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EC number: 232-433-8 | CAS number: 8028-48-6 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus sinensis, 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
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Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 12 May 2003 - 26 August 2003
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: This study was not conducted according to an OECD guideline or under GLP conditions, as it is a human study. No infomration is available on test concentration or vehicle, therefore the study was assigned Klimish 3.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Marzulli-Maibach sensitization technique
- Principles of method if other than guideline:
- 100 male or female volunteers (18-64 years) were exposed to the test article on the back during the induction phase 3 times/week for 48 hours for 3 weeks. Following a two week resting period, the subjects were challenged by application of test article for 24 hours on the induction and a control site. Skin reactions were scored immediately and 24, 48 and 72 hours after removal of the patches.
- GLP compliance:
- no
Test material
- Reference substance name:
- Orange, sweet, ext.
- EC Number:
- 232-433-8
- EC Name:
- Orange, sweet, ext.
- Cas Number:
- 8028-48-6
- Molecular formula:
- This reference substance is a UVCB of the NCS type. It is a complex mixture of compounds and therefore molecular formula, molcular weight, and structural formula cannot be given.
- IUPAC Name:
- Essential oil of orange obtained from the peel of Citrus sinensis (Rutaceae) by expression and/or distillation, including cold pressed, distilled, terpenes and essence qualities
- Reference substance name:
- Orange oil
- IUPAC Name:
- Orange oil
- Reference substance name:
- Huille essentielle d'orange douce de floride
- IUPAC Name:
- Huille essentielle d'orange douce de floride
- Details on test material:
- - Name of test material (as cited in study report): Huile essentielle d'orange douce de floride (Orange oil)
Constituent 1
Constituent 2
Constituent 3
Method
- Type of population:
- general
- Controls:
- Patches without test article applied were used as control group
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: open
- Vehicle / solvent: No data
- Concentrations: No data
- Volume applied: 30 µl
- Testing/scoring schedule: Skin reactions were scored immediately and 24, 48 and 72 hours after removal of the patches
EXAMINATIONS
- Grading/Scoring system: Erythema and desquamation scores were used to determine irritation index Z
- Statistical analysis: No data
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: 4% of the subjects showed a positive skin reaction at the first reading (24 hours) after challenge. No reaction was noted in the test group at the 48 and 72 hours reading and at any timepoint in the control group. Based on these results the substance was not considered to be sensitising.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
24 hours reading
- Number of subjects with positive reactions: 4
- Number of subjects with negative reactions: 96
- Number of subjects with equivocal reactions: 0
48 hours reading
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 100
- Number of subjects with equivocal reactions: 0
72 hours reading
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 100
- Number of subjects with equivocal reactions: 0
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, 4% of the subjects showed a positive skin reaction at the first reading (24 hours) after challenge. No reaction was noted in the test group at the 48 and 72 hours reading and at any timepoint in the control group. Based on these results the substance was not considered to be sensitising.
- Executive summary:
100 male or female volunteers (18-64 years) were exposed to the test article on the back during the induction phase 3 times/week for 48 hours for 3 weeks. Following a two week resting period, the subjects were challenged by application of test article for 24 hours on the induction and a control site. Skin reactions were scored immediately and 24, 48 and 72 hours after removal of the patches.
Under the conditions of this study, 4% of the subjects showed a positive skin reaction at the first reading (24 hours) after challenge. No reaction was noted in the test group at the 48 and 72 hours reading and at any timepoint in the control group. Based on these results the substance was not considered to be sensitising.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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