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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
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

Constituent 1
Chemical structure
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%.