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EC number: 294-351-9 | CAS number: 91697-89-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Abies sibirica, Pinaceae.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: 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
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1976
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Documentation insufficient for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Principles of method if other than guideline:
- Method according to the typical testing for acute dermal toxicity in a limit test: topical application of substance on rabbits at one high dose.
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw - Duration of treatment / exposure:
- Single treatment (24 h exposure)
- Observation period:
- 14 days
- Number of animals:
- Total: 10 animals
- Details on study design:
- no details
- Remarks on result:
- probability of mild irritation
- Irritant / corrosive response data:
- - Slight and moderate redness was observed in 6/10 and 4/10 animals, respectively.
- Slight and moderate edema was observed in 1/10 and 9/10 animals, respectively. - Other effects:
- - No mortality was observed.
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the test conditions, Abies Sibirica Oil induced slight to moderate skin irritation in rabbits.
- Executive summary:
In an acute dermal toxicity study, ten rabbits were topically applied with a single dose of Abies Sibirica Oil at 5000 mg/kg bw. All animals were observed for mortality, clinical signs and local reactions.
No mortality occurred at the tested dose level. Slight and moderate redness was observed in 6/10 and 4/10 animals, respectively. Slight and moderate edema was observed in 1/10 and 9/10 animals, respectively.
Under the test conditions, Abies Sibirica Oil induced slight to moderate skin irritation in rabbits.
This study was conducted according to a non-standard method and adequate scoring of skin effects was not provided, therefore it was not possible to take a decision of classification based solely on this study.
None
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
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 sibirica, ext.
- EC Number:
- 294-351-9
- EC Name:
- Fir, Abies sibirica, ext.
- Cas Number:
- 91697-89-1
- Molecular formula:
- not applicable
- IUPAC Name:
- Essential oil of Abies sibirica Ledeb. (Pinaceae) obtained from needles and branches by distillation.
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Abies Sibirica Oil
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- no details
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- Total: 10 animals
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Observations for mortality and toxic effects were made daily for 14 days
- Necropsy of survivors performed: No data - Statistics:
- None
Results and discussion
- Preliminary study:
- None
Effect levels
- Key result
- Sex:
- not specified
- 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:
- - Slightly flaccid muscle tone was observed on Day 1
- Diarrhea and ptosis were observed in some animals from Days 1-3. - Body weight:
- No data
- 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 test conditions, the oral LD50 for test item 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), ten rats were given a single oral dose of Abies Sibirica Oil at 5000 mg/kg bw. Animals were observed for mortality and clinical signs for 14 days.
No mortality was observed. Slightly flaccid muscle tone was observed on Day 1. Diarrhea and ptosis were observed in some animals from Days 1-3. In this study, the oral LD50 of Abies Sibirica Oil was higher than 5000 mg/kg bw in rats.
Under the test conditions, oral LD50 of Abies Sibirica Oil is higher than 5000 mg/kg bw in rats therefore it is not classified according 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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