4-amino-2,5-dichloro-N,N-dimethylbenzenesulphonamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed GLP and OECD guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD guideline for testing of chemicals; section 4: Health Effects; Acute oral Toxicity; Adopted May 12, 1981

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-amino-2,5-dichloro-N,N-dimethylbenzenesulphonamide

EC Number:

247-501-2

EC Name:

4-amino-2,5-dichloro-N,N-dimethylbenzenesulphonamide

Cas Number:

26175-68-8

Molecular formula:

C8H10Cl2N2O2S

IUPAC Name:

4-amino-2,5-dichloro-N,N-dimethylbenzene-1-sulfonamide

Details on test material:

- Name of test material (as cited in study report): 1-Amino-2,5-dichlorbenzol-4-sulfonsaeure-dimethylamid (ADCS)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, 4414 Fuellinsdorf/Switzerland
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: males: 151 - 194 g; females 150 - 176 g
- Housing: Groups of five animals in Macrolone cages Type 3 with wire mash tops
- Diet: Pelleted standard Kliba 24/343/1 rat maintenance diet ad libitum
- Water : tap water ad libitum
- Acclimation period: 1 week under test conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-2
- Humidity (%): 55 +-10
- Air changes (per hr):
- Photoperiod: Light Cycle 12 hours/day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

2% solution in dist water

Doses:

group 1: 1000 mg/kg bw
group 2: 3000 mg/kg bw
group 3: 5000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 femals per dose group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily for specified symptomes and mortality, bodyweights were recorded at day 1, 7, 14
- Necropsy of survivors and animals found dead performed: yes
- Other examinations performed: clinical signs, body weight, autopsy and macroscopical examination

Statistics:

Logit Estimation

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 087 mg/kg bw

Based on:

test mat.

Mortality:

group 1 (1000 mg/kg bw): 0/5 males, 0/5 females
group 2 (3000 mg/kg bw): 1/5 males, 1/5 females
group 3 (5000 mg/kg bw): 2/5 males, 5/5 females

Clinical signs:

other: 1000 MG/KG: SEDATION, DYSPNOEA, EXOPHTHALMOS, VENTRAL- OR CURVED BODY POSITION, RUFFLED FUR 3000 MG/KG: SEDATION, COMA, DYSPNOEA, ATAXIA, VENTRAL-, LATERO-ABDOMINAL-, OR CURVED BODY POSITION, RUFFLED FUR 5000 MG/KG: SEDATION, SOMNOLENCE, COMA, DYSPNO

Gross pathology:

NO MACROSCOPICAL ORGAN CHANGES WERE OBSERVED.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

LD50 male and female: 4087 mg/kg bw

Executive summary:

The test substance was abministered orally to rats of both sexes in doses of 1000, 3000 and 5000 mg(kg bw. The death rates were 0% at 1000 mg/kg bw, 20% at 3000 mg/kg bw and 70% at 5000 mg/kg bw. Based on these observations the LOGIT-ESTIMATION for the acute oral LD50 in rats of both sexes is 4087 mg/kg bw.