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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:
13-14 March 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Vinylene Carbonate
- Physical state: clear colourless liquid
- Analytical purity: 99.9%
- Purity test date: 7 January 2002
- Lot/batch No.: 011220
- Storage condition of test material: approx. 4 ºC in the dark, under nitrogen

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: suspended metal cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye remained untreated and was used for control purposes.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
The pH of a 90% v/v aqueous preparation of the test material was determined prior to commencement of the study and found to be approx. 5.0.
Duration of treatment / exposure:
24 hrs
Observation period (in vivo):
24 hours
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure:


SCORING SYSTEM: according to Draize
Immediately after administration of the test material, an assessment of the initial pain reaction was made according to the six point scale. In order to minimize pain on application of the test material, one drop of local anaesthetic was instilled into both eyes of the animal 1 to 2 minutes before treatment.

TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope

INTERPRETATION of eye irritation test: classified according to the modified Kay and Calandra system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 1 hr
Score:
21
Reversibility:
not specified
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 24 hrs
Score:
65
Reversibility:
not specified
Remarks:
animal was killed immediately after 24h
Irritant / corrosive response data:
Dulling of the normal lustre of the cornea was noted in the treated eye one hour after treatment. Translucent corneal opacity (grade 2) was noted in the treated eye at the 24-hour observation.
Iridial inflammation (grade 1) and severe conjunctival irritation (grade 2-4) were noted in the treated eye one and 24 hours after treatment.
Other ocular effects noted in the treated eye at the 24-hour observation were areas of haemorrhage on the nictitating and lower conjunctival membranes and blood stained discharge.
Due the severity of ocular reactions, the animal was killed for humane reasons immediately after the 24-hour observation in accordance with current UK Home Office Guidelines. No further animals were treated.

Applicant's summary and conclusion

Interpretation of results:
other: irritating
Conclusions:
The test material produced a maximum total score of 65 and was considered to be at least a severe irritant (class 6 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system (based on one rabbit only).
The test material was also considered to be irritant according to EU labelling regulations Commission Directive 93/21/EEC. It is reasonable to assume that the symbol Xi, the indication of danger Itrritant and the highest risk phrase R41 (Risk of serious damage to eyes) are therefore required.
Executive summary:

The irritancy potential of VC to the eye of the New Zealand White rabbit was tested according to OECD 405. The test material produced a maximum total score of 65 and was considered to be at least a severe irritant (class 6 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system (based on one rabbit only). The test material was also considered to be irritant according to EU labelling regulations Commission Directive 93/21/EEC. It is reasonable to assume that the symbol Xi, the indication of danger Irritant and the highest risk phrase R41 (Risk of serious damage to eyes) are therefore required.