Registration Dossier

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:
not available
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Secondary source but one that is considered highly reliable since data (generated to guideline) has undergone a peer review process before inclusion and detailed experimental results are available per animal and per timepoint. Data used in this source has been subject to a peer review process by a reputable body which mitigates the fact that the original source document for studies presented are not referenced. It should be noted that the publication is intended as a reference work of in vivo results for the development of in vitro methods.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
not specified
Remarks:
Study is reported to be GLP compliant but there is no information on the testing laboratory.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
99% pure, tested as pure substance, Fisher product number E-145

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
single instillation, as per guideline
Observation period (in vivo):
no data
Number of animals or in vitro replicates:
4
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: average at time points 24, 48, 72hrs
Score:
0.41
Max. score:
4
Reversibility:
fully reversible within: 2 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: average at time points 24, 48, 72hrs
Score:
0.08
Max. score:
2
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: average at time points 24, 48, 72hrs
Score:
1.25
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: average at time points 24, 48, 72hrs
Score:
0.58
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: average at time points 24, 48, 72hrs
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: average of results for 2 worst affected animals.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: average at time points 24, 48, 72hrs
Score:
0.17
Max. score:
2
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: average of results for 2 worst affected animals.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: average at time points 24, 48, 72hrs
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: average of results for 2 worst affected animals.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: average at time points 24, 48, 72hrs
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: average of results for 2 worst affected animals.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: average at time points 24, 48, 72hrs
Score:
15
Max. score:
110
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: See notes below
Irritant / corrosive response data:
Overall irritation score = (Corneal Opacity+area)x5 + Irisx5 + (Conjunctival redness + chemosis + discharge)x2. Maximum possible = 110.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
On the basis of these results, the substance does not warrant irritation under either the DSD or EU GHS regulation.
Executive summary:

In a reliable secondary source, which reported the results from peer reviewed guideline studies, ethyl acetate was found to be only midly irritating to rabbit eyes, with all effects disappearing within 7 days.

Synopsis

Based on these results, this substance would not be classified as irritating under either the DSD or the EU GHS regulation.