Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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: Study performed according to EG B.5 Teil B / OECD 405

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EG B.5 Teil B / OECD 405
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
Nature of substance:liquid

Test animals / tissue source

Species:
other: rabbit,Weiße Neuseeländer

Test system

Amount / concentration applied:
0.1mg
Number of animals or in vitro replicates:
3

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:
1.7
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.7
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Max. score:
2
Remarks on result:
other: Max. duration: 14 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.7
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 at 24, 48 and 72 h
Score:
1
Irritation parameter:
chemosis score
Max. score:
2
Remarks on result:
other: Max. duration: 7 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: overall at 24, 48 and 72 h
Score:
2.3
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.3
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.6
Irritation parameter:
cornea opacity score
Max. score:
3
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 2 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Max. score:
1
Remarks on result:
other: Max. duration: 7 h; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes not fully reversible within 21 days
Other effects:
The test was also conducted as follows:
4 seconds after instillation of the test article in the eyes of 3 rabbits the eyes were washed for 5 min with water. the results correspond to the results achieved with out washing:
Cornea: in all animals turbation of cornea. In 2 animals vascularization.
Iris: in 2 animals inflamation of iris.
conjunctiva: in 2 animals diffuse highly red discolouration
of the conj., also swelling.
The eyes were after 14 days free of symptoms.
Another test was conducted as follows:
30 seconds after instillation of the test article in the
eyes of 3 rabbits the eyes were washed for 5 min with water.
the results correspond to the results achieved with out
washing:
Cornea: in all animals turbation of cornea.
Iris: in 2 animals inflamation of iris.
conjunctiva: in all animals diffuse highly red
discolouration of the conj., also swelling.
The eyes were after 7 days free of symptoms.

Applicant's summary and conclusion

Interpretation of results:
other: not classified