Soybean oil, deodorizer distillate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

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), but used in the Cosmetic Ingredient Review (CIR) assessment report.

Justification for data waiving:

other:

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

Principles of method if other than guideline:

The skin sensitization potential of palm oil was evaluated in the Magnusson-Kligman Maximization Test. Induction phase consisted of intradermal injection of 5% palm oil followed by epicutaneous application of 100% palm oil as booster. All the groups were challenged with 0.5 mL 5% palm oil. Reactions were observed 24 and 48 h after patch removal.

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

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

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

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

female

Details on test animals and environmental conditions:

None

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

propylene glycol

Induction 2

Concentration / amount:

See details of study design

Challenge

Challenge 1

Route:

other: epicutaneous

Vehicle:

propylene glycol

Challenge 2

Concentration / amount:

See details of study design

No. of animals per dose:

10 animals in both control and test groups

Details on study design:

INDUCTION:
During the induction, 3 pairs of sites per animals in the test group were injected with following materials:
5% palm oil in propylene glycol
5% palm oil in 50% aqueous Freund's Complete Adjuvant
50% Freund's Complete Adjuvant
Each material (0.5 mL) was injected intradermally.
In the booster phase, initiated 1 wk after induction, an occlusive dressing pad containing full strength palm oil (0.5 mL) was applied on the induction injection sites on each animal in the test group.

CHALLENGE:
2 wks after the booster phase, animals in first and second test groups were challenged with 0.5 mL 5% palm oil. Patches were applied to previously untreated sites and remained in place for 24 h. Reactions were observed 24 and 48 h after patch removal.

SCORING:
Following scale was used during the observation of skin sensitization:
0 (no evidence of any effects) to 4 (severe, deep red erythema with vesiculation or weeping with or without edema).

Challenge controls:

The three pairs of sites on each control animal were injected intradermally with full strength propylene glycol, 1:1 propylene glycol: 50% aqueous Freund's Complete Adjuvant, 50% aqueous Freund's Complete Adjuvant respectively, during induction. 1 wk after induction, a full strength petrolatum (booster) was applied according to the same procedure as in the test group.

Positive control substance(s):

not specified

Study design: in vivo (LLNA)

Concentration:

Not applicable

No. of animals per dose:

Not applicable

Details on study design:

Not applicable

Statistics:

No data

Results and discussion

Positive control results:

Not applicable

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

5%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

No data

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No data.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

5%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

No data

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No data.

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: Not applicable

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Not applicable

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Under the test conditions, 5% test substance was found to be non-sensitizing to guinea pigs.

Executive summary:

The skin sensitization potential of ‘glycerides, C16-18 and C18-unsatd.’ (as palm oil) was evaluated in the Magnusson-Kligman Maximization Test, using three groups of 10 female guinea pigs of the Hartley strain.

In the induction phase, the test group was injected with: 5% test substance in propylene glycol, 5% test substance in 50% aqueous Freund's Complete Adjuvant and 50% Freund's Complete Adjuvant. In the booster phase, full strength test substance (0.5 mL) was applied occlusively. Two of the groups served as controls. All the groups were challenged with 0.5 mL 5% test substance. Reactions were observed 24 and 48 h after patch removal.

No reactions were observed in any of the tested group.

Under the test conditions, 5% test substance was found to be non-sensitizing to guinea pigs.