Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
1974
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Unpublished report to RIFM.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

Constituent 1
Chemical structure
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

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.