Plant Sterols

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to a scientifically acceptable protocol, but not in compliance with GLP. There was limited information on the purity of the test substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

See 'Principles of method other than guideline'

Principles of method if other than guideline:

The treated eyes of six animals remained unwashed and three rabbits' eyes were irrigated with physiological saline 30 seconds after instillation of the test article. The treated eyes were examined with sodium fluorescein and an ultraviolet lamp at 24, 48 and 72 hours using the Draize scoring for ocular lesions.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Not applicable-UVCB

EC Number:

619-079-3

Cas Number:

949109-75-5

Molecular formula:

UVCB- Mixture of many formulae.

IUPAC Name:

Not applicable-UVCB

Details on test material:

Gernerol 122, Lot IKI6257

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Duration of treatment / exposure:

The treated eyes of six animals remained unwashed and three rabbits' eyes were irrigated with physiological saline 30 seconds after instillation of the test article.

Observation period (in vivo):

24, 48 and 72 hours

Number of animals or in vitro replicates:

6 animals with no washout after test material instillation
3 animals with washout after test material instillation

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

animal #1

Time point:

other: 24 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

other: 24 hours

Score:

3

Max. score:

3

Reversibility:

fully reversible

Results 3

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24 hours

Score:

3

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

animal #1

Time point:

other: 24 hours

Score:

3

Max. score:

3

Reversibility:

fully reversible

Results 5

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24 hours

Score:

1

Max. score:

2

Reversibility:

fully reversible

Irritant / corrosive response data:

All scores in all animals were zero at all time points, except for one animal (out of the six animals the eyes of which were not washed out 30 seconds after instillation). Irritant effects were only present at the 24 hour reading (reported in the results table), which were fully reversible by the 72 hour reading.

Any other information on results incl. tables

Results: mean eye irritation scores (+/- S.D) at -

	24 hours	48 hours	72 hours
6 eyes ( no wash out)	4.7 (+/- 11.4)	0	0
3 eyes washed 10 seconds after instillation	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Based on the scoring and classification system employed by the study authors, the test substance is considered to be minimally (slightly) irritating to the eyes of rabbits without a washout, and non irritating with a washout 30 seconds after instillation. Only one animal had any irritant effects at 24 hours, which were fully reversible by 72 hours. In accordance with current guideline (EC 1272/2008), the results of the test are not considered irritating.

Executive summary:

In a well conducted study to determine the ocular irritation potential of the test substance, 0.1 ml of test material (as 100%) was instilled in one eye of 9 white New Zealand rabbits.

The treated eyes were then examined with sodium fluorescein and a UV lamp at 24, 48 and 72 hours using the Draize scale for scoring ocular lesions. The treated eyes of the six animals remained unwashed and three rabbits' eyes were irrigated with physiological saline 30 seconds after instillation of the test article.Based on the scoring and classification system as shown above, Generol 122 is considered to be minimally (slightly) irritating to the rabbit eyes without a wash out and non irritating with a wash out 30 seconds after instillation.