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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: method not exactly as in standard, no GLP; short report with limited data

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
intact an abraded skin; 6 Animals; evaluation at 24 and 72 hours only
GLP compliance:
no
Remarks:
predates GLP regulation

Test material

Constituent 1
Chemical structure
Reference substance name:
Trisodium bis[2-[[2,4-dihydroxy-3-[(2-methyl-4-sulphophenyl)azo]phenyl]azo]benzoato(3-)]chromate(3-)
EC Number:
278-145-6
EC Name:
Trisodium bis[2-[[2,4-dihydroxy-3-[(2-methyl-4-sulphophenyl)azo]phenyl]azo]benzoato(3-)]chromate(3-)
Cas Number:
75234-41-2
Molecular formula:
C40H26CrN8O14S2.3Na
IUPAC Name:
trisodium bis[2-[[2,4-dihydroxy-3-[(2-methyl-4-sulphophenyl)azo]phenyl]azo]benzoato(3-)]chromate(3-)
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
No data

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
500 mg per patch
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 1 square inch per patch
- Type of wrap if used: the gauze patches were held in place by a rubberized cloth.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to US CFR title 16, section 1500.41; similar to Draize system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals showed identical reactions
Time point:
other: 24 h and 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals showed identical reactions
Time point:
other: 24 h and 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24h and 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No irritation
Other effects:
none

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material did not induce skin irritation.
Executive summary:

After single occlusive exposure of intact as well as abraded clipped skin for 24 hours with 500 mg of moistened test material per site none of 6 animals showed irritation reactions. Neither erythema nor edema were observed at any treated site.