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

Skin irritation / corrosion

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

Test material information

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

Results

Results 1

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.

Results 2

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