Registration Dossier

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

Reference
Name:
Unnamed
Type:
Constituent
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.