Registration Dossier
Registration Dossier
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EC number: 930-986-6 | CAS number: -
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:
- 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:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 191, April, 1972
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- - Name of test material (as cited in study report): Zeolite S-D
- 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
Constituent 1
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
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