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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:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically reliable study containing sufficient basic detail on method and results to judge it reliable.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sample reference 46-350, 47-116. No further data.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: second eye used as a control for each animal
Amount / concentration applied:
0.1ml
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
Observations at 1, 4, 24, 48 and 72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none reported

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein (2%) staining used to determine corneal injury before dosing and at readings after 1 day.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: no data
Score:
0.53
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72hrs
Score:
0.1
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 73hrs
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Irritant / corrosive response data:
Some iris inflammation was seen in first 4 hours in half the animals but this resolved by the 24 hour reading. Chemosis and conjunctival irritation quite marked in first four hours (scores 2-3) but rapid recovery seen such that only a single animal showed minimal chemosis and two minimal redness by the time of the 24 hour reading. Maximum average score seen was for conjunctival irritation at 1 hour (=2.3). All symptoms were resolved within 48 hours.

Applicant's summary and conclusion

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

In an eye irritation study , rabbit eyes were exposed to 2 -(2 -methoxyethoxy) ethanol and observed the resultant effects observed for a period of 3 days. The primary irritation score reported was 0.53, a result which is not indicative of significant eye irritation potential. Individual data shows no iris or corneal effects and full recovery from mild to moderate conjunctival irritation and chemosis within 48 hours. These results show that eye irritancy is not a significant property of this substance and that classification for eye irritancy is not warranted.