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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

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): Vinylacetate (stabilised)
- Physical state: Liquid
- Analytical purity: 99.9%
- Lot/batch No.: 29.01.2003
- Expiry date: 30 April 2003
- Storage condition of test material: In the original container, in the refrigerator (range of 2 to 8°C)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: 12-13 weeks (male), 9-10 weeks (females)
- Weight at study initiation: 2197 g (male), 2311 and 2386 g (females)
- Housing: Individually in stainless steel cages
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water: Community tap water ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17-23°C
- Humidity: 30-70%
- Air changes (per hr): 10-15
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 31 March 2003 To: 4 April 2003

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Single application
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Eyes were not washed

SCORING SYSTEM:
- The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/691EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours after application.

TOOL USED TO ASSESS SCORE:
- Eye examinations were made with a Varta Cliptrix diagnostic-lamp (Roth AG, CH-4153 Reinach, Switzerland)

Results and discussion

In vivo

Resultsopen allclose all
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:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: sl. conjuctival reddening in all eyes at 24 h.
Irritant / corrosive response data:
No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals. Moderate reddening of the conjunctivae was observed in all animals at the 1 hour reading. Slight reddening was still present in all animals 24 hours after treatment. Slight to moderate swelling was noted in all animals at the 1 hour examination. Moderate reddening of the sclerae was present in all animals at the 1 hour reading and slight reddening persisted in one animal up to 24 hours after treatment. Slight ocular discharge was observed in two animals 1 hour after treatment. No abnormal findings were observed in the treated eye of any animal 48 hours after treatment.
Other effects:
None

Any other information on results incl. tables

Individual mean scores for conjunctival reddening at 24, 48 and 72 hours were 0.33, 0.33 and 0.33. the overall mean was therefore 0.33. There were no effects in the cornea or iris and no chemosis at 24, 48 or 72 hours in any animals.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: OECD and EU
Conclusions:
VINYLACETATE (STAB.) is considered to be "not irritating" to the rabbit eye.
Executive summary:

The primary eye irritation potential of VINYLACETATE (STAB.) was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 mL into the left eye of each of three young adult New Zealand White rabbits. Irritation effects were scored at approximately 1, 24, 48 and 72 hours after test item application. The instillation of VINYLACETATE (STAB.) into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis at 1 hour. However at 24 hours, there were no corneal or iridial effects and no chemosis in any animals. Slight conjunctival reddening was present in all 3 animals at 24 hours but was not present at 48 hours.

The overall mean score for conjunctival reddening was 0.33 and based upon the referred classification criteria (Commission Directive 2001/59/EC of August 06. 2001), VINYLACETATE (STAB) is considered to be "not irritating" to the rabbit eye.