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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 September 2006 to 19 September 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 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute 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:

male/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 old
- Weight at study initiation: 308 +/- 9 g for the males and 219 +/- 10 g for the females
- Housing: polycarbonate cages with stainless steel lid.
- Diet (e.g. ad libitum): SsniffR/M-H pelleted diet
- Water (e.g. ad libitum): filtered water.
- Acclimation period: at least 5 days before the beginning of the study.


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

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 5 cm x 7 cm for the males and 5 cm x 6 cm for the females
- % coverage: 10% of the total body surface
- Type of wrap if used: semi-occlusive dressing


REMOVAL OF DRESSING
- Washing (if done): any residual test substance was removed using a moistened cotton pad.
- Time after start of exposure: 24 hours


TEST MATERIAL
- Concentration (if solution): test item applied in its original form (powder)
- Constant volume or concentration used: 2000 mg/kg
- For solids, paste formed: no, but hydrophilic gauze pad was moistened with purified water.

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

other: historical control animals

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: at least once a day, and weighing: day 1, 8 and 15
- Necropsy of survivors performed: yes
- other observations performed: cutaneous reactions

Statistics:

None

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

None

Clinical signs:

None

Body weight:

Not affected

Gross pathology:

No apparent abnormalities

Other findings:

- Other observations: yellow coloration of the skin, crusts (5/10 animals), dryness of the skin (2/10 animals)

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No deaths were observed after a single dermal application of the test item at the dose-level of 2000 mg/kg in Sprague-Dawley rats.