Glycerides, C16-18 and C18-unsatd., deodorizer distillates

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Not available

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Secondary literature source (documentation insufficient for assessment)

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

review article or handbook

Title:

Unnamed

Year:

2000

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

A modified Draize test was conducted to evaluate skin irritation and sensitization potential of palm oil (15%) in human. During induction, the test substance was applied occlusively to skin sites using a Finn Chamber. Total of 10 inductions applications were made to each subject for 3 consecutive wks. Induction reactions were scored 48 and 72 h post application according to following scoring system: 0 (no reaction) to 4 (erythema, edema and bullae). After 12 d of rest, an occlusive challenge patch was applied to a new site. Challenge patches were remained in place for 48 h. Reactions were scored at 48 and 96 h post application.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, C16-18 and C18-unsatd.

EC Number:

266-948-4

EC Name:

Glycerides, C16-18 and C18-unsatd.

Cas Number:

67701-30-8

Molecular formula:

No generic molecular formula is available

IUPAC Name:

Glycerides, C16-18 and C18-unsatd.

Details on test material:

- Name of test material (as cited in study report): Palm oil (CAS N° 8002-75-3, EC N° 232-316-1). Under the SDA nomenclature, the name of this substance is 'Glycerides, C16-18 and C18-unsatd.'
- Substance type: Triglycerides of vegetable origin

Method

Type of population:

not specified

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 88 females and 22 males
- Age: 20-76 yrs

Clinical history:

Not applicable

Controls:

Not applicable

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: Finn Chamber
- Vehicle / solvent: petrolatum
- Concentrations: 15%
- Amount applied: 0.025 g
- Frequency of application: 3 applications per wk for total of 10 induction applications followed by challenge application (after 12 d of rest)
- Scoring system: 0 (no reaction) to 4 (erythema, edema and bullae)
- Scoring frequency: 48 and 72 h post application in induction phase and 48 and 96 h post application in challenge phase

Results and discussion

Results of examinations:

Palm oil did not induce sensitization in the 110 subjects studied.

Details:
- Number of subjects with positive reactions: 3 (score = 1) during the induction but no reactions in the challenge phase
- Number of subjects with negative reactions: 107
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:

Under the test conditions, 15% of the test substance did not induce sensitization in humans.

Executive summary:

A study was conducted to evaluate skin irritation and sensitization potential of ‘glycerides, C16-18 and C18-unsatd.’ (as 15% palm oil) in human.

During induction, the test substance was applied occlusively to skin sites on the scapular region of the back of 110 subjects using a Finn Chamber. Total of 10 inductions applications were made to each subject for 3 consecutive wks. Induction reactions were scored 48 and 72 h post application according to modified Draize method. After 12 d of rest, an occlusive challenge patch was applied to a new site in the scapular region. Challenge patches were remained in place for 48 h. Reactions were scored at 48 and 96 h post application.

Reactions (score = 1) were observed in three subjects during induction, and no reactions were observed during the challenge phase.

Under the test conditions, 15% of the test substance did not induce sensitization in humans.