2-phenylpropan-1-ol

Skin sensitisation

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

Test material information

Constituent 1

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)

Results

Results 1

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

Results 2

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

Results 3

Reading:

1st reading

Group:

negative control

Remarks on result:

not measured/tested

Results 4

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.