Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
23 February 1988 - 26 February 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The analogue isobornyl acetate which shares the same functional groups with dextro alpha fenchyl acetate also has comparable values for the relevant molecular properties. Test method according to OECD 405. GLP study.

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:
(1S,2S,4S) 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
- Molecular formula (if other than submission substance): C12H20O2
- Molecular weight (if other than submission substance): 196.286
- Smiles notation (if other than submission substance): CC(=O)O[C@H]1C[C@@H]2CC[C@@]1(C)C2(C)C
- InChl (if other than submission substance): 1/C12H20O2/c1-8(13)14-10-7-9-5-6-12(10,4)11(9,2)3/h9-10H,5-7H2,1-4H3
- Structural formula attached as image file (if other than submission substance): see Fig.
- Physical state: Liquid
- Analytical purity: 93.5 – 95.5 %
- Impurities (identity and concentrations): other terpene esters and camphene
- Storage condition of test material: in the dark, at 22ºC

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
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 light / 12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
24 h
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): Physiological saline solution (37 ° C)
- Time after start of exposure: 24 h

SCORING SYSTEM: Grading of ocular lesions in accordance with OECD 405.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24-72h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
0
Max. score:
3
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
After one hour exposure, the skins of the animals showed from very little binding to distinct swelling and a diffuse red color. Between 24 and 48 hours after exposure very light, barely perceptible, swelling and redness of the conjunctivae was observed. There effects were fully reversible by 72 hours after exposure.


One hour revealed the binding very light skins of animals to clear swelling and a diffuse crimson-red to bright red diffuse color. Have 24 hours to 48 hours some very light barely perceptible redness and swelling of the conjunctiva are noted. 72 hours were all lovely reversible phenomena.






Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the read-across approach from experimental data on the analogue isobornyl acetate, dextro alpha fenchyl acetate is determined to be not irritating to the eye.
Executive summary:

An in-vivo eye irritation test was performed on the analogue substance isobornyl acetate according to OECD Guideline 405. The right eye of three New Zealand White rabbits were exposure to 0.1 mL (unchanged) test sample. The other one was used as control. The effects were observed after 1, 24, 48 and 72 hours exposure. Two rabbits showed a chemosis score of 0.33 (mean 24 -72h) which was fully reversible after 48 hours of exposure. One rabbit showed a conjunctivae score of 0.66 (mean 24 -72h) which was fully reversible after 72 hours of exposure. Based on these results, the read-across approach was applied and dextro alpha fenchyl acetate was determined to be not irritating to the eye.