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Diss Factsheets
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EC number: 946-433-7 | CAS number: -
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
- Principles of method if other than guideline:
- Pre testing: The material was pre-tested on twenty-five subects in order to determine wheater sodium lauryl sulfate pre-treatment was required. A patch of the materials was applied to normal sites on the volar forearms or backs for 48 hours under occlusion.
Maximization test: The material was applied under occlusion to the same site on volar forearm or back of all subects for five alternate-day 48 hour periods. The patch site was pre-treated for 24 hours with 2.5% aqueous sodium lauryl sulfate under occlusion. The challenge site was read on removal of the patch and 24 hours thereafter. - GLP compliance:
- no
Test material
- Reference substance name:
- Essential oil of Petitgrain obtained from the leaves and twigs of Citrus aurantium (Rutaceae) by distillation
- EC Number:
- 946-433-7
- Cas Number:
- Not available
- Molecular formula:
- Not applicable for a natural complex substance (UVCB)
- IUPAC Name:
- Essential oil of Petitgrain obtained from the leaves and twigs of Citrus aurantium (Rutaceae) by distillation
- Test material form:
- liquid
- Details on test material:
- CAS #
For specific details on test material if available - See in RSS
Name of test material (as cited in study report or in reference): Petitgarin oil, Petitgrain oil (Paraguay), Petitgrain oil (Bigarade) and Petitgrain oil (Terpeneless)
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: RIFM#75-8-112 Petitgrain bigarde oil
Test animals
- Species:
- other: human
Test system
- Type of coverage:
- occlusive
- Vehicle:
- other: petrolatum
- Amount / concentration applied:
- TEST MATERIAL
- Concentration: 8% in petrolatum
- Duration of treatment / exposure:
- 48 hours
- Observation period:
- 24 hours
- Number of animals:
- 25 humans: 10 male and 15 female
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- other: 25 humans 18+
- Remarks:
- Dose 8% in petrolatum
- Time point:
- 48 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- other: 25 humans 18+
- Remarks:
- Dose 8% in petrolatum
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- none
- Other effects:
- none
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- based on CLP criteria (EC 1272/2008 and its updates)
- Conclusions:
- Under the conditions of this study, the testing material gave no instances of irritation. Based on this result, the test substance does not need to be classified for skin irritation in accordance with the criteria outlined in CLP (1272/2008/EC).
- Executive summary:
The skin irritating potential of Petitgrain Bigarde Oil on humans was tested on 25 healthy adult volunteers. The material was applied under occlusion on the volar aspects of the forearm or backs for 48 hours. No subject had any irritation from the testing material. Under the conditions of this study, the testing material gave no instances of irritation. Based on this result, the test substance does not need to be classified for skin irritation in accordance with the criteria outlined in CLP (1272/2008/EC).
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