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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:
1995-08-07 / 1995-08-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to the OECD Guideline 405 and it is GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

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-methyl-2-(1-methylbutyl)-5-propyl-1,3-dioxane
EC Number:
279-482-1
EC Name:
5-methyl-2-(1-methylbutyl)-5-propyl-1,3-dioxane
Cas Number:
80480-24-6
Molecular formula:
C13H26O2
IUPAC Name:
5-methyl-2-(1-methylbutyl)-5-propyl-1,3-dioxane
Details on test material:
- Physical state: colourless liquid
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
other: SPF albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Möllegaard Breeding and Research Centre Ltd., Ejby, DK-4623 Lille Skensved
- Weight at study initiation: 2.5-2.6 kg
- Housing: room provided with filtered air
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±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(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
The eyes were examined and grade of ocular reaction was recorded 1 and 24 hours later.
Observation period (in vivo):
The eyes were examined 48 and 72 hours as well after the treatment.
Number of animals or in vitro replicates:
Three females

Results and discussion

In vivo

Resultsopen allclose all
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:
0.7
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
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:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
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:
0.7
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible

Any other information on results incl. tables

 Rabbit Nº / Weight kg      1h  24  24 h (F)  48h  72 h  Individual mean values
 648/2.5  Area of opacity    0  0    0  0  0
   Cornea    0  0  0  0  0  0
   Iris    0  0    0  0  0
   Conjunctiva  Redness  1  1    1  0  0.67
     Chemosis  2  1    0  0  0.33
     Discharge  0  0    0  0  0
 656/2.6  Area of opacity    0  0    0  0  0
   Cornea    0  0  0 0  0  0
   Iris    0  0    0  0  0
   Conjunctiva  Redness  1  1    1  0  0.67
     Chemosis  2  0    0  0  0
     Discharge  1  0    0  0  0
 671/2.5  Area of opacity    0  0    0  0  0
   Cornea    0  0  0  0  0  0
   Iris    0  0    0  0  0
   Conjunctiva  Redness  1  1    0  0  0.67
     Chemosis  2  1    0  0  0.33
     Discharge  1  0    0  0  0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to the criteria and mean values, it must be concluded that the test substance caused no eye irritation.
Executive summary:

The primary eye irritant effect of the substance was investigated according to the method recommended in the OECD Guideline 405 and EU Method B.5.

Three female albino rabbits were exposed to 0.1 mL of the test article 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.

As it was anticipated that the test article could cause marked changes in the eye, the study was initiated with 1 rabbit. Since no marked eye irritation was seen in this animal another 2 rabbits were included in the study.

After the treatment only slight changes were observed in the eyes.

The following mean values, based on the results from the 24, 48 and 72 hours readings, were calculated.

Cornea opacity: 0.0

Iris lesion: 0.0

Redness of conjuntiva: 0.7

Oedema of conjunctiva: 0.2

According to the directive of the commission 93/21/EEC the substance caused no eye irritation.