Tar acids, xylenol fraction

Sensitisation data (human)

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.

Materials and methods

Test material

Test material information

Constituent 1

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.