Cycloheptapentylose

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: 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

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cycloheptapentylose

EC Number:

231-493-2

EC Name:

Cycloheptapentylose

Cas Number:

7585-39-9

Molecular formula:

C42H70O35

IUPAC Name:

5,10,15,20,25,30,35-heptakis(hydroxymethyl)-2,4,7,9,12,14,17,19,22,24,27,29,32,34-tetradecaoxaoctacyclo[31.2.2.2~3,6~.2~8,11~.2~13,16~.2~18,21~.2~23,26~.2~28,31~]nonatetracontane-36,37,38,39,40,41,42,43,44,45,46,47,48,49-tetradecol (non-preferred name)

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

Results

Results 1

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Reversibility:

fully reversible within: 2 days

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Reversibility:

fully reversible within: 2 days

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

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:

GHS criteria not met

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.