4-amino-N-(4-aminophenyl)benzenesulphonamide

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:

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

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

Test material information

Constituent 1

Reference substance name:

4-amino-N-(4-aminophenyl)benzenesulphonamide

EC Number:

240-834-4

EC Name:

4-amino-N-(4-aminophenyl)benzenesulphonamide

Cas Number:

16803-97-7

Molecular formula:

C12H13N3O2S

IUPAC Name:

4-amino-N-(4-aminophenyl)benzenesulphonamide

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 or test system 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:

other: Symptoms of poisoning such as dyspnea, apathy, bitten tails, dark yellow urin, calm behavior, slight tumbling was observed in animals.

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.