Toluene-4-sulphonamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study was performed pre-GLP. Alike OECD 404, but with some deviations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: U.S. FDA (Fed. Reg. 28 (119), 5582, 1963)

Principles of method if other than guideline:

- exposure period 24 hours
- rabbit skin is exposed under occlusion
- the test substance is not moistened to ensure optimal skin contact
- the animal skin is exposed intact (6 animals) and abraded (6 animals)
- it cannot be assessed if/when effects are reversible. Observation were made up to 72 hour after exposure.
- no details on test animals and their accomodation

GLP compliance:

no

Remarks:

pre-GLP

Test material

Test material information

Constituent 1

Reference substance name:

Toluene-4-sulphonamide

EC Number:

200-741-1

EC Name:

Toluene-4-sulphonamide

Cas Number:

70-55-3

Molecular formula:

C7H9NO2S

IUPAC Name:

4-methylbenzene-1-sulfonamide

Constituent 2

Reference substance name:

p-Toluenesulfonamide

IUPAC Name:

p-Toluenesulfonamide

Test material form:

solid: crystalline

Details on test material:

Name: para toluenesulfonamide
Appearance: a white solid
Date received: 15 March 1978

No further data

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

Duration of treatment / exposure:

24 hours

Observation period:

The skin is evaluated 24 and 72 hours after the start of exposure.

Number of animals:

6 with intact and 6 with abraded skin

Details on study design:

TEST SITE
- Area of exposure: back of the animal
- % coverage: 2.5x2.5 cm
- Type of wrap if used: Surgical patch measuring 1 inch x 1 inch (2.5 x2.5 cm). The patches are fixed to the application site by means of adhesive tape and the entire trunk of the rabbits is wrapped with an impervious material.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: not applicable


SCORING SYSTEM: Draize
Erythema and eschar formation
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) to slight eschar formation (injuries in depth)

Oedema formation
0 No oedema
1 Very slight edema(barely perceptible)
2 Slight edema(edges of the area well defined by definite raising)
3 Moderate edema(raised approximately 1mm)
4 Severe edema( raised more than 1 mm and extending beyond the area of exposure)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-72 hours

Score:

0.3

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: intact + abraded skin

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-72 hours

Score:

0

Max. score:

4

Remarks on result:

other: intact + abraded skin

Irritant / corrosive response data:

after 24 hours: Highest score: very slight erythema, no oedema
after 72 hours: Highest score: very slight erythema, no oedema

No difference was observed between intact and abraded skin

Any other information on results incl. tables

Results

Rabbit No and sex		Hours after instillation		Average 24-72 hours: Intact	Rabbit No and sex	Hours after instillation		Average 24-72 hours: Abraded
	Site	24	72			24	72
7247	erythema	1	0	0.5	7241	0	0	0
	oedema	0	0	0		0	0	0
7248	erythema	D	D	D	7242	1	0	0.5
	oedema	D	D	D		0	0	0
7249	erythema	0	0	0	7243	1	0	0.5
	oedema	0	0	0		0	0	0
7250	erythema	0	0	0	7244	1	0	0.5
	oedema	0	0	0		0	0	0
7251	erythema	1	0	0.5	7245	1	0	0.5
	oedema	0	0	0		0	0	0
7252	erythema	0	1	0.5	7246	1	1	1
	oedema	0	0	0		0	0	0

D = dead

Highest grade observed: very slight erythema, no oedema

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The results show that the test substance is very slightly irritating to skin. It causes minimal erythema and no oedema. The contact time is too long but the test substance was not moistened so contact with the skin may not have been optimal. Reversibility cannot be assessed but the effects are of such minimal nature that full reversibility is expected well within 14 days. Although this study has deviations performing a new study is not warranted because it will not provide any new information. With this study it has been shown that the substance is not a skin irritant according to GHS.

Executive summary:

The primary irritation of p-TSA to the skin is measured by a occlusive patch-test technique on the abraded and intact skin of albino rabbits. The study was performed according to methods similar to OECD404. but with the following deviations:

- exposure period 24 hours

- rabbit skin is exposed under occlusion

- the test substance is not moistened to ensure optimal skin contact

- the animal skin is exposed intact and abraded

- it cannot be assessed if/when effects are reversible. Observations were made up to 72 hour after exposure.

- no details on test substance identity or composition

- no details on test animals and their accommodation

Twelve healthy adult New Zealand White albino rabbits are used. Twenty four hours prior to applying the materials, the hair is removed from the backs of the animals with an electric clipper in such a way as to avoid abrasions. An amount of 0.5 g is placed on the skin under occlusion for 24 hours. The skin is evaluated 24 and 72 hours after the start of exposure. After 24 hours: very slight erythema after 72 hours: very slight erythema. No difference was observed between intact and abraded skin.

The results show that the test substance is very slightly irritating to skin. It causes minimal erythema (Very slight erythema - barely perceptible)

and no oedema. The contact time is too long but the test substance was not moistened so contact with the skin may not have been optimal. Reversibility cannot be assessed but the effects are of such minimal nature that full reversibility is expected well within 14 days. Although this study has many deviations performing a new study is not warranted because it is not expected to provide any new information. With this study it has been shown that the substance is not a skin irritant according to GHS.