Registration Dossier
Registration Dossier
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EC number: 215-478-8 | CAS number: 1327-43-1
Eye irritation
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:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Principles of method if other than guideline:
- A single application of the test sample was made into the conjuctival sac of the right eye of six rabbits. The eyes were examined and the grade of ocular reaction recorded at 24, 48, and 72 hours following application.
- GLP compliance:
- no
Test material
- Reference substance name:
- Silicic acid, aluminum sodium salt
- EC Number:
- 215-684-8
- EC Name:
- Silicic acid, aluminum sodium salt
- Cas Number:
- 1344-00-9
- Details on test material:
- - Name of test material (as cited in study report): Zeolex 23A (sodium aluminosilicate)
- Physical state: fine white powder
- Analytical purity: 95-99 weight %
- Impurities (identity and concentrations): 1-5 weight % sodium sulfate
- Other: pH: 9.8-10.6 (5 % water suspension)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Diet (e.g. ad libitum): Purina Rabbit Chow; ad libitum
- Water (e.g. ad libitum): water; ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye of the tested animals served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- test material was not removed
- Observation period (in vivo):
- 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: The reactions were based on the "Illustrated Guide for Grading Eye Irritation by Hazardous Substances", Federal Hazardous Substances Act Regulations.
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effect
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
Any other information on results incl. tables
Based on the results of this study, Zeolex 23A would not be considered an ocular irritant.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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