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Toxicological information

Skin sensitisation

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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:
1971
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
Name:
Unnamed
Type:
Constituent
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
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 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

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).