Tetrasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[(6-sulphonato-2-naphthyl)azo]naphthalene-2-sulphonate]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EPA guideline (§ 163.81-5 "Primary dermal irritation study". Federal Register, Vol. 43, No. 163, August 22, 1978)

GLP compliance:

no

Remarks:

pre-GLP

Test material

Test material information

Constituent 1

Reference substance name:

FAT 11178/B

IUPAC Name:

FAT 11178/B

Details on test material:

- Name of test material (as cited in study report): FAT 11178/B
- Physical appearance: red powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Exp. Toxicology Sisseln, CIBA-Geigy Ltd.
- Age at study initiation: adult animals
- Weight at study initiation: 2 - 3 kg
- Housing: single housing in metal cages
- Diet: standard rabbit food ad libitum (NAFAG, No. 814, Gossau SG)
- Water: ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 14 / 10

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved intact and scarified skin

Vehicle:

other: polyethylene glycol (PEG 400) + saline 0.9 % (70 : 30 parts)

Controls:

other: untreated skin of same animal

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: 50%

Duration of treatment / exposure:

24 hours

Observation period:

7 days

Number of animals:

6 (3 males + 3 females)

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm on back and flank
- Type of wrap if used: impermeable

SCORING SYSTEM: according to Draize

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:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

No irritant response data after a 24-hours occlusive exposure to intact skin. Grade 1 edema was noted after 24 and 48 h for some animals with abraded skin.

Any other information on results incl. tables

Individual cutaneous examinations and mean values (24-hour exposure, occlusive, intact skin):

Readings	Animal	Exposure period: 24 h, occlusive
		Erythema	Edema
24 h	01	0	0
	02	0	0
	03	0	0
	04	0	0
	05	0	0
	06	0	0
48 h	01	0	0
	02	0	0
	03	0	0
	04	0	0
	05	0	0
	06	0	0
72 h	01	0	0
	02	0	0
	03	0	0
	04	0	0
	05	0	0
	06	0	0
Mean (24, 48, 72 h)	01	0	0
	02	0	0
	03	0	0
	04	0	0
	05	0	0
	06	0	0
Mean (24, 48, 72 h)		0.0	0.0

 

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

The test material is not irritating to the rabbit skin.

Executive summary:

The test item contained 89% active ingredient and 10% urea and was applied at a concentration of 50% in vehicle (propylene glycol and saline, 70:30 parts). Three male and female New Zealand rabbits were shaved on the back. The left side was abraded. Gauze patches of 6.25 cm² were loaded with 0.5 g of the test item. Both the abraded and non abraded sites were treated and covered with an impermeable material for 24h. The skin irritation was assessed after 1, 2, 3, 4 and 7 days. Grade 1 edema was noted after 24 and 48 h for some animals with abraded skin only. Erythema could not be assessed due to the coloration by the dye.