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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
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
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
review article or handbook
Title:
Final report on the safety assessment of coconut oil, coconut acid, hydrogenated coconut acid, and hydrogenated coconut oil
Author:
Cosmetic Ingredients Review (CIR) Panel
Year:
1986
Bibliographic source:
Int. J. Toxicol. 5(3):103-121

Materials and methods

Principles of method if other than guideline:
Dermal irritation was evaluated after application of fully hydrogenated coconut oil via 24 h single-insult occlusive patch.
GLP compliance:
not specified

Test material

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): Fully hydrogenated coconut oil (CAS N° 84836-98-6, EC N° 284-283-8); under the SDA nomenclature, the name of this substance is ‘Glycerides, C8-18 and C18-unsatd.’

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
No data

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
Undiluted
Duration of treatment / exposure:
24 h
Observation period:
24 h
Number of animals:
9 animals
Details on study design:
No data

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 h
Score:
0.11
Max. score:
8
Irritant / corrosive response data:
Minimal irritation
Other effects:
No data

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, fully hydrogenated coconut oil was found to be minimally irritating to rabbit skin.
Executive summary:

In a skin irritation study, fully hydrogenated coconut oil was applied to the skin of 9 rabbits by means of a 24 h single-insult occlusive patch.

Minimal irritation was observed after 24 h of treatment (PII = 0.11).

Under the test conditions, fully hydrogenated coconut oil was found to be minimally irritating to rabbit skin.