Sodium sulphanilate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 09 May 1995 to 16 May 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline and EU method. GLP study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium sulphanilate

EC Number:

208-208-5

EC Name:

Sodium sulphanilate

Cas Number:

515-74-2

Molecular formula:

C6H7NO3S.Na

IUPAC Name:

sodium 4-aminobenzenesulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Physical state: white powder
- Analytical purity: 91.5%
- Lot/batch No.: 868 TO
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd., Wyton, Huntingdon, England
- Weight at study initiation: 3.9-4.3 kg
- Housing: The rabbits were individually housed in stainless steel cages with flat rod bases or plastic cages with perforated bases, under standardized conventional conditions.
- Diet (e.g. ad libitum): Standard diet "Ssniff K4", approx. 100-120 g per animal/day; once per day in the morning.
- Water (e.g. ad libitum): Tap water; ad libitum.
- Acclimation period: Approximately one week.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 ºC (higher when ambient temperature over 24 ºC)
- Humidity (%): 50-70%
- Air changes (per hr): 12-15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours, artificial illumination from 6 a.m. to 6 p.m.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: the test substance was moistened with deionized water

Controls:

other: no control animals (the contralateral skin area not treated with test substance served as control)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of the pulverized test substance.

Duration of treatment / exposure:

Four hours

Observation period:

1, 24, 48 and 72 hours and 7 days

Number of animals:

Three animals

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: A patch was placed on the exposed area and held in place with a semiocclusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exposed skin areas were carefully washed with water without altering the existing response or the integrity of the epidermis.
- Time after start of exposure: Four hours.

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 (R) to slight eschar formation (S) 4R or 4S

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24-72 h

Score:

0

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24-72 h

Score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24-72 h

Score:

0

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24-72 h

Score:

0

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24-72 h

Score:

0

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24-72 h

Score:

0

Any other information on results incl. tables

Table 1: Dermal irritation scores

 

	Erythema			Oedema
Animal No	1	2	3	1	2	3
after 24 h	0	0	0	0	0	0
after 48 h	0	0	0	0	0	0
after 72 h	0	0	0	0	0	0
Mean score 24 – 72 h	0			0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The results of the exposure of the test substance to the skin indicate that the test substance may be regarded as not irritating to the skin.

Executive summary:

The acute skin irritation/corrosion study was performed according to the OECD Guideline No. 404 and EU Method B.4. The test item in the amount of 0.5 g was applied only once to the shaved skin of three animals. The exposure lasted four hours. Detailed clinical observations of the treated skin were performed 1, 24, 48 and 72 hours and 7 days after the end of the exposure. The results of the exposure of the test substance to the skin indicate that the test substance may be regarded as not irritating to the skin.