Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Study period:
1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
Inquiry number 06-2120856042-62-0000

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
92/69/EEC
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
424-870-1
EC Name:
-
Cas Number:
27624-67-5
Molecular formula:
C14H16N4O9S3
IUPAC Name:
2,4-diamino-5-(2-{4-[2-(sulfooxy)ethanesulfonyl]phenyl}diazen-1-yl)benzene-1-sulfonic acid
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
other: distilled water
Controls:
not specified
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other:
Remarks:
Max. duration: 3 d; Max. value at end of observation period: 0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other:
Remarks:
Max. duration: 3 d; Max. value at end of observation period: 0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other:
Remarks:
Max. duration: 3 d; Max. value at end of observation period: 0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Max. duration: 3 d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Max. duration: 3 d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Max. duration: 3 d; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days
Other effects:
Orange/yellow-coloured staining was noted at all treated
skin sites throughout the study. The staining prevented
accurate evaluation of erythema at all treated sites one
hour after patch removal. Eryhtematous reactions were
evaluated at less than or equal to grade 1 redness. The
staining did not affect evaluation of erythema at all
treated skin sites at the 24-hour observation and at
subsequent observations.
Moderate desquamation was noted at one treated skin site at
the 7-day observation.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met