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Registration Dossier
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EC number: 946-433-7 | CAS number: -
Skin sensitisation
Administrative data
- 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
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:
- - 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
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
In vivo test system
Test animals
- Species:
- other: human
- Sex:
- male/female
- Details on test animals and environmental conditions:
- 10 Male and 15 Female
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 8%
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- not specified
Challenge
- 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.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- 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
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 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).
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