1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 March 1988 to 13 June 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(adopted 24 February 1987)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol

EC Number:

402-950-5

EC Name:

1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol

Cas Number:

87826-41-3

Molecular formula:

C22 H26 O6

IUPAC Name:

(1R)-1-[(4R,4aR,8aS)-2,6-bis(4-methylphenyl)-hexahydro-[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol

Details on test material:

- Name of test material (as cited in study report): Gel-All-MD
- Substance type: White powder
- Physical state: solid
- Analytical purity: Active ingredient concentration: 98.6% (specified 95%)
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: 4140626
- Stability under test conditions: No data
- Storage condition of test material: When not in use the material was stored in the dark at room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Healthy female rabbits were obtained from Goreside Rabbits, Northchurch, Berkhamsted, Hereford
- Age at study initiation: At receipt the animals were 8 weeks of age, but left to acclimatise for at least 9 days.
- Weight at study initiation: See table.
- Housing: The rabbits were individually housed in grid-bottomed metal cages.
- Diet (e.g. ad libitum): A commercially available antibiotic free rabbit diet (SQC standard rabbit pellets produced by Special Diet Services, Witham, Essex), ad libitum.
- Water (e.g. ad libitum): Mains drinking water via an automatic nozzle, ad libitum.
- Acclimation period: At least 9 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 20°C
- Humidity (%): Relative humidity within the range 44 - 77%.
- Photoperiod (hrs dark / hrs light): Fluorescent lighting was controlled to give an artificial cycle of 12 hours light/12 hours dark per day.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL of the supplied material (weighing approximately 30 mg)

Duration of treatment / exposure:

Single exposure with observation for 7 days

Observation period (in vivo):

One, 24, 48 and 72 hours and 7 days following instillation of the test material the animals eyes were examined macroscopically under a standard light source.

Number of animals or in vitro replicates:

3

Details on study design:

One restrained rabbit was dosed initially to assess the severity of any irritant response. As no marked irritation was seen a further two restrained animals were dosed, bringing the group size to three.

The test material was instilled into the right eye of each restrained animal by gently pulling away the lower lid from the eyeball to form a cup into which the test material was placed. The lids were then held shut for a few seconds. The treated eyes of the rabbits were not rinsed after dosing. The left eye was untreated and served as a control.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Remarks:

(No 781)

Time point:

other: mean of scores at 24, 48 and 72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24 hours

Results 2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Remarks:

(No 777)

Time point:

other: mean of scores at 24, 48 and 72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Remarks:

(No 778)

Time point:

other: mean of scores at 24, 48 and 72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(No 781)

Time point:

other: mean of scores at 24, 48 and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: No chemosis observed at any observation

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

(No 777)

Time point:

other: mean of scores at 24, 48 and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: No chemosis observed at any observation

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(No 778)

Time point:

other: mean of scores at 24, 48 and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: No chemosis observed at any observation

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(No 781)

Time point:

other: mean of scores at 24, 48 and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: No cornea effects observed at any observation

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(No 777)

Time point:

other: mean of scores at 24, 48 and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: No cornea effects observed at any observation

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(No 778)

Time point:

other: mean of scores at 24, 48 and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: No cornea effects observed at any observation

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(No 781)

Time point:

other: mean of scores at 24, 48 and 72 h

Score:

0

Max. score:

2

Remarks on result:

other: No iris effects observed at any observation

Results 11

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(No 777)

Time point:

other: mean of scores at 24, 48 and 72 h

Score:

0

Max. score:

2

Remarks on result:

other: No iris effects observed at any observation

Results 12

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(No 778)

Time point:

other: mean of scores at 24, 48 and 72 h

Score:

0

Max. score:

2

Remarks on result:

other: No iris effects observed at any observation

Irritant / corrosive response data:

One hour after instillation, well defined conjunctival redness was seen in two rabbits and slight redness in the third animal. Only slight conjunctival redness was seen after 24 hours in two animals. All eyes were normal within 48 hours.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Slight to moderate conjunctival irritancy (redness) was observed up to 24 hours post-installation.

Executive summary:

The purpose of the study was to assess the eye irritation potential of Gel All MD in rabbits.

The method used was designed to meet the requirements of OECD Guideline No. 405.

Gel All MD was instilled into the right eye of three rabbits. Assessments of eye irritation were made 1, 24, 48 and 72 hours and 7 days after installation.

One hour after instillation, well defined conjunctival redness was seen in two rabbits and slight redness in the third animal. Only slight conjunctival redness was seen after 24 hours in two animals. All eyes were normal within 48 hours. No chemosis, iridial irritation or cornea effects were observed.

The slight irritation (redness) was fully reversible and not sufficient for classification.