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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:
Aug - Sept 1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well reported guideline conform study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 4-ethoxycarbonylphenoxide
EC Number:
252-487-6
EC Name:
Sodium 4-ethoxycarbonylphenoxide
Cas Number:
35285-68-8
Molecular formula:
C9H10O3.Na
IUPAC Name:
sodium 4-ethoxycarbonylphenoxide
Test material form:
other: solid

Test animals / tissue source

Species:
rabbit
Strain:
other:
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Weight at study initiation: 3500 g
- Housing: Animals were housed individually
- Diet: ssniff K, ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Not required, the untreated eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL finely powdered test substance (corresponding to max. 0.1 mg test substance)
Duration of treatment / exposure:
24 h
Observation period (in vivo):
15 d
reading time points: 1, 24, 48, 72 h, 7 d and 15 d
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: At the 24 h reading time point, 1% fluorescein solution was used to stain the cornea.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
other: 15 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
other: 15 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
other: 15 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within:
Remarks on result:
other: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
1.7
Max. score:
2
Reversibility:
not fully reversible within:
Remarks on result:
other: 7 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within:
Remarks on result:
other: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within:
Remarks on result:
other: 15 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within:
Remarks on result:
other: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within:
Remarks on result:
other: 15 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
other: 15 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
other: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
other: 15 days

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the observed effects and the reversibility the substance has to be classified with H 319 (causes serious eye irritation).
Executive summary:

The test item ether was tested for its eye irritant properties in 3 New Zealand White rabbits. The study was performed according to OECD Guideline 405. Effects on conjunctivae (redness and swelling) as well as on the cornea and iris were observed in all animals one hour after application. These signs were fully reversible within 15 d.

With reference the reported scores and the reversibility of the observed effects test substance has to be classified as irritant to the eyes according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).