Salicylic acid

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The test conditions are well described and followed the recognized Maximization procedure.

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 AM

Year:

1966

Bibliographic source:

J Investigative Toxicol, 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: Volunteers are initially exposed to five sequences of alternaing 24 hour irritant (sodium lauryl sulfate) and 48 hour allergen patches applied to the same site under an occlusive patch (induction exposure). Then, volunteers are exposed to a challenge dose for 48 hours. The challenge reaction is read immediately after removal of the 48 hour patch and again in another two days.

GLP compliance:

no

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

Molecular formula:

C7H6O3

IUPAC Name:

2-hydroxybenzoic acid

Details on test material:

- Name of test material (as cited in study report): salicylic acid
no other data

Method

Type of population:

other: prisoners

Ethical approval:

not specified

Subjects:

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

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: 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



EXAMINATIONS
- Grading/Scoring system: Maximization grading (see Table 1 in field "any other information on materials and methods incl. tables)
- Statistical analysis: no data

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:

Under the conditions of this test, salicylic acid is not a skin sensitizer.

Executive summary:

In a human maximization test (Kligman AM, 1966), institutional volunteers (prisoners) were dermally exposed to salicylic acid. A panel of 25 healthy adult subjects (18 -50 years) was used. A concentration of salicylic acid of 20 % and 10 % were applied respectively during the induction phase and the challenge test. None subjects showed sensitization after salicylic acid exposure.Under the conditions of this test, salicylic acid is not a sensitizer.