Reaction mass of Disodium dihydroxy[2-{[5-(hydroxy-kO)-3-methyl-1-(4-sulfophenyl)-1H-pyrazol-4-yl]diazenyl-kN1}benzoato(3-)-kO]chromate(2-) and Sodium hydroxy[2-{[5-(hydroxy-kO)-3-methyl-1-(4-sulfophenyl)-1H-pyrazol-4-yl]diazenyl-kN1}benzoato(3-)-kO]chromate(1-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

None

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81- 5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978

Principles of method if other than guideline:

None

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

[2-[[4,5-dihydro-3-methyl-5-oxo-1-(4-sulphophenyl)-1H-pyrazol-4-yl]azo]benzoato(3-)]chromium

EC Number:

276-702-8

EC Name:

[2-[[4,5-dihydro-3-methyl-5-oxo-1-(4-sulphophenyl)-1H-pyrazol-4-yl]azo]benzoato(3-)]chromium

Cas Number:

72496-90-3

Molecular formula:

C17H11CrN4O6S

IUPAC Name:

[2-[[4,5-dihydro-3-methyl-5-oxo-1-(4-sulphophenyl)-1H-pyrazol-4-yl]azo]benzoato(3-)]chromium

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

None

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2 to 3 kgs
- Housing: housed individually in metal cages, numbered by ear tags
- Diet: standard rabbit food ad libitum - NAFAG, No. 814, Gossau SG
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2° C
- Humidity (%): 55 +/- 10 %
- Photoperiod (hrs dark / hrs light): 10 hours light cycle day

Test system

Type of coverage:

occlusive

Preparation of test site:

other: abraded and intact skin

Vehicle:

other: propylene glycol : saline. (70 : 30 parts)

Controls:

not specified

Amount / concentration applied:

0.5 g of the test material were applied to the prepared abraded and intact skin.

Duration of treatment / exposure:

single application for 24 hours, no washing performed

Observation period:

7 days

Number of animals:

3 male and 3 female

Details on study design:

Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and Immediately before treatment the shaven skin on one side was slightly scarified with the help of a "SchröpfSchnäpper", Aesculap, Switzerland. Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin.

The patches were covered with an Impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour application. The skin reaction was appraised upon removal and during an observation period of 7 days.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

on intact skin

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

on intact skin

Irritant / corrosive response data:

None

Other effects:

None

Any other information on results incl. tables

	erythema		edema
Time after exposure h	intact skin	abraded skin	intact skin	abraded skin
24	0	0.5	0	0.5
72	0	0.3	0	0.3

primary irritation index 1.6 : 4 = 0.4

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 20041/B is to be considered as a non-irritant to the skin of rabbits.

Executive summary:

A study was performed to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound, FAT 20041/B, on the skin of the rabbits. Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "SchröpfSchnäpper", Aesculap, Switzerland. Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour application. The skin reaction was appraised upon removal and during an observation period of 7 days. The study was performed on intact and abraded skin. However, abraded skin is an elevated testing condition and the results obtained with abraded skin normally do not have to be taken into account for hazard assessment. No irritation was observed on the exposed intact skin. Hence, FAT 20041/B can be classified as non-irritant to the skin of rabbits.