Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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: This study was carried out in accordance with internationally valid GLP principles.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 84/449/EWG, B.5
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:
C21H21FeO9S3
IUPAC Name:
iron(3+) tris(4-methylbenzene-1-sulfonate)
Details on test material:
Nature of substance: pulverized solid

Test animals / tissue source

Species:
other: rabbit (w), Stamm HC: NZW

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
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.7
Max. score:
2
Remarks on result:
other: max. duration: h; Max. value at end of observation period: 1 (related to all animals)
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
Max. score:
2
Remarks on result:
other: max. duration: h; Max. value at end of observation period: 1 (related to all animals)
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
Max. score:
2
Remarks on result:
other: max. duration: h; Max. value at end of observation period: 1 (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
Max. score:
3
Remarks on result:
other: max. duration: h; Max. value at end of observation period: 1 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Max. score:
3
Remarks on result:
other: max. duration: h; Max. value at end of observation period: 1 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
2.3
Max. score:
3
Remarks on result:
other: max. duration: h; Max. value at end of observation period: 1 (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:
4
Max. score:
4
Remarks on result:
other: max. duration: h; Max. value at end of observation period: 4 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
3
Max. score:
4
Remarks on result:
other: max. duration: h; Max. value at end of observation period: 4 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
3.3
Max. score:
4
Remarks on result:
other: max. duration: h; Max. value at end of observation period: 4 (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
Max. score:
1
Remarks on result:
other: max. duration: h; Max. value at end of observation period:1 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
1
Remarks on result:
other: max. duration: h; Max. value at end of observation period:1 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
1
Remarks on result:
other: max. duration: h; Max. value at end of observation period:1 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 21 days
Other effects:
Destruction of tissue of the mucousa skin membrane, visible by a white-yellow discolouration of the conjuctiva in all three animals. In one animal the lower part of the front eye chamber was filled with milky content.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information