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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
19 March, 1979
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Referenceopen allclose all

Reference Type:
other: results
Title:
Unnamed
Year:
1979
Report date:
1979
Reference Type:
other: summary
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: ETAD Method No. 002 - Normen/Kaninchen
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of Cobalt, 4-[4-[[4-[[[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxyphenyl]sulfonyl]amino]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonate 4-[4-[[4-[[[3-[[4,5-dihydro-3-methyl-5-oxo-1-(4-sulfophenyl)-1H-pyrazol-4-yl]azo]-4-hydroxyphenyl]sulfonyl]amino]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonate sodium complexes and Cobaltate(3-), bis[4-[4-[[4-[[[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxyphenyl]sulfonyl]amino]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonato(3-)]-, trisodium and Cobaltate(5-), bis[4-[4-[[4-[[[3-[[4,5-dihydro-3-methyl-5-oxo-1-(4-sulfophenyl)-1H-pyrazol-4-yl]azo]-4-hydroxyphenyl]sulfonyl]amino]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonato(4-)]-, pentasodium
EC Number:
916-898-0
Molecular formula:
C64H46CoN18Na5O22S6 C64H47CoN18Na4O19S5 C64H48CoN18Na3O16S4
IUPAC Name:
Reaction mass of Cobalt, 4-[4-[[4-[[[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxyphenyl]sulfonyl]amino]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonate 4-[4-[[4-[[[3-[[4,5-dihydro-3-methyl-5-oxo-1-(4-sulfophenyl)-1H-pyrazol-4-yl]azo]-4-hydroxyphenyl]sulfonyl]amino]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonate sodium complexes and Cobaltate(3-), bis[4-[4-[[4-[[[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxyphenyl]sulfonyl]amino]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonato(3-)]-, trisodium and Cobaltate(5-), bis[4-[4-[[4-[[[3-[[4,5-dihydro-3-methyl-5-oxo-1-(4-sulfophenyl)-1H-pyrazol-4-yl]azo]-4-hydroxyphenyl]sulfonyl]amino]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonato(4-)]-, pentasodium
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
not specified
Duration of treatment / exposure:
not specified
Observation period:
72 h
Number of animals:
3 males and 3 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1 and #6
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: intact and wound skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: intact and wound skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: wound skin
Irritation parameter:
erythema score
Basis:
animal: #4 and #5
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal: #4 and #5
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: wound skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: wound skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
other:
Remarks:
intact and wound skin
Irritation parameter:
edema score
Basis:
animal: #3, #4, #5 and #6
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal: #3, #4, #5 and #6
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: wound skin
Irritant / corrosive response data:
Not corrosive

Any other information on results incl. tables

As the observation times were only at 24 and 72 h, the mean calculations of 24/48/72 h were not able to be performed. In order to approximate the 48 hour score, a worst-case approach was employed, using the higher of the 24 h and 72 h scores in place of the 48 h score.

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC) No. 1272/2008
Conclusions:
The test item was found to be not irritating to rabbit skin.
Executive summary:

The skin irritation potential of the test item was evaluated in an in vivo experimental study. The test item was applied to both the intact and abraded skin of six rabbits (three males and three females). As the only observation times recorded were at 24 h and 72 h, the mean calculations of 24/48/72 h were not able to be performed. In order to approximate the 48 hour score, a worst-case approach was employed, using the higher of the 24 h and 72 h scores in place of the 48 h score.

The mean (24/48/72 hour) erythema and oedema scores were found to be 2.3 or lower in all animals. Moreover, reversibility of all effects was observed within 72 hours after application to the intact skin; reversibility of all effects was observed in four of the six animals within 72 hours after application to abraded skin: erythema (grade 1) to abraded skin was present in animal #3 at 72 hours, and oedema (grade 1) to abraded skin was present in animal #1 at 72 hours.