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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
Endpoint summary
Administrative data
Description of key information
Acute toxicity, oral: LD50 > 5000 mg/kg bw (K, Rel.2).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Pre-guideline and pre-GLP study. Only basic data given. However, only one death was observed at the dose level of 5000 mg/kg bw, which is 2.5 times more than the limit dose of the OECD 401/423/425. A repeat study is unlikely to show worse effects, therefore this study was considered sufficiently robust to cover this endpoint.
- 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:
- Standard acute method (limit test)
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- No data
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- Total animals: 10
- Control animals:
- no
- Details on study design:
- No data
- Statistics:
- None
- Preliminary study:
- None
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Mortality (1/10) was observed on Day 6 at 5000 mg/kg bw
- Mortality:
- - Mortality (1/10) was observed on Day 6 at 5000 mg/kg bw
- Clinical signs:
- - At 5000 mg/kg bw, ataxia and lethargy were noted in five or more animals. Isolated instances of chromorhinorrhea, dyspnea, ptosis, diarrhea, and piloerection were also noted.
- Body weight:
- No data
- Gross pathology:
- - No macroscopic abnormalities were observed in 7/10 animals.
- The following lesions were noticed in some animals: red exudate in nose/mouth, brown exudate in anogenital region, reddish/yellowish and bloated intestines, reddish areas in stomach, dark liver, lungs, kidney and spleen, mucus-like covering in heart and lungs, white nodules in lungs and pale liver were noticed. - Other findings:
- None
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the oral LD50 for Myrte essence (Myrtle oil) is higher than 5000 mg/kg bw in rats therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the Regulation (EC) No. 1272/2008 (CLP).
- Executive summary:
In an acute oral toxicity (limit test) study, a group of 10 rats were given a single oral dose of Myrte essence (Myrtle oil) at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days and were all sacrificed for macroscopic examination.
Mortality (1/10) was observed on Day 6 at 5000 mg/kg bw. At 5000 mg/kg bw, ataxia and lethargy were noted in five or more animals. Isolated instances of chromorhinorrhea, dyspnea, ptosis, diarrhea, and piloerection were also noted. No macroscopic abnormalities related to treatment were observed during necropsy. In this study, the oral LD50 of test item was higher than 5000 mg/kg bw in rats.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Only basic data given in the available study. However, only one death out of ten animals was observed at the dose level of 5000 mg/kg bw, which is 2.5 times more than the limit dose of the OECD 401/423/425. A repeat study is unlikely to show worse effects, therefore this study was considered sufficiently robust to cover this endpoint.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute toxicity: via oral route:
A key study was identified (Moreno, 1979, Rel. 2). In this limit acute oral toxicity study, 10 rats were administered a single oral dose of test material of 5000 mg/kg bw. The animals were observed for mortality for 14 days.
Mortality (1/10) was observed on Day 6 at 5000 mg/kg bw. At 5000 mg/kg bw, ataxia and lethargy were noted in five or more animals. Isolated instances of chromorhinorrhea, dyspnea, ptosis, diarrhea, and piloerection were also noted. No macroscopic abnormalities related to treatment were observed during necropsy. In this study, the oral LD50 of test item was higher than 5000 mg/kg bw in rats.
Justification for selection of acute toxicity – oral endpoint
Only one study available
Justification for classification or non-classification
Harmonized classification:
Myrtle oil has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Acute toxicity via Oral route:
Based on the available information, Myrtle oil is:
- not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 2000 mg/kg bw
- not classified according to the Directive 67/548/EEC as the LD50 is greater than 2000 mg/kg bw.
Acute toxicity via Dermal route: This information is not available
Acute toxicity via Inhalation: This information is not available.
Specific target organ toxicity: single exposure (Oral):
The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C ≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw ≥ C > 300 mg/kg bw). No classification is required.
Specific target organ toxicity: single exposure (Dermal): This information is not available.
Specific target organ toxicity: single exposure (Inhalation): This information is not available.
Based on its composition (> 10% of aspiration toxicants, i.e. limonene, pinene), Myrtle oil should be classified for aspiration hazard:
- H304,May be fatal if swallowed and enters airways according to the regulation (EC) No. 1272/2008
- Xn, R65, Harmful: may cause lung damage if swallowed according to the Directive 67/548/EEC.
Source: ECHA disseminated dossiers
-Pinene:
http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d952924-c8ed-4614-e044-00144f67d249/DISS-9d952924-c8ed-4614-e044-00144f67d249_DISS-9d952924-c8ed-4614-e044-00144f67d249.html
- Limonene:
http://apps.echa.europa.eu/registered/data/dossiers/DISS-9eb16d5d-b83e-2831-e044-00144f67d031/DISS-9eb16d5d-b83e-2831-e044-00144f67d031_DISS-9eb16d5d-b83e-2831-e044-00144f67d031.html
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