Registration Dossier

Diss Factsheets

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:
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.