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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:
Mar 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

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 bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-N,N-dimethylbenzene-1-sulphonamidato(2-)]chromate(1-)
EC Number:
278-137-2
EC Name:
Sodium bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-N,N-dimethylbenzene-1-sulphonamidato(2-)]chromate(1-)
Cas Number:
75214-69-6
Molecular formula:
C36H34CrN10NaO8S2
IUPAC Name:
hydroxylamine
Test material form:
solid: granular

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd., Huntingdon, UK
- Weight at study initiation: 3.4 - 3.5 kg (all female)
- Housing: polyethylene cages
- Diet (e.g. ad libitum): "Ssniff K 4" , Ssniff Spezialdiaten GmbH, Soer - approx. 100 - 120 g per animal and day; feeding once per day in the morning
- Water (e.g. ad libitum): ad lib.
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): approx. 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: powder slightly moistened with water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 h
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- % coverage: 6 cm²
- Type of wrap if used: hypoallergenic patch

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

OBSERVATION TIME POINTS
1, 24, 48, 72 h and 7 d 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.

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