Registration Dossier
Registration Dossier
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EC number: 203-398-6 | CAS number: 106-44-5
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 in monograph pf a peer-reviewed of an international journal
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- p-Cresol in Fragance raw materials monographs: report to RIFM of Kligman AM/22. November 1972
- Author:
- Opdyke DLJ
- Year:
- 1 974
- Bibliographic source:
- Fd Cosmet Toxicol 12, 389-390
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- maximisation test with voluteers
Test material
- Reference substance name:
- p-cresol
- EC Number:
- 203-398-6
- EC Name:
- p-cresol
- Cas Number:
- 106-44-5
- Molecular formula:
- C7H8O
- IUPAC Name:
- p-cresol
- Details on test material:
- no data on purity
Constituent 1
Method
- Type of population:
- other: volunteers
- Ethical approval:
- not specified
- Subjects:
- voluteers
- Clinical history:
- no data
- Controls:
- no data
- Route of administration:
- dermal
- Details on study design:
- A maximization test was conducted on 25 volunteers using a 4% concentration of p- cresol in petrolatum. The maximization test involves an induction phase of five consecutive 48-hr covered patch tests, sometimes separated by 24-hr periods of treatment with a mild irritant, followed 10-14 days later by a 48-hr challenge patch using the same concentration
(see: Kligman AM, 1966: The identification of contact allergens by human assay. III. The maximization test. A procedure for screening and rating contact sensitizers, J. Invest. Derm. 47, 393).
Results and discussion
- Results of examinations:
- There were no sensitization reactions in any of the volunteers (0/25)
Any other information on results incl. tables
no further data
Applicant's summary and conclusion
- Executive summary:
p-Cresol was evaluated as being non-sensitizing following a maximization test in human volunteers.
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