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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A study that has been reported in a number of publications which between them contain sufficient detail to be able to reliably judge the eye irritancy properties of this substance.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
An objective method for the evaluation of eye irritation in vivo
Author:
Jacobs G, Martens M
Year:
1989
Bibliographic source:
Fd Chem Toxicol, 27, p255-8
Reference Type:
publication
Title:
No information
Author:
Parent RA
Year:
1992
Bibliographic source:
J Am Coll Toxicol 11, 378
Reference Type:
publication
Title:
Evaluation of the in vitro uridine uptake inhibition assay in comparison with the in vivo eye irritation test as prescribed by the EEC
Author:
Jacobs GA, Dierickx PJ, Martens MA
Year:
1988
Bibliographic source:
Alt Lab Animals, 15, p290-6
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Observations for only 4 days
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: liquid
- Analytical purity: 99.8%
- Composition of test material, percentage of components: Stabilised with 50ppm BHT
- Other: Supplied by Janssen Chimica, Beerse, Belgium

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Proefstations voor veeteelt (Merelbeke, Belgium)
- Weight at study initiation: 2-3.5kg
- Housing: individually in mesh wire bottom cages. 40x46x47.5cm
- Diet (e.g. ad libitum): ad libitum, pelleted Aliment Complet, 'lapins entretien ref 112, animolabo, Brussels.
- Water (e.g. ad libitum): ad libitum Brussels tap water.
- other: sex, male and female, albino

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: experiment was part of a larger study which examined a large number of chemicals for their eye irritancy
Amount / concentration applied:
0.1ml
Duration of treatment / exposure:
Single application
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Draize scoring criteria used for Erythema, chemosis, iritis and corneal opacity

TOOL USED TO ASSESS SCORE: Application of one drop of 2% sodiumfluoroscein before visual scoring of percentage corneal damage. This was also done 72 hrs before testing to check for absence of existing lesions. Reading of ocular lesions was facilitated by use of a handslit lantern.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.2
Max. score:
3
Reversibility:
not fully reversible within: 96 hours
Remarks on result:
probability of mild irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
not fully reversible within: 96 hours
Remarks on result:
probability of mild irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
< 0.1
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Remarks on result:
probability of weak irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
< 0.1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
probability of weak irritation
Irritant / corrosive response data:
The mean corneal upperlayer damage (loss of epithelium measured by fluorescein retention on the cornea using a hand-slit lamp) was 5% after 4 hrs and an average of 3% over the 72 hour test period. Pain response was measured and described as "a few blinks only, normal within one or two minutes; animals didn't squeal or rub their eyes". There was no evidence of Pannus.
Other effects:
Average rabbit response after instillation of substance was to blink for a few minutes then to return to normal.

Any other information on results incl. tables

Whilst the cited observation period was 7 days, observations were only reported for 4 days.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

A study reported in a number of publications assessed the eye irritancy potential of 2 -methoxyethanol in rabbits. Even without a washing stage, the substance showed negligible iritis or corneal effects. Very mild chemosis was seen and slight to moderate conjunctivitis. Both of the latter were still present at the end of the experiment (96 hours of observations) but were showing signs of recovery suggesting that they would have vanished within the normal 21 day observation period. The conclusion from this study was that the initial lesions were of a mild nature and did not meet the criteria for classification as an eye irritant. Those lesions that were seen had either disappeared or were showing signs of recovery by the end of the 4 day study.

Synopsis

Not irritating.