ß-Cyclodextrin, acetyl

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD Guideline Study

Data source

Reference

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Type:

Constituent

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

> 98%

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

New Zealand albino rabbit
Charles River Deutschland GmbH 88353 Kißlegg
3 animals
3.5 - 3.9 kg b.w. at start of study
numbered ear tags for identification

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

see details on study design

Observation period (in vivo):

see details on study design

Number of animals or in vitro replicates:

3 animals

Details on study design:

About 24 hours before the start of the study the test eyes of all animals were examined
under UV light for comeallesions after instillation of one drop of a 0.01 %
fluorescein-sodium solution. Only animals without ocular abnormalities were used for
the study.
100 mg Beta W 7 A 1.0 was administered once to the conjunctival sac of the left eye
of three rabbits. The untreated eyes served in each case as a control.
24 hours after administration and at all other designated examination times at which
the treated eyes still showed discharge or at which a corneal examination with
fluorescein sodium solution took place, the treated eyes were washed out thoroughly
with isotonic saline at approx. 37 °C.
The eyes were examined 1, 24, 48 and 72 hours after administration of the test substance.
At 24 and 72 hours the eyes were also examined for corneal lesions under UV
light after instillation of one drop of a 0.01 % fluorescein-sodium solution. Lesions in
cornea, iris or conjunctivae were graded numerically (see Appendix "Scale for scoring
ocular reactions" page 11 and 12). All other changes or toxic effects were recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0.33

Results 2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0.66

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0.33

Results 4

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Max. score:

1

Remarks on result:

other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)

Results 5

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 6

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 7

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 8

Irritation parameter:

chemosis score

Max. score:

0

Remarks on result:

other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 11

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 12

Irritation parameter:

cornea opacity score

Max. score:

0

Remarks on result:

other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)

Results 13

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 14

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 15

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 16

Irritation parameter:

iris score

Max. score:

0

Remarks on result:

other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)

Irritant / corrosive response data:

Reversibility of any observed effect: changes fully reversible within 2 days.

Other effects:

One hour up to one day after application the conjunctiva of the animals showed
definitely injected blood vessels up to more diffuse deeper crimson red colours and
slight swellings of lids. The irritations were attended by clear coloured eye discharge.
Two days p.a all irritations were reversible.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

Testing of Beta W 7 A 1.0 for primary eye irritation in the rabbit according to OECD 405 showed that the substance is not irritating to eye.

Executive summary:

Testing of Beta W 7 A 1.0 for primary eye irritation in the rabbit according to OECD 405 showed that the substance is not irritating to eye.