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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
supporting study
Reliability:
3 (not reliable)

Data source

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

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Guideline:
other: No guideline followed
Principles of method if other than guideline:
200 men were dermally exposed to a 10% preparation of the substance for 1 week. After a 10 day rest period the volunteers were re-exposed in the same manner for a further week. Those who reacted were further exposed to a 1% preparation to rule out simple irritation.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Trimethyl-3-[(1-oxo-10-undecenyl)amino]propylammonium methyl sulphate
EC Number:
304-990-8
EC Name:
Trimethyl-3-[(1-oxo-10-undecenyl)amino]propylammonium methyl sulphate
Cas Number:
94313-91-4
Molecular formula:
C17H35N2O.CH3O4S
IUPAC Name:
bis(2-ethylhexyl) adipate
Test material form:
other: Ointment
Details on test material:
The substance was tested under the name of D-250

Method

Type of population:
not specified
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 200
- Sex: Male
Controls:
No controls were used. However a total of 6 substances were tested in this study and 3 of these gave zero responses.
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: Webril patch, 2 square inches
- Vehicle / solvent: Hydrophilic
- Concentrations: 10% (induction and challenge)
- Removal of test substance: After one week

EXAMINATIONS
- Grading/Scoring system: Not reported

Results and discussion

Results of examinations:
NO. OF PERSONS WITH REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 41



Applicant's summary and conclusion

Conclusions:
The substance gave rise to sensitisation responses in 41 out of 200 men tested. The authors conclude that the substance is a sensitiser.