Disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 May 1975

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:

1975

Report date:

1975

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:

Disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]

EC Number:

276-882-8

EC Name:

Disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]

Cas Number:

72828-69-4

Molecular formula:

C47H42N10O12S4.2Na

IUPAC Name:

disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]

Details on test material:

A yellow powder, labelled FAT 21015/A

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

SOURCE ANIMAL
- Source: New Zealand White
- Sex: male and female
- Age at study initiation (in days): 63 - 105 days
- Weight at study initiation: 2.60 kgs (males) and 2.58 kgs (females)
- Housing: Semi-barrier system
- Die: Styles-Oxoid commercial irradiated diet ad libitum
- Water: Sterile filtered water ad libitum
- Acclimation period: 1 week

Animals:
Healthy New Zealand white rabbits (Porton strain) aged 9-15 weeks with average body weights of 2.60 Kgs. (M) and 2.58 Kgs. (F), bred on the premises and maintained under a semi-barrier system. Six rabbits (3M and 3F) were acclimatized in the test area for one week prior to the start of the trial.

Husbandry:
The rabbits were caged singly in an experimental room maintained at a temperature of 20 °C. (± 1°) and a relative humidity of 50-70 %. Animals were exposed to artificial light for 10 h daily from 08.00 - 18.00 h. A commercial irradiated diet (Styles-Oxoid) was fed ad lib. Sterile filtered water was available at all times.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: one side abraded and other side shaved only

Vehicle:

water

Controls:

no

Amount / concentration applied:

10 g of the test compound was mixed with 10 ml of water to make a solution of 15 ml; 0.75 ml of which was applied.

Dose: 0.5 g

Duration of treatment / exposure:

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. The assessment of the macroscopic skin reaction was made according to the following grading system.

Observation period:

72 h

Number of animals:

6 rabbits (3 males and 3 females)

Details on study design:

Method:
The test was carried out according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965). 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 was mixed with 10 ml of water to make a solution of 15 ml, 0.75 ml of which was applied to each test site on a 2.5 c.m. square gauze pad. These were covered with aluminium foil secured with "Sleek"* adhesive tape. The test sites were then enclosed by a 6" wide "Coban" self adhesive bandage the edges of which were fixed to the skin by strips of "Sleek" 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. The assessment of the macroscopic skin reaction was made according to the following grading system.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

mean

Remarks:

6 animal

Time point:

24 h

Score:

0.17

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

erythema score

Remarks:

Abraded skin

Basis:

mean

Remarks:

6 animal

Time point:

24 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 3

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

mean

Remarks:

6 animal

Time point:

72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

erythema score

Remarks:

Abraded skin

Basis:

mean

Remarks:

6 animal

Time point:

72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

mean

Remarks:

6 animal

Time point:

24 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 6

Irritation parameter:

edema score

Remarks:

Abraded skin

Basis:

mean

Remarks:

6 animal

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 7

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

mean

Remarks:

6 animal

Time point:

72 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

edema score

Remarks:

Abraded skin

Basis:

mean

Remarks:

6 animal

Time point:

72 h

Score:

0.67

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 9

Irritation parameter:

erythema score

Remarks:

intact and abraded skin

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Results 10

Irritation parameter:

edema score

Remarks:

intact and abraded skin

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Any other information on results incl. tables

Individual Animal Score: Erythema

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

 

Individual Animal Score: Edema

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

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 21015/A is to be considered as a non-irritant to the skin of rabbits.

Executive summary:

A study was performed to determine skin irritation of FAT 21015/A in rabbits according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965). Six animals with intact and abraded skin were used for this purpose. 10 g of the test compound was mixed uith 10 ml 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 (conc:0.5 g). Slight erythema and very slight to moderate oedema were seen in 3/6 and 6/6 rabbits respectively 24 h after application of the compound. Very slight oedema was still present on 4/6 abraded sites only at 72 h. The primary irritation score was 1.3. However, the substance did not warrant classification according to the CLP (Regulation 1272/2008) criteria. Hence, FAT 21015/A is to be considered as a non-irritant to the skin of rabbits.