Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 282-012-8 | CAS number: 84082-67-7 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Myrtus communis, Myrtaceae.
- 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:
- 19 March 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well conducted and well described study in accordance with GLP and OECD Guideline 437 without any deviation.
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:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Myrtus communis, ext.
- EC Number:
- 282-012-8
- EC Name:
- Myrtus communis, ext.
- Cas Number:
- 84082-67-7
- IUPAC Name:
- Myrtus communis, ext.
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Myrtle oil
- Physical state: Yellow liquid
- Analytical purity: Conforms to Standard
- Lot/batch No.: 0213/1
- Date received: 22 February 2013
- Expiration date of the lot/batch: 14 February 2015
- Storage condition of test material: Room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- other: Bovine eyes
- Details on test animals or tissues and environmental conditions:
- Not applicable
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL
- Concentration (if solution): Undiluted - Duration of treatment / exposure:
- - The undiluted test item was applied in BCOP chamber for 10 minutes followed by an incubation period of 120 ± 10 minutes.
- Observation period (in vivo):
- - The condition of the cornea was visually assessed immediately after rinsing and at the final opacity measurement.
- Number of animals or in vitro replicates:
- Not applicable
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period the test item and control items were removed from the anterior chamber and the cornea was rinsed three times with fresh complete minimum essential medium (MEM) containing phenol red before a final rinse with complete MEM. The anterior chamber was refilled with fresh complete MEM.
EVALUATION OF RESULTS:
- Results from the two test method endpoints, opacity and permeability, were combined in an empirically derived formula to generate an in vitro irritancy score.
- The following formula was used to determine the in vitro irritancy score:
In Vitro Irritancy Score = mean opacity value + (15 x mean OD492 value)
Additionally, the opacity and permeability values were evaluated independently to determine whether the test item induced a response through only one of the two endpoints.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: In vitro irritancy score for negative control
- Basis:
- mean
- Remarks:
- 3 corneas
- Score:
- 2.5
- Reversibility:
- other: not applicable
- Irritation parameter:
- other: In vitro irritancy score for test item
- Basis:
- mean
- Remarks:
- 3 corneas
- Score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- other: In vitro irritancy score for positive control
- Basis:
- mean
- Remarks:
- 3 corneas
- Score:
- 45.1
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Corneal epithelium condition: The corneas treated with the test item were clear post treatment and post incubation. The corneas treated with the negative control item were clear post treatment and post incubation. The corneas treated with the positive control item were cloudy post treatment and post incubation.
- Other effects:
- None
Any other information on results incl. tables
See the attached document for tables of results
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, Myrtle oil is considered not to be an ocular corrosive or severe irritant. According to the last revision of the OECD Guideline 437 (26 July 2013), with an IVIS = 3, Myrtle oil does not require classification for eye irritation.
- Executive summary:
In an in vitro eye irritation study conducted according to the OECD Guideline 437 and in compliance with GLP, 3 bovine corneas were applied with 0.75 mL of undiluted Myrtle oil for 10 minutes at 32 ±1 ºC followed by an incubation period of 120 ± 10 minutes at 32 ±1 ºC. Negative and positive control items were tested concurrently. After incubation the BCOP holders were removed from the incubator and a final opacity reading was taken. Each cornea was visually observed. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an in vitro irritancy score.
The corneas treated with the test item were clear post treatment and post incubation. The corneas treated with the negative control item were clear post treatment and post incubation. The corneas treated with the positive control item were cloudy post treatment and post incubation. The in vitro irritancy score for negative and positive controls were 2.5 and 45.1, respectively and the values were within the respective ranges and therefore the study was considered valid. The in vitro irritancy score for the test item was 3, which is considered not to be an ocular corrosive or severe irritant.
Under the test conditions, Myrtle oil is considered not to be an ocular corrosive or severe irritant.
According to the last revision of the OECD Guideline 437 (26 July 2013), with an IVIS = 3, Myrtle oil does not require classification for eye irritation.
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.