Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
sensitisation data (humans)
Type of 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 for cross-reference:
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

Constituent 1
Chemical structure
Reference substance name:
(carboxylatomethyl)dodecyldimethylammonium
EC Number:
211-669-5
EC Name:
(carboxylatomethyl)dodecyldimethylammonium
Cas Number:
683-10-3
Molecular formula:
C16H33NO2
IUPAC Name:
[dodecyl(dimethyl)ammonio]acetate
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