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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:
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%.

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