3-({[(4-methylphenyl)sulfonyl]carbamoyl}amino)phenyl 4-methylbenzenesulfonate;N-(p-toluenesulfonyl)-N'-(3-(p-toluenesulfonyloxy)phenyl)urea

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: OECD-guideline and GLP-compliant study report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

(1996)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

432-520-2

EC Name:

-

Cas Number:

232938-43-1

Molecular formula:

C21 H20 N2 O6 S2

IUPAC Name:

3-{[(4-methylbenzenesulfonyl)carbamoyl]amino}phenyl 4-methylbenzene-1-sulfonate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain as stated in the report: Hanlbm: WIST (SPF)
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, CH-4414 Fullinsdorf / Switzerland
- Age at study initiation:Females: 10 weeks, Males: 8 weeks
- Weight at study initiation: no data
- Housing: Groups of three in Makrolon type-4 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz)
- Diet:ad libitum
- Water:ad libitum
- Acclimation period: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22±3°C
- Humidity (%):40-70% (values above 70% during cleaning process possible)
- Air changes (per hr):10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.2 g/ml
- Amount of vehicle: 10 ml/ kg bw
- Justification for choice of vehicle: solubility

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality: Four times during test day 1 and once daily during days 2-15.
Body weights: On test day 1 (pre-administration), 8 and 15.
Clinical signs: Each animal was examined for changes in appearance and behavior four times during day 1, and once daily during days 2-15. A description of all abnormalities was recorded.
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was used as only one death occurred.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One of three males was found dead 3 hours after treatment. None of the treated females died.

Clinical signs:

other: Ruffled fur was observed in one male on test day 3. No clinical signs were noted during the observation period in all other surviving animals.

Gross pathology:

No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Single oral administration of 2000 mg/kg bw test article to female and male rats resulted in one unscheduled death, ruffled fur and no clinical signs or macroscopic findings. Thus, the LD50 was above 2000 mg/kg bw for both sexes.