Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Description of key information
Skin sensitisation non-LLNA (human closed patch test): not sensitising
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- - Principle of test:
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
- Type of study:
- patch test
- Justification for non-LLNA method:
- Human data available
- 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 - Species:
- other: human
- Sex:
- male/female
- Details on test animals and environmental conditions:
- 10 Male and 15 Female
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 8%
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 8% in petrolatum
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 25 humans: 10 male and 15 female
- Details on study design:
- The patch site was pre-treated for 24 hours with 2.5% aqueous SLS under occlusion.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 8% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 8% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other:
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Reading:
- other:
- Group:
- positive control
- Remarks on result:
- not measured/tested
- 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 test material gave no instances of irritation or contact-sensitization. Based on this result, the test substance does not need to be classified for skin irritation or sensitization in accordance with the criteria outlined in CLP (1272/2008/EC).
- Executive summary:
The irritating and sensitizing potential of Petitgrain Bigarde Oil on humans was tested in a maximization test on 25 healthy adult volunteers. The test material was pretested to determine whether Sodium Lauryl Sulfate (SLS) pretreatment was required. No subject had any irritation from the test material. In the maximization test all subjects were pretreated with 2.5 % SLS (the patch sites were pretreated for 24 hours). The material was applied 8% in petrolatum under occlusion on the volar aspects of the forearm or backs for 5 alternate day-48 hour periods. The challenge site was read on removal of the patch and after 24 hours. Under the conditions of this study, the test material gave no instances of irritation or contact-sensitization. Based on this result, the test substance Petitgrain Bigarde Oil does not need to be classified for skin irritation or sensitization in accordance with the criteria outlined in CLP (1272/2008/EC).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Key study
The irritating and sensitizing potential of Petitgrain Bigarde Oil on humans was tested in a maximization test on 25 healthy adult volunteers (10 Male, 15 Female). The test material was pretested to determine whether Sodium Lauryl Sulfate (SLS) pretreatment was required. No subject had any irritation from the test material. In the maximization test all subjects were pretreated with 2.5 % SLS (the patch sites were pretreated for 24 hours). The material was applied under occlusion on the volar aspects of the forearm or backs for 5 alternate day-48 hour periods. The challenge site was read on removal of the patch and after 24 hours. Under the conditions of this study, the test material gave no instances of irritation or contact-sensitization. Based on this result, the test substance
Petitgrain Bigarde Oil does not need to be classified for skin irritation or sensitization in accordance with the criteria outlined in CLP (1272/2008/EC).
Supporting study
The irritating and sensitizing potential of Petitgrain Oil on human skin was tested in a closed patch test on both males and females with normal health and dermatosis. Doses were: 5% on 30 subjects with normal health, 2% on 30 subjects with normal health and 0.1% on 48 subjects with dermatosis. Under the conditions of this study, the testing material gave no instances of irritation or contact-sensitization. Based on this result, the test substance does not need to be classified for skin sensitization in accordance with the criteria outlined in CLP (1272/2008/EC).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available information, Petitgrain oil citrus aurantium does not need to be classified for skin sensitization in accordance with the criteria outlined in CLP (1272/2008/EC).
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.