3-phenylpropan-1-ol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

sufficient for assessment with restrictions (non-guideline study)

Data source

Reference

Reference Type:

publication

Title:

Fragrance contact dermatitis - a worldwide multicenter investigation (Part III)

Author:

Larsen, W., Nakayama, H., Fischer, T., Elsner, P., Frosch , P., Burrwos, D., Jordan, W., Shaw, S., Wilkinson, J., Marks, J., Sugawara, M., Nethercott, M., Nethercott, J.

Year:

2002

Bibliographic source:

Contact Dermatitis 46:141-144

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The substance was tested on fragrance sensitive volunteers.

GLP compliance:

no

Type of study:

patch test

Justification for non-LLNA method:

The data is obtained from a publication on a study performed with humans. Based on this information the LLNA criteria are not seen as requirement.

Test material

Test material information

Constituent 1

Reference substance name:

3-phenylpropan-1-ol

EC Number:

204-587-6

EC Name:

3-phenylpropan-1-ol

Cas Number:

122-97-4

Molecular formula:

C9H12O

IUPAC Name:

3-phenylpropan-1-ol

In vivo test system

Test animals

Species:

human

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

- Number of subjects exposed: 218
- History of allergy or casuistics for study subject or populations: All of the probands were fragrance-sensitive.

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Concentration / amount:

5 %

Challenge

Route:

epicutaneous, occlusive

Concentration / amount:

5 %

No. of animals per dose:

218

Details on study design:

MAIN STUDY
A total of 218 patients with proven contact dermatitis due to fragrance materials were entered into the study. Many patients reported a personal history of hay fever, asthma or atopic dermatitis. Patch test methods and reading were according to internationally accepted criteria The patch test sites were evaluated initially at 2 - 3 days. The sites were re-examined in the majority of cases, usually between 2 and 5 days after the 1st reading.

Challenge controls:

The challenge concentrations were evaluated after treatment of 20 control subjects without evidence of fragrance allergy.

Positive control substance(s):

not required

Results and discussion

Positive control results:

Not applicable.

In vivo (non-LLNA)

Results

Key result

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

5 %

No. with + reactions:

20

Total no. in group:

218

Clinical observations:

positive skin reactions

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

0.9 % of the human probands were tested positive in a study on the sensitising potential of the test substance at a concentration of 5%.

Executive summary:

0.9 % of the human probands were tested positive in a study on the sensitising potential of the test substance at a concentration of 5%.