Registration Dossier
Registration Dossier
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EC number: 946-913-6 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 01-06-1971
- 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:
- 1 971
- Report date:
- 1971
Materials and methods
- Principles of method if other than guideline:
- Principle of test: Maximization test with twenty five healthy inmate volunteers.
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Type of study:
- patch test
- Justification for non-LLNA method:
- Human data availabe.
Test material
- Reference substance name:
- Essential oil of Copaiba obtained from the exudate of Copaifera (Fabaceae) trees by distillation
- EC Number:
- 946-913-6
- Molecular formula:
- Not applicable for UVCB Substance
- IUPAC Name:
- Essential oil of Copaiba obtained from the exudate of Copaifera (Fabaceae) trees by distillation
- Test material form:
- liquid
- Details on test material:
- For specific details on test material if available - See in RSS
Name of test material (as cited in study report or in reference): Copaiba oil, Copiaba Balsam oil, Copaiba oleoresin
Constituent 1
- Specific details on test material used for the study:
- Copaiba oil (RIFM 56-8-452)
In vivo test system
Test animals
- Species:
- other: human
- Sex:
- male
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- Copaiba oil at 8% in petrolatum were placed on sodium lauryl sulfate-pretreated sites on the forearms for 5 alternate-day 48-hour periods.
- Day(s)/duration:
- five alternate-day 48-periods
- Adequacy of induction:
- other: non-irritant substance, but skin pre-treated with 5% Sodium Lauryl Sulfate (SLS)
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- Copaiba oil at 8% in petrolatum
- Day(s)/duration:
- 48 hours (preceded by one-hour application of 10% Sodium Lauryl Sulfate (SLS)
- Adequacy of challenge:
- other: non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, open
- Vehicle:
- petrolatum
- Concentration / amount:
- Copaiba oil at 8% in petrolatum
- Day(s)/duration:
- 24 hours after the patch removal
- Adequacy of challenge:
- other: non-irritant concentration
- No. of animals per dose:
- 25 humans
- Details on study design:
- RANGE FINDING TESTS:
material was pretested on five subjects in order to determine if SLS pretreatment was needed. A patch was applied to normal site on the backs for 48 hours under occlusion. No subject had any rritation from the material and it was decided to use SLS-pretreatment in the test.
MAIN STUDY
A. INDUCTION EXPOSURE
- Exposure period: on 25 subjects closed applications with copaiba oil at 8% in petrolatum were placed on sodium lauryl sulfate-pretreated sites five alternate-day 48-hour periods
- Test groups: one group of 25 healthy adult male volunteers
- Site: forearms
B. CHALLENGE EXPOSURE
- No. of exposures: 1, after a 10-day resting period
- Exposure period: 48 hours, preceded by one-hour application of 10% SLS
- Test groups: one group of 25 healthy adult male volunteers
- Site: fresh site
- Evaluation (hr after challenge): at 0 and 24 hours thereafter - Challenge controls:
- No
- Positive control substance(s):
- no
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% copaiba oil 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% copaiba oil in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Vehicle
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Chalenge concentration 10% Petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other:
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Chalenge concentration 10% Thephorin®
- No. with + reactions:
- 23
- Total no. in group:
- 24
- Clinical observations:
- None
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Remarks:
- based on criteria outlined in CLP (1272/2008/EC)
- Conclusions:
- Under the conditions of this study, the testing material gave no instances of 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).
- Executive summary:
The sensitizing potential of Copaiba oil on humans was tested in a maximization test on 25 healthy adult volunteers. The testing material was pretested to determine whether Sodium Lauryl Sulfate (SLS) pretreatment was required. No subject had any irritation from the testing material. In the maximization test all subjects were pretreated with 5% SLS (the patch sites were pretreated for 24 hours). The material was applied under occlusion on the forearms for five alternate day-48 hour periods. Following a ten-day resting period challenge patches were applied for 48 hours (the challenge sites were pretreated for 24 hours with 10% SLS). The challenge site was read on removal of the patch and after 24 hours. Under the conditions of this study, the testing material gave no instances of skin 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).
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