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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
- Skin irritation/corrosion: irritating, based on available data and additivity principles.
- Eye irritation: not irritating (OECD 437, GLP, K, Rel.1)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- 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.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- 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)
- Species:
- other: Bovine eyes
- Details on test animals or tissues and environmental conditions:
- Not applicable
- 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. - 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
- 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.
Reference
See the attached document for tables of results
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion:
The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2013) was used to determine the skin irritation/corrosion hazard of Myrtle oil. The decision of classification as skin irritant was based on the following arguments:
1 - Existing animal data from irritation study: Skin irritation was observed in guinea-pigs in an acute dermal toxicity study (Moreno, 1979) at the dose of 5000 mg/kg bw. Dermal reactions noted were slight redness (3/10), moderate redness (7/10), slight edema (4/10) and moderate oedema (6/10) at the site of application. Adequate scoring of skin effects was not provided, therefore it was not possible to take a decision of classification based solely on this study.
2 - Existing data on constituents (additivity principles):
- all Myrtle oils have more than 10% of their constituents classified as Skin irritant Category 2, therefore according to the Regulation (EC) No 1272/2008, Myrtle oil should be classified as a skin irritant without further testing.
- all Myrtle oils have more than 20% of their constituents classified as Skin irritant - R38 - , therefore according to the Directive 1999/45/EEC, Myrtle oil should be classified as a skin irritant without further testing.
Constituent |
Classification according to the Regulation (EC) No. 1272/2008 (CLP) |
Classification according to the Directive 67/548/EEC |
Source |
||
Skin irritation |
Eye irritation |
Skin irritation |
Eye irritation |
||
Pinene |
SCI2, H315 |
- |
Xi ; R38 |
- |
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 |
Terpineol |
SCI2, H315 |
EDI2, H319 |
Xi ; R38 |
Xi ; R36 |
http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d944137-bb01-5d50-e044-00144f67d249/DISS-9d944137-bb01-5d50-e044-00144f67d249_DISS-9d944137-bb01-5d50-e044-00144f67d249.html |
Linalool |
SCI2, H315 |
EDI2, H319 |
Xi ; R38 |
- |
http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d93c699-8de9-6b59-e044-00144f67d249/DISS-9d93c699-8de9-6b59-e044-00144f67d249_DISS-9d93c699-8de9-6b59-e044-00144f67d249.html |
Source: ECHA disseminated dossiers
Eye irritation:
A key study was identified (Warren, 2013, Rel.1). In this BCOP assay conducted according to the OECD Guideline 437 and in compliance with GLP, the in vitro irritancy score for the test item was 3.
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.
Justification for selection of skin irritation / corrosion endpoint:
Available data indicates that the criteria are met for classification as irritating to the skin
Justification for selection of eye irritation endpoint:
Only one study available. The key study is GLP-compliant and of high quality (Klimisch score = 1).
Effects on skin irritation/corrosion: irritating
Justification for classification or non-classification
Harmonized classification:
Myrtle oil has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Based on the typical composition provided by the Lead Registrant, Myrtle oil is classified as skin irritant:
- Irritating to skin (Xi; R38) according to the criteria of the Directive 1999/45/EEC,
- Skin Irritant Category 2 (H315: Causes skin irritation) according to the criteria of the Regulation (EC) No. 1272/2008 (CLP).
Based on the typical composition provided by the Lead Registrant, Myrtle oil is not classified as eye irritant according to the Regulation (EC) No. 1272/2008 (CLP) and the Directive 67/548/EEC.
No information was available regarding respiratory irritation.
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.
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