Disodium oxybis[methylbenzenesulphonate]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Disodium oxybis[methylbenzenesulphonate]

EC Number:

277-242-0

EC Name:

Disodium oxybis[methylbenzenesulphonate]

Cas Number:

73037-34-0

Molecular formula:

C14H12Na2O7S2

IUPAC Name:

disodium oxybis(methylbenzenesulfonate)

Test material form:

solid

Details on test material:

Active content reported: 90-95 %

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: female: approx. 23-24 weeks
- Weight at study initiation: > 2 kg
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18
- Humidity (%): 55
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: test substance was only moistened

Controls:

other: The opposite site of the treatment area served as control.

Amount / concentration applied:

0.5 g to each test side, moistened with water to ensure good contact to the skin.

Duration of treatment / exposure:

4 hours

Observation period:

up to 72 hours post treatment

Number of animals:

3

Details on study design:

The test item ws applied first to a gauze patch.
To ensure good skin contact it was moistened with tap water.
The patch was then applied to the skin on a small area (approx 6cm² of the left side of the dorsal area ; the right side served as control).
The patch was fixed with a semi-occlusive dressing for a 4-hour period.
At the end of the exposure operiod the residual test item was removed with tap water.
All animals were observed for 72 hours after the patch removal.
Scoring for oedema and erythema was made according to Draize.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: up to 72 hours

Score:

ca. 0

Max. score:

4

Reversibility:

other: no signs of erythema were reported

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: up to 72 hours

Score:

ca. 0

Max. score:

4

Reversibility:

other: no signs of oedema were reported

Irritant / corrosive response data:

No irritant or corrosive effects were observed on the intact skin of thee female rabbits after a contact time of 4 hours.

Other effects:

Neither mortality nor significant clinical signs of toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Executive summary:

Three New Zealand white rabbits received dermal application of 0.5 g moistened ditolylether disulfonic acid disodium salt, isomer mixture to the shaved dorsal skin (left side) for 4 hours. The right side of the dosal skin served as control (OECD TG 404). The test substance was held in place by a semi-occlusive dressing. After termination of the exposure the residue test substance was removed with tap water. The animals were observed for 72 hours post treatment. Under the conditions of the study ditolylether disulfonic acid disodium salt, isomer mixture caused no irritating or corrosive skin effect. No clinical signs of systemic intoxication are observed.