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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995
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:
1994
Report date:
1995

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

Constituent 1
Chemical structure
Reference substance name:
Sodium p-(3-amino-4-methylbenzamido)benzenesulphonate
EC Number:
275-177-2
EC Name:
Sodium p-(3-amino-4-methylbenzamido)benzenesulphonate
Cas Number:
71077-34-4
Molecular formula:
C14H14N2O4S.Na
IUPAC Name:
sodium 4-[(3-amino-4-methylbenzoyl)amino]benzenesulfonate

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
-Strain: Wistar rat / Hoe: WISKf (SPF71)
- Source: HOECHST AG, Kastengrund, SPF breeding colony
- Age at study initiation: males about 7 weeks; females about 8 weeks
- Weight at study initiation: males 169+-5 grams; females 172+-5 grams
- Fasting period before study: 3 - 4 hours
- Housing: in fully air-conditioned rooms in makrolon cages on soft wood granulate in groups of 5 animals
- Diet: Altromin 1324 rat diet, Altromin GmbH, Lage/Lippe ( ad libitum)
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: not necessary (breeding at identical conditions)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%): 50+-20
- Lighting time: 12 hours daily

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg body weight
The animals received the compound as a 20 % suspension in deionised water, the application volume being 10 ml/kg body weight.
Details on study design:
- Duration of observation period following administration: 14 days (
- Frequency of observations: twice a day and weighing: weekly
- Other examinations performed: macroscopically visible changes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
no
Clinical signs:
stilted gait and squatting posture
Body weight:
Development of body weight was not impaired.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
For the substance the LD0 was determined as 2000 mg/kg bw and the LD50>2000 mg/kg bw
Executive summary:

Acute oral toxicity testing of the substance in the Wistar rat yielded a median lethal dose above 2000 mg/kg body weight in both male and female animals.

The prepared test substance was administered by gavage to fasted animals at the stated dosage. The observation period following treatment lasted for 14 days. Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and holidays only once. During this time the animals were weighed weekly. At the end of the observation period the animals were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.

No lethality after application of 2000 mg/kg body weight. Only stilted gait and squatting posture were observed after application in males and females. All clinical signs of intoxication were reversible on day three of the study and thereafter.

Development of body weight was not impaired.

The animals killed at the end of the observation period showed no macroscopically visible changes.

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