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Sensitisation data (human)

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sensitisation data (humans)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Summary of available data used for the endpoint assessment of the target substance
Adequacy of study:
key study
Justification for type of information:
refer to analogue justification provided in IUCLID section 13
Reason / purpose for cross-reference:
read-across source
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: cited in monograph of a peer-reviewed international journal;
Type of sensitisation studied:
Study type:
study with volunteers
Principles of method if other than guideline:
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)
GLP compliance:
not specified
Type of population:
not specified
Ethical approval:
not specified
- Number of subjects exposed: 25
no further data
Clinical history:
no data
no data
Route of administration:
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

- Type of application: covered patch test (no further information)
- Vehicle / solvent: petrolatum
- Concentrations: 4% (induction and challenge)
- Testing/scoring schedule: 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 of examinations:
There was no sensitization reaction in any of the volunteers.
p-Cresol was evaluated as being non-sensitizing following a maximization test in human volunteers.

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Tar acids, xylenol fraction
EC Number:
EC Name:
Tar acids, xylenol fraction
Cas Number:
Molecular formula:
not applicable
2,3-dimethylphenol; 2,4-dimethylphenol; 2,5-dimethylphenol; 2,6-dimethylphenol; 3,4-dimethylphenol; 3,5-dimethylphenol

Results and discussion

Results of examinations:
There was no sensitisation reaction in any of the volunteers.

Applicant's summary and conclusion

p-Cresol was evaluated as being non-sensitising following a maximisation test in human volunteers. As there are no skin sensitisation data available for Tar acids, Xylenol fraction (CAS 84989-06-0) a worst-case approach was conducted taken into account all available data on the source substances and Tar acids, Xylenol fraction (CAS 84989-06-0) was therefore classified as Skin Sens. 1B (H317) according to Regulation (EC) No 1272/2008.