Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]-, disodium

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From April 18 to 21, 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

1992

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4470 (Acute Dermal Irritation)

Version / remarks:

1991

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]-, disodium

EC Number:

281-013-0

EC Name:

Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]-, disodium

Cas Number:

83833-37-8

Molecular formula:

C36H24CrN9Na2O9S

IUPAC Name:

hydroxylamine

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: Dr. Karl Thomae GmbH, Postfach 1755, D-88397 Biberach a.d. Riss
- Age at start of acclimatization: male - 14 weeks, females - 14 weeks
- Body weight at start of acclimatization: male - 2.7 kg, females - from 2.7 to 2.9 kg
- Identification: by unique cage number and corresponding ear tags.
- Housing: individually in stainless steel cages with an automatic cleaning system, equipped with feed hoppers, drinking water bowls and wood for gnawing.
- Diet: pelleted standard Kliba 341, Batch 82/94 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum.
- Water: ad libitum
- Acclimation period: four days under test conditions after health examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 20-24°C
- Humidity (%): between 40-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light (approx. 100 Lux)/12 hours dark

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

0.5 g of test item

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

3 (1 male and 2 females)

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- % coverage: 3.0 cm x 3.0 cm patch of surgical gauze
- Type of wrap if used: esemi-occlusive dressing wrapped around the abdomen and anchored with an elastic bandage.

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

OBSERVATION TIME POINTS
The skin reaction was assessed at 1, 24, 48, 72 hours and 7 days after the removal of the dressing, gauze patch and test article.

SCORING SYSTEM:
- Method of calculation: to classify the irritating potential of the test article, the mean values of erythema / eschar as well as of edema formation were calculated for each individual, using the scores between 24 and 72 hours (EEC Commission Directive 93/21/EEC, April 27, 1993).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 10, 11

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: no signs

Results 2

Irritation parameter:

erythema score

Basis:

animal: 12

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible

Results 3

Irritation parameter:

edema score

Basis:

animal: 10, 11, 12

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: no signs

Any other information on results incl. tables

CLINICAL SIGNS AND VIABILITY / MORTALITY

No systemic symptoms were observed in the animals during the test and observation period, and no mortality occurred.

IRRITATION

The test substance showed a primary irritation score of 0.33 (max. 8.0) when applied to healthy intact rabbit skin. Local signs (mean values from 24 to 72 hours) consisted of grade 0.33 erythema and grade 0.00 edema. They were reversible until day 7.

COLORATION

In the area of application violet staining of the treated skin by pigment or coloring of the test article was observed.

CORROSION

No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.

BODY WEIGHTS

The body weight gain of all rabbits was within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

Non irritant.

Executive summary:

Method

The primary skin irritation potential of the test material was investigated by topical application of 0.5 g onto 6 cm2 intact dorsal skin of each of three young adult New Zealand rabbits. The scoring of skin reactions was performed 1, 24, 48, 72 hours and 7 days after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) was used in calculating the respective mean values for each type of lesion. The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then divided by the number of figures.

Results

Local signs (mean values from 24 to 72 hours) consisted of grade 0.33 erythema and grade 0.00 edema. In the area of application, violet staining of the treated skin by coloring of the test article was observed. No corrosive effect occurred on the treated skin of any animal at each measuring interval.

Conclusion

Non irritant.