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Skin sensitisation

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
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

Test material

Constituent 1
Reference substance name:
Eucalyptus citriodora
IUPAC Name:
Eucalyptus citriodora
Constituent 2
Reference substance name:
85203-56-1
Cas Number:
85203-56-1
IUPAC Name:
85203-56-1
Details on test material:
- Name of test material (as cited in study report): Eucalyptus citriodora
- Physical state: Liquid
- Analytical purity: Confidential information
- Lot/batch No.: Confidential information
- Expiration date of the lot/batch: Confidential information
- Storage condition of test material: Room temperature in the dark

In vivo test system

Test animals

Species:
other: human
Sex:
male

Study design: in vivo (non-LLNA)

Induction
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)
Challenge
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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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

Applicant's summary and conclusion

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).

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