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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
Study period:
04 - 07 Dec 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 4-[[4-[(4-hydroxy-2-methylphenyl)azo]phenyl]amino]-3-nitrobenzenesulphonate
EC Number:
274-950-1
EC Name:
Sodium 4-[[4-[(4-hydroxy-2-methylphenyl)azo]phenyl]amino]-3-nitrobenzenesulphonate
Cas Number:
70865-20-2
Molecular formula:
C19H16N4O6S.Na
IUPAC Name:
sodium 4-[[4-[(4-hydroxy-2-methylphenyl)azo]phenyl]amino]-3-nitrobenzenesulphonate
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Kisslegg, Germany
- Age at study initiation: 13 weeks
- Weight at study initiation: male: 2.3 kg, females: 2.2 and 2.6 kg
- Housing: stainless steel cages
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 40 - 70% rh
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12 h

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: powder slightly moistened with H2O bidest.
Controls:
not required
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
1 male, 2 females
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- % coverage: 9 cm²
- Type of wrap if used: gauze, elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): tap water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
1, 24, 48, 72 h after removal

SCORING SYSTEM:
- Method of calculation: Draize system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema 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 corrosive effects were noted on treated skin at any time.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item did not cause any signs of irritation/corrosion on rabbit skin. The substance is not classifiable according to the CLP Regulation.