Sorbitan, (Z)-9-octadecenoate (2:3)

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1959

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Only short abstract available

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1959

Report date:

1959

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Human patch test

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sorbitan, (Z)-9-octadecenoate (2:3)

EC Number:

232-360-1

EC Name:

Sorbitan, (Z)-9-octadecenoate (2:3)

Cas Number:

8007-43-0

Molecular formula:

C42H76O7

IUPAC Name:

(1R)-1-[(2R,3R,4S)-4-hydroxy-3-[(9Z)-octadec-9-enoyloxy]oxolan-2-yl]-2-[(9Z)-octadec-9-enoyloxy]ethyl (9Z)-octadec-9-enoate; (2R)-2-[(2R,3R,4S)-3,4-dihydroxyoxolan-2-yl]-2-hydroxyethyl (9Z)-octadec-9-enoate; (2R)-2-hydroxy-2-[(2R,3R,4S)-3-hydroxy-4-[(9Z)-octadec-9-enoyloxy]oxolan-2-yl]ethyl (9Z)-octadec-9-enoate

Details on test material:

- Name of test material (as cited in study report): Only trade name given
- Analytical purity: no data
- Lot/batch No.: 157

Method

Type of population:

not specified

Subjects:

- Number of subjects exposed: 50
- Sex: no data
- Age: no data
- Race: no data
- Demographic information: no data

Controls:

no data

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: absorbent cotton twill (2.5x5 cm) saturated with test material, sealed with elastoplast coverlet (5x7.5 cm)
- Concentrations: undiluted
- Volume applied: no data
- Testing/scoring schedule: Initial application for 3 days, challenging application for 3 days 7 days after removal of initial patch

EXAMINATIONS
- Grading/Scoring system: no data

Results and discussion

Results of examinations:

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0/50
- Number of subjects with negative reactions: 50/50
- Number of subjects with equivocal reactions: 0/50
- Number of subjects with irritating reactions: 0/50

Applicant's summary and conclusion

Conclusions:

At the end of the 72 h exposure period in the initial application there were no reactions on the skin of any of the subjects. This shows that the chemical is not a primary skin irritant.
At the end of the 72 h exposure period in the challenging application there were no reactions on the skin of any of the subjects. There were no delayed reactions after the first and second series of patches. This indicates that the chemical is not a sensitizer.