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Registration Dossier
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EC number: 204-727-6 | CAS number: 125-12-2
Toxicological information
Eye irritation
Currently viewing:
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:
- 1 988
- 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
- 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:
- 1,7,7-trimethylbicyclo[2.2.1]hept-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
Constituent 1
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.
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