Registration Dossier
Registration Dossier
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EC number: 946-433-7 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Essential oil of Petitgrain obtained from the leaves and twigs of Citrus aurantium (Rutaceae) by distillation
- EC Number:
- 946-433-7
- Cas Number:
- Not available
- Molecular formula:
- Not applicable for a natural complex substance (UVCB)
- IUPAC Name:
- Essential oil of Petitgrain obtained from the leaves and twigs of Citrus aurantium (Rutaceae) by distillation
- Test material form:
- liquid
- Details on test material:
- CAS #
For specific details on test material if available - See in RSS
Name of test material (as cited in study report or in reference): Petitgarin oil, Petitgrain oil (Paraguay), Petitgrain oil (Bigarade) and Petitgrain oil (Terpeneless)
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 75-112 Petitgrain Bigarde Oil
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals in total
- Control animals:
- no
- Details on study design:
- - Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: symptomatology.
Results and discussion
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: None
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Based on CLP criteria (EC 1272/2008 and its updates)
- Conclusions:
- Under the conditions of this study, Petitgrain oil - citrus aurantum does not need to be classified for acute oral toxicity, based on Based on CLP criteria (EC 1272/2008 and its updates).
- Executive summary:
In an acute oral toxicity study 5 rats were given asingle oral dose of 5000 mg/kg bw Petitgrain Bigarde Oil. No mortality or clinical signs were noted. The Oral LD50 was established to be higher than 5000 mg/kg bw. This study was performed according to the 401 OECD Guideline. Under the conditions of this study, Petitgrain oil - citrus aurantum does not need to be classified for acute oral toxicity, based on Based on CLP criteria (EC 1272/2008 and its updates).
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