Registration Dossier
Registration Dossier
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EC number: 419-370-3 | CAS number: 84632-66-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994-12-20 to 1995-01-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted February 24, 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 92/69/EEC, 31-Jul-1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1175 (Acute Oral Toxicity)
- Version / remarks:
- Revised as of July 01, 1991
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Testing Methods for New Chemical Substances according to the Revised Japanese Chemical Substance Law (March 31, 1987)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wolferstrasse 4, 4414 Füllinsdorf / Switzerland
- Age at study initiation: males: 8 weeks, females: 10 weeks
- Weight at study initiation: males: 199.6 - 210.9 g, females: 176.3 - 187.6 g
- Fasting period before study: yes, fasting for approximately 16 hours
- Housing: Groups of five per sex in Makrolon type-4 cages with autoclaved standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet: Pelleted standard Kliba 343, Batch no. 82/94 rat maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst) available ad libitum (except for the overnight fasting period prior to application).
- Water: Community tap water from Füllinsdorf, available ad libitum.
- Acclimation period: One week under laboratory conditions, after health examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-20.5
- Humidity (%): 46-62
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1994-12-13 To: 1995-01-03
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: standard vehicle according to guideline - Doses:
- single dose of 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 and weighing:
Mortality / Viability: Four times during test day 1 and daily for surviving animals during days 2-15.
Body Weights: On test day 1 (pre-administration), 8 and 15 for surviving animals.
Clinical Signs: Each animal was examined for changes in appearance and behaviour four times during day 1, and once daily for surviving animals during days 2-15. All abnormalities were recorded.
- Necropsy of survivors performed: yes
At the end of the observation period all surviving animals were anesthetized by intraperitoneal injection of NARCOREN (Rhone Merieux GmbH, D-88471 Laupheim, Germany) at a dose of at least 2.0 mL/kg body weight (equivalent to at least 320 mg sodium pentobarbitone/kg bw) and sacrificed by exsan- guination. The animals were examined macroscopically and all abnormalities recorded. - Statistics:
- No statistical assessment was performed due to lack of mortality.
Results and discussion
- Preliminary study:
- No preliminary study.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths as a result of treatment with the test article.
- Clinical signs:
- other: No clinical signs of toxicity were observed during the observation period.
- Gross pathology:
- No organ abnormalities were observed at necropsy.
- Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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