m-(4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl)benzenesulphonic acid

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:

other: Well performed GLP and OECD guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

m-(4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl)benzenesulphonic acid

EC Number:

204-303-0

EC Name:

m-(4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl)benzenesulphonic acid

Cas Number:

119-17-5

Molecular formula:

C10H10N2O4S

IUPAC Name:

3-(3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-1-yl)benzene-1-sulfonic acid

Details on test material:

- Name of test material (as cited in study report): Pyrazolsäure 3 TF

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Strain: Hoe: WISKf(SPF71)
- Source: Hoechst AG breeding colony
- Weight: male: mean 195 +/- 2 g, female: mean 180 +/- 6g
- Age: male: approx. 7 weeks, female: approx. 8 weeks
- Randomisation: yes
- Housing: Makrolon cages in air conditioned rooms, groups of 5 animals
- Temperature: 22 +/- 3 °C
- Rel. humidity: 50 +/- 20 %
- Lighting: 12 hrs daily
- Acclimatisation: at least 5 days
- Withdrawal of food: approx. 16 hours before and 3-4 hours post application
- Diet: Altromin 1324, ad libitum
- Water: tap water in plastic bottles, ad libitum
- Labelling: Labelling of fur with KMnO4 as well as numbering of cages

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 2% potato starch mucilage

Details on oral exposure:

VEHICLE

- Concentration in vehicle: 20 % (v/v)
- Amount of vehicle (if gavage): 10 ml/kg bw

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

Doses:

single dose (2000 mg/kg bw)

No. of animals per sex per dose:

5 male, 5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: On day of application the urine of the animals showed a reddish discoloration.

Gross pathology:

No findings at end of study.

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 rat): >2000 mg/kg bw

Executive summary:

Testing of acute oral toxicity of Pyrazolsäure 3 TF in male and female Wistar rats according to OECD guideline 401 yielded an LD50 value above 2000 mg/kg body weight. After application of 2000 mg/kg bw neither deaths nor other symptoms of toxicity were seen during the observation period. The urine of the animals showed a reddish discoloration on the day of application. The body weight development was not affected.

Gross pathology at the end of study did not yield any findings.