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EC number: 289-904-6 | CAS number: 90045-43-5 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus paradisi M., 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:
- August 21, 2006 - September 29, 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The clinical study was conducted following applicable guidelines and regulations in conformance with ICH Guidelines E6 for Good Clinical Practice and requirements provided in 21 CFR parts 50 and 56.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ICH Guideline E6
- Deviations:
- not specified
- Principles of method if other than guideline:
- A repeated insult patch test was performed in 106 male and female subjects. Nine induction treatmens were followed by a challenge treatment after a 2-wk rest period. Dermal reactions were evaluated after 24, 48, and 72 hrs.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Grapefruit oil
- IUPAC Name:
- Grapefruit oil
- Details on test material:
- - Name of test material (as cited in study report): Grapefruit flower oil, morocco
- Lot/batch No.: confidential
- Other: 1% in DEP/ethanol (3:1)
Constituent 1
Method
- Type of population:
- general
- Controls:
- - Control group: same subjects receiving distilled water instead of test substance (control substance: distilled water, 1% in DEP/ethanol)
- Route of administration:
- dermal
Results and discussion
- Results of examinations:
- SYMPTOMS: 1 subject showed barely perceptible erythema at the 2nd reading 48 hours after challenge.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 1 out of 106
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 |
24 |
test group |
0.055 cc/cm2 test substance |
0 |
106 |
|
2nd reading |
48 |
test group |
0.055 cc/cm2 test substance |
1 |
106 |
1 subject showed barely perceptible erythema |
other: 3rd reading |
72 |
test group |
0.055 cc/cm2 test substance |
0 |
106 |
|
1st reading |
24 |
negative control |
0.055 cc/cm2 distilled water |
0 |
106 |
|
2nd reading |
48 |
negative control |
0.055 cc/cm2 distilled water |
0 |
106 |
|
other: 3rd reading |
72 |
negative control |
0.055 cc/cm2 distilled water |
0 |
106 |
Applicant's summary and conclusion
- Conclusions:
- Grapefruit oil did not have sensitising properties in the repeated insult patch test, under the conditions of this test.
- Executive summary:
In a repeated insult patch test, the sensitising properties of Grapefruit oil were investigated. Humans were induced with 0.2 cc test material (0.055 cc/cm2) by occluded patch applied to the upper back. Distilled water was used as control substance. The patches were applied to the same site for a total of 9 applications during the induction period. Following an approximately 2-week rest period, challenge patches were applied to previously untreated test sites on the back. After 24 hours, the patches were removed and evaluated for dermal reactions. Re-evaluation was performed at 48 and 72 hours. 106 subjects completed the study, none of them showed sensitisation. Based on the EU criteria outlined in 1272/2008/EC and 67/548/EEC, Grapefruit oil is not a sensitiser.
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