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Diss Factsheets

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:
1984-09-25 to 1984-09-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
5-hexyldihydro-5-methylfuran-2(3H)-one
EC Number:
230-291-1
EC Name:
5-hexyldihydro-5-methylfuran-2(3H)-one
Cas Number:
7011-83-8
Molecular formula:
C11H20O2
IUPAC Name:
5-hexyldihydro-5-methylfuran-2(3H)-one

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.14-2.42 kg
- Housing: individually, in suspended metal cages
- Diet: ad libitum, Rabbit Diet, A.W. Tindall Limited, Holbeach, Lincolnshire
- Water: ad libitum, tap water
- Acclimation period: min. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 2.0
- Humidity (%): 65-68
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of each animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: 100 %

Duration of treatment / exposure:
Single treatment.
Test substance was not removed from the eye (only self-cleaning of eye).
Observation period (in vivo):
max. 21 days
Observations done after 1, 24, 48 and 72 h and as necessary at day 7, 14 and 21.
Number of animals or in vitro replicates:
3 (sex not specified)
Details on study design:
SCORING SYSTEM:
- Assessment of damage/irritation: Draize J.H., 1959, Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics"
- classification of ocular irritation potential: modified version of the system described by Kay J.H. and Calandra J.C., J.Soc. Cosmet, Chem. 1962 13 281 to 289

TOOL USED TO ASSESS SCORE: standard opthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.11
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Other effects:
1 h after application dulling of the cornea was observed in all animas. After 24 h the effect was not observed anymore.

Any other information on results incl. tables

Mean scores

Animal Mean score redness (24/48/2 h) Mean score chemosis (24/48/72 h)
1 0.00 0
2 0.33 0
3 0.00 0
Mean 0.11 0

Individual scores

Animal 1 2 3
Time after treatment [h] 1 24 48 72

7 days

 1 24 48 72

7 days

 1 24 48 72

7 days
Cornea
E=Degree of opacity D 0 0 0 - D 0 0 0 - D 0 0 0 -
F=Area of opacity 2 0 0 0 - 1 0 0 0 - 2 0 0 0 -
Score (E*F)*5 0 0 0 0 - 0 0 0 0 - 0 0 0 0 -
Iris
D 0 0 0 0 - 0 0 0 0 - 0 0 0 0 -
Score (D*5) 0 0 0 0 - 0 0 0 0 - 0 0 0 0 -
Conjuntivae
A=Redness 1 0 0 0 - 2 1 0 0 - 1 0 0 0 -
B=Chemosis 1 0 0 0 - 1 0 0 0 - 1 0 0 0 -
C=Discharge 2 0 0 0 - 2 0 0 0 - 1 0 0 0 -
Score (A+B+C)*2 8 0 0 0 - 10 2 0 0 - 6 0 0 0 -
Total Scores 8 0 0 0 - 10 2 0 0 - 6 0 0 0 -

D=Dulling of the cornea

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A study in rabbits was conducted to evaulate the irritation potential of the test substance in the eye. The results showed a minimal irritation effect of the test substance on rabbit eyes.
Executive summary:

The potential of the test substance to cause eye irritation was tested using rabbits. The animals were observed for 72 hours with data recorded and up to 21 days if necessary. The mean score for cornea opacity and iris were 0 for 24/48/72 h. For all animals a reversible dulling of the cornea was observed 1 h after treatment. For conjuntivae redness it was 0.11 and for chemosis 0 at 24/48/72 h. For all animals the individual mean scores for cornea opacity and iris were 0 for 24/48/72 h. Animal 1 had a score for conjuntivae redness of 0 and 0 for chemosis at 24/48/72 h. Animal 2 had a score for conjuntivae redness of 0.33 and 0 for chemosis at 24/48/72 h. Animal 3 had a score for conjuntivae redness of 0 and 0 for chemosis at 24/48/72 h. All effects observed were reversible within 24 to 48 h. Due to these results the test substance was found to be slightly irritating for the eye but without classification.