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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

Referenceopen allclose all

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 group
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 group
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 group
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).

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).