Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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).