Registration Dossier
Registration Dossier
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EC number: 204-587-6 | CAS number: 122-97-4
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- 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:
- 2 002
- Bibliographic source:
- Contact Dermatitis 46:141-144
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The substance was tested on fragrance sensitive volunteers.
- GLP compliance:
- no
Test material
- 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
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 218
- Clinical history:
- - History of allergy or casuistics for study subject or populations: All of the probands were fragrance-sensitive.
- Controls:
- no
- Route of administration:
- dermal
- Details on study design:
- RANGE FINDING TESTS:
the challenge concentrations were evaluated after treatment of 20 control subjects without evidence of fragrance allergy
TYPE OF TEST(S) USED: patch test (epicutaneous test)
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 20
- Number of subjects with negative reactions 198
Applicant's summary and conclusion
- 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:
A publication (Larsen et al. 2002) is available in which a study is described that was conducted on 218 human volunteers with known allergies to fragrance materials. The test substance was applied at a concentration of 5 %. As a result, 0.9 % of the probands exhibited a positive skin reaction.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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