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Toxicological information

Skin irritation / corrosion

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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.