Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 for cross-reference:
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

Constituent 1
Chemical structure
Reference substance name:
Tar acids, xylenol fraction
EC Number:
284-895-5
EC Name:
Tar acids, xylenol fraction
Cas Number:
84989-06-0
Molecular formula:
not applicable
IUPAC Name:
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

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.