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Diss Factsheets

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
Study period:
02 June 1992 to 24 August 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Read across to substance with the same functional groups.
Cross-reference
Reason / purpose for cross-reference:
other: read-across target
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information
Justification for type of information:
Read across to substance with the same functional groups.
Reason / purpose for cross-reference:
read-across source

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)
GLP compliance:
yes

Test material

1
Chemical structure
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
Test material form:
liquid
Details on test material:
- Appearance: Colourless, transparent, slightly viscous liquid
- 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
- 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: diet was available ad libitum except during the actual dosing period.
- Water: 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: 16.1 - 21.6 °C
- Humidity: 40 - 60 %
- Photoperiod: 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

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
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 material 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.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Not eye irritating
Conclusions:
Under the conditions of this study, the test material was considered to be non irritating to eyes. As a result of this, the test material does not require classification according to Regulation EC No. 1272/2008.
Executive summary:

In a study conducted by Myers et al., (1992),the test material was investigated for its potential to act as an eye irritant. The study was conducted in accordance with the standardised guideline OECD 405, under GLP conditions.

0.1mL of the test material was placed into the conjunctival sac of one eye of each of 4 animals (2 per sex). The test material 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.

Under the conditions of this study, the test material was considered to be non irritating to eyes. As a result of this, the test material does not require classification according to Regulation EC No. 1272/2008.