Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 to 23 July 2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
guideline study not conducted under GLP
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
no data on purity; no certificate of analysis of the test substance; non-ocular local and systemic adverse effects were not followed
Principles of method if other than guideline:
not applicable
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
Batch No.: LF-238-042-F3
Name of test material (as cited in study report): 2-VINYL-1,3-DIOXOLANE
Physical state: colourless liquid
Storage conditions: ambient temperature, protected from light

Test animals / tissue source

Species:
rabbit
Strain:
other: albino rabbits of the stock New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
Source: VIVALIS (49450 Roussay, France)
Weight:> 1.8 kg
Housing: Housed individually in PPO cages with perforated floor
Diet: Pelleted complete rabbit diet "Ergilap Anco" (COFNA, 37018 Tours, France)), ad libitum
Water: Domestic quality drinking water
Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
Temperature: 20 ± 3 °C
Humidity: 50 ± 20 %
Air changes: 10/h
Photoperiod: 12 h dark / 12 h light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
Amount(s) applied (volume or weight with unit): 0.1 mL
Concentration (if solution): undiluted
Duration of treatment / exposure:
4 h
Observation period (in vivo):
72 hours after the treatment
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
Washing: after the first 24 h reading fluorescein was instilled. After rinsing with 5 mL 0.9 % sodium chloride solution, the eyes were examined again.

SCORING SYSTEM: According to OECD Guideline 405

TOOL USED TO ASSESS SCORE: Eyes of the animals were examined with a hand held inspection lamp fitted with white light.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Irritant / corrosive response data:
At day 5, all scores were at 0.
Other effects:
no data

Any other information on results incl. tables

Table 7.3.2/1: Scores for ocular lesions

Rabbit

No.

Region of eye

 

Scores

1 h

24 h

48 h

72 h

Mean#

 

9668

Cornea

0

2

1

0

1.0

 

Iris

1

1

0

0

0.3

 

Conjunctiva: redness

2

2

1

1

1.3

 

Conjunctiva: chemosis

2

1

1

0

0.7

 

9669

Cornea

0

1

1

0

0.7

 

Iris

1

1

1

0

0.7

 

Conjunctiva: redness

3

3

2

1

2.0

 

Conjunctiva: chemosis

1

1

1

1

1.0

 

9670

Cornea

0

1

1

0

0.7

 

Iris

1

1

0

0

0.3

 

Conjunctiva: redness

3

3

2

2

2.3

 

Conjunctiva: chemosis

1

1

0

0

0.3

 

 

#: Mean scores of 24, 48 and 72 h

At Day 5, all scores were at 0.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
The mean scores obtained with 2-vinyl-1,3-dioxolane at 24, 48 and 72 h were 0.8 for cornea, 0.4 for iris, 1.9 for conjunctivae and 0.7 for chemosis, therefore it is not classified as irritating to the eyes according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.
Executive summary:

In an eye irritation study conducted according to OECD Guideline No 405, 3 male albino rabbits of the stock New Zealand White were exposed to 0.1 mL of undiluted 2 -vinyl-1,3 -dioxolane in one eye, while other eye remained untreated and served as control. The eyelids were then gently held together for one hour before releasing. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h after treatment and graded according to the method of OECD Guideline No 405.

The calculated mean scores for each individual lesions for all animals within three scoring times (24, 48 and 72 h) were as follows: 0.8 for cornea score; 0.4 for iris score; 1.9 for conjunctivae score and 0.7 for chemosis score. All effects were reversible on Day 5.

Therefore, 2 -vinyl-1,3 -dioxolane is not classified as irritating to the eyes according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.