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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guideline studies

Data source

Referenceopen allclose all

Reference Type:
other: short report
Title:
Unnamed
Year:
1977
Report Date:
1977
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
The test substance was applied to the skin for 48 hours under an occlusive dressing
GLP compliance:
not specified
Type of study:
other: maximization study
Justification for non-LLNA method:
The study was performed before the LLNA method was established.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
human
Strain:
other: 24 white and 1 black American citizens
Sex:
male/female
Details on test animals and environmental conditions:
25 healthy male and female volunteers attended

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
8% in petrolatum
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
8% in petrolatum
No. of animals per dose:
25
Details on study design:
RANGE FINDING TESTS:
In pre-testing the test material was not irritating to the skin in any of the 25 subjects. A patch of the test material was applied to normal sites of the forearms or backs for 48 hours under occlusion.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5
- Exposure period: 48 hours
- Test groups: 25 male and female volunteers
- Control group: none
- Site: volar forearms or backs
- Frequency of applications: alternate day
- Duration: 48 hours
- Concentrations: 8% in petrolatum

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2
- Exposure period: 48 hours; under occlusion
- Test groups: 25 male and female volunteers
- Control group: none
- Site: other site than during challenge
- Concentrations: 8% in petrolatum
- Evaluation (hr after challenge): immediately after removal of teh challenge patch and 24 hours thereafter

OTHER: rest period between induction and challenge: 10 days
Positive control substance(s):
not required

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
8% in petrolatum
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
no sensitisation reactions noted in any of the subjects
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 8% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 25.0. Clinical observations: no sensitisation reactions noted in any of the subjects.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
8% in petrolatum
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
no sensitisation reactions noted in any of the subjects
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 8% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 25.0. Clinical observations: no sensitisation reactions noted in any of the subjects.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Executive summary:

3,5,5- trimethylhexanol was tested in a maximisation study for its skin sensitising potential in 25 healthy volunteers. The test substance (8% in petrolatum) was applied to the skin for 48 hours under an occlusive dressing. No sensitisation reactions were noted (Belsito et al. 2010; p. S33 and Table 10 on p. S41). A synopsis of the study is available (Kligman1977).

The study is considered to be reliable and suitable for assessment of this endpoint.