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EC number: 943-520-1 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From June 25 1981 to August 6, 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- Source study has reliability 2. Details on the read across are available in section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" published for Food and Drug Officials of the United States, pag. 49-52, 1959.
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2- 3 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- Directly injected into the conjunctival sac
- Observation period (in vivo):
- 1, 2, 3, and 7 days
- Number of animals or in vitro replicates:
- 6 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: yes, after 24 hours with a sodium chloride solution
SCORING SYSTEM: Draize test
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope and fluorescein after 24 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1, 2, 3, 4, 6
- Time point:
- other: mean score after 24, 48 and 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- other: rinsed eye
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- other: mean score after 24, 48 and 72 hours
- Score:
- ca. 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: rinsed eye
- Irritation parameter:
- iris score
- Basis:
- animal: 1, 2, 4, 6
- Time point:
- other: mean score after 24, 48 and 72 hours
- Score:
- ca. 0
- Max. score:
- 2
- Remarks on result:
- other: rinsed eye
- Irritation parameter:
- iris score
- Basis:
- animal: 3, 5
- Time point:
- other: mean score after 24, 48 and 72 hours
- Score:
- ca. 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: rinsed eye
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 1, 4, 5
- Time point:
- other: mean score after 24, 48 and 72 hours
- Score:
- ca. 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: rinsed eye
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: mean score after 24, 48 and 72 hours
- Score:
- ca. 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: rinsed eye
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- other: mean score after 24, 48 and 72 hours
- Score:
- ca. 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: rinsed eye
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1, 2, 4, 6
- Time point:
- other: mean score after 24, 48 and 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- other: rinsed eye
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean score after 24, 48 and 72 hours
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: rinsed eye
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- other: mean score after 24, 48 and 72 hours
- Score:
- ca. 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: rinsed eye
- Irritant / corrosive response data:
- All signs were reversible within 7 days after the application
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not irritant to the rabbit eye.
- Executive summary:
Method
The substance was tested for eye irritation according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" published for Food and Drug Officials of the United States, pag. 49-52, 1959.
Results
All signs are reversible within 7 days of observation period.
Under the test conditions the substance is considered to be not irritant.
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