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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
For read across justification see the attachment in the read across object attached to chapter 7.4.1 (skin sensitisation).
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
not available
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This experiment was carried out to quantify the irritancy of the similar acetate ester, ethyl acetate. Secondary source but one that is considered highly reliable since data (generated to guideline) has undergone a peer review process before inclusion and key experimental results are available. Data used in this source has been subject to a peer review process by a reputable body.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
not specified
Remarks:
Source indicates data generated to GLP, but no indication of test laboratory.
Species:
rabbit
Strain:
New Zealand White
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
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.
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, ethyl acetate would not be classified as irritating under the EU GHS regulation.

Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
not available
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This experiment was carried out to quantify the irritancy of the similar acetate ester, n-butyl acetate. Secondary source but one that is considered highly reliable since data (generated to guideline) has undergone a peer review process before inclusion and key experimental results are available. Data used in this source has been subject to a peer review process by a reputable body.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
not specified
Remarks:
Source indicates data generated to GLP, but no indication of test laboratory.
Species:
rabbit
Strain:
New Zealand White
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
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: average at time points 24, 48, 72hrs
Score:
0.08
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
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: average at time points 24, 48, 72hrs
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: one animal showed a rating of 1 at 7 days.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: average at time points 24, 48, 72hrs
Score:
0.25
Max. score:
4
Reversibility:
fully reversible within: 2 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: average at time points 24, 48, 72hrs
Score:
0.33
Max. score:
4
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
Max. score:
3
Reversibility:
fully reversible within: 14 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:
0.33
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:
7.5
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.
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, n-butyl acetate was found to be only midly irritating to rabbit eyes, with all effects disappearing within 14 days (most within 7).

Synopsis

Based on these results, n-butyl acetate would not be classified as irritating under the EU GHS regulation.

Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1961
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
This study was conducted prior to GLP and test guidelines, but sufficient data is available for interpretation of results
Qualifier:
no guideline followed
Principles of method if other than guideline:
The eye irritation potential was examined by depositing 0.5 ml test material in the eye of albino rabbits. Eighteen to twenty four hours later the eyes are reexamined without and then with fluorescein administration in the eye.
GLP compliance:
no
Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
No additional information available.
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 ml of test material was applied
Duration of treatment / exposure:
18 to 24 hours
Observation period (in vivo):
After 18-24 hours, the eyes are examined for irritation and then fluorescein is administered and the eyes are reexamined.
Number of animals or in vitro replicates:
5
Details on study design:
Prior to treatment with test material, the eyes of albino rabbits were examined with 5% fluorescein solution to ensure the eyes used for the test are normal. The eyes were washed with water approximately 20 seconds later. After approximately a two hour interval, 0.5 ml test material was applied to five eyes and examined after 18 -24 hours. The eyes were examined in strong diffuse daylight, then stained with fluorescein and the injury scored.
Irritant / corrosive response data:
Instillation of 0.5 ml test material in 5 rabbit eyes caused some diffuse necrosis of corneal cells which healed quickly.
Other effects:
No additional information available.

Instillation of 0.5 ml test material in 5 rabbit eyes caused some diffuse necrosis of corneal cells which healed quickly.

Conclusions:
Instillation of 0.5 ml test material in 5 rabbit eyes caused some diffuse necrosis of corneal cells which healed quickly. No definitive conclusions concerning classification can be drawn from this study as 0.5 ml of test material have been used, while the guideline requires 0.1 ml.
Executive summary:

The eye irritation potential of propyl acetate was examined. Instillation of 0.5 ml test material in 5 rabbit eyes caused some diffuse necrosis of corneal cells which healed quickly. No definitive conclusions concerning classification can be drawn from this study as 0.5 ml of test material have been used, while the guideline requires 0.1 ml.

Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
See attached justification below.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Remarks on result:
no indication of skin sensitisation

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopropyl acetate
EC Number:
203-561-1
EC Name:
Isopropyl acetate
Cas Number:
108-21-4
Molecular formula:
C5H10O2
IUPAC Name:
isopropyl acetate
Details on test material:
- Name of test material (as cited in study report): isopropyl acetate

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
> 7.5 - < 15
Max. score:
110
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
> 0.33 - < 0.5
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: average results of 2 worst animals reported as per CLP criteria
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
> 0 - < 0.17
Max. score:
2
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: average results of 2 worst animals reported as per CLP criteria
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
> 1 - < 1.33
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: average results of 2 worst animals reported as per CLP criteria
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
> 0.33 - < 0.67
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: average results of 2 worst animals reported as per CLP criteria

Applicant's summary and conclusion