Sodium bis[2-chloro-4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-5-hydroxybenzenesulphonamidato(2-)]chromate(1-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 1976

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:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965).

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium bis[2-chloro-4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-5-hydroxybenzenesulphonamidato(2-)]chromate(1-)

EC Number:

266-577-8

EC Name:

Sodium bis[2-chloro-4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-5-hydroxybenzenesulphonamidato(2-)]chromate(1-)

Cas Number:

67109-27-7

Molecular formula:

C32H24Cl2CrN10O8S2.Na

IUPAC Name:

sodium bis[2-chloro-4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-5-hydroxybenzenesulphonamidato(2-)]chromate(1-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Inhouse
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: Male 2.93 kg and Female 2.78 kg
- Housing: caged singly
- Diet: A commercial irradiated diet (Styles-Oxoid) was fed ad lib ad libitum
- Water: Sterile filtered water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): 10 h light

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

FAT 20028/A was applied to each side in quantities of 0.5 g.

Duration of treatment / exposure:

The gauze patches were removed 24 h after the application.

Observation period:

24 -72 h

Number of animals:

6 rabbits (3 males and 3 females)

Details on study design:

Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10 % of the total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand site remained intact. 10g of the test compound mixed with 10 mls of water to make a solution of 15 ml 0.75 ml of which was applied to each test site on a 2.5cm square gauze pad. These were covered with aluminium foil secured with "Sleek"* adhesive tape. The test sites were then covered by a 6" wide "Coban" self adhesive bandage in order to retain the test substance in close contact with the skin. After 24 h the dressing was removed and' the intact and abraded application sites were assessed for oedema and erythema. A further assessment was made at 72 h and for any further period considered necessary up to 14 days.

SCORING SYSTEM:
Evaluation of Skin Reactions

Erythema and Eschar Formation
-No erythema: 0
-Slight erythema (barely perceptible): 1
-Well defined erythema: 2
-Moderate to severe erythema: 3
-Severe erythema (beet red) to slight eschar formation: 4

Edema 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 the area of exposure): 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 males and 3 females

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: Intact skin

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 males and 3 females

Time point:

24 h

Score:

1.17

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: Abraded skin

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6 rabbits

Time point:

48 h

Remarks on result:

not measured/tested

Remarks:

intact skin and abraded skin

Results 4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 males and 3 females

Time point:

72 h

Score:

0

Max. score:

4

Remarks on result:

other: intact skin and abraded skin

Results 5

Irritation parameter:

edema score

Basis:

mean

Remarks:

3 males and 3 females

Time point:

24 h

Score:

2.17

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: Intact skin

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

3 males and 3 females

Time point:

72 h

Score:

0

Max. score:

4

Remarks on result:

other: Intact skin

Results 7

Irritation parameter:

edema score

Basis:

mean

Remarks:

3 males and 3 females

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

other: Abraded skin

Results 8

Irritation parameter:

edema score

Basis:

mean

Remarks:

3 males and 3 females

Time point:

72 h

Score:

0.17

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

other: Abraded skin

Results 9

Irritation parameter:

edema score

Basis:

mean

Remarks:

6 rabbit

Time point:

48 h

Remarks on result:

not measured/tested

Remarks:

intact skin and abraded skin

Results 10

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Remarks:

3 males and 3 females

Time point:

24/48/72 h

Score:

1.63

Max. score:

4

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 1.6.

Any other information on results incl. tables

Erythema Score

Animal Number	Intact skin		Abraded skin
	24 h	72 h	24 h	72 h
11	1	0	1	0
13	1	0	1	0
15	1	0	1	0
12	1	0	1	0
14	1	0	2	0
16	1	0	1	0
Mean	1	0	1.17	0

 

Edema Score

Animal Number	Intact skin		Abraded skin
	24 h	72 h	24 h	72 h
11	2	0	1	0
13	3	0	3	1
15	2	0	2	0
12	2	0	2	0
14	2	0	2	0
16	2	0	2	0
Mean	2.17	0	2	0.17

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 20028/B cosidered as to be non-irritating to rabbit skin.

Executive summary:

The purpose of this test was to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound on the skin of the rabbits. The procedure adopted was the patch-test technique described in the " "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1955). Six rabbits (3 males/3 females), New Zealand White (Porton strain), weighing 2.78 to 2.93 kg and aged 12 -16 weeks. Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10 % of the total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand site remained intact. 10 g of the test compound mixed with 10mls of water to make a solution of 15 ml 0.75 ml of which was applied to each test site on a 2.5 cm square gauze pad. These were covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then covered by a 6" wide "Coban" self-adhesive bandage in order to retain the test substance in close contact with the skin. After 24 h the dressing was removed and' the intact and abraded application sites were assessed for oedema and erythema. Slight to well defined erythema and very slight to moderate oedema were seen on all sites after 24 h while very slight oedema was seen on 1/6 abraded sites after 72 h. All other sites were normal. The remaining site was become normal 6 days. In conclusion, the primary irritation to the skin of rabbits was found to be 1.6 and FAT 20028/B cosidered as to be non-irritating to rabbit skin.