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EC number: 283-272-5 | CAS number: 84603-73-6 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Laurus nobilis, Lauraceae.
- 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 = 3950 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:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given, but considered sufficiently reliable for the purpose of hazard assessment
- 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
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
- 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:
- 2050, 3200, 5000 and 7730 mg/kg bw
- No. of animals per sex per dose:
- 10 animals/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Statistics:
- None
- Preliminary study:
- none
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 3 950 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 3 170 - 4 740
- Remarks on result:
- other: No mortality was observed at 2050 mg/kg bw. Mortality was observed in 4/10, 7/10 and 10/10 animals at 3200, 5000 and 7730 mg/kg bw, respectively.
- Mortality:
- - No mortality was observed at 2050 mg/kg bw.
- Mortality was observed in 4/10, 7/10 and 10/10 animals at 3200, 5000 and 7730 mg/kg bw, respectively. - Clinical signs:
- - At 2050 mg/kg bw, piloerection; at 3200 and 5000 mg/kg bw, lethargy; at 7730 mg/kg bw, piloerection, lethargy and loss of righting reflex in 5/10 animals were observed.
- Body weight:
- No data
- Gross pathology:
- No data
- 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 Laurel leaf oil is 3950 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 study, group of 10 rats/dose were given a single oral dose of Laurel leaf oil at 2050, 3200, 5000 and 7730 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days.
No mortality was observed at 2050 mg/kg bw. Mortality was observed in 4/10, 7/10 and 10/10 animals at 3200, 5000 and 7730 mg/kg bw, respectively. At 2050 mg/kg bw, piloerection; at 3200 and 5000 mg/kg bw, lethargy; at 7730 mg/kg bw, piloerection, lethargy and loss of righting reflex in 5/10 animals were observed. In this study, the oral LD50 of test item was 3950 mg/kg bw in rats.
Under the test conditions, the oral LD50 for Laurel leaf oil is 3950 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).
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 950 mg/kg bw
- Quality of whole database:
- Basic data given, but considered sufficiently reliable for the purpose of hazard assessment.
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, 1974, Rel. 2). In this acute oral toxicity study, group of 10 rats/dose were given a single oral dose of Laurel leaf oil at 2050, 3200, 5000 and 7730 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days.
No mortality was observed at 2050 mg/kg bw. Mortality was observed in 4/10, 7/10 and 10/10 animals at 3200, 5000 and 7730 mg/kg bw, respectively. At 2050 mg/kg bw, piloerection; at 3200 and 5000 mg/kg bw, lethargy; at 7730 mg/kg bw, piloerection, lethargy and loss of righting reflex in 5/10 animals were observed.In this study, the oral LD50 of test item was 3950 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:
Laurel leaf oil has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Acute toxicity via Oral route:
Based on the typical composition provided by the Lead Registrant, Laurel leaf 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 the typical composition provided by the Lead Registrant (> 10% of aspiration toxicants, i.e. limonene, pinene), Laurel leaf 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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