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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
review article or handbook
Title:
Final report on the safety assessment of Elaeis Guineensis (palm) oil, Elaeis Guineensis (palm) kernel oil, hydrogenated palm oil and hydrogenated palm kernel oil
Author:
Cosmetics Ingredients Review (CIR) Panel
Year:
2000
Bibliographic source:
Int. J. Toxicol. 19(2):7-28

Materials and methods

Principles of method if other than guideline:
The skin sensitization potential of the constituent palm oil was evaluated in the Magnusson-Kligman maximization test. The 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
Justification for non-LLNA method:
Conducted prior to the mandate of in vitro test requirement

Test material

Constituent 1
Reference substance name:
Glycerides, C16-18 and C18-unsatd.
IUPAC Name:
Glycerides, C16-18 and C18-unsatd.
Constituent 2
Reference substance name:
67701-30-8
Cas Number:
67701-30-8
IUPAC Name:
67701-30-8
Constituent 3
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:
266-948-4
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

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
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 undiluted 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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
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:
no indication of skin sensitisation
Key result
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:
no indication of skin sensitisation
Key result
Reading:
1st reading
Group:
negative control
Dose level:
No details given
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No details given
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Group:
positive control
Dose level:
No details given
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
No details given
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, 5% of the substance was found to be non-sensitizing to guinea pigs.
Executive summary:

A study was conducted to determine the skin sensitization potential of the constituent ‘glycerides, C16 -18 and C18 -unsatd.’ (as palm oil) according to 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% substance in propylene glycol, 5% substance in 50% aqueous Freund's Complete Adjuvant and 50% Freund's Complete Adjuvant. In the booster phase, the undiluted substance (0.5 mL) was applied occlusively. Two of the groups served as controls. All the groups were challenged with 0.5 mL of 5% 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% substance was found to be non-sensitizing to guinea pigs (CTFA, 1978).

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