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Toxicological information

Eye irritation

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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:
1988
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

Constituent 1
Chemical structure
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

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