Fatty acids, palm-oil, hydrogenated

Eye irritation

Administrative data

Endpoint:

eye 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), 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:

Eye irritation potential of coconut oil was determined in rabbits after single ocular administration.

GLP compliance:

not specified

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.’

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

No data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated eye acted as control

Amount / concentration applied:

No data

Duration of treatment / exposure:

Single administration without eye wash

Observation period (in vivo):

Until reversal of effects

Number of animals or in vitro replicates:

Six

Details on study design:

No data

Results and discussion

In vivo

Results

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: Until reversal of effects

Score:

2

Max. score:

110

Reversibility:

fully reversible within: 3 d

Irritant / corrosive response data:

Minimal irritation

Other effects:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the test substance was found to be minimally irritating to rabbit eyes.

Executive summary:

In an ocular irritation test, ‘glycerides, C8-18 and C18-unsatd.’ (as coconut oil) was instilled into eyes of six rabbits in a single dose without subsequent eye wash.

Minimal irritation (score: 2/110) was observed. The eyes appeared normal by the third day.

Under the test conditions, the test substance was found to be minimally irritating to rabbit eyes.