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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Cited as secondary source in a peer reviewed journal. Basic data given.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Appraisal of sensitizing powers by maximization testing in humans
Author:
Kligman AM
Year:
1971
Bibliographic source:
Report to RIFM, cited in Opdyke DLJ, Food Cosmet. Toxicol., Fragrance Raw Materials Monographs, Vol. 12: 239, 1974
Reference Type:
secondary source
Title:
Appraisal of sensitizing powers by maximization testing in humans. Report to RIFM
Author:
A.M.Kligman
Year:
1971
Bibliographic source:
Cited in RIFM Database, Location 1805;

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Human maximization study was conducted on 25 male volunteers.
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was conducted.

Test material

Constituent 1
Chemical structure
Reference substance name:
4-methylanisole
EC Number:
203-253-7
EC Name:
4-methylanisole
Cas Number:
104-93-8
Molecular formula:
C8H10O
IUPAC Name:
1-methoxy-4-methylbenzene
Details on test material:
- Name of test material (as cited in study report): p-Methylanisloe
- Analytical purity: no data given

Method

Type of population:
not specified
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 25
- Sex: male
- Age: no data given
- Race: no data given
Clinical history:
no data
Controls:
no data
Route of administration:
dermal
Details on study design:
Closed patch applications with the test material in petrolatum were made to the same site on the volunteers´forearms for 5 alternate day 48-hour periods.
Patch sites were pretreated with 5 % sodium lauryl sulphate (SLS) for 24 hours.
Following a 10 day rest period, challenge patches were applied to fresh sites under occlusion for 48 hours and the challenge sites were pretreated for 1 hour with 10 % SLS under occlusion.
The sites were read at patch removal (48 h) and 48 h after patch removal (72 h).

Results and discussion

Results of examinations:
According to the authors, no sensitization effects were seen when using 2 % of the test material.
In the 48-hour closed patch test, performed prior to the human maximization study, no irritating effects were observed using 2 % of the test material.

Applicant's summary and conclusion

Conclusions:
The purpose of the study was to determine the contact sensitization potential of the test material in humans. The Kligman maximization test was used in the study. According to the authors, no sensitization effects were seen when using 2 % of the test material in petrolatum.