Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
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

Constituent 1
Chemical structure
Reference substance name:
N-{2-[(phenylcarbamoyl)amino]phenyl}benzenesulfonamide
EC Number:
806-543-7
Cas Number:
215917-77-4
Molecular formula:
C19H17N3O3S
IUPAC Name:
N-{2-[(phenylcarbamoyl)amino]phenyl}benzenesulfonamide
Specific details on test material used for the study:
Batch: CDC-003

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:
2000mg/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:
Hunched posture and/or piloerection were noted for the animals between Days 1 and 3.
Body weight:
The bodyweight gain showed by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
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 OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.