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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Quillaja saponaria, ext.
EC Number:
273-620-4
EC Name:
Quillaja saponaria, ext.
Cas Number:
68990-67-0
Molecular formula:
Monomeric saponins range from ca. 1800 to ca. 2300, consistent with a triterpene with 8-10 monosaccharide residues
IUPAC Name:
Quillaja saponaria, ext.
Test material form:
gas under pressure: refrigerated liquefied gas
Details on test material:
Quillaja Extract (QL AGRI 35 LOT 170507-1630)
Product description: Ambar liquid
Physical state of the test substance: Liquid
pH of the test substance: 4,1 (Method: CIPAC MT 75 to 1% in aqueous solution)

Test animals / tissue source

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.

Test system

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.

Results and discussion

In vivo

Resultsopen allclose all
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

Applicant's summary and conclusion

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).