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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only short abstract available. The analytical purity of the test substance was not specified, the available documentation is limited, the test substance concentration is not specified.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1968
Report date:
1968

Materials and methods

Principles of method if other than guideline:
20 volunteers were exposed to the test substance in a sensitisation study, using a modified version of the test described by Schneider (Tübingen, Germany). The induction was performed by applying the test substance daily for 14 consecutive days. The challenge was performed folllowing a 14-day recovery period.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, C8-10, C12-18-alkyl esters
EC Number:
306-082-7
EC Name:
Fatty acids, C8-10, C12-18-alkyl esters
Cas Number:
95912-86-0
Molecular formula:
Unspecified
IUPAC Name:
Fatty acids, C8-10, C12-18 (even numbered)-alkyl esters
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Analytical purity: no data

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 20
Controls:
No data
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Other: the induction was performed by applying the test substance daily for 14 consecutive days. The challenge was performed 14 days later.

Results and discussion

Results of examinations:
OTHER RESULTS:
No sensitizing effect was observed following the challenge exposure.

Applicant's summary and conclusion