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Toxicological information

Eye irritation

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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: GLP Compliant OECD Guideline study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
BETA-CYCLOOEXTRIN (KLEPTOSE®)

Test animals / tissue source

Species:
rabbit
Strain:
other: albino (no further details reported)
Details on test animals or tissues and environmental conditions:
Species: rabbit
Strain: albino
Origin: VASSEUR, PROUZEL. FRANCE
Sex: males
Weight: 2.0 kg - 3.0 kg
Number :6/group

Housing: individual stainless steel cage. wire-floor size 61 x 48 x 37 cm
Feed: SANDERS / LAPIPLUS - ROBENZ
Beverage: drinking water, automatic drinking bowl
Environment:
temperature 20° C +/- 1
hygrometry 50 %+/- 10
artificial lighting 12 hrs/day
air renewal 12 times/hr

The animals were housed for at least one week before the beginning of the experiment.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other eye served as control
Amount / concentration applied:
0,1 ml of the substance
Duration of treatment / exposure:
The animals were placed in restraining devices (type IFFA CREDO les Oncins). The test substance was introduced into the conjonctival sac of the right eye of each rabbit. the left eye serving as a control; the instillation was unique. The eye was kept shut for one minute to avoid any loss of substance.
The animals were kept in the restraining devices for one hour, after which the
first reading was taken.
Observation period (in vivo):
1 hour, then 1, 2, 3, 4 and 7 days after the instilllation of the substance
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
According to the AFNOR NF T03-264 standard we determined:
- IIOI Individual Index of Ocular Irritation.
- MIOI Mean Index of Ocular Irritation
- IAOI The greatest Mean Index of Ocular Irritation (MIOI)
obtained from these readings is the Index of Acute Ocular Irritation.

IAOI MIOI (*) IIOl (*)
0 - 5 = 0 after 2 days non irritant
5 - 15 < 5 after 2 days slightly irritant
15 - 30 < 5 after 4 days irritant
30 - 60 < 20 after 7 days after 7 days very irritant
< 30 in 6 rabbits out of 6
and
< 15 in at least
4 rabbits out of 6

60- 80 < 40 after 7 days after 7 days severely irritant
< 60 in 6 rabbits out of 6
and
< 30 in at least
4 rabbits out of 6
80 - 110 extremely irritant


TOOL USED TO ASSESS SCORE: biomicroscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: none
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
2.5
Max. score:
5
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: none
Irritation parameter:
iris score
Basis:
mean
Time point:
other: all
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: all
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
given in tables
Other effects:
not reported

Any other information on results incl. tables

Reading

Time

 Rabbit

Conjunctiva

IRIS

Cornea Opacticity

IIOI

MIOI

 

 

 

Chemosis

A

Lachrynation

B

Enanthena

C

Reflex

Congest ions

D

Degree

E

Surface

F

 

 

 

1 hr

1

2

3

4

5

6

4

1

1

1

1

1

2

2

2

2

2

2

1

1

1

1

1

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

-

-

-

-

-

-

14

8

8

8

8

8

 

 

9.0

 

1 d

1

2

3

4

5

6

1

0

1

0.5

1

1

0

0

0

0

0

0

1

1

1

1

1

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

-

-

-

-

-

-

4

2

4

3

4

4

 

 

3.5

 

2 d

1

2

3

4

5

6

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

-

-

-

-

-

-

0

0

0

0

0

0

 

 

0

 

 

3 d

1

2

3

4

5

6

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

-

-

-

-

-

-

0

0

0

0

0

0

 

 

0

 

4 d

1

2

3

4

5

6

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

-

-

-

-

-

-

0

0

0

0

0

0

 

 

0

 

7 d

1

2

3

4

5

6

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

-

-

-

-

-

-

0

0

0

0

0

0

 

 

0

 

 

x =2 (A + B + C)

y=5 x (D)

z= 5 x E x F

x+y+z = IIOI

Reading

Time

 Rabbit

Conjunctiva

Iris

 

Cornea

 

 

 

Redness

Swelling

1 hr

1

2

3

4

5

6

1

1

1

1

1

1

4

1

1

1

1

1

0

0

0

0

0

0

0

0

0

0

0

0

1 d

1

2

3

4

5

6

1

1

1

1

1

1

1

0

1

0.5

1

1

0

0

0

0

0

0

0

0

0

0

0

0

2 d

1

2

3

4

5

6

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

3 d

1

2

3

4

5

6

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

4 d

1

2

3

4

5

6

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

7 d

1

2

3

4

5

6

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is only slightly irritating to eyes when administered to rabbits.
Executive summary:

In an eye irrtation assay with beta-Cyclodextrin (purity 100%) according to OECD Guideline 405 on 6 albino rabbits received 0.1 ml of the substance. The substance was administered to the conjonctival sac of the right eye of each rabbit. the left eye serving as a control; the instillation was unique. The substance was left in the sack and reading was performed after 1 h and 1, 2, 3, 4 and 7 days after administration. The scoring scheme used was that given by kay and Calanora. Only slight effects were seen in the conjunctiva score (especially chemosis, lachrynation and enanthena) which were fully reversible within 2 days. Under the conditions used beta Cyclodextrin can be clssified as only slightly irritant to the eyes of rabbits.