Trisodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)][2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzenesulphonato(3-)]chromate(3-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted according to internationally accepted testing guideline.

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)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)][2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzenesulphonato(3-)]chromate(3-)

EC Number:

274-230-7

EC Name:

Trisodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)][2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzenesulphonato(3-)]chromate(3-)

Cas Number:

69943-66-4

Molecular formula:

C32H18CrN8O14S2Na3

IUPAC Name:

Trisodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)][2hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzenesulphonato(3-)]chromate(3-)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Spolkem breeder of Hrace Králové.
- Weight at study initiation: above 2.5 kg.
- Housing: individually housed, in commercially metal cages (supplied by s.p. Velaz Prague), without litter and climatic control.
- Diet: standard granular commercial food for rabbits, KO-16 provided by s.p. Velaz Prague.
- Water: drinking water, ad libitum.
Cleaning and disinfection of premises menagerie were made at dates determined, according to the standard operating procedures and compliance regime measures.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C.
- Humidity: 50 ± 15 %.
- Photoperiod: 12 hrs dark / 12 hrs light, by fluorescent lamp.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact and abraded skin

Vehicle:

water

Amount / concentration applied:

TEST MATERIAL
- Amoun applied: 0.5 g

Duration of treatment / exposure:

24 hours

Observation period:

72-hours

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: 24 hours after the test material application, rabbits were shaved (skin area of ​​6 x 6 cm) on the left and right side of the lateral surface of the abdominal wall localized in the region epigastrium, mesogastrium and hypogastrium. Left side was intact, while the right side was scarificated.
- Type of wrap if used: test material was applied to skin on left side and covered with a gaude. Then water was applied to a gauze using a syringe, in order to obtain an aqueous paste. Furthermore on gauze were enclosed aluminium foil and cellulose wadding. The coverage was fixed by technical tape.

SCORING SYSTEM: OECD guideline scoring system.

Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beef redness) to slight eschar formation (injuries in depth): 4
Maximum possible: 4

Oedema Formation
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well defined by definite raising): 2
Moderate oedema (raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure): 4
Maximum possible: 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

< 2.3

Max. score:

4

Remarks on result:

other: both intact and abraded skin

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

< 2.3

Max. score:

4

Remarks on result:

other: both intact and abraded skin

Irritant / corrosive response data:

Primary dermal irritation index (PDII): 0.5
Degree of dermal irritation: 2. Weakly irritant.
INTACT SKIN
Rabbit 1: a well-defined erythema and oedema.
Rabbit 2: very slight erythema and oedema very weak.
Rabbit 3: very slight erythema and oedema well defined.
For 24 hours were found very slight erythema and oedema very weak. At 48 and 72 hours no functional macroscopical, nor patomorphological changes were recorded.

SCARIFIED SKIN
Rabbit 1: a well-defined erythema and oedema.
Rabbit 2: very slight erythema and oedema very weak.
Rabbit 3: very slight erythema and oedema well defined.
At 48 and 72 hours no functional macroscopical, nor patomorphological changes were recorded.

Any other information on results incl. tables

Reactions observed

N. animal cage	Reaction	Reaction after				Mean 24, 48 and 72 hrs
		4 hrs	24 hrs	48 hrs	72 hrs
Intact skin
1	Erythema	2	0	0	0	0.00
	Oedema	2	1	0	0	0.33
2	Erythema	1	0	0	0	0.00
	Oedema	1	1	0	0	0.33
3	Erythema	1	0	0	0	0.00
	Oedema	2	0	0	0	0.00
Abraded skin
1	Erythema	2	0	0	0	0.00
	Oedema	2	0	0	0	0.00
2	Erythema	1	1	0	0	0.33
	Oedema	1	1	0	0	0.33
3	Erythema	2	1	0	0	0.33
	Oedema	3	2	0	0	0.67

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information according to the CLP Regulation (EC 1272/2008) Criteria used for interpretation of results: EU

Conclusions:

Not irritating.

Executive summary:

The skin irritation potential of the substance was determined by the skin irritation test, according to the OECD guideline 404.

0.5 g of test material were applied to intact and scarified skin of rabbits and removed after 24 hours. Observations were made for 72 hours.

Primary dermal irritation index (PDII) was determined to be 0.5 and the degree of dermal irritation was stated at 2.

The scoring system criteria used to record the hardness of the skin reactions followed in the current test are the same as those reported into the OECD guideline, therefore it is possible to re-evaluate the results according to the CLP Regulation (EC 1272/2008), because the raw tables are included into the study report.

Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions (in both intact and abraded skin).

Conclusion

The test item can be not classified as skin irritating, according to the CLP Regulation (EC 1272/2008).