Registration Dossier
Registration Dossier
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EC number: 281-682-9 | CAS number: 84012-38-4 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Ruscus aculeatus, Liliaceae.
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: the Study was performed in 1980
- Deviations:
- not specified
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Ruscus aculeatus, ext.
- EC Number:
- 281-682-9
- EC Name:
- Ruscus aculeatus, ext.
- Cas Number:
- 84012-38-4
- Molecular formula:
- not applicable
- IUPAC Name:
- Ruscus aculeatus, ext.
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 5000; 6294; 7924 and 10.000 mg/kg
- No. of animals per sex per dose:
- 5 males/ 5 females
- Control animals:
- no
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 0
- Clinical signs:
- Clinical observations consisted of soft faces, observed at all dose levels;
Urine stains, observed at 5000, 7924 and 10.000 mg/kg dose levels.
Slight depression and rough coat, observed at the 6294, 7924 and 10.000 dose levels. - Body weight:
- All animals gained weight during the 14 day observation period.
- Gross pathology:
- No observable gross pathology was noted in any of the animals
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- Based upon the findings of this study, the acute oral LD50 in rats of both sexes was estimated to be greater than 10.000 mg/kg of body weight.
Mortality: there were no deaths at any dose level.
No observable gross pathology was noted in any of the animals.
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