Registration Dossier
Registration Dossier
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EC number: 258-380-0 | CAS number: 53126-67-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1978
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Phosphoric acid, butyl ester, sodium salt
- EC Number:
- 258-380-0
- EC Name:
- Phosphoric acid, butyl ester, sodium salt
- Cas Number:
- 53126-67-3
- Molecular formula:
- C4H11O4P.Na
- IUPAC Name:
- Phosphoric acid, butyl ester, sodium salt
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- not specified
- Controls:
- not required
- Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- the eyes were examined after 1, 2 and 3 days
- Number of animals or in vitro replicates:
- 6 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- mean
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 10
- Max. score:
- 56
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- mean
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 6.7
- Max. score:
- 56
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- mean
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 12
- Max. score:
- 56
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- mean
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 8.7
- Max. score:
- 56
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- mean
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 6
- Max. score:
- 56
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- mean
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 13.3
- Max. score:
- 56
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 20
- Max. score:
- 56
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 56
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 20
- Max. score:
- 56
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 6.7
- Max. score:
- 56
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 20
- Max. score:
- 56
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- iris score
- Remarks:
- mean
- Basis:
- animal: #1 - #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 56
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 - #6
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- Conjunctiva and cornea findings were not reversible within 72 hours.
Applicant's summary and conclusion
- Interpretation of results:
- other: The study cannot be used for assessment due to its insufficient documentation.
- Conclusions:
- The tested substance caused weak signs of irritation to the eyes, but based on the available data no conclusion on classification can be made.
- Executive summary:
A study was performed to assess the irritation of the test material to the eyes. Six rabbits were used. As a result, conjunctiva and cornea findings were made which were not reversible within 72 hours. Based on the applied scoring system, the substance was found to cause weak signs of irritation to the eyes. Due to the limited documentation no conclusion can be made on classification.
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