Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scienific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Study type:
study with volunteers
Principles of method if other than guideline:
The test substance was applied to the skin of 25 healthy human volunteers of both sexes under occlusive patches. For induction, the patches remained on the skin for 48 h or for the first 2 weekends for 72 h, and the challenge patches were removed after 48 h. Macroscopic examination of the application sites were then conducted about 24 and 48 hours after challenge patch removal.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Isooctadecyl isooctadecanoate
EC Number:
255-485-3
EC Name:
Isooctadecyl isooctadecanoate
Cas Number:
41669-30-1
Molecular formula:
C36H72O2
IUPAC Name:
2-methylheptadecyl 3-methylheptadecanoate
Details on test material:
- Name of test material (as cited in study report): Isostearate Isostearyle
- Physical state: very light yellow liquid
- Analytical purity: no data
- Lot/batch No.: 13782
- Storage condition of test material: protected from heat (between + 5°C and + 25°C and light

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: 25
- Sex: 20 women, 5 men
- Age: 20 - 56


Controls:
not required, untreated sites of the same volunteer served as control
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: Finn Chambers on Scanpor, it is composed of an aluminium 8 mm in diameter covering a contact surface of 50 mm2. Each capsule was individually mounted onto an adhesive tape and was applied in such a manner to exert equal equal pressure on all capsules.
- Vehicle / solvent: Kernel stone oil
- Concentrations: 30%
- Volume applied: 0.02 mL
- Testing/scoring schedule: 9 application allocated on 3 weeks as follows:
1st week: day 1 (Monday: 1st application), day 3 (Wednesday), day 5 (Friday),
2nd week: day 8 (Monday), day 10 (Wednesday), day 12 (Friday)
3rd week: day 15 (Monday), day 17 (Wednesday), day (Friday)

EXAMINATIONS
- Grading/Scoring system: no visible cutaneous reaction - 0, very slight and hardly visible erythema - 1, erythema with small infiltration and sometimes papulae (no vesicles, no bullae), erythema with infiltration, papulae, vesicles -3, and severe erythema with infiltration, coalescent vesicles leading to bullae -4.

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions:
Induction + Challenge : none

- Number of subjects with negative reactions:
Induction + Challenge : 24. One volunteer abandonned during the induction phase therefore only results from 24 are available
- Number of subjects with irritating reactions: none

Applicant's summary and conclusion

Conclusions:
CLP: not classified
DSD: not classified