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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Because of skin reaction of a laboratory worker using the test substance, the subject was challenged with this material to determine if sensitization had occurred. To provide a control for the positive reaction obtained with the test subject, a four-person panel (two men and two women) was treated the same way.

Test material

Constituent 1
Reference substance name:
Propane, 1,2-epoxy-3-phenoxy
IUPAC Name:
Propane, 1,2-epoxy-3-phenoxy
Details on test material:
- Name of test material (as cited in study report): Propane, 1,2-epoxy-3-phenoxy
No further information.

Method

Type of population:
other: one worker, no information about the other subjects
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 5
- Sex: 3 men, 2 women
- Age: no data
- Race: no data
- Demographic information: no data
Clinical history:
- History of allergy or casuistics for study subject or populations: One subject, a worker using the test substance at workplace, was sensitized.
Controls:
2 men, 2 women
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: unocclusive
- Description of patch: 1 1/2 " x 1 1/2" 12-ply gauze patch held in place with Dermicel Tape for 6 hours
- Vehicle / solvent: ethanol
- Concentrations: 1:100, 1:1000, 1:10000
- Volume applied: one drop
No further information.

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: 4, 6, 24 and 72 hours after application

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 1
- Number of subjects with negative reactions: 4

RESULT OF CASE REPORT: The worker, who was already sensitized, showed a definite allergic response with a reaction of 2+, erythema, edema and papules (not further specified).

Applicant's summary and conclusion