Benzenesulfonamide, N-[2-[[(phenylamino)carbonyl]amino]phenyl]-

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF Guidelines, 2000

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-(2-benzenesulfonamidophenyl)-3-phenylurea

EC Number:

806-543-7

Cas Number:

215917-77-4

Molecular formula:

C19H17N3O3S

IUPAC Name:

1-(2-benzenesulfonamidophenyl)-3-phenylurea

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: Approximately 8 weeks old
- Weight at study initiation: Did not exceed ± 20% of sex mean. Approximately 149 g.
- Fasting period before study: Animals were deprived of food overnight prior to dosing and until 3-4 hours after dosing.
- Housing: Group housing of 3 animals per cage in labelled makrolon cages containing sterilized sawdust as bedding.
- Diet (e.g. ad libitum): Free access to pelleted rodent diet.
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: At least 5 days prior to treatment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24°C
- Humidity (%): 40 - 70%
- Air changes (per hr): 10 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours ligh/ 12 hours dark cycle

IN-LIFE DATES: From: To: 2014-06-17 to 2014-07-03

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

Oral gavage, using plastic feeding tubes.
Vehicle: Propylene glycol (Merck, Darmstadt, Germany) (specific gravity 1.036)
Preparation: The formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level.
Adjustment was made for specific gravity of the vehicle. No correction was made for purity of the test substance.

Doses:

2000 mg/kg body weight to two successive groups.

No. of animals per sex per dose:

3 (6 in total, two successive doses)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Bodyweights - Days 1 (pre-administration), 8 and 15.
Clinical signs - At periodic intervals on the day of dosing (Day 1) and once daily thereafter until Day 15.

- Necropsy of survivors performed: Yes
- Other examinations performed: Macroscopic abnormalities

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No unscheduled mortality occured

Clinical signs:

other: Hunched posture and/or piloerection were noted for the animals between Days 1 and 3.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the study according to OECD TG 423 the LD50 value exceeds 2000 mg/kg bw.