Registration Dossier

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:
1974
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
Name:
Unnamed
Type:
Constituent
Details on test material:
no data on purity

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:
ME-Freetext: 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