4-amino-2,5-dimethoxy-N-phenylbenzenesulphonamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets basic scientific principles. Study was conducted prior to GLP and OECD guideline implementation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: company guideline similar to OECD 401

Deviations:

no

Principles of method if other than guideline:

Due to its slightly higher sensitivity, demonstrated in pre-tests, only male rats were tested in the main study.

GLP compliance:

no

Remarks:

prior to GLP implementation

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-amino-2,5-dimethoxy-N-phenylbenzenesulphonamide

EC Number:

257-821-4

EC Name:

4-amino-2,5-dimethoxy-N-phenylbenzenesulphonamide

Cas Number:

52298-44-9

Molecular formula:

C14H16N2O4S

IUPAC Name:

4-amino-2,5-dimethoxy-N-phenylbenzene-1-sulfonamide

Details on test material:

- Name of test material (as cited in study report): Chinonbasesulfanilid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG breeding station
- Weight at study initiation: 80 - 114 grams (average 94 grams)
- Fasting period before study: 16 hours
- Housing: plastic-cages with wood shavings
- Diet : Altromin 1324 (Fa. Altrogge, Lage/Lippe) ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10%

Doses:

530, 1000, 1600, 2500, 5000 mg/kg bw

No. of animals per sex per dose:

10 male

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: daily; weighing: intially, after 7 days, after 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

Probit analysis (according to LINDER und WEBER)

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

1 445 mg/kg bw

Based on:

test mat.

Mortality:

630 mg/kg bw 0 of 10
1000 mg/kg bw 1 of 10
1600 mg/kg bw 6 of 10
2500 mg/kg bw 10 of 10
5000 mg/kg bw 10 of 10

Clinical signs:

other: Lethaly intoxicated animlas showed disequilibrium and prone position before dying.

Gross pathology:

No abnormal findings in survivors or animals found dead.

Other findings:

No other findings.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

LD50: 1445 mg/kg bw

Executive summary:

Acute toxicity of Chinonbasesulfanilid was tested according to a company operating procedure similar to OECD 401. Following this protocol five doses of the test item were administered by gavage to 10 male rats per dose. During the observation period of 14 days mortality occured at doses of 1000 (1/10), 1600 (6/10), 2500 (10/10), and 5000 mg/kg bw (10/10). The LD50 of 1445 mg/kg was calculated by probit analysis (according to Linder and Weber).