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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
Study period:
September 1974
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:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A human patch test with 25 healthy adult volunteers was performed as described in J.I.D., Vol 47; No. 5; 393-409; 1966 by A.M. Kligman et al.
GLP compliance:
no
Remarks:
pre-dates GLP
Type of study:
patch test
Justification for non-LLNA method:
study was available

Test material

Constituent 1
Chemical structure
Reference substance name:
2-phenylpropan-1-ol
EC Number:
214-379-7
EC Name:
2-phenylpropan-1-ol
Cas Number:
1123-85-9
Molecular formula:
C9H12O
IUPAC Name:
2-phenylpropan-1-ol
Test material form:
liquid
Specific details on test material used for the study:
Hydratropic alcohol as supplied was used, purity >95%, technical grade.

In vivo test system

Test animals

Species:
other: human volunteers
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
Twenty five (25) healthy adult human volunteers completed the experiment.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Day(s)/duration:
five alternate days 48 hours period
Adequacy of induction:
other: non-irritat substance, but skin pre-treated with 5% aqueous sodium lauryl sulfate (SLS) under occlusion.
Challenge
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Day(s)/duration:
on removal of patch and 24 hours thereafter
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
24 adult healthy volunteers completed the study (13 males and 11 females)
Details on study design:
The material was pre-tested on five subjects in order to determine whether sodium lauryl sulfate (SLS) pre-treatment was required. A patch of this material was applied to normal sites on the backs for 48 hours under occlusion. No subject had any irritation from this material and it was decided to use SLS pre-treatment in the test.
The material was applied under occlusion to the same site on the volar forearms of all subjects for five alternate-day 48 hour periods. The patch site was pre-treated for 24 hours with 5% aqueous sodium lauryl sulftae under occlusion.
The challenge sites were read on removal of the patch and 24 hours thereafter.
Positive control substance(s):
no

Results and discussion

Positive control results:
not applicable

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
24
Clinical observations:
none
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
24
Clinical observations:
none
Reading:
1st reading
Group:
negative control
Remarks on result:
not measured/tested
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
There were no instances of contact-sensitisation from hydratropic alcohol in this maximisation test with 24 human volunteers.