Registration Dossier
Registration Dossier
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EC number: 203-253-7 | CAS number: 104-93-8
Sensitisation data (human)
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:
- 1 971
- 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:
- 1 971
- 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
- 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
Constituent 1
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
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