Registration Dossier
Registration Dossier
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EC number: 402-370-2 | CAS number: 149057-70-5 AOC 1020X
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987 - 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Version of 1981
- GLP compliance:
- yes
Test material
- Reference substance name:
- (ethyl-3-oxobutanoato-O'1,O'3)(2-dimethylaminoethanolato)(1-methoxypropan-2-olato)aluminium(III), dimerised
- EC Number:
- 402-370-2
- EC Name:
- (ethyl-3-oxobutanoato-O'1,O'3)(2-dimethylaminoethanolato)(1-methoxypropan-2-olato)aluminium(III), dimerised
- Cas Number:
- 149057-70-5
- Molecular formula:
- C14H28AlNO6
- IUPAC Name:
- octaaluminium(3+) octakis((2Z)-4-ethoxy-4-oxobut-2-en-2-olate) octakis(1-methoxypropan-2-olate) octakis(2-(dimethylamino)ethan-1-olate)
- Details on test material:
- purity not specified
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0,1 mL
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- A volume of 0.1 ml of the test material was instilled into the right eye of each rabbit by gently pulling the lower lid away from the eyeball to form a cup into which the test material was dropped. The upper and lower eyelids were held together for about one second immediately after application, to prevent loss of the test material from the eye, and then released. The left eye remained untreated and was used for control purposes.
Assessment of damage/irritation was made 1, 24, 48 and 72 hours following treatment, according to the numerical evaluation given {i.e. Oraize J.H., 1959 Association of Food and Drug Officials of the United States, Austin)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1/24/48/72h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1/24/48/72h
- Score:
- ca. 0.1
- Max. score:
- 0.3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1/24/48/72h
- Score:
- ca. 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1/24/48/72h
- Score:
- ca. 0.23
- Max. score:
- 0.7
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- A dulling of the normal lustre of the corneal surface was noted in one treated eye one hour after instillation and at the 24-hour observation. No other corneal effects were noted.
Iridial inflammation was noted in two treated eyes one hour after treatment but was confined to one treated eye at the 24-hour observation. No other adverse iridial effects were noted. Minimal to moderate conjunctival irritation was noted in all treated eyes one hour after treatment. The conjunctival irritation regressed and minimal conjunctival irritation persisted in one treated eye at subsequent 24 and 48- hour observations. The other two treated eyes appeared normal during this period and all treated eyes appeared normal at the 72-hour observation.
The test material was found to be non-irritant to the rabbit eye
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was found to be non-irritant to the rabbit eye
- Executive summary:
In an OECD 405 assay in 3 New-Zealand rabbits, the test material was found to be non-irritant to the rabbit eye
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