Cyclooctapentylose

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cyclooctapentylose

EC Number:

241-482-4

EC Name:

Cyclooctapentylose

Cas Number:

17465-86-0

Molecular formula:

C48H80O40

IUPAC Name:

cyclooctapentylose

Details on test material:

- Designation: .gamma.-cyclodextrin
- Date of receipt: October 11, 1990
- general appearance: white powder
- Batch no.: 888
- CAS. Reg. no.: 17465-86-0
- Storage conditions: ambient (circa 20°C)

Prior to the start of the study, the weight of 0.1 ml of the test substance was measured to be circa 0.063 gram.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Species: conventionally bred New Zealand White albino rabbits
Supplier: ENKI-Konijnenfarm, Someren, the Netherlands
Sex and age: males, young adult
Date of arrival: October 23, 1990
Body weight range at start of study: 2992-3129 g
Identification: earmarking: 5451-5453
Acclimatization period: 27 days
Caging: individually in suspended galvanized cages, fitted with wire-mesh floor and front
Lighting: 12 hours light/12 hours dark cycle
Temperature: 16-19 °C
Humidity: 62.5% - 80% (but higher for short periods of time after wet cleaning of the animal room)
Ventilation: ca. 10 air changes/hour
Diet: standard laboratory rabbit diet and tap water, ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated eye served as a control

Amount / concentration applied:

An amount of 0.1 ml (0.063 g) of the test substance was instilled in the conjunctival cul-de-sac of the right eye of the rabbit.

Duration of treatment / exposure:

according to guideline

Observation period (in vivo):

3 days

Number of animals or in vitro replicates:

3 males

Details on study design:

The study was started with one rabbit. After the acclimatization period both eyes of the rabbit selected were examined just before testing. Only rabbits without observable eye defects were to be used. The selected rabbit was treated as follows:
An amount of 0.1 ml (0.063 g) of the test substance was instilled in the conjunctival cul-de-sac of the right eye of the rabbit. After administration, the upper and lower eye lid were carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material. The left eye remaining untreated, served as a control.
At one hour after treatment, only a slight eye effect was observed in this rabbit. Therefore, it was decided to complete the study with another two rabbits.
Ocular reactions of the test eye were judged at circa one hour, 24, 48, and 72 hours after treatment using the scoring scale.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

other: ocular discharge

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

At 1 hour after treatment, the eye effects observed in the three rabbits consisted of very slight redness with or without very swelling of the conjunctivae.
At 24 hours after treatment, the eye effects observed in the three rabbits consisted of very slight redness of the conjunctivae only.
At 48 hours after treatment, all eye effects had cleared completely.
At 72 hours after treatment again, no signs of eye irritation were observed in any of the three rabbits.

Other effects:

none

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

On the basis of the results obtained it is concluded that, under the conditions of this study and according to the EEC-standards (mentioned in EEC-Directive 83/467/EEC and published in the Official Journal of the European Communities, L 257, Volume 26, 16 September 1983), .gamma.-cyclodextrin is not irritating or corrosive to eyes.

Executive summary:

A sample of .gamma.-cyclodextrin was examined for acute eye irritating/corrosive properties in an experiment with three albino rabbits

The test substance caused slight redness with or without slight swelling of the conjunctivae. At 48 hours after treatment, all eye effects had cleared completely.

On the basis of the results obtained it was concluded that, under the conditions of this study and according to the EU standards, gamma.-cyclodextrin is not irritating or corrosive to eyes.