
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Test system: New Zealand rabbits, white rabbits
Source: DIPAGA Rabbit House - Ruta 8, Km 94 - 2764 Solis - San Andres de Giles - Buenos Aires - Argentina
Number of animals for the study: 3 male were used. Additional animals were required to clarify uncertain results.
Body weight and age at the start of the test: Young-adults 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: 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 was 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 darkness 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
Animals were watered ad libitum with tap water dechlorinated by flow through an activated carbon cartridge.
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
14 days
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3
Details on study design:
0.1 ml of the test substance was placed in the conjunctival sac of one eye of each animal, under the lower lid.
The lids were held together for one second in order to prevent loss of material. The other eye, which remained untreated, served as the control.
The eyes were examined at 1, 24, 48, 72 hs., 7 and 14 days. Since no eye irritation was manifested after 14 days, the test was concluded.
Observations of the cornea, iris and conjunctivae, and any other lesions which were noted, were recorded. Suitable devices such as binocular loupe and slit- lamp were used to examine the irritation and/or corrosion of the eyes. After recording the observations at 24 hours, the eyes of all the rabbits were examined with the aid of fluorescein. The eyes of the test animals were examined with a UV lamp, and no superficial or deep ulceration was observed.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 60 min
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 60 min
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 60 min
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 60 min
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 hours
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 hours
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 7 days
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 7 days
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 7 days
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 14 days
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 14 days
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 14 days
Score:
0
Max. score:
3
Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acutc eye irritation/corrosion of a liquid Quillaja saponaria extract was tested in three albino rabbits according to US EPA Guideline EPA OPPTS 870.2400 . The test item was instilled as the original substance at a single dose of 0.1 ml to one of the eyes in each animal. The untreated eye was used as control.
The animals were examined for clinical signs and the eyes were examined for lesions of the conjunctivae, cornea and iris 60 minutes, 24, 48, 72 hours, 7 days and 14 days after instillation of the test item. The grades for ocular lesions were recorded in accordance with the Guideline.

Well defined signs of irritation were observed on the treated eyes. All effects were fully reversible within 14 days.
None of the animals died or showed clinical signs during the course of testing.

Based on the respective mean scores classification of the test item as causing serious eye irritation (Cat. 2) is required according to CLP; EU GHS (Regulation (EC) No 1272/2008).
Executive summary:

The acutc eye irritation/corrosion of a liquid Quillaja saponaria extract was tested in three albino rabbits according to US EPA Guideline EPA OPPTS 870.2400 . The test item was instilled as the original substance at a single dose of 0.1 ml to one of the eyes in each animal. The untreated eye was used as control.

The animals were examined for clinical signs and the eyes were examined for lesions of the conjunctivae, cornea and iris 60 minutes, 24, 48, 72 hours, 7 days and 14 days after instillation of the test item. The grades for ocular lesions were recorded in accordance with the Guideline.

Well defined signs of irritation were observed on the treated eyes. All effects were fully reversible within 14 days.

None of the animals died or showed clinical signs during the course of testing.

Based on the respective mean scores classification of the test item as causing serious eye irritation (Cat. 2) is required according to CLP; EU GHS (Regulation (EC) No 1272/2008).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No data gaps were identified. The available data are adequate for risk assessment and classification and labelling purposes.


Justification for selection of skin irritation / corrosion endpoint:
The key study is GLP compliant and reliable without restrictions.

Justification for selection of eye irritation endpoint:
The key study is GLP compliant and reliable without restrictions.

Effects on eye irritation: irritating

Justification for classification or non-classification

Skin 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.

According to CLP; EU GHS (Regulation (EC) No 1272/2008) no classification is required for skin irritation.

 

Eye irritation:

The acutc eye irritation/corrosion of a liquid Quillaja saponaria extract was tested in three albino rabbits according to US EPA Guideline EPA OPPTS 870.2400 . Well defined signs of irritation were observed on the treated eyes. All effects were fully reversible within 14 days.

None of the animals died or showed clinical signs during the course of testing.

Based on the respective mean scores classification of the test item as causing serious eye irritation (Cat. 2) is required according to CLP; EU GHS (Regulation (EC) No 1272/2008).