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EC number: 282-013-3 | CAS number: 84082-68-8 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Myristica fragrans, Myristicaceae.
- 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: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No guideline followed, no GLP, but acceptable basic data.
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:
- publication
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The LD50 was calculated using the method described by Lorke (1983). Nutmeg oil at a dose of 10, 100 and 1000 ul/kg was administered intraperitoneal (i.p.) to groups of three mice each. Based on the results of mortality in each group after 24 h., four more mice were administered different doses of nutmeg oil in order to obtain the least and most toxic values and the LD50 was calculated by the geometric mean of these values (Lorke D. 1983. A new approach to practical acute toxicity testing, Arch Toxicol 54: 275-287).
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Myristica fragrans, ext.
- EC Number:
- 282-013-3
- EC Name:
- Myristica fragrans, ext.
- Cas Number:
- 84082-68-8
- Molecular formula:
- Unspecified (UVCB)
- IUPAC Name:
- Nutmeg Oil (Myristica fragrans, ext.)
- Details on test material:
- - Name of test material (as cited in study report): Nutmeg Oil
- Physical state: liquid
- Composition of test material, percentage of components:
Chemical analysis of the sample of volatile oil of nutmeg (nutmeg oil) that was used for this study indicates the presence of 37 constituents representing 99.3% of the total of nutmeg oil. The percentage of major and most important constituents were terpinen-4-ol (31.3%), γ-terpinene (7.8%), myristicin (7.1%), p-cymene (6.5%), α-terpineol (5.2%), α-pinene (4.9%), β-pinene (4.6%), elemicin (4.8%), α-terpinene (3.5%), limonene (3.2%), methyleugenol (0.8%), eugenol (0.2%), trans-methylisoeugenol (0.1%), and linalool (0.4%).
- Stability under test conditions: no data
- Storage condition of test material: no data
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- polyethylene glycol
- Remarks:
- diluted in water at a ratio of 30:70
- Doses:
- 10, 100 and 1000 ul/kg was administered intraperitoneal (i.p.) to groups of three mice each. Based on the results of mortality in each group after 24 h., four more mice were administered different doses of nutmeg oil in order to obtain the least and most toxic values.
- No. of animals per sex per dose:
- 3/dose and 4/dose
- Control animals:
- not specified
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 150 other: uL/kg/24h.
- Remarks on result:
- other: mouse, i.p.
Any other information on results incl. tables
All the animals lost their righting reflex followed by clonic seizures before death. This clonus was accompanied by periods of running (running-bouncing clonus).
Applicant's summary and conclusion
- Conclusions:
- The LD50 i.p. of nutmeg oil for mice was 2150 uL/kg/24 h. All the animals lost their righting reflex followed by clonic seizures before death. This clonus was accompanied by periods of running (running-bouncing clonus). Based on these results, the test substance does not need to be classified for acute toxicity according to the EU criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.
- Executive summary:
The acute intraperitoneal (i.p.) toxicity of nutmeg oil to mice was investigated. Chemical analysis of the sample of volatile oil of nutmeg (nutmeg oil) that was used for this study indicates the presence of 37 constituents representing 99.3% of the total of nutmeg oil. The percentage of major and most important constituents were terpinen-4-ol (31.3%),γ-terpinene (7.8%), myristicin (7.1%), p-cymene (6.5%),α-terpineol (5.2%),α-pinene (4.9%),β-pinene (4.6%), elemicin (4.8%),α-terpinene (3.5%), limonene (3.2%), methyleugenol (0.8%), eugenol (0.2%), trans-methylisoeugenol (0.1%), and linalool (0.4%). Briefly, nutmeg oil at a dose of 10, 100 and 1000 ul/kg was administered intraperitoneal (i.p.) to groups of three mice each. Based on the results of mortality in each group after 24 h., four more mice were administered different doses of nutmeg oil in order to obtain the least and most toxic values and the LD50 was calculated by the geometric mean of these values (Lorke D. A new approach to practical acute toxicity testing, Arch Toxicol 54: 275-287). This method requires a few animals to give median values and has been proved valid for its accuracy (van Noordwijk AJ, van Noordwijk J. 1988. An accurate method for estimating an approximate lethal dose with few animals, tested with a Monte Carlo procedure. Arch Toxicol 61: 333-343). The LD50 i.p. of nutmeg oil for mice was 2150 uL/kg/24 h. All the animals lost their righting reflex followed by clonic seizures before death. This clonus was accompanied by periods of running (running-bouncing clonus). Based on these results, the test substance does not need to be classified for acute toxicity according to the EU criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.
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