Sodium 4-(4-methyl-3-nitrobenzoylamino)benzenesulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed OECD study with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 4-(4-methyl-3-nitrobenzoylamino)benzenesulphonate

EC Number:

281-719-9

EC Name:

Sodium 4-(4-methyl-3-nitrobenzoylamino)benzenesulphonate

Cas Number:

84029-45-8

Molecular formula:

C14H12N2O6S.Na

IUPAC Name:

sodium 4-(4-methyl-3-nitrobenzoylamino)benzenesulphonate

Details on test material:

purity: 89.9 %

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Hoe: WISKf(SPF71)
- Source: HOECHST AG, Kastengrund, SPF-breeding
- Age at study initiation: males: about 7 weeks; females: about 8 weeks
- Weight at study initiation: males: 189 - 198 g; females: 159 - 175 g
- Fasting period before study: 16 hours
- Housing: in macrolone-cages in completely air-conditiones rooms
- Diet: Rattendiat Altromin 1324, ad libitum
- Water: tap water from trinking bottles, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%): 50+-20
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 2% potatoe starch in deionized water

Details on oral exposure:

dosis: 2000 mg/kg bw
concentration: 20 % (w/v)
application volume: 10 ml/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: twice a day and weighing: once a week
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Results and discussion

Preliminary study:

doses: 500, 1000 and 2000 mg/kg bw with one male and one female per dose.
no mortality, normal development of the body weights
the animals of the 1000 mg group showed squatting posture at the day of application,
the animals of the 2000 mg goup showed additionally decreased sponataneous activity.
One day post application all these eymptoms were reversible

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no

Clinical signs:

other: Decreased sonateous activity and squatting posture at the day of application. Completely reversible on the next day

Gross pathology:

no macroscopic findings

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the test result the LD50 ist greater than 2000 mg/kg bw for acute oral toxicity

Executive summary:

The substance was tested for acute oral toxicity according to OECD guideline 401. 5 male and 5 femal Wistar-rats were administered one single dose of 2000 mg/kg bw via gavage. No mortality occured, only one female showed a reduced development of the body weight. Symptoms such as squatting posture and decreased spontaneous activity were reversible at the the day after application.