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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:
1998-09-07 to 1998-09-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1992-12-29
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987-02
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
429-100-6
EC Name:
-
Cas Number:
23911-56-0
Molecular formula:
C11H10O2
IUPAC Name:
1-(3-methyl-1-benzofuran-2-yl)ethan-1-one

Test animals / tissue source

Species:
rabbit
Strain:
other: Mol:Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.0-2.3 kg
- Housing: Individually in PPO cages (floor area: 2576 cm^2) with perforated floor
- Diet: Ad libitum
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3
- Humidity (%): 55± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: Undiluted
Duration of treatment / exposure:
The substance remained in the eye throughout the whole study period (last reading 72 hours after beginning of treatment)
Observation period (in vivo):
72 hours (1, 24, 48 and 72 hours after treatment)
Number of animals or in vitro replicates:
Four animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No washing was done

SCORING SYSTEM
See "Any other information on materials and methods, incl. tables" (table 1-3)

TOOL USED TO ASSESS SCORE: Fluorescein (24 hour reading), tool for other readings not specified

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks:
The score was 1 one hour after treatment
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks:
The score was 1 one hour after treatment
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks:
The score was 1 one hour after treatment
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks:
The score was 1 one hour after treatment
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks:
The score was 1 one hour after treatment
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks:
The score was 1 one hour after treatment
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks:
The score was 1 one hour after treatment
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks:
The score was 1 one hour after treatment
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
One hour after application of the test article all animals showed some vessels definitely injected and swelling and discharge more than normal. After 24 hours there were no signs of irritation observed due to the test article in the eyes of all animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was found to be not irritating to the rabbit's eye.
Executive summary:

The eye irritant effect of the test item was investigated in a GLP compliant study according to OECD guideline 405. Four female albino rabbits were exposed to 0.1 mL of the test item in the left eye. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48 and 72 hours after dosing. Very slight signs of irritation were observed among the rabbits. The following mean values, based on the results from the 24, 48 and 72 hour readings, were calculated:

 

Cornea opacity

Iris lesion

Redness of

conjunctiva

Oedema of

conjunctiva

Test item

0.0

0.0

0.0

0.0

 

According to Regulation (EC) No 1272/2008, the test item shall not be classified as eye irritating.