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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Study period:
- 1985
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Non adjuvant method, relevant deficiencies. Uncovered test site. Application site changed if very strong reactions provoked. No detail on test results / dose tested and selection.
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:
- publication
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
- Principles of method if other than guideline:
- Method: Open epicutaneous test
- GLP compliance:
- not specified
- Type of study:
- open epicutaneous test
Test material
- Reference substance name:
- Laurus nobilis, ext.
- EC Number:
- 283-272-5
- EC Name:
- Laurus nobilis, ext.
- Cas Number:
- 84603-73-6
- IUPAC Name:
- Laurus nobilis, ext.
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Laurel leaf oil
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 300-450 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: unchanged or concurrent vehicle
- Concentration / amount:
- Range finding tests: 1, 3, 10, 30 and 100 %
Main test:
- Induction phase: 0.3, 1, 3, 10, 30 and 100 %
- Challenge phase: Minimal irritating and some lower primary non-irritating concentrations
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: unchanged or concurrent vehicle
- Concentration / amount:
- Range finding tests: 1, 3, 10, 30 and 100 %
Main test:
- Induction phase: 0.3, 1, 3, 10, 30 and 100 %
- Challenge phase: Minimal irritating and some lower primary non-irritating concentrations
- No. of animals per dose:
- At least 6 animals in each treatment group (maximum: 20) and 10 animals in control group
- Details on study design:
- RANGE FINDING TESTS: On a day before starting the exposure (Day -1), a single application of 0.025 mL of each test concentration (1, 3, 10, 30 and 100 %) was simultaneously performed on clipped flank skin (2 cm2) of 6-8 animals and the reactions were recorded after 24 h. The minimal irritating and the maximal non-irritating concentrations were determined by an all-or-none criterion.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 21
- Test groups: Open epicutaneous application of 0.1 mL of each test concentration (0.3, 1, 3, 10, 30 and 100 %)
- Control group: No treatment or topical (uncovered) application of 0.1 mL of vehicle
- Site: Clipped flank skin (8 cm2)
- Frequency of applications: Daily for 3 weeks or 5 times weekly for 4 weeks, usually on the same skin sites. When very strong skin reactions were provoked, the application sites were changed.
- Duration: Days 0-20
- Evaluation: Dermal reactions were recorded at 24 h after each application or at the end of each week and the minimal irritating and the maximal non-irritating concentrations were determined by an all-or-none criterion.
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: Days 21 and 35
- Test and control groups: Open epicutaneous application of 0.025 mL of minimal irritating and some lower primary non-irritating concentrations of the test material
- Site: Contralateral flank (2 cm2)
- Evaluation (h after challenge): 24, 48 and/or 72 h - Challenge controls:
- Open epicutaneous application of 0.025 mL of minimal irritating and some lower primary non-irritating concentrations of the test material was performed on control animals during challenge phase.
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- Not applicable
Any other information on results incl. tables
No positive reaction was observed after challenge exposure.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Under the test conditions, Laurel leaf oil was found to be a non-sensitiser to skin of guinea pigs in an open epicutaneous test (OET).
- Executive summary:
In an open epicutaneous test (OET), groups of guinea pigs were topically (uncovered) induced with 0.1 mL of Laurel leaf oil at doses of 0.3, 1, 3, 10, 30 and 100 % on clipped flank skin (8 cm2), daily for 3 weeks or 5 times weekly for 4 weeks, usually on the same skin sites. The application sites were changed if very strong skin reactions were provoked. At least 6 animals were used in each treatment group and 10 animals in control group. On Days 21 and 35, an open epicutaneous challenge application of 0.025 mL of minimal irritating and some lower primary non-irritating concentrations of the test material was performed on the contralateral flank (2 cm2) of the animals and the dermal reactions were recorded after 24, 48 and/or 72 h. Range finding test was conducted at the concentrations of 1, 3, 10, 30 and 100 % to determine the doses for main study.
No positive reaction was observed after challenge exposure.
Under the test conditions, Laurel leaf oil was found to be a non-sensitiser to skin of guinea pigs in an open epicutaneous test (OET).
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