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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
10 Jan 1989 - 03 Feb 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: basic data given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Federal Register 191, April, 1972
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Zeolite S-D
- Chemical name: Zeolite, silica rich, crystalline, synthetic, non-fibrous
- Framework: orthorhombic
- Related CAS number: 1318-02-1
- Analytical purity: 99.4wt%
- Impurities: 0.79wt% Al203, <0.01% Na2O, 11.6% L0I
- Substance type: white powder

Test animals / tissue source

Species:
rabbit
Strain:
other: white japanese
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.43 - 3.12 kg
- Diet (e.g. ad libitum): solid diet for rabbits (RM-3 feeding)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): equivalent volume of 0.1 mL
Duration of treatment / exposure:
5 min (group 1) or 24 h (group 2)
Observation period (in vivo):
1, 24, 48 and 72 h as well as 7 days after instillation
Number of animals or in vitro replicates:
5 animals in group 1; 3 animals in group 2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 300 mL of distilled water for injections
- Time after start of exposure: 5 min or 24 h


SCORING SYSTEM: comparable to Draize


TOOL USED TO ASSESS SCORE: hand-slit lamp; fluorescein (1, 24 and 72 h and 7 days after washing)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
5
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
5
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
5
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
5
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Two control eyes also had score 1.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information