Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles, acceptable for assessment. Limited documentation.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report Date:
1963

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Study with 20 volunteers, 6 days occlusive epicutaneous induction, epicutaneous challenge after 10 days rest period
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: aqueous formulation
Details on test material:
- Name of test material (as cited in study report): N-lauryl betaine
- Analytical purity: 0.1% active ingredient

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 20
- Sex: 9 man, 11 woman
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: three-quarter inch square of an adsorbant material, moistened with 10 drops of 0.1% solution covered with cellophane and held in place by adhesive tape
- Concentrations: 0.1 % active ingredient
- Volume applied: 10 drops
- Testing/scoring schedule: 6 days induction, after 10 days resting period: 24h epicutaneous challenge

EXAMINATIONS
- Other: Observations were made 1, 2 and 6 days after the first application and 1-4 days after the final application

Results and discussion

Results of examinations:
After 6 days induction period there was one strong reaction and on day 7 a mild reaction on a second subject, demonstrating that the concentration used was capable to induce local irritation reactions under occlusive conditions. No reactions were observed immediatly after challenge. 4 delayed reactions were noted during the next 4 days, 1 strong, 1 moderate, 2 mild. Because of the nature of these reactions they were considered due to primary irritation and not to sensitisation.

Applicant's summary and conclusion