Registration Dossier
Registration Dossier
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EC number: 921-820-3 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999/01/19 to 1999/02/02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was conduced in accoradance to an accepted guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
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
- Reference substance name:
- Montanov L
- IUPAC Name:
- Montanov L
- Details on test material:
- - Common name: Montanov L
- Batch: 1556 MP
- Colour: beige
- Laboratory's reference: 98-4788
- Stockage: ambiant temperature, away from light and in a dedicated local
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Sepcies: albinos rats, no pathogen organism, Sprague-Dawley
- Origin: IFFA CREDO (69592 L'Abresle Cedex, France)
- Between 5 and 7 weeks old
- Acclimatization: at least 5 days before the study
- Weight: the animal have been weighted the day before the beginning of the study
- Identification of animals: individually, by a number with picric acid
- Housing: 5 per cage
- Temperature:22 +/- 2°C
- Relative humidity: 50 +/- 20%
- Air renewal: 10 cycles per hour
- Light: 12/12
- Feeding: supplied by an external client
- Drinking: water analysed by an external laboratory
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2000mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- The substance was diluted in PPI water.
Each rat received 7.5mL/kg, depending on their weight.
After administration, the rats received no feeding during 3 to 4 hours.
Animals have been weight on day 0, 4, 8 and 15.
Clinical obervations have been done 30 minutes, 1h, 2h, 3h, 4h, 5h, and 6h after administration, and at least once a day and for 14 days.
Observed parameters: spontaneous activity, Preyer's reflex, respiratory activity, convulsion, trembling, temperature, musculary tonus, gripping force, mydriase, salivation, watering, turnaround, diarrhea, lethargy, coma, skin, eyes modifcation, mortality.
All survival animals have been autopsied, they have been euthanasied with a pentobarbital injection.
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No martality occured in this test.
- Clinical signs:
- other: No clinical sign was noticed.
- Gross pathology:
- No findings.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the criteria of Directive 67/548/CEE, the substance was not classified as dangerous by oral route.
- Executive summary:
The aim of this study was to assess qualitively and quantitatively the toxic effects and the delay of appearence after single oral administration of 2000mg/kg body weight, of test item suspended with distilled water, in 10 Sprague-Dawley rats
(5 males and 5 females).This study was conduced according to OECD guideline 401 and in compliance with the GLP.
The animals were daily observed for at least 14 days after administration and the signs of toxicity (mortality...) were noted. The test substance was classified as dangerous or not dangerous by ingestion in accordance with the EEC 67/548 directive and its amendements.
LD0 and LD50 are superior to 2000mg/kg.
The test substance is not classified among the substances dangerous if swallowed.
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