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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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 for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
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

Constituent 1
Chemical structure
Reference substance name:
Ethyl acetate
EC Number:
205-500-4
EC Name:
Ethyl acetate
Cas Number:
141-78-6
Molecular formula:
C4H8O2
IUPAC Name:
ethyl acetate
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.