Reaction mass of Cobaltate(1-), bis[6-(amino-κN)-5-[2-[2-(hydroxy-κO)-4-nitrophenyl]diazenyl-κN1]-N-methyl-2-naphthalenesulfonamidato(2-)]-, sodium (1:1) and disodium [6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]-N-methylnaphthalene-2-sulphonamidato(2-)][6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-2-sulphonato(3-)]cobaltate(2-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Environmental Pr otection Agency (EPA), Paragraph 163.81-5 "Primary dermal irritaion study", Federal Register, Vol 43 No. 163, August 22, 1978

Deviations:

yes

Remarks:

Animals have been scarified prior to the treatment. This procedure represents an elevated testing conditions, because the intact skin barrier is destroyed.Therefore care must be taken to use results of these animals for the overall hazard assessment.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of Cobaltate(1-), bis[6-(amino-κN)-5-[2-[2-(hydroxy-κO)-4-nitrophenyl]diazenyl-κN1]-N-methyl-2-naphthalenesulfonamidato(2-)]-, sodium (1:1) and disodium [6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]-N-methylnaphthalene-2-sulphonamidato(2-)][6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-2-sulphonato(3-)]cobaltate(2-)

EC Number:

943-062-2

Molecular formula:

not available

IUPAC Name:

Reaction mass of Cobaltate(1-), bis[6-(amino-κN)-5-[2-[2-(hydroxy-κO)-4-nitrophenyl]diazenyl-κN1]-N-methyl-2-naphthalenesulfonamidato(2-)]-, sodium (1:1) and disodium [6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]-N-methylnaphthalene-2-sulphonamidato(2-)][6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-2-sulphonato(3-)]cobaltate(2-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Specific details on test material used for the study:

Code No: FAT 20036/D
Batch No: EN 91018.22
Stability: May 1987
Description: powder
Test Article Received: June 6, 1982

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Weight at study initiation: 2-3 Kg
- Housing: Animals were housed individually in metal cages.
- Diet: Rabbit food, NAFAGf No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water: ad libitum
- Individual identification: ear numbers

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Photoperiod: 12 hours light cycle day
- Air changes: Approximately 15 air changes/h.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and scarified on one side

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

24 hours

Observation period:

7 days

Number of animals:

3 male and 3 female rabbits

Details on study design:

24 hours before treatement the flanks of the rabbits were shaved with an electric clipper (approximately 6 sq.cm each) and immediately before treatment, the shaven skin on one side was slightly scarified with the help of a "Schroepfschnaepper", Aesculap, Switzerland.
Gauze patches soaked (or loaded) 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 24 hours.

The skin reaction was assessed upon removal and during a subsequent observation period of 7 days on the basis of the following evaluation scheme.


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 (beet redness) to slight eschar formation (injuries in depth): 4
Total possible erythema 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
Total possible edema score 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

mean

Time point:

24 h

Score:

1.5

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Results 2

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

mean

Time point:

48 h

Score:

1.5

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Results 3

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

mean

Time point:

72 h

Score:

1.5

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Results 4

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

mean

Time point:

24 h

Score:

1.3

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Results 5

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

mean

Time point:

48 h

Score:

1.17

Max. score:

4

Reversibility:

not fully reversible within:

Remarks:

7 days

Results 6

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

mean

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Irritant / corrosive response data:

PRIMARY IRRITATION INDEX = 8.5 / 4 = 2.13

Any other information on results incl. tables

CALCULATION OF THE PRIMARY SKIN IRRITATION INDEX (TABLE 1)

The scores read after 24 and 72 hours for erythema and edema for the intact as well for the abraded skin were summed up and divided by 4 (FHSLA paragraph 191.11)

MEAN REACTION SCORE
	Erythema		Edema
Time after exposure hours	Intact skin	Abraded skin	Intact skin	Abraded skin
24	1.5	1.0	1.3	1.0
72	1.5	1.0	1.0	0.2
Total	3.0	2.0	2.3	1.2	8.5

PRIMARY IRRITATION INDEX =8.5 / 4 = 2.13

ASSESSMENT OF IRRITATION

- no irritation: 0

- minimal : 0.1-1.0

- slight : 1.1 -2.0

- moderate: 2.1-4.0

- marked: 4.1-6.0

- extreme: 6.1-8.0

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Conclusions:

FAT 20036/D was concluded to be not a skin irritant.

Executive summary:

FAT 20036/D was tested for skin irritation potential in a test performed on 3 males and 3 female New Zealand White rabbits. The procedure used is based, but not in every part identical with the Proposed Guidelines of the United States Environmental Pr otection Agency (EPA), Paragraph 163.81-5 "Primary dermal irritaion study", Federal Register, Vol 43 No. 163, August 22, 1978. 24 hours prior to the treatment, the flanks of the rabbits were shaved with an electric clipper (approximately 6 sq.cm each). Immediately before treatment, the shaven skin on one side was slightly scarified with the help of a "Schroepfschnaepper". 0.5 g of the test material was applied to the prepared abraded and intact skin respectively. The skin reaction was assessed upon removal of test material patch and subsequently observed for a period of 7 days.

 

The exposure was found to have some irritation reactions on intact as well as abraded skin, however the scores did not meet the classification criteria as set by Regulation (EC) No. 1272/2008. The calculated primary irritation index was 2.13. Hence, under the conditions of the present experiment FAT 20'036/D wasconcluded to be not a skin irritant.