Benzoic acid, 4-hydroxy-, C18-22-alkyl esters

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Repeated insult patch test (based on the Draize-Shelanski Test): A panel of minimum 200 volunteers was tested for primary or cumulative irritation and/or sensitisation after repeated dermal contact with the test item.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Benzoic acid, C12-15-alkyl esters

EC Number:

270-112-4

EC Name:

Benzoic acid, C12-15-alkyl esters

Cas Number:

68411-27-8

IUPAC Name:

68411-27-8

Details on test material:

- Name of test material (as cited in study report): trade name
- Analytical purity: no data

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: minimum 200
- Age: adult
- The criteria for selection were:
1. Willingness to cooperate
2. Absence of any visible skin disease which might be confused with skin reactions from the test material
3. Dependability and intelligence in following directions
4. Reading, understanding and signing an informed consent contract

Clinical history:

Absence of any visible skin disease which might be confused with skin reactions from the test material

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
- Description of patch: 1.5'' x 2.0'' gauze portion of a Coverlet adhesive dressing
- Vehicle / solvent: mineral oil
- Concentrations: 10%
- Volume applied: 0.15 mL
- Testing/scoring schedule:
Induction: 3 times/week (Monday, Wednesday and Friday) for a total of 10 applications. the evaluatiuon of each test site was made just prior to re-application. Rest periods consisted of 24 h following the Tuesday and Thursday removal and 48 h following the Saturday removal.
Challenge: At the conclusion of a 14-day rest period follwing the 10th induction exposure, a challenge path was applied to the original test site and a virgin site. Skin reactions were evaluated 24 and 48 h following application.
- Removal of test substance: The subjects were instructed to remove the patches after 24 h
- Test site: volar forearm or upper back between the scapulae. Each test site was marked to ensure the continuity of patch application.

EXAMINATIONS
- Grading/Scoring system:
0 - no visible reaction
+ - mild erythema
++ - well-defined erythema
+++ - erythema and oedema
++++ - erythema and oedema with vesiculation and ulceration

Results and discussion

Results of examinations:

No sensitisation was observed.
No irritation was noted.

Applicant's summary and conclusion

Conclusions:

The test item is not sensitising or irritating to humans after repeated dermal application of 10% solution in mineral oil.