Registration Dossier
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EC number: 304-990-8 | CAS number: 94313-91-4
Sensitisation data (human)
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:
- 1 963
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
- 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
Constituent 1
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.
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