Registration Dossier
Registration Dossier
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EC number: 202-940-9 | CAS number: 101-41-7
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given, acceptable, well documented publication, no guideline and no GLP study.
Data source
Reference
- Reference Type:
- publication
- Title:
- Report on human maximization studies
- Author:
- Kligman A.M.
- Year:
- 1 974
- Bibliographic source:
- Unpublished report to RIFM. Report 1779
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:
- Human patch test with the test substance on 25 healthy inmalte volunteers.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Methyl phenylacetate
- EC Number:
- 202-940-9
- EC Name:
- Methyl phenylacetate
- Cas Number:
- 101-41-7
- Molecular formula:
- C9H10O2
- IUPAC Name:
- methyl phenylacetate
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - 25 adult volunteers
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST USED: Human patch test
ADMINISTRATION
- Type of application: occlusive
- Description of patch: The patch sites were pre-treated for 24 hours with 5 % aqueous sodium lauryl sulfate under occlusion. The challenge sites were read on removal of the patch and 24 hours thereafter.
- Vehicle: Sodium lauryl sulfate
Results and discussion
- Results of examinations:
- There were no instances of contact-sensitization. It is unlikely that the test material would present a danger of contact-sensitization in normal, intended use.
Applicant's summary and conclusion
- Conclusions:
- There were no instances of contact-sensitization. It is unlikely that the test material would present a danger of contact-sensitization in normal, intended use.
- Executive summary:
A human maximization test was conducted to determine the contact-sensitizing potential of the test item. 25 healthy adult volunteers were used in a maximization test. In the main test the test item was applied under occlusion to the same sites on the volar forearms of all subjects for five alternate-day 48 hour periods. The patch sites were pre-treated for 24 hours with 5 % aqueous sodium lauryl sulfate under occlusion. The challenge sites were read on removal of the patch and 24 hours thereafter. No instances of contact-sensitization from any material on the maximization test were found.
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