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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
Oct 1959
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1959
Report date:
1959
Reference Type:
other company data
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Principles of method if other than guideline:
The protocol by Barail was followed. For details please refer to box "Details on study design".
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-[4-[[2,5-dimethoxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonic acid, sodium salt
EC Number:
263-418-4
EC Name:
4-[4-[[2,5-dimethoxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonic acid, sodium salt
Cas Number:
62121-76-0
Molecular formula:
C20H20N4Na2O12S3
IUPAC Name:
4-[4-[[2,5-dimethoxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonic acid, sodium salt
Test material form:
solid

Test animals

Species:
rabbit
Strain:
other: Silver Yellow
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: -
- Age at study initiation: -
- Weight at study initiation:
- Housing: single
- Diet: Altromin standard diet ad libitum
- Water: tap ad libitum
- Acclimation period: -

Test system

Type of coverage:
open
Preparation of test site:
other: depilated, shaved
Vehicle:
water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL of 10% aqueous solution
Duration of treatment / exposure:
single treatment
Observation period:
4 days
Number of animals:
3/test
Details on study design:
Animals were exposed with 0.5 mL of a 10% solution on the depilated intact skin on the flank.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation were observed.

Any other information on results incl. tables

The study has been re-evaluated in 1992 by Kreiling. Dr Kreiling concluded, that the results can not be used for classification based on the available data.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
No signs of skin irritation have been observed in this study. As only limited information is provided, this study cannot be used for classification.
Executive summary:

In a primary skin irritation study, 0.5 mL of 10% aqueous solution of the test material were tested on the intact rabbit skin. No further information on the study design was available. No signs of irritation were reported. Based on the available data, this study cannot be used for classification.