Hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Standard guideline study according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)

EC Number:

276-857-1

EC Name:

Hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)

Cas Number:

72812-34-1

Molecular formula:

C32H18CrN6O8.C11H25NO.H

IUPAC Name:

Chromate(1-), [1-[2-[2-(hydroxy-kO)-4-nitrophenyl]diazenyl-kN1]-2-naphthalenolato(2-)-kO][1-[2-[2-(hydroxy-kO)-5-nitrophenyl]diazenyl-kN1]-2-naphthalenolato(2-)-kO]-, hydrogen, compd. with 3-[(2-ethylhexyl)oxy]-1-propanamine (1:1:1)

Test animals

Species:

rabbit

Strain:

other: Chbb: NZW (SPF)

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 study initiation: 15 weeks
- Weight at study initiation: 2,7-2,92 kg
- Housing: individual in stainless steel cages (size: 120x52x60 em)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 40 -70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 /12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: PEG 400 / 0,9% NaCl in Water (7/3)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): moistened solid

Duration of treatment / exposure:

4 hours

Observation period:

3 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm

- Type of wrap if used: semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of exposure with warm water
- Time after start of exposure: 4 h

SCORING SYSTEM:
EVALUATION OF SKIN REACTION
Erythema and eschar formation
No erythema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0
Very slight erythema (barely perceptible) . .. . . ........... 1
Well defined erythema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Moderate to severe erythema ....... ........ .. ........ .. . .. 3
Severe erythema (beet redness) to slight eschar
formation (injuries in depth) . . . . ..... .. ................. 4
Maximum possible score 4

Edema formation
No edema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0
Very slight edema (barely perceptible) ................ ... 1
Slight edema (edges of area well defined by
definite raising) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Moderate edema (raised approximately 1 mm) . .. .. .......... 3
Severe edema (raised more than 1 mm and
extending beyond area of exposure) ......... .............. 4
Maximum possible score 4
Maximum cumulative score: 8

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: mean of all observations

Score:

0.22

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

Only one of three animals showed a very slight erythema at 24 and 48 ours after exposure

Other effects:

blacj discoloration of the skin due to the color of the test material (black pigment)

Any other information on results incl. tables

Time	Animal	Sex	Erythema	Edema	Cumulative	Mean
1h	40	M	0	0	0
	41	F	0	0	0
	42	F	0	0	0	0
24 h	40	M	0	0	0
	41	F	0	0	0
	42	F	1	0	1	0,33
48h	40	M	0	0	0
	41	F	0	0	0
	42	F	1	0	1	0,33
72 h	40,41,42	M,F,F	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the observation and on the refered classification criteria (EEC Commission Directive 93/21/EEC, April 27,1993) the test material is classified as non-irritant to the skin of rabbits

Executive summary:

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 and 72 hours after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) were 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.

Under the conditions of this experiment, the test item was found to cause a primary irritation score of 0.22 (max. 8.0) when applied to healthy intact rabbit skin. Local signs (mean values from 24 to 72 hours) consisted of grade 0.22 erythema and grade 0.00 edema. In the area of application, a slightly black staining of the treated skin by coloring of the test article was observed during the whole observation period.

No corrosive effect occurred on the treated skin of any animal at each measuring interval.

According to EEC Commission Directive 93/21/EEC, April 27, 1993, the mean values of the scores for each type of lesion, calculated for each animal separately, are the following:

Animal No.,       Sex                     Mean 24 - 72 Hours

Erythema       Edema

40                     male                     0.00                    0.00

41                     female                  0.00                    0.00

42                     female                 0.67                     0.00

Due to the results described above, the test article is classified as non-irritant to the skin of rabbits.