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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 01, 2010 - September 06, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test was performed according to OECD Guideline 439 and under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for the Testing of Chemicals 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method (Original Guideline adopted July 22, 2010).
- Deviations:
- yes
- Remarks:
- updated guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Commission Regulation (EC) No. 440/2008 B 46".
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ECVAM international validation study on in vitro tests for acute skin irritation: Report on the validity of the EpiSkin™™ and EpiDerm assays and on the Skin Integrity Function Test (Altern Lab Anim. 2007 Dec; 35 (6): 559-601).
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Remarks:
- Statement of Compliance
Test material
- Reference substance name:
- Nutmeg Oil - Myristica Fragrance Oil
- IUPAC Name:
- Nutmeg Oil - Myristica Fragrance Oil
- Details on test material:
- - Name of test material (as cited in study report): Nutmeg Oil - Myristica Fragrance Oil
- Analytical purity: Confidential
- Lot/batch No.: Confidential
- Stability in Solvent: Not relevant
- Storage condition of test material: At room temperature
Constituent 1
Test animals
- Species:
- human
- Details on test animals or test system and environmental conditions:
- Human skin model EpiSkin™
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Deionised water
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µL of the test item were applied to each of triplicate tissues.
- Concentration (if solution): 100%
Positive and negative controls: 10 µL were dosed per tissue. - Duration of treatment / exposure:
- 15 ± 1 min
- Observation period:
- Not applicable
- Number of animals:
- Three tissues of the human skin model EpiSkin™ were treated with the test item, the negative or the positive control.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Using a wash bottle the tissues were gently rinsed with PBS to remove any residual test material.
- Time after start of exposure: 15 ± 1 min
After further incubation for about 42 hours the tissues were treated with the MTT [(3-4,5-dimethyl thiazole 2-yl) 2,5-diphenyl-tetrazoliumbromide]solution for 3 hours following approx. 71 hours extraction of the colorant from the cells. The amount of extracted colorant was determined photometrically at 570 nm.
SCORING SYSTEM: The mean Optical Density (OD 570 nm ) of the 3 negative control tissues was calculated. This value corresponds to 100% tissue viability in the current test. For each individual tissue treated with the test item or the positive control the individual relative tissue viability is calculated. For the test item and the positive control the mean relative viability +/- standard deviation of the 3 individual tissues are calculated and used for classification. For the current test, an irritation potential of a test item according to EU classification Irritant (I), R38 (according to Directive 67/548/EEC), and H315 (category 2) (according to Regulation (EC) 1272/2008) is recommended if the mean relative tissue viability of 3 individual tissues < 50% of the negative control.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: Relative Absorbance (% of Negative Control)
- Value:
- 100
- Remarks on result:
- other:
- Remarks:
- Basis: other: Tissue 1, 2 and 3 - Negative control. Reversibility: other: Not applicable. Remarks: non-skin irritant. (migrated information)
- Irritation / corrosion parameter:
- other: other: Relative Absorbance (% of Negative Control)
- Value:
- 12.5
- Remarks on result:
- other:
- Remarks:
- Basis: other: Tissue 1, 2 and 3 - Positive control. Reversibility: other: Not applicable. Remarks: skin irritant. (migrated information)
- Irritation / corrosion parameter:
- other: other: Relative Absorbance (% of Negative Control)
- Value:
- 21.7
- Remarks on result:
- other:
- Remarks:
- Basis: other: Tissue 1, 2 and 3 - Test substance. Reversibility: other: Not applicable. Remarks: skin irritant (I), H315 (category 2). (migrated information)
In vivo
- Irritant / corrosive response data:
- After treatment with the test item Nutmeg Oil - Myristica Fragrance Oil the relative absorbance values decreased to 21.7%. This value is below the threshold for irritancy of ≤ 50%. Therefore, the test item is considered to possess an irritant potential.
Any other information on results incl. tables
After treatment with the negative control the absorbance values were within the required acceptability criterion of mean OD ≥ 0.6 till ≤1.5 for the 15 minutes treatment interval thus showing the quality of the tissues.
Treatment with the positive control induced a decrease in the relative absorbance as compared to the negative control to 12.5%, thus ensuring the validity of the test system.
The standard deviations between the % variabilities of the test item, the positive and negative controls were below 7% (threshold of the OECD Guideline 439: 18%), thus ensuring the validity of the study.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- After treatment with the test item Nutmeg Oil - Myristica Fragrance Oil the relative absorbance values decreased to 21.7%. This value is below the threshold for irritancy of ≤ 50%. Therefore, the test item is considered to possess an irritant potential. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Nutmeg Oil - Myristica Fragrance Oil is irritant to skin and according to EU classification needs to be classified as Irritant (I), R38 (according to Directive 67/548/EEC), and H315 (category 2) (according to Regulation (EC) 1272/2008).
- Executive summary:
This in vitro study was performed according to OECD 439 to assess the irritation potential of Nutmeg Oil - Myristica Fragrance Oil by means of the Human Skin Model Test. Three tissues of the human skin model EpiSkin™ were treated with the test item, the negative or the positive control for 15 minutes. 10 µL of the test item were applied to each tissue, spread to match the tissue size. The test item and the positive and negative controls were washed off the skin tissues after 15 minutes treatment. After further incubation for about 42 hours the tissues were treated with the MTT [(3-4,5-dimethyl thiazole 2-yl) 2,5-diphenyl-tetrazoliumbromide] solution for 3 hours following approx. 71 hours extraction of the colorant from the cells. The amount of extracted colorant was determined photometrically at 570 nm. 10 µL of either the negative control (deionised water) or the positive control (5% Sodium lauryl sulfate) were applied to each tissue. After treatment with the negative control the absorbance values were within the required acceptability criterion of mean OD ≥ 0.6 till ≤1.5 for the 15 minutes treatment interval, thus showing the quality of the tissues. Treatment with the positive control induced a decrease in the relative absorbance as compared to the negative control to 12.5%, thus ensuring the validity of the test system. The standard deviations between the % variabilities of the test item, the positive and negative controls were below 7% (threshold of the OECD Guideline 439: 18%), thus ensuring the validity of the study. After treatment with the test item Nutmeg Oil - Myristica Fragrance Oil the relative absorbance values decreased to 21.7%. This value is below the threshold for irritancy of ≤ 50%. Therefore, the test item is considered to possess an irritant potential. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Nutmeg Oil - Myristica Fragrance Oil is irritant to skin and according to EU classification needs to be classified as Irritant (I), R38 (according to Directive 67/548/EEC), and H315 (category 2) (according to Regulation (EC) 1272/2008).
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