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:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Justification for type of information:
Data is from study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as metioned below
Principles of method if other than guideline:
Acute oral toxicity test of 4-amino-N-(4-aminophenyl)benzenesulphonamide (16803-97-7) in Rat.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name - 4-amino-N-(4-aminophenyl)benzenesulphonamide
InChI - 1S/C12H13N3O2S/c13-9-1-3-10(4-2-9)15-11-5-7-12(8-6-11)18(14,16)17/h1-8,15H,13H2,(H2,14,16,17)
Smiles - O=S(=O)(c1ccc(cc1)Nc1ccc(cc1)N)N
Mol. formula: C12H13N3O2S
Molecular Weight - 263.32 g/mole
Specific details on test material used for the study:
Name - 4-amino-N-(4-aminophenyl)benzenesulphonamide
InChI - 1S/C12H13N3O2S/c13-9-1-3-10
(4-2-9)15-11-5-7-12(8-6-11)18(14,16)17/h1-8,15H,13H2,(H2,14,16,17)
Smiles - O=S(=O)(c1ccc(cc1)Nc1ccc(cc1)N)N
Mol. formula: C12H13N3O2S
Molecular Weight - 263.32 g/mole
Purity - 90-95%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: SPF-breeding: Company WIGA, Sulzfeld
- Weight at study initiation: male animals -222 g, female animals -182 g
- Diet (e.g. ad libitum): The rats received Altromin-R ad libitum
- Water (e.g. ad libitum):ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10000, 6400, 3200 and 1600 mg/kg
- Amount of vehicle (if gavage): The product was administered once in different doses as 16 and 20 % aqueous suspension (w / v) with carboxymethylcellulose through the gavage
MAXIMUM DOSE VOLUME APPLIED: 10000mg/kg
Doses:
10000, 6400, 3200 and 1600 mg/kg
No. of animals per sex per dose:
Total = 20 (Male/Female)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality was observed at 1, 24 and 48 h as well as after 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: Animals were observed for symptoms of intoxication, macroscopical examination.
Statistics:
The median lethal dose (LD50) was calculated according to LITCHFIELD and WILCOXON.

Results and discussion

Preliminary study:
No data
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
7 100 mg/kg bw
Based on:
test mat.
95% CL:
5 504 - 9 159
Remarks on result:
other: 50% mortality observed
Mortality:
At 6400 mg/kg - Female: 1/5 died at 48 hours and 3/5 died at 7 days; Male: 1/5 died at 48 hours.
At 10000 mg/kg - Female: 1/5 died at 24 hours, 4/5 at 48 hours and 5/5 at 7 days period; Male: 2/5 died at 24 hours, 3/5 died at 48 hours and 3/5 died at 7 days period.
Clinical signs:
Symptoms of poisoning such as dyspnea, apathy, bitten tails, dark yellow urin, calm behavior, slight tumbling was observed in animals.
Body weight:
No data
Gross pathology:
In Died animals - acute stasis hyperemia, acute cardiac dilation, Liver clay gray, a bit bright Kidneys were observed.
In Killed animals - Internal organs were found without any pathological findings after macroscopic examination.
Other findings:
No data

Any other information on results incl. tables

Table - Mortality

Dose mg/kg

Conc. %

Animal number

dies within

1 Hour

24 Hours

48 Hours

7 Days

14 Days

10000

 

 

20

5 M

5 F

0/5

0/5

2/5

1/5

3/5

4/5

3/5

5/5

3/5

5/5

6400

5 M

5 F

0/5

0/5

1/5

0/5

1/5

1/5

1/5

3/5

1/5

3/5

3200

5 M

5 F

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

1600

16

5 M

5 F

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

 

LD 50: 7100 (5504 - 9159) mg/kg

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The LD50 was considered to be 7100 mg/kg bw with the confidential limit of 5504 – 9159mg/kg, when Sprague-Dawley male and female rats were treated with 4-amino-N-(4-aminophenyl)benzenesulphonamide via oral gavage route.
Executive summary:

The acute oral toxicity of 4-amino-N-(4-aminophenyl)benzenesulphonamide (16803-97-7) was tested in Sprague-Dawley male and female rat at the dose concentration of 10000, 6400, 3200 and 1600 mg/kg bw at 16 and 20 % aqueous suspension (W / v) with Carboxymethylcellulose. The test substance (90-95%) was applied through the gavage route. The animals was taken from SPF-breeding:Company WIGA,Sulzfeld of body weight-male animals 222g and female animals-182g. The rats received Altromin-R from the company Altrogge, Lage / Lippe, and water ad libitum. Mortality was observed at 1, 24 and 48 h as well as after 7 and 14 days. Animals were observed for symptoms of intoxication, macroscopical examination.The median lethal dose (LD50) was calculated according to LITCHFIELD and WILCOXON.50% mortality observed at 7100(5504-9159) mg/kg bw. Symptoms of poisoning such as dyspnea, apathy, bitten tails, dark yellow urin, calm behavior, slight tumbling was observed in animals. In Died animals - acute stasis hyperemia, acute cardiac dilation, Liver clay gray, a bit bright Kidneys were observed. In Killed animals - Internal organs were found without any pathological findings after macroscopic examination.Therefore, LD50 was considered to be 7100 mg/kg bw with the confidential limit of 5504 – 9159mg/kg, when Sprague-Dawley male and female rats were treated with 4-amino-N-(4-aminophenyl)benzenesulphonamide via oral gavage route.