Disodium oxybis[methylbenzenesulphonate]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

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:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8-12 weeks
- Weight at study initiation: step 1/animals no.1-3: 177-181 g, step 2/animals no 4-6: 178-183 g
- Fasting period before study: 16-19 hours
- Housing: in groups
- 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

Route of administration:

oral: gavage

Vehicle:

other: sterile water

Details on oral exposure:

The test item was administered at a single dose by gavage using a feeding tube.
The test item was administered at a dose volume of 10 mg/ kg bw.
All animals were observed for 14 days after dosing for general clinical signs, morbidity and mortality.

Doses:

The starting dose was selected to be 2000 mg/kg bw. ( step 1 and step 2).
As no animal died no further testing is required.

No. of animals per sex per dose:

3 females in each step

Control animals:

no

Details on study design:

The test item was administered at a single dose by gavage using a feeding tube to 3 female rats in each step.
The test item was administered at a dose volume of 10 mg/ kg bw.
All animals were observed for 14 days after dosing for general climical signs, morbidity and mortality.
All animals were weighed on day 1 prior to dosing and on days 8 and 12.
A careful examination was made severla times on the day of dosing and thereafter once daily.

Statistics:

no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No compound - related mortality was recorded for any animal of step 1 and step 2.

Clinical signs:

other: female rat 1-6: No signs of toxicity were observed during the whole observation period.

Gross pathology:

At necropsy, some macroscopic changes (female 4 and 5: red spots on the lungs) were observed. These findings are not considered to be test item related.
No specific gross pathological changes were reported.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Executive summary:

Two groups, each of three female Wistar rats, are treated with ditolylether disulfonic acid disodium salt, isomer mixture by oral gavage administration at a dosage of 2000 mg/kg bw (OECD TG 423 and GLP). All animals were observed for 14 days post dosing. No mortality occurred and no clinical signs of intoxication were noted. Body weight gain was within the normal range. At necropsy, no treatment related macroscopic findings were observed in any animal of any step. Thus, the LD50 is > 2000 mg/kg bw.