Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation
Adequacy of study:
other information

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.5; 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: Pulver

Test animals / tissue source

Species:
other: rbt, Crl:KBL(NZW)BR

Test system

Amount / concentration applied:
100 MG
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:
2.7
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Max. score:
3
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: (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:
3
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
2.7
Irritation parameter:
chemosis score
Max. score:
3
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: (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:
0.3
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Irritation parameter:
cornea opacity score
Max. score:
1
Remarks on result:
other: Max. duration: 72 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: overall at 24, 48 and 72 h
Score:
0
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:
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 not fully reversible within 21 days
Other effects:
Die Substanz verursacht Schädigungen am Auge die nicht
innerhalb von 21 Tagen reversibel sind.

"ENGLISH"

The substance causes damage to the eye which is not
reversible within 21 days.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information

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