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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Iron (III) tris(4-methylbenzenesulfonate)
EC Number:
420-960-8
EC Name:
Iron (III) tris(4-methylbenzenesulfonate)
Cas Number:
77214-82-5
Molecular formula:
C21 H21 Fe O9 S3
IUPAC Name:
iron(3+) tris(4-methylbenzene-1-sulfonate)
Test material form:
solid: pellets

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
1.7
Remarks on result:
other: Max. value at end of observation period: 1 (related to all animals)
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
1
Remarks on result:
other: Max. value at end of observation period: 1 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
1.7
Max. score:
2
Remarks on result:
other: Max. value at end of observation period: 1 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Max. score:
2
Remarks on result:
other: Max. value at end of observation period: 1 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
2.3
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
4
Max. score:
4
Remarks on result:
other: Max. value at end of observation period: 4 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
3
Max. score:
3
Remarks on result:
other: Max. value at end of observation period: 4 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
3.3
Max. score:
4
Remarks on result:
other: Max. value at end of observation period: 4 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
1
Remarks on result:
other: Max. value at end of observation period: 1 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Remarks on result:
other: Max. value at end of observation period: 1 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
1
Remarks on result:
other: Max. value at end of observation period: 1 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes not fully reversible within 21 days
Other effects:
Destruction of tissue of the mucousa skin membrane, visible by a white-yellow discolouration of the conjunctiva in all three animals. In one animal the lower part of the froint eye chamber was filled with milky content.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU