Registration Dossier

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:
no data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
The study was performed according to a valid guideline without any deviations and was conducted under GLP conditions. Furthermore, the data were submitted by another legal entity, under Directive 67/548/EEC, at least 12 years previously. The registrant has been granted permission to use the information, which has been extracted from the ECHA databases, for REACH registration purposes. No full information related to the experimental result are available but these deficiencies do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
no data
Specific details on test material used for the study:
no data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
91 mg
Duration of treatment / exposure:
no data
Observation period (in vivo):
no data
Duration of post- treatment incubation (in vitro):
no data
Number of animals or in vitro replicates:
3
Details on study design:
no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Remarks:
(means score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Irritation parameter:
conjunctivae score
Remarks:
redness
Max. score:
2
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to ali animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall 24, 48 and 72 h
Score:
0.3
Irritation parameter:
chemosis score
Max. score:
2
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: over all at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: over all 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: over all 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: (related to all animals))._
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: over all 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: over all 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: over all 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days
Other effects:
No corneal or iridial effects were noted during the study.
Minimal to moderate conjunctival irritation was noted in all treated eyes at the 1-hour observation.
All eyes appeared normal at the 72-hour observation.

Any other information on results incl. tables

91 mg is equivalent to a volume of 0,1 ml.              

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the detailed test conditions, the test material was judged to be non-irritating/non-corrosive to the eyes.
Executive summary:

The eye irritation potential of the test material was investigated in a study which was conducted under GLP conditions.

During the study 91 mg of test material was instilled in the eyes of 3 New Zealand White rabbits. Signs of ocular irritation were observed over a period of 72 hours.

No corneal or iridial effects were noted during the study. Minimal to moderate conjunctival irritation was noted in all treated eyes at the 1-hour observation. All eyes appeared normal at the 72-hour observation.

Under the detailed conditions of the study, the test material was judged to be non-irritating/non-corrosive to the eyes.