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Diss Factsheets

Administrative data

Description of key information

Skin sensitisation: sensitising

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
no guideline followed
Principles of method if other than guideline:
Maximization test (modified after JID 47:393-409):
- Principle of test: To determine the skin sensitizing and skin irritating potential of Eucalyptus citriodora
- Short description of test conditions: Forty five healthy inmate volunteers were screened and 32 completed the study.
- Parameters analysed / observed: Skin sensitization and skin irritation.
GLP compliance:
no
Type of study:
patch test
Justification for non-LLNA method:
Study in human subjects
Species:
other: human
Sex:
male
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
not specified
Day(s)/duration:
5 alternate day - 48 hour period
Adequacy of induction:
other: non-irritant substance, but pretreated with 5% Sodium Lauryl Sulfate (SLS)
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
not specified
Day(s)/duration:
2
Adequacy of challenge:
not specified
No. of animals per dose:
32 humans
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5 (alternate days)
- Exposure period: 48 hours
- Site: volar aspects of the forearms

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 48 hours
- Site: volar aspects of the forearms
- Concentrations: not specified
- Evaluation (hr after challenge): 72
Positive control substance(s):
no
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Undiluted substance
No. with + reactions:
0
Total no. in group:
33
Clinical observations:
No reactions were considered significantly irritant or allergic
Remarks on result:
other: without SLS pre-treatment
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
Undiluted substance
No. with + reactions:
2
Total no. in group:
32
Clinical observations:
No reactions were considered significantly irritant or allergic
Remarks on result:
other:
Remarks:
without SLS pre-treatment
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Undiluted substance
No. with + reactions:
1
Total no. in group:
33
Clinical observations:
No reactions were considered significantly irritant or allergic
Remarks on result:
other: with SLS pre-treatment
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
Undiluted substance
No. with + reactions:
3
Total no. in group:
32
Clinical observations:
No reactions were considered significantly irritant or allergic
Remarks on result:
other: with SLS pre-treatment
Interpretation of results:
other: not classified
Remarks:
based on CLP criteria
Conclusions:
Under the conditions of this study, the testing material gave no reactions that were considerted significantly irritant or allergic. Based on this result, the test substance does not need to be classified for skin irritation in accordance with the criteria outlined in the CLP Regulation (1272/2008/EC).
Executive summary:

The sensitizing and irritation potential of Eucalyptus Citrodora on humans was tested in a maximization test. Materials were pretested to determine whether Sodium Lauryl Sulfate (SLS) pretreatment was required; and as a result all subjects were pretreated with 5% SLS (patch sites were pretreated for 24 hours). The materials were applied under occlusion on the volar aspects of the forearm for 5 alternate day 48 hour periods. After a 10-14 day resting period, challenge patches were applied under occlusion to fresh sites for 48 hours. The challenge application was preceded by 30-minute applications of 5% SDS, and without SLS on the right side. Under the conditions of this study, the testing material gave no reactions that were considered significantly irritant or allergic. Based on this result, the test substance does not need to be classified for skin irritation in accordance with the criteria outlined in the CLP Regulation (1272/2008/EC).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The sensitizing and irritation potential of Eucalyptus Citrodora on humans was tested in a maximization test. Materials were pretested to determine whether Sodium Lauryl Sulfate (SLS) pretreatment was required; and as a result all subjects were pretreated with 5% SLS (patch sites were pretreated for 24 hours). The materials were applied under occlusion on the volar aspects of the forearm for 5 alternate day 48 hour periods. After a 10-14 day resting period, challenge patches were applied under occlusion to fresh sites for 48 hours. The challenge application was preceded by 30-minute applications of 5% SDS, and without SLS on the right side. Under the conditions of this study, the testing material gave no reactions that were considered significantly irritant or allergic. Based on this result, the test substance does not need to be classified for skin irritation in accordance with the criteria outlined in the CLP Regulation (1272/2008/EC).

Although the available data suggests that the substance is not a skin sensitiser, the major constituent 1,(+)-Citronellal (CAS 2385-77-5) is currently classified as skin sensitiser (Skin Sens. 1 / H317). Based on the fact that this classified constituent represents typically 76% of the composition of Eucalyptus citriodora, which is well above the 10% classification limit for mixtures in the CLP Regulation, it was decided to that the substance needs to be regarded a skin sensitiser as well.

Justification for classification or non-classification

Based on the available data, Eucalyptus citriodora is classified as a skin sensitiser (Skin Sens. 1 / H317) in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).