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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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: Draize, J.H. Dermal Toxicity. Appraisal of Safety of Chemicals in Foods, Drugs and Cosmetics. 46-59; 1959
- Deviations:
- not specified
- GLP compliance:
- not specified
- Test type:
- standard acute method
- 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:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 14 day
- Doses:
- 200; 2000; 5000 mg/kg
- No. of animals per sex per dose:
- 2 males and 2 females
- Control animals:
- no
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Eleven of the twelve animals gained weight during the course of the study, while one lowe dose male lost weight.
- Mortality:
- There were no deaths among the test animals during the 14 days observation period
- Clinical signs:
- Clinical observations consisted of soft feces, noted on Day 3 in one female dosed a 2000 mg/kg.
- Body weight:
- Eleven of the twelve animals gained weight during the course of the study, while one low dose male lost weight.
- Gross pathology:
- No gross pathology was observed in any of the test animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- The acute dermal LD50 was estimated to be greater than 5000 mg/kg of body weight.
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