Registration Dossier
Registration Dossier
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EC number: 283-911-8 | CAS number: 84775-83-7 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Salvia sclarea, Labiatae.
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Basic data given, but considered sufficiently reliable for the purpose of hazard assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- no guideline available
- Principles of method if other than guideline:
- Standard acute method
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Sage, Salvia sclarea, ext.
- EC Number:
- 283-911-8
- EC Name:
- Sage, Salvia sclarea, ext.
- Cas Number:
- 84775-83-7
- Molecular formula:
- Not applicable (UVCB)
- IUPAC Name:
- Essential oil of Salvia sclarea (Lamiaceae) obtained from leaves, flowers and twigs by steam distillation
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Test item: Compound No. 72-8-48
- Source of test material: Research Institute for Fragrance Materials, Inc., USA.
- Physical state: Clear liquid
- Date of receipt: 06 April 1972
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 200-250 g
- Fasting period during the study: Animals were fasted for a minimum of 16 h prior to administration of the test item.
- Diet: Food, ad libitum
- Water: Water, ad libitum
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- - Test substance was administered as a concentrate.
- Doses:
- 4000, 5000, 6250 and 7800 mg/kg bw
- No. of animals per sex per dose:
- 10 males/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Observations for mortality were made at 1 and 6 h after dosing and daily thereafter for 14 days.
- Necropsy of survivors performed: Yes; all surviving animals were sacrificed for gross necropsy examination. - Statistics:
- None
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 5 600 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 5 000 - 6 200
- Mortality:
- - Deaths occurred overnight following administration of test substance.
- 1/10, 4/10, 7/10 and 10/10 animals were died at 4000, 5000, 6250 and 7800 mg/kg bw, respectively. - Clinical signs:
- other: Rats experienced lethargy, diarrhea and urinary incontinence.
- Gross pathology:
- No data
- Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
- Executive summary:
In an acute oral toxicity study, groups (10 males/dose) of Wistar rats were given a single oral dose of test substance at 4000, 5000, 6250 and 7800 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days and all survivors were sacrificed for macroscopic examination.
Rats experienced lethargy, diarrhea and urinary incontinence. Deaths occurred overnight following administration of test substance. 1/10, 4/10, 7/10 and 10/10 animals were died at 4000, 5000, 6250 and 7800 mg/kg bw, respectively. In this study, the oral LD50 of test substance was 5600 mg/kg bw with 95 % confidence limits of 5000-6200 mg/kg bw in male rats.
Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
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