7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 2nd 1992 to August 24th 1992.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Proprietary guideline study.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

Not relevant

GLP compliance:

yes

Test material

Test material information

1

Reference substance name:

7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate

EC Number:

219-207-4

EC Name:

7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate

Cas Number:

2386-87-0

Molecular formula:

C14H20O4

IUPAC Name:

7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate

Specific details on test material used for the study:

- Name of test material (as cited in study report): Cyracure UVR-6110
- Substance type: epoxy resin
- Physical state: Colourless, transparent, slightly viscous liquid
- Analytical purity: 100%
- Impurities (identity and concentrations): Not documented
- Composition of test material, percentage of components: 100% 3,4-epoxy cyclohexyl methyl-3,4 epoxy cyclohexyl
carboxylate
- Purity test date: Not documented
- Lot/batch No.: 55-61
- Expiration date of the lot/batch: Not documented
- Stability under test conditions: Not documented
- Storage condition of test material: Stored 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: Hazleton Research Products, Inc. (Denver, PA).
- Age at study initiation: 12 to 18 weeks of age
- Weight at study initiation: 2.9 - 3.3 kg or 2.6 to 3.5 kg for males and females respectively
- Housing: Housed individually in cages with wire floors (approximately 18 x 24 x 15 in).
- Diet (e.g. ad libitum): AGWAY PROLAB Animal Diet High Fibre Rabbit was available ad libitum except during the actual dosing period.
- Water (e.g. ad libitum): Tap water from the Municipal Authority of Westmoreland County was available ad libitum except during dosing and was supplied by an automatic watering system with demand control valves mounted on each rack.
- Acclimation period: At least 5 days prior to dosing.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.1 - 21.6°C
- Humidity (%): 40 - 60%
- Air changes (per hr): Not documented
- Photoperiod (hrs dark / hrs light): 12 hour light / dark cycle.

IN-LIFE DATES: From: June 2, 1992 To: June 11, 1992

Test system

Vehicle:

not specified

Controls:

other: the untreated eye of each animal served as the control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml

Duration of treatment / exposure:

9 days

Observation period (in vivo):

9 days
(Animals were observed at 1, 24, 48 and 72 hours and at 7 and 9 days following instillation)

Number of animals or in vitro replicates:

4 rabbits (2 males and 2 females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not documented

SCORING SYSTEM: Draize (1959) scoring method.

TOOL USED TO ASSESS SCORE: fluorescein staining performed on day 1 and at each subsequent examination days.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other:

Remarks:

No effects observed

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other:

Remarks:

No effects observed

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

> 0 - <= 2

Max. score:

4

Reversibility:

fully reversible within: 9 days

Irritant / corrosive response data:

A volume of 0.1 ml of test substance instilled into rabbit eyes produced no corneal injury or iritis in any of 4 rabbit eyes dosed. Minor conjunctival irritation was observed in all 4 rabbits within 1 hour. The dosed eye of 1 rabbit healed by 48 hours. The 3 remaining rabbits had a normal ocular appearance within 72 hours to 9 days.

Other effects:

No additional effects observed.

Any other information on results incl. tables

No additional information

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Following instillation of 0.1ml of the test substance into the eyes of rabbits, it was determined that CYRACURE UVR-6110 was not irritating to the eyes. Based on these results, the test substance does not require classification according to Regulation EC No. 1272/2008 as it does not meet the criteria for classification outlined. None of the mean scores for corneal iridial or conjunctival reactions exceeded the threshold values requiring classification inaccordance wit Directive 67/548/ EEC, as amended.

Executive summary:

In a study conducted by Myers et al., (1992),the test substance, CYRACURE UVR-6110 was investigated for its potential to act as an eye irritant. 0.1ml of the test susbtance was placed into the conjunctival sac of one eye of each of 4 animals (2 per sex). The test substance was not removed so the exposure period was 9 days. Following exposure, no corneal injury or iritis in any of 4 rabbit eyes dosed was observed. Minor conjunctival irritation was observed in all 4 animals within one hour, with the dosed eye of 1 rabbit healing by 24 hours and the 3 remaining rabbits had a normal appearance within 72 hours to 9 days. Based on these results, the test substance was considered to be non irritating to eyes. As a result of this, the test substance does not require classification according to Regulation EC No. 1272/2008.