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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:
February 23th to 26th, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: According to OECD guideline with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate
EC Number:
204-727-6
EC Name:
Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate
Cas Number:
125-12-2
Molecular formula:
C12H20O2
IUPAC Name:
(1R,2R,4R)-1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl acetate (1S,2S,4S)-1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl acetate
Details on test material:
- Name of test material (as cited in study report): Isobornylacetat-Extra
- Physical state: liquid
- Analytical purity: 93.5 – 95.5 % Isobornylacetat
- Impurities (identity and concentrations): other terpene esters and camphene
- Composition of test material, percentage of components:
93.5 – 95.5 % Isobornylacetat
2.4 - 3.2 % Isofenchylacetat
0.5 - 0.8 % Pseudobornylacetat
0.4 - 0.7 % Fenchylacetat
0.4 - 0.8 % Isoborneol
0.2 - 0.8 % Camphen
- Storage condition of test material: in the dark, at 22ºC

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand albine
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund, konventionelle Zucht
- Age at study initiation: 3-5 months
- Weight at study initiation: 2,3 - 3,0 kg
- Housing: in air-conditioned rooms in individual cages (battery cages)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3ºC
- Humidity (%): 50 +/- 20%
- Photoperiod (hrs dark / hrs light): 12 hours of light a day

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL/eye
Observation period (in vivo):
1, 24, 48 and 72 hours after application of the test.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes

SCORING SYSTEM: damage to the cornea, iris and conjunctiva were evaluated numerically, by a rating system.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
conjunctival swelling
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
conjunctival swelling
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
conjunctival swelling
Basis:
animal #2
Time point:
other: 1 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
conjunctival swelling
Basis:
animal #2
Time point:
other: 24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
conjunctival swelling
Basis:
animal #2
Time point:
other: 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
conjunctival swelling
Basis:
animal #3
Time point:
other: 1 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
conjunctival swelling
Basis:
animal #3
Time point:
other: 24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
conjunctival swelling
Basis:
animal #3
Time point:
other: 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
conjunctival redness
Basis:
animal #1
Time point:
other: 1 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
conjunctival redness
Basis:
animal #1
Time point:
other: 24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
conjunctival redness
Basis:
animal #1
Time point:
other: 48 and 72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
conjunctival redness
Basis:
animal #2
Time point:
other: 1 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
conjunctival redness
Basis:
animal #3
Time point:
other: 1 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
conjunctival redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
other: all animals
Time point:
other: all time points
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Remarks:
corneal opacity
Basis:
other: all animals
Time point:
other: all time points
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within:
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
Isobornyl acetate is not irritating for eyes.
Executive summary:
The eye irritation test of isobornyl acetate was performed in 3 rabbits according to OECG guideline. The results shows that the substance has not to be not classified as irritating to eyes.