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Diss Factsheets
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EC number: 277-143-2 | CAS number: 72968-50-4 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus aurantium, 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Detailed information on the test substance was not reported. No details on materials & methods and results were reported. Data on materials and methods could be found in the article of Kligman (1966). The results are acceptable as basic data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: JID; Vol 47; No 5; 393-409; 1966
- Deviations:
- not specified
- Principles of method if other than guideline:
- A human maximisation test was performed to study the sensitising potential of Orange Oil Bitter. The maximisation procedure consisted of 5 induction exposures and 1 challenge exposure (Kligman, 1966).
- GLP compliance:
- no
- Remarks:
- pre-GLP test
Test material
- Reference substance name:
- Orange Oil Bitter
- IUPAC Name:
- Orange Oil Bitter
- Details on test material:
- - Name of test material (as cited in study report): Orange Oil Bitter
- Lot/batch No.: Confidential
Constituent 1
Method
- Type of population:
- general
- Controls:
- Control patch for the provocative test consisting of petrolatum applied for 48 hours to a site pre-treated for one hour with 10% SLS. No positive controls included.
- Route of administration:
- dermal
Results and discussion
- Results of examinations:
- SYMPTOMS
- No data.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
Any other information on results incl. tables
Reading |
Hours after challenge |
Group |
Dose level |
No. with + reactions |
Total no. in group |
Clinical observations |
1st reading |
48 |
test group |
undiluted |
0 |
25 |
no data |
2nd reading |
72 |
test group |
undiluted |
0 |
25 |
no data |
Applicant's summary and conclusion
- Conclusions:
- In a human maximization test, Orange Oil Bitter did not induce contact sensitization in any of the 25 healthy adult males under the conditions of this test.
- Executive summary:
The sensitising properties of Orange Oil Bitter were investigated in a human maximisation test. Twenthy-five healthy male volunteers completed the experiment. The test material was applied under occlusion to the forearms of all subjects for 5 alternate day 48-hour periods. SLS was used as pre-treatment. Following a 10-day rest period, challenge patches were applied under occlusion to fresh sites for 48 hours, also preceeded by 1 hour application of SLS. The challenge sites were read on removal of the patch and 24 hours thereafter. None of the subjects showed sensitisation. Based on these results and according to the EU classification outlined in 1272/2008/EC and 67/548/EEC, the substance Orange Oil Bitter is not a sensitiser.
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