Sodium toluene-4-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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As described in the U.S. Federal Register Vol. 38, No. 187, Section 1500:41, 1973

Deviations:

not specified

Principles of method if other than guideline:

Shaved skin; abraded and non-abraded; two sites per animal; exposed area covered; oedema and erythema assessed at 24 and 72 hours; primary irritation index evaluated following Draize scoring procedure.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium toluene-4-sulphonate

EC Number:

211-522-5

EC Name:

Sodium toluene-4-sulphonate

Cas Number:

657-84-1

Molecular formula:

C7H7O3S.Na

IUPAC Name:

4-methylbenzenesulfonic acid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: "recognized breeders"
- Age at study initiation: 14-16 weeks
- Weight at study initiation: 2.3 Kg average
- Housing: caged singularly
- Diet: ad libitum (commercial rabbit diet supplied by Rank Hovis MacDougal)
- Water: filtered water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 °C +/- 2 °C
- Humidity (%): 50-70%- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): natural lighting conditions

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted

VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle

Duration of treatment / exposure:

single application; patch removed at 24 hours but no indication of excess material wiped off

Observation period:

24 and 72 hours

Number of animals:

6 females

Details on study design:

TEST SITE
- Area of exposure: Two 2.5 cm sites, one abraded and one not abraded- % coverage: no data
- Type of wrap if used: Smith & Nephew Elastic bandage covered entire trunk of animal

STUDY DESIGN
24 hours prior to dermal application, the backs of the rabbits were shaved over an area of at least 10% of the trunk. Two test sites lateral to the mid line of the back were used on each animal. Immediately before the application of the test substance, the right hand site was abraded witht he 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.
0.5 ml of the pre—application preparation of the test compound was applied to each test site on a 2. 5 cms square gauze pad, which was secured by adhesive tape.
The entire trunk of the animal was covered with Smith & Nephew Elastic bandage to prevent evaporation of the test material.
After 24 hours the dressing was removed and the intact and abraded si tes were assessed for oedema and erythema.
Readings were again made at the end of a total of 72 hours (4B hours after the first reading).

REMOVAL OF TEST SUBSTANCE- Washing (if done): not indicatedSCORING SYSTEM: J.H. Draize (1959) - primary irritation score (average for erythema and oedema for all six animals)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No irritation on intact skin.
Slight erythema (score = 1) in 3 of 6 animals at 24 hours with abraded skin fully reversible in 72 hours.
No oedema observed in any animals.

Other effects:

None reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Not irritant

Executive summary:

The skin irritation of Sodium toluene 4-sulphonate was assessed following official method U.S. Federal Register Vol. 38, No. 187, Section 1500:41, 1973. The results showed no irritation on intact skin, slight erythema (score = 1) in 3 of 6 animals at 24 hours with abraded skin fully reversible in 72 hours and no oedema observed in any animals.