Registration Dossier

Toxicological information

Sensitisation data (human)

Currently viewing:

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
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
Cross-reference
Reason / purpose:
read-across source
Reference
Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: cited in monograph of a peer-reviewed international journal;
Type of sensitisation studied:
skin
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
Subjects:
- Number of subjects exposed: 25
no further data
Clinical history:
no data
Controls:
no data
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- 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.
Conclusions:
p-Cresol was evaluated as being non-sensitizing following a maximization test in human volunteers.

Data source

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

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

Applicant's summary and conclusion

Conclusions:
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.