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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 27, 2010 - July 27, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test was conducted according to OECD Test Guideline No. 437, 2009, under GLP Standards, and QA.
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 Testing of Chemicals 437: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants (September, 2009)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: INVITTOX (UK) protocol no. 98 "The Bovine Corneal Opacity and Permeability Assay", February 1994
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Bovine Corneal Opacity and Permeability (BCOP) Assay, SOP of Microbiological Associates Ltd., UK, Procedure Details, April 1997
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
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
- Expiration date of the lot/batch: Confidential
- Stability in Solvent: Not relevant
- Storage condition of test material: At room temperature
Constituent 1
Test animals / tissue source
- Species:
- other: not relevant: in vitro test
- Strain:
- other: Bovine
- Details on test animals or tissues and environmental conditions:
- BOVINE EYES
- Source: Odenwaldschlachthof Brensbach, 64395 Brensbach, Germany
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Yes, Saline
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 ml
POSITIVE CONTROL: 2-Ethoxyethanol - 0.75 ml
NEGATIVE CONTROL: 0.9% (w/v) NaCl in deionised water (Saline) - 0.75 ml - Duration of treatment / exposure:
- 130 minutes (10+120)
- Observation period (in vivo):
- Not applicable
- Number of animals or in vitro replicates:
- 9 freshly isolated bovine cornea: negative control, positive control and test item: 3 cornea each.
- Details on study design:
- EXPOSURE OF THE CORNEA: in cornea holder.
REMOVAL OF TEST SUBSTANCE:
- Washing (if done): The test item or control items, respectively, were rinsed off from the application side by changing cMEM (complete Minimum Essential Medium)
- Time after start of exposure: at 10 minutes and again at 2 hours after incubation.
SCORING SYSTEM: (See also: Other information on materials and methods)
The following formula was used to determine the in vitro score of the negative control:
In vitro Score = opacity value + (15 x OD490 value).
The following formula was used to determine the in vitro score of the positive control and the test item:
In vitro Score = (opacity value - opacity value mean negative control) + (15 x corrected OD490 value).
The in vitro Score was calculated for each individual treatment and positive control cornea. The mean in vitro Score value of each treated group was calculated from the individual in vitro Score values.
TOOL USED TO ASSESS SCORE:
Cornea opacity value: opacitometer (OP_KiT opacitometer (Electro Design, 63-Riom France).
Permeability (optical density value) at 490 nm (OD490): fluorescein; spectrophotometer.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Mean in vitro Score Negative control
- Basis:
- other: Cornea 1, 2, and 3
- Score:
- ca. 0.39
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Non eye irritant
- Irritation parameter:
- other: Mean in vitro Score Positive control
- Basis:
- other: Cornea 1, 2, and 3
- Score:
- ca. 85.07
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Very severe eye irritant
- Irritation parameter:
- other: Mean in vitro Score Test substance
- Basis:
- other: Cornea 1, 2, and 3
- Score:
- ca. 2.72
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Non eye irritant
- Irritant / corrosive response data:
- The test item, Nutmeg Oil - Myristica fragrance oil, did not cause any opacity or permeability of the corneae compared with the results of the negative control.
Any other information on results incl. tables
Negative and positive controls were within historical ranges.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item Nutmeg Oil - Myristica fragrance oil did not cause any opacity or permeability of the corneae compared with the results of the negative control. The calculated mean in vitro Score was 2.72 and therefore, the test item was classified as non eye irritant. 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 not considered to be an eye irritant.
- Executive summary:
This in vitro study was performed according to OECD Guideline 437 to assess the corneal irritation and damage potential of Nutmeg Oil - Myristica fragrance oil by means of the Bovine Corneal Opacity and Permeability Assay (BCOP) using fresh bovine corneae. After a first opacity measurement of the fresh bovine corneae (t0), the neat test item Nutmeg Oil - Myristica fragrance oil, the positive, and the negative controls were applied to corneae and incubated for 10 minutes at 32 ± 1 °C in complete medium. After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneae and opacity was measured again (t10). Further, the corneae were incubated for another 120 minutes at 32 ± 1 °C in complete medium, and opacity was measured a third time (t130). After the opacity measurements permeability of the corneae was determined while application of 1 mL of a fluorescein solution for 90 minutes at 32 ± 1 °C in a horizontal position. The liquid coming out was measured spectrophotometrically. With the negative control (0.9% NaCl solution) neither an increase of opacity nor permeability of the corneae could be observed. The mean in vitro Score was calculated as 0.39. The positive control (2-Ethoxyethanol) showed clear opacity and distinctive permeability of the corneae and therefore, is classified as very severe eye irritant. The mean in vitro Score was calculated as 85.07. The test item Nutmeg Oil - Myristica fragrance oil did not cause any opacity or permeability of the corneae compared with the results of the negative control. The calculated mean in vitro Score was 2.72 and therefore, the test item was classified as non eye irritant. 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 not considered to be an eye irritant.
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