Registration Dossier
Registration Dossier
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EC number: 289-870-2 | CAS number: 90028-76-5 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Abies alba, Pinaceae.
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:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- Basic data given, but considered sufficiently reliable for the purpose of hazard assessment
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Standard acute method (limit test)
- GLP compliance:
- no
- Remarks:
- (pre-GLP)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Fir, Abies alba, ext.
- EC Number:
- 289-870-2
- EC Name:
- Fir, Abies alba, ext.
- Cas Number:
- 90028-76-5
- IUPAC Name:
- (4Z)-4,11,11-trimethyl-8-methylidenebicyclo[7.2.0]undec-4-ene; 1-methyl-4-(prop-1-en-2-yl)cyclohex-1-ene; 2,2-dimethyl-3-methylidenebicyclo[2.2.1]heptane; 2,6,6-trimethylbicyclo[3.1.1]hept-2-ene; 6,6-dimethyl-2-methylidenebicyclo[3.1.1]heptane
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Abies alba oil from needles
- Physical state: Clear liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sherman-Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Fasting period before study: Animals were fasted for 24 h prior to administration of the test item
- Diet: Food, ad libitum
- Water: Water, ad libitum
- Acclimation period: 1 week
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed for mortality and clinical signs daily for 14 days
- Necropsy of survivors performed: No data - Statistics:
- None
Results and discussion
- Preliminary study:
- Not applicable
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: No mortality was observed
- Mortality:
- - No mortality was observed
- Clinical signs:
- other: - Animals were lethargic soon after dose administration and full recovery was observed 24 h later.
- Gross pathology:
- No data
- Other findings:
- No data
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, oral LD50 of Abies alba oil from needles is higher than 5000 mg/kg bw in rats therefore it must not be classified according to the CLP Regulation (EC) No. 1272/2008 and Globally Harmonized System (GHS).
- Executive summary:
In an acute oral toxicity study (limit test), groups of Sherman-Wistar rats (5/sex/dose) were given a single oral dose of Abies alba oil from needles at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs daily for 14 days.
No mortality was observed. Animals were lethargic soon after dose administration and full recovery was observed 24 h later. In this study, the oral LD50 of Abies alba oil from needles was higher than 5000 mg/kg bw in rats.
Under the test conditions, oral LD50 of Abies alba oil from needles is higher than 5000 mg/kg bw in rats therefore it must not be classified according to the CLP Regulation (EC) No. 1272/2008 and Globally Harmonized System (GHS).
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
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