Fatty acids, palm-oil, hydrogenated

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:

1986

Materials and methods

Principles of method if other than guideline:

Skin sensitization potential of coconut oil was determined in guinea pigs using Magnusson-Kligman Maximization Procedure.

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, C8-18 and C18-unsatd.

EC Number:

266-946-3

EC Name:

Glycerides, C8-18 and C18-unsatd.

Cas Number:

67701-28-4

IUPAC Name:

Glycerides, C8-18 and C18-unsatd.

Details on test material:

- Name of test material (as cited in study report): Coconut oil (CAS N° 8001-31-8, EC N° 232-282-8); under the SDA nomenclature, the name of this substance is ‘Glycerides, C8-18 and C18-unsatd.’

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

No data

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

other: propylene glycol

Induction 2

Concentration / amount:

Induction: 5%
Booster: 100%
Challenge: 50 and 100%

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: propylene glycol

Challenge 2

Concentration / amount:

Induction: 5%
Booster: 100%
Challenge: 50 and 100%

No. of animals per dose:

10 animals both in test and control groups

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
Test animals: received two injections of each of the following in separate locations on the back:
1) 50% aqueous Freund’s complete adjuvant
2) 5% coconut oil in propylene glycol
3) 5% coconut oil in 50% Freund’s complete adjuvant
Control animals: received the same treatment regimen of vehicles only.

B. BOOSTER EXPOSURE
Test animals: 1 wk after induction, 5% sodium lauryl sulfate in petrolatum was applied to each induction site. 24 h later, a topical booster of 100% coconut oil was applied to the same sites.
Control animals: received 5% sodium lauryl sulfate in petrolatum and, 24 h later, full strength petrolatum as a booster. All control and test animals were wrapped occlusively for 48 h.

C. CHALLENGE EXPOSURE
2 wks after the topical booster, the animals were challenged with topical applications of 50% and 100% coconut oil via 24 h occlusive patch. The challenge sites were graded 48 and 72 h after the beginning of the challenge.

Challenge controls:

Same treatment as used for test group but using only the vehicle

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 (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

Coconut oil was non-irritating and failed to produce an allergic response (no further details reported).

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Under the test conditions, the test substance was found to be non-sensitizing to guinea pig skin.

Executive summary:

‘Glycerides, C8-18 and C18-unsatd.’ (as coconut oil) was evaluated for skin sensitization potential in guinea pig using the Magnusson-Kligman Maximization Procedure.

10 test animals and 10 controls were used in the induction, booster, and challenge phases. Induction was done by intradermal injection of 5% the test substance with Freund’s complete adjuvant. 1 wk after induction, 5% sodium lauryl sulfate in petrolatum was applied to each induction site. 24 h later, a topical booster of 100% test substance was applied to the same sites. 2 wks after the topical booster, the animals were challenged with topical applications of 50% and 100% test substance. Sites were graded after 48 and 72 h of challenge application.

Coconut oil was non-irritating and failed to produce an allergic response.

Under test conditions, the test substance was found to be non-sensitizing to guinea pig skin.