Registration Dossier
Registration Dossier
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EC number: 946-913-6 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Skin sensitization, Maximization test: non-sensitizing
Skin sensitization, Open Epicutaneous Test (OET): non-sensitizing
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:
- 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
- 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.
- Specific details on test material used for the study:
- Copaiba oil (RIFM 56-8-452)
- Species:
- other: human
- Sex:
- male
- 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)
- 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
- 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
- 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).
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1979
- 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: The open epicutanous test for testing new chemcials and cosmetics, simulate conditions in human use, yield quantitative data and minimise the effect of subjective factors in evaluating results.
- GLP compliance:
- no
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- In vivo data available.
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Route:
- epicutaneous, open
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- copaiba oil at 8% in an unspecified vehicle.
- Day(s)/duration:
- A total of 21 daily induction applications were placed on a clipped area on the flank and at the challenge on days 21 and 35, the guinea pigs were treated with copaiba oil at 8% in an unspecified vehicle.
- Adequacy of induction:
- other: highest concentration not inducing macroscopic reactions
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- not specified
- Concentration / amount:
- copaiba oil at 8% in an unspecified vehicle.
- Day(s)/duration:
- A total of 21 daily induction applications were placed on a clipped area on the flank and at the challenge on days 21 and 35, the guinea pigs were treated with copaiba oil at 8% in an unspecified vehicle.
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 1 to 6 experimental groups and one control group, 8 animals per dose.
- Details on study design:
- RANGE FINDING TESTS: To determine minimal irritating concentration (A) and the maximal tolerated one (B) after a single application by simultaneously applying four different concentrations to the left flank skin of a special animal group. Reactions are read 24 hours after application. The maximum non-irritant concentration (B) is defined as the highest one not inducing macroscopic reactions in any of the animals.
MAIN STUDY
A. INDUCTION EXPOSURE
- Test groups: 1 to 6
- Control group: yes
- Site: The clipped flank skin
- Concentrations: 8%
B. CHALLENGE EXPOSURE
- Test groups: 1 yo 6
- Control group: yes
- Site: The clipped flank skin
- Concentrations: 8%
- Evaluation (hr after challenge): 24 hous after application - Positive control substance(s):
- yes
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 8% in an unspecified vehicle
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other:
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- unspecified vehicle
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other:
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- 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 at a concentration of 8%. 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 irritating and sensitizing potential of Copaiba oil was tested in an open epicutaneous test (OET) on guinea pigs. In a first test, to determine minimal irritating concentration (A) and the maximal tolerated one (B) after a single application by simultaneously applying four different concentrations to the left flank skin of a special animal group. Reactions are read 24 hours after application. The maximum non-irritant concentration (B) is defined as the highest one not inducing macroscopic reactions in any of the animals. The materials was applied on the clipped flank skin of the animals. Under the conditions of this study, the testing material gave no instances of contact-sensitization at a concentration of 8%.
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).
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Additional information:
Main constituent classification
Copaiba Balsam oil has one main consituent β-Caryophyllene (CAS # 87 -44 -5) with concentration range values between 35% to 85%. The substance β-Caryophyllene is recently registered in the EU (EC # 201 - 746 -1) with classification Skin Sens. 1B in accordance with the criteria outlined in CLP (1272/2008/EC).
Skin sensitization: Maximization test
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).
Skin sensitization: Open Epicutaneous Test (OET)
The irritating and sensitizing potential of Copaiba oil was tested in an open epicutaneous test (OET) on guinea pigs. In a first test, to determine minimal irritating concentration (A) and the maximal tolerated one (B) after a single application by simultaneously applying four different concentrations to the left flank skin of a special animal group. Reactions are read 24 hours after application. The maximum non-irritant concentration (B) is defined as the highest one not inducing macroscopic reactions in any of the animals. The materials was applied on the clipped flank skin of the animals. Under the conditions of this study, the testing material gave no instances of contact-sensitization at a concentration of 8%. 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).
Justification for classification or non-classification
Copaba Balsam oil has one main constituent β-Caryophyllene (CAS 87 -44 -5) with concentration range values between 35% to 85%. The substance β-Caryophyllene is recently classified as Category 1B skin sensitizer. Despite no significant effects for skin sensitisation were found in tests with Copaiba Balsam oil on humans and guinea pigs under the conditions of those tests, Copaiba Balsam oil is classified as skin sensitizer based on the classification of the main constituent β-Caryophyllene.
Based on the available data, Copaiba balsam oil should be classified as Skin sensitizer (Skin Sens. 1B / H317) in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
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