1,3,4,5-tetrahydroxycyclohexanecarboxylic acid

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is not done according to OECD guideline, but it is a well documented study.

Data source

Reference

Reference Type:

publication

Title:

The identification of contact allergens by human assay III. The maximization test: A procedure for screening and rating contact sensitizers.

Author:

Kligman, A. M.

Year:

1966

Bibliographic source:

J Invest Dermatol. 47(5):393-409

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Maximization test: Squares of Webril, 1.5" along the sides, are used for the induction exposures. The challenge patches are also of Webril except that the size is reduced to 1" squares. For induction, a volume of 1.0 ml of the test material is delivered to the Webril patch via a plastic syringe, minus the needle. For challenge 0.4 ml is used with the smaller patch. Crystalline substances are vigorously triturated into U.S.P. white petrolatum. A panel of 25 healthy adult Volunteers is used. Deliver 1.0 ml of 5% aqueous sodium lauryl sulfate to a 1.5" square of Webril. Fasten occlusivly for 24 hours. Apply to the same site a 48 hour occlusive patch with the test material. Repeat this sequence of alternating 24 hour irritant and 48 hour allergen patches for a total of five exposures of each. The procedure therefore consists of five 48 hour exposures, each one preceded by a 24 hour pre-treatment with 5%sodium lauryl sulfate.
Challange test: The test consists of pre-treating the skin occlusively with 0.4 ml of 10% SLS on a 1.0" Webril square for one hour. This produces sub-clinical inflammation in 48 hours. The challenge reaction is read immediately after removal of the 48 hour patch and again in another two days. A control patch is necessary for the test consisting of petrolatum applied for 48 hours to a site pretreated for one hour with 10% aqueous sodium lauryl sulfate. The control site will usually show no reaction, or occasionally a very mild erythema may be present.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Salicylic acid

EC Number:

200-712-3

EC Name:

Salicylic acid

Cas Number:

69-72-7

IUPAC Name:

salicylic acid

Test material form:

other: crystals, saturated aqueous solution

Details on test material:

- Name of test material (as cited in study report): salicylic acid

Method

Type of population:

other: prisoners

Ethical approval:

not specified

Subjects:

- Number of subjects exposed:25
- Age: 18 to 50 years
- Race: 90 % of experimental subjects were black

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive / semiocclusive /other:
- Description of patch: occlusive
- Vehicle / solvent: petrolatum
- Concentrations: 20 % (induction); 10 % (challenge)
- Volume applied: 1 ml (induction); 0.4 ml (challenge)
- Testing/scoring schedule: The challenge reaction is read immediately after removal of the 48 hour patch and again in another two days
- Removal of test substance: no

Results and discussion

Results of examinations:

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 25
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Applicant's summary and conclusion

Conclusions:

In the human maximization test, salicylic acid is not skin sensitizing.

Executive summary:

In a human maximization test salicylic acid was tested as a potential skin sensitizer. 25 healthy adult subjects (18 -50 years) were tested. A concentration of salicylic acid of 20 % and 10 % were applied respectively during the induction phase and the challenge test. None of these tested subjects showed sensitization after salicylic acid exposure. Therefore we assume that, quinic acid is not skin sensitizing, too