1,4:3,6-dianhydro-2,5-di-O-methyl-D-glucitol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 Mar - 14 Apr 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

24 Apr 2002

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,4:3,6-dianhydro-2,5-di-O-methyl-D-glucitol

EC Number:

226-159-8

EC Name:

1,4:3,6-dianhydro-2,5-di-O-methyl-D-glucitol

Cas Number:

5306-85-4

Molecular formula:

C8H14O4

IUPAC Name:

1,4:3,6-dianhydro-2,5-di-O-methyl-D-glucitol

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: CEGAV breeding establishment, Passais la Conception, France
- Age at study initiation: 9 -12 weeks
- Weight at study initiation: 2.552 - 3.387 kg
- Housing: individually in cages of standard size
- Diet: SDS/DIETEX STANRAB (P) SQC feed, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 21
- Humidity (%): 45 -65
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

8 days
Reading time points: 1 h after instillation and on Day 2, 3, 4, 5 and 8 (The day of instillation was taken as the first study day/ Day 1.)

Number of animals or in vitro replicates:

3 females

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: Confirmation of the presence of corneal damage was carried out (except for reading at time one hour) by examination after instillation of a 0.5 to 2% aqueous solution of sodium fluorescein and rinsing with sterile and pyrogen free isotonic saline (generally 10 mL); Lesions of the conjunctiva, iris and cornea were monitored by direct examination.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 4 days

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

chemosis score

Basis:

animal: #1 and #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 7

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Slight chemosis and lacrimation were observed in all animals 1 hour after instillation of the test substance. All animals had slight to moderate conjuctiva redness (score 1 to 2) one hour after instillation which persisted in one animal up to Day 2, in second animal up to Day 3 and in third animal up to Day 4. No lesions of the iris were observed during the study. One animal had slight opacity of the cornea greater than three-quarters of the area, up to whole area until day 2. In two other animals, slight opacity involved greater than half but less than three quarters of the cornea one hour after instillation and greater than one quarter but less than half of the cornea on Day 2.

Other effects:

- Other observations: No abnormality was seen in body weight gain.

Any other information on results incl. tables

Table 1: Results of the eye irritation study.

Observations (range of scores; normal score)	Animal No.	Time (h) after instillation
		1	24	48	72	mean 24/48/72 h	reversible within
Cornea (0-4; 0)	1	1	1	0	0	0.33	48 h
	2	1	1	0	0	0.33	48 h
	3	1	1	0	0	0.33	48 h
Area of Cornea involved (0-4; 0)	1	4	4	0	0	1.33	48 h
	2	3	2	0	0	0.67	48 h
	3	3	2	0	0	0.67	48 h
Iris (0-2; 0)	1	0	0	0	0	0.00	-
	2	0	0	0	0	0.00	-
	3	0	0	0	0	0.00	-
Conjunctivae Redness (0-3; 0)	1	1	1	1	0	0.67	72 h
	2	1	2	2	1	1.67	4 days
	3	1	2	0	0	0.67	48 h
Conjunctivae Chemosis (0-4; 0)	1	1	0	0	0	0.00	24 h
	2	1	0	0	0	0.00	24 h
	3	1	1	0	0	0.33	48 h
Lacrimation (0-3; 0)	1	1	0	0	0	0.00	24 h
	2	1	0	0	0	0.00	24 h
	3	1	0	0	0	0.00	24 h

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

Under the conditions of this eye irritation study in rabbits the test substance was not irritating to the eye.