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EC number: 291-076-6 | CAS number: 90320-49-3 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Amyris balsamifera, Rutaceae.
- 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:
- weight of evidence
- Study period:
- not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test was performed according to valid method (human maximisation test; Kligman 1966), but not according to OECD guideline or GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Version / remarks:
- Test was performed according to valid method (human maximisation test; Kligman 1966)
- Principles of method if other than guideline:
- - Principle of test: Test was performed according to valid method (human maximisation test; Kligman J.I.D.; Vol 47; No 5; 393-409; 1966)
- GLP compliance:
- no
- Remarks:
- GLP was not yet enforced at the time
- Type of study:
- patch test
- Justification for non-LLNA method:
- As the results of a previously performed human maximisation test are already available, this data will be used for the WoE evaluation.
Test material
- Reference substance name:
- Amyris balsamifera, ext.
- EC Number:
- 291-076-6
- EC Name:
- Amyris balsamifera, ext.
- Cas Number:
- 90320-49-3
- Molecular formula:
- Not applicable due to the UVCB nature of the substance.
- IUPAC Name:
- Essential oil of Amyris obtained from the wood of Amyris balsamifera (Rutaceae) trees by steam distillation.
- Test material form:
- liquid: viscous
- Details on test material:
- For specific details on test material if available - See in RSS
Name of test material (as cited in study report or in reference): Amyris oil
Constituent 1
- Specific details on test material used for the study:
- Not specified further
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- Inmate volunteers
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Not Specified
- Day(s)/duration:
- 5 alternate-day 48 hour periods
- Adequacy of induction:
- other: Non-irritant substance, but skin pre-treated with 5% aqueous sodium lauryl sulphate
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Not Specified
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- other: Skin pretreated with 1h application of 10% aqeous sodium Lauryl Suplhate under occlusion, before challenge.
- No. of animals per dose:
- 25 volunteers
- Details on study design:
- RANGE FINDING TESTS: The materials were pre-tested on five subjects. Amyris Oil was applied to the (untreated) backs of 5 healthy male volunteers for 48 hours under occlusion. After this period the site was inspected, and no sign of irritation was observed. Based on this result the maximisation test was performed using an SLS pre-treatment.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: five (alternate-days)
- Exposure period: 5 alternate-day 48-hour periods
- Test groups: 25 male healthy inmate volunteers
- Control group: n/a
- Site: volar forearms
- Frequency of applications: once per exposure
- Duration: 48-hour periods
- Pre-treatment: patch sites were pre-treated for 34 hours with 5% aqueous sodium lauryl sulphate under occlusion
B. CHALLENGE EXPOSURE
- No. of exposures: once
- Day(s) of challenge: 10 days after last application (10 day rest period)
- Exposure period: 48 hours
- Test groups: 25 male healthy inmate volunteers
- Control group: n/a
- Site: volar forearms (fresh site)
- Evaluation (hr after challenge): on removal of the patch and 24 hours thereafter
- Pre-treatment: Challenge applications were preceded by one-hour applications of 10% aqueous sodium lauryl sulphate under occlusion. - Challenge controls:
- not specified
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- not specified
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- pure
- No. with + reactions:
- 2
- Total no. in group:
- 25
- Clinical observations:
- Contact sensitisation observed, clinical effects are not further specified
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Pure
- No. with + reactions:
- 2
- Total no. in group:
- 25
- Clinical observations:
- Contact sensitisation observed, clinical effects are not further specified
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Sub-category 1B: potential to produce sensitisation
- Remarks:
- based on CLP criteria
- Conclusions:
- Under the conditions of the test, the substance produced 2 cases of contact-sensitisation and can be considered a weak sensitizer. Based on the results of this study the test substance should therefore be classified as a skin sensitizer (Sub-category 1B) in accordance with the CLP Regulation (1272/2008/EC).
- Executive summary:
Pre-Testing: The materials were pre-tested on five subjects. Amyris Oil was applied to the (untreated) backs of 5 healthy male volunteers for 48 hours under occlusion. After this period the site was inspected, and no sign of irritation was observed. Based on this result the maximisation test was performed using an SLS pre-treatment.
Maximization test: (Kligman; J.I.D.; Vol 47; No 5; 393-409; 1966) the material was applied under occlusion to the volar forearms of 25 male healthy inmate volunteers, for five alternate-day 48-hour periods. The patch sites were pre-treated for 24 hours with 5% aqueous sodium lauryl sulphate under occlusion. Following a ten-day rest-period, challenge patches of the material was applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by one-hour applications of 10% aqueous sodium lauryl sulphate under occlusion. The challenge sites were read on removal of the patch and 24 hours thereafter.
Under the conditions of the test, the substance produced 2 cases of contact-sensitisation and can be considered a weak sensitizer. Based on the results of this study the test substance should therefore be classified as a skin sensitizer (Sub-category 1B) in accordance with the CLP Regulation (1272/2008/EC).
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