Disodium oxybis[methylbenzenesulphonate]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: males 9 weeks, females 14 weeks
- Weight at study initiation: males 222-246 g, females 211-224 g
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The test item was applied at a single dose, uniformly over an area which was approximately 10 % of the total body surface.
The test item was moistened with water to ensure good skin contact and was held in place by semi-occlusive dressing for 24 hours.
At the end of the exposure period (24 hours) the residual test item was removed using tap water

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

other: the opposite site to the treatment area

Details on study design:

The test item was applied at a single dose, uniformly over an area which was approximately 10 % of the total body surface.
The test item was moistened with water to ensure good skin contact and was held in place by semi-occlusive dressing for 24 hours.
At the end of the exposure period (24 hours) the residual test item was removed using tap water.
Animals were observed for 14 days for clinical signs and mortality. Necropsy was performed at the end of the study.

Statistics:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no rat died, no signs of acute dermal toxiciy, no significant signs of dermal irritation

Mortality:

no rat died

Clinical signs:

other: no clinical signs of systemic toxicity: no significant signs of irritation

Gross pathology:

No specific gross pathological changes were recorded for any animal.

Other findings:

No erythema or oedema was observed. Eschar was observed in 3 or 5 male and 4 of 5 female animals. These signs of irritation were reversible within the observation period in all animals with exception of one female rat.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Executive summary:

5 male and 5 female rats were dermally treated with moistened 2000 mg/kg bw ditolylether disulfonic acid disodium salt, isomer mixture for 24 hours. (OECD TG 402, limit test). The test item was held in place by semi-occlusive dressing.

Under the condition of this study single dermal application of ditolylether disulfonic acid disodium salt, isomer mixture to rats was associated with no mortality and neither signs of toxicity nor significant signs of irritation.

The dermal LD50 was determined to be > 2000 mg/kg bw.