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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
9th April to 24th May 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
- Principle of test: To determine by repetitive epidermal contact the potential of the test substance to induce primary or cumulative irritation and/or allergic contact sensitisation.
- Short description of test conditions: The upper back between the scapulae served as the treatment area. Approximately 0.2g of the substance was applied to the 1"x1" absorbent pad portion of a clear adhesive dressing. This was then applied to the appropriate treatment site to form a semi-occlusive patch. There were essentially two phases to the test, these were induction phase and challenge phase. The induction phase involved the initial application of the substance followed by the induction phase where a challenge patch was applied 2 weeks after the initial induction patch. The patch was then removed and the site scored at 24 and 72 hours post-application.
- Parameters analysed / observed: Erythma was scored numerically and if present any additional dermal sequalae was indicated.
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
The HRIPT study presented is considered to be an adequate study to investigate the sensitisation potential of the substance and therefore a LLNA was not warranted.

Test material

Constituent 1
Reference substance name:
Undecanolactone
EC Number:
254-399-3
EC Name:
Undecanolactone
Cas Number:
39282-36-5
Molecular formula:
C11H20O2
IUPAC Name:
undecanolactone

In vivo test system

Test animals

Species:
other: Human
Strain:
other:
Sex:
male/female
Details on test animals and environmental conditions:
Male and female human subjects aged between 18 to 79 years. A total of 103 subjects completed the study.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.2g
Day(s)/duration:
Patches applied 3 times per week for a total of 9 applications
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.2g
Day(s)/duration:
Patch applied 2 weeks after the final induction patch
Adequacy of challenge:
not specified
Positive control substance(s):
no

Results and discussion

Positive control results:
Not applicable.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.2g
No. with + reactions:
0
Total no. in group:
103
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0.2g
No. with + reactions:
0
Total no. in group:
103
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance did not indicate a potential for dermal irritation or allergic contact sensitisation in a HPRIT.
Executive summary:

In a HRIPT test the substance did not indicate a potential for dermal irritation or allergic contact sensitisation under the test conditions employed.