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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: Scientifically reliable study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
>98% triethylene glycol monomethyl ether

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: 3 - 5 months
- Weight at study initiation: 2.8-3.l kg
- Housing: in a fully air-conditioned rooms in Einzelkafigen (Battery cages)
- Diet: Altromin 2123 Haltungsdiit - rabbits Altromin GmbH, Lage / Lippe, ad libitum and hay (about two cups of coffee 15g)
- Water: deionized, chlorinated water from automatic watering entities, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3 °C
- Humidity: 50 ± 20 %
- Photoperiod: 12 hours a day

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye was used in each case as a control.
Amount / concentration applied:
0.1 ml of triethylene was applied once into the conjunctival sac of the left eye.
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
No data
Number of animals or in vitro replicates:
3

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:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.56
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
probability of weak irritation
Remarks:
For individual animal data see table in other information.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation

Any other information on results incl. tables

INDIVIDUAL FINDINGS:

Time post-application   1h 24h   48h  72h
Animal number  1 2 3  1 2 3  1 2 3  1 2 3
conjunctival swelling  1 1 1  0 0 0  0 0 0  0 0 0
conjunctival redness  1 2 1  1 1 2  0 0 1  0 0 0
Iris  0 0 0  0 0 0  0 0 0  0 0 0
Corneal opacity  0 0 0  0 0 0  0 0 0  0 0 0
Fluorescein-Test    0 0 0    0 0 0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

In a guideline eye irritation study using the substance 2 -(2 -(2 -methoxyethoxy)ethoxy)ethanol, no corneal, iris or chemosis response was seen. Slight conjunctival redness was seen with an average score of 0.55 across the three observation timepoints of 24, 48, and 72 hours, but these effects fully resolved across all three animals by the time of the 72 hour observation. On this basis, the substance is regarded as not irritating for classification purposes.