1H,5H-Pyrazolo(1,2-a)pyrazol-1-one, 2,3-diamino-6,7-dihydro-, dimethanesulfonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 september 2006 to 03 October 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): R0054002C, synonym IMEXINE OBH
- Physical state: beige to yellow powder
- Purity: 99.7%
- Impurities (identity and concentrations): not indicated
- Purity test date: 20 July 2006
- Lot/batch No.: R0054002C 013 L 001, synonym 0604070001
- Expiration date of the lot/batch: 01 August 2007
- Stability under test conditions: not indicated
- Storage condition of test material: at room temperature and under nitrogen gas

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Janvier, Le-Genest-Saint-Isle, France
- Age at study initiation: 8 weeks
- Weight at study initiation: 194 +/- 4 g
- Fasting period before study: 18 hours
- Housing: Polycarbonate cages with stainless steel lid
- Diet (e.g. ad libitum): SsniffR/M-H pelleted diet
- Water (e.g. ad libitum): drinking water filtered by FG Millipore membrane
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 30 to 70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 2006-09-07 To: 2006-10-03

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: purified water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg


DOSAGE PREPARATION (if unusual): The test item dosage forms were prepared extemporaneously under nitrogen atmosphere.
The test item preparations were kept under nitrogen gas.



CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on the results of a previous study, the starting dose-level was 2000 mg/kg.

Doses:

2000 mg/kg.

No. of animals per sex per dose:

6

Control animals:

other: historical control animals

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once a day (for observation) and on days 1, 8 and 15 (for weighing)
- Necropsy of survivors performed: yes
- Other examinations performed: none

Statistics:

None

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

None.

Clinical signs:

Hypoactivity and piloerection (all the animals) and dyspnea (3/6 animals) were observed within 4 hours of treatment. No clinical signs persisted thereafter, until the end of the observation period (day 15).

Body weight:

Not affected.

Gross pathology:

No apparent abnormalities.

Other findings:

None.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 of the test item was higher than 2000 mg/kg in rats.