Registration Dossier
Registration Dossier
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EC number: 310-094-8 | CAS number: 102242-62-6 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Zanthoxylum, Rutaceae.
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Directive Comunitary 88/320/CEE e 90/18/CEE
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Zanthoxylum, ext.
- EC Number:
- 310-094-8
- EC Name:
- Zanthoxylum, ext.
- Cas Number:
- 102242-62-6
- Molecular formula:
- NA
- IUPAC Name:
- Zanthoxylum, ext.
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 615 mg/kg; 456 mg/kg; 337 mg/kg and 250 mg/kg
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- no
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 416 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 344 - <= 503
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 416 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 344 - <= 503
- Mortality:
- males: 100% at 615 mg/kg - 60% at 456 mg/kg - 20% at 337 mg/kg and 0% at 250 mg/kg
females: 100% at 615 mg/kg - 60% at 456 mg/kg - 20% at 337 mg/kg and 0% at 250 mg/kg - Clinical signs:
- the animals treated with the letal doses had the following toxic symptoms:
piloerection - swollen abdomen - nose and mouth bleeding - tremors - Body weight:
- males: 179 g average value
females: 188 g average value - Gross pathology:
- gastro enteric hemorrhage
Applicant's summary and conclusion
- Conclusions:
- The LD50, estimated on the test item, Zanthoxylum extract., is equal to 416 mg/kg with confidence limits from 344 mg/kg to 503 mg/kg for both males and females
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