Sodium anisate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

10 Aug - 03 Nov 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

according to guideline

Guideline:

other: Human Repeat Insult Patch Test (RIPT)

Principles of method if other than guideline:

- Principle of test: The sensitization potential of the test item (3% in glycerine) was tested on 56 subjects (19 males and 37 females). Testing was done in accordance with a modified Draize assay employing an 8 mm Finn Chamber (an occlusive patch). For the induction phase the products were applied to the scapular back Monday, Wednesday, and Friday of each week for 3 consecutive weeks, with a final patch on Monday of the 4th week, for a total of ten applications. Scoring of the skin sites was made at the end of each 48 hour patch period (72 hours on Weekends). The final reading was made on Wednesday of the fourth week.
Following a 12-day rest period each subject received a single 48-hour occlusive challenge patch of the product on a naive skin site on the scapular back. Scoring of the challenge sites was made after removal of the patch and again two days later.
- Parameters analysed / observed: erythema, edema, vesicles, bullae, toxicity/adverse effects

GLP compliance:

no

Remarks:

not applicable

Test material

Test material information

Constituent 1

Reference substance name:

p-anisic acid

EC Number:

202-818-5

EC Name:

p-anisic acid

Cas Number:

100-09-4

Molecular formula:

C8H8O3

IUPAC Name:

4-methoxybenzoic acid

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 56
- Sex: 19 males and 37 females
- Age: not specified
- Race: not specified
- Demographic information: not specified

Clinical history:

not applicable

Controls:

not applicable

Route of administration:

dermal

Details on study design:

TYPE OF TEST USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: 8 mm Finn chamber
- Vehicle / solvent: unchanged (no vehicle)
- Volume applied: approximately 0.025 mL (0.017 - 0.025 mL)
- Testing/scoring schedule: The test material was applied 3 times a week (Monday, Wednesday, Friday) for a total af 10 applications. At the end of each 48 h period (72 h an the weekend), the patches were removed and the sites were read. After reading the tenth induction patch, the subjects were rested for 12 days, during which time no patches were applied. At the end of the rest period, occlusive challenge patches were applied to new sites on the scapular back. The challenge patches remained in place for 48 h, after which the subjects returned for a reading of the test sites. Subjects then returned 2 days later for a 96 h reading.
- Removal of test substance: after removal of the test sites, the sites were rinsed with distilled water

EXAMINATIONS
- Grading/Scoring system: 0 = No reaction (negative reading), 1 = Erythema throughout the entire patch area, 2 = Erythema and edema, 3 = Erythema, edema and vesicles, 4 = Erythema, edema and bullae
- Statistical analysis: not specified

Results and discussion

Results of examinations:

SYMPTOMS
- No product-related systemic adverse reactions were noted during the study. However, one subject suffered a transient ischernic attack just prior to the challenge week and one subject was hospitalized for a kidney infection during challenge week. Both subjects have completely recovered.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 56
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 3 (11 reactions noted)

Applicant's summary and conclusion

Conclusions:

The test item was tested for its skin sensitizing potential in an RIPT in volunteers at a concentration of 3% in glycerine. Based on the results of this study the test substance is not considered a skin sensitizer in humans.