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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:
Jul. 4 - Oct. 15, 1990; experimental phase: Jul. 10-20, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Zeolite, cuboidal, crystalline, synthetic, non-fibrous
EC Number:
930-915-9
Cas Number:
1318-02-1
Molecular formula:
M2/nO • Al2O3 • ySiO2 • wH2O (n is the valency of the cation M, predominantly Na, y can range from 0.64 to 8.8, and w is the number of water molecules (general formula) Na: 1.34 - 24.02%, Al: 2.20 - 39.51%, Si: 15.52 - 68.64% (general composition); additionally, depending on the water quality: Ca, Mg and K might be present below 6%
IUPAC Name:
Zeolite, cuboidal, crystalline, synthetic, non-fibrous
Test material form:
solid: particulate/powder
Remarks:
no surface treatment
Specific details on test material used for the study:
Test Substance/ Trade Name/Identity: Wessalith AP 400 (A Zeolite)
Chemical Name/Synonym: Sodium-aluminiumsilicate
CAS No.: 1344-00-9
Batch No.: 89/100
Physical Appearance: White powder
Content/Purity: No known impurities
Solubility: Insoluble in water
pH-Value: Approx. 10 (suspension)
Storage: The test substance was kept in an exsiccator in a refrigerator.
Stability: According to information from the sponsor, the test substance was stable throughout the experimental period.

Test animals / tissue source

Species:
rabbit
Strain:
other: White Russian (albino)
Details on test animals or tissues and environmental conditions:
Origin/Breeder: ASTA Pharma AG, 4800 Bielefeld; Germany
Age of the Animals at Treatment: 11 months
Body Weight of the Animals at Treatment : 2.77 - 3.00 kg
Caging: Stainless steel cages with grating floor, type ASTA, size: 48.5x40x36.5 cm (LxBxH)
Number of Animals per Cage: 1
Diet: Approx. 120 gram/day x animal; Standard Diet ssniff K, "Special diet for rabbits"
Water: Water was provided ad libitum in drinking water quality
Room Temperature: 18 - 22° C
Relative Humidity: 40 - 70 %
Room Lighting: 6 a.m. - 6 p.m. artificial lighting 6 p.m. - 6 a.m. natural light-dark-rhythm

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.09 g (c. 0.1 ml)
Duration of treatment / exposure:
once (unrinsed)
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
0.09 gram (representing a volume of about 0.1 ml) of the test substance were applied into the conjunctival sac of the right eye. Then both lids were briefly closed by gentle finger pressure. The other eye of each animal was not treated and acted as control. The treated eye was not rinsed.
The treated eye was examined using a Cliptrix pencil light. Signs of irritation on the cornea, iris, and conjunctiva were assessed quantitatively and qualitatively using the Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 h
Score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 h
Score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 h
Score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
The single application of 0.09 gram (representing a volume of about 0.1 ml) Wessalith AP 400 into one conjunctival sac each of three rabbits caused only slight changes. Because of the physical properties of the test substance the dose had to be limited to the a.m. level.
In the cornea and iris no alterations were detectable.
The conjunctiva of one animal reacted with hyperemia (grade 1). 24 hours after application the finding had completely disappeared.
Discharge occurred in all three animals only at the day of application. In two animals discharge moistened considerable areas around the eye (grade 3) and in one animal lids and hair just adjacent to lids (grade 2).
The irritation index was 2.

Other effects:
There were no systemic toxic effects after conjunctival application of the test substance. The general condition of the animals was undisturbed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The primary irritation index was 2.
Wessalith AP 400 was classified as non-irritant on the eye of the rabbit.
Executive summary:

The objective of the study was to indicate the possible existence of hazards likely to arise from exposure of the eyes and associated mucous membranes to Wessalith AP 400. Alterations of cornea, iris, and conjunctiva and any other changes as well as the progress of the lesions (and their reversibility or irreversibility) had to be observed and recorded. Attention was additionally paid to the occurrence of systemic toxic effects.