1,2,3-propanetriyl trioleate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

3 Mar - 26 Apr 1967

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 1

Reference Type:

other: monthly report

Title:

Unnamed

Year:

1967

Report date:

1967

Reference 2

Reference Type:

other: monthly report

Title:

Unnamed

Year:

1967

Report date:

1967

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

The test substance was applied to the skin of 105 human volunteers under occlusive patches. For induction, the initial patches remained on the skin for 72 h whereas the challenge patches were removed after 48 h. Volunteers that showed a primary irritation after induction were further exposed to the test item under semi-occlusive patches. Beside the test substance, 5 additional chemicals were tested simultaneously on the same volunteers.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Oleic acid, monoester with glycerol

EC Number:

247-038-6

EC Name:

Oleic acid, monoester with glycerol

Cas Number:

25496-72-4

IUPAC Name:

2-hydroxy-1-(hydroxymethyl)ethyl octadec-9-enoate

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Analytical purity: no data
- Composition of test material, percentage of components: 87.5% [trade name], 6.5% Tween 20, 6.0% H2O
- Lot/batch No.: 5850

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 203
- Sex: 120 males, 83 females
- Age: 5 - 65
- Demographic information: white and coloured volunteers (females: 1 white and 5 coloured, males: 95 white and 4 coloured; not further specified)

Controls:

not required, untreated sites of the same volunteers 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 and semiocclusive (for further details see "Any other information on materials and methods incl. tables")
- Description of patch:
occlusive patch: closed vinyl plastic patch ("Tech Tabs")
semi-occlusive patch: gauze patch held in place with adhesive tape (secured only above and below the gauze patch)
- Vehicle / solvent: none
- Concentrations: 100%

Results and discussion

Results of examinations:

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions:
Induction: 26 out of 203 volunteers
Challenge: 17 out of 203 volunteers
- Number of subjects with negative reactions:
Induction: 177
Challenge: 186
- Number of subjects with equivocal reactions:
Induction: 6
Challenge: 8
- Number of subjects with irritating reactions:
Induction: 20
Challenge: 9

OTHER RESULTS:
NO. OF PERSONS WITH/OUT REACTIONS AFTER SEMI-OCCLUSIVE PATCH
- Number of subjects with positive reactions:
After induction: 3 out of 21 volunteers
After challenge: 4 out of 26 volunteers
- Number of subjects with negative reactions:
After induction: 18
After challenge: 22
- Number of subjects with equivocal reactions:
After induction: not further specified
After challenge: 4
- Number of subjects with irritating reactions:
After induction: not further specified
After challenge: 0

Any other information on results incl. tables

Table 1: Skin reactions

Volunteer	Induction (occlusive)	Challenge (occlusive)
1	±	0
2	±	0
3	±	±
4	±	±
5	±	1+
6	±	1+
7	1+	0
8	1+	0
9	1+	0
10	1+	0
11	1+	0
12	1+	0
13	1+	0
14	1+	0
15	1+	0
16	1+	0
17	1+	±
18	1+	±
19	1+	1+
20	1+	2+
21	1+	3+
22	2+	±
23	2+	1+
24	2+	1+
25	2+	2+
26	3+	±

 

Applicant's summary and conclusion

Conclusions:

The test item induced a positive skin reaction after the induction period under occlusive patches in 26 volunteers with 14 of those showing a positive skin reaction after the challenge thereby suggesting the induction of a sensitisation reaction. However, when volunteers were re-exposed to the test item under semi-occlusive patches, only 3 or 4 volunteers showed a positive skin reaction after the first or second re-exposure, respectively. Thus, the type of application seems to have a strong impact on the skin reaction. Additionally, considering the fact that the test item induced only equivocal effects after re-exposure under semi-occlusive patches, the skin reactions seem to be related to mild skin irritation instead of sensitisation.