Registration Dossier
Registration Dossier
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EC number: 201-116-6 | CAS number: 78-42-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tris(2-ethylhexyl) phosphate
- EC Number:
- 201-116-6
- EC Name:
- Tris(2-ethylhexyl) phosphate
- Cas Number:
- 78-42-2
- Molecular formula:
- C24H51O4P
- IUPAC Name:
- tris(2-ethylhexyl) phosphate
- Details on test material:
- Chemical name: Trioctyl phosphate, colourless liquid.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eyes served as control
- Duration of treatment / exposure:
- up to 72 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Residual test material was noted around the treated eye of all animals one hour after treatment.
No corneal or irridial effects were noted during the study.
Minimal conjunctival redness was noted in two treated eyes one hour after treatment.
All treated eyes appeared normal after treatment.
The test substance was non-irritating when tested in the eyes of three albino rabbits according to OECD 405 Test Guideline.
Applicant's summary and conclusion
- Executive summary:
A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit according to OECD TG 405.
A single instillation of the test material to the non-irrigated eye of three rabbits produced incidents of minimal conjunctival redness. All treated eyes appeared normal 24 hours after treatment.
The test material was classified as non-irritant according to CLP classification criteria. No classification is required.
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