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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and OECD testing guideline compliant study with well characterized test material.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
tert-(dodecyl/tetradecyl)-ammonium bis(3-(4-((5-(1,1-dimethyl-propyl)-2-hydroxy-3-nitrophenyl)azo)-3-methyl-5-hydroxy-(1H)pyrazol-1-yl)benzenesulfonamidato)chromate
EC Number:
413-210-6
EC Name:
tert-(dodecyl/tetradecyl)-ammonium bis(3-(4-((5-(1,1-dimethyl-propyl)-2-hydroxy-3-nitrophenyl)azo)-3-methyl-5-hydroxy-(1H)pyrazol-1-yl)benzenesulfonamidato)chromate
Cas Number:
192662-33-2
Molecular formula:
UVCB substance
IUPAC Name:
chromium(3+) 2-methyltridecan-2-aminium bis(4-{2-[5-(2,2-dimethylpropyl)-3-nitro-2-oxidophenyl]diazen-1-yl}-3-methyl-1-(3-sulfamoylphenyl)-1H-pyrazol-5-olate)
Details on test material:
- Substance type: pigment, powder
- Physical state: solid
- Analytical purity: 96.1%
- Purity test date: no data
- Lot/batch No.: Misch.PA1+3/91
- Expiration date of the lot/batch: January 1997
- Stability under test conditions: yes
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Age at study initiation: no data
- Weight at study initiation: 2380 to 2560 g
- Housing: individually
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1992-11-24 To: 1992-12-01

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: the pigment was moistened with 0.5% CMC and 0.1% polysorbate 80 in water
Controls:
not required
Amount / concentration applied:
0.5g
Duration of treatment / exposure:
4h
Observation period:
1, 24, 48, 72 hours, and 7 days after removing the gauze patches
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure:36 cm2
- % coverage:
- Type of wrap if used: A gauze patch, loosely covered with an aluminum foil (approx. 36 cm2) and held in place for 4 hours by an adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: The time point of 24 could not be scored for the other 2 animals because of the staining properties of the test item. At 48h, no animal showed erythema.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU

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