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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999-05-17 to 1999-05-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted under GLP conditions and in accordance with the official OECD guideline No 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

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:
Allyl 3-cyclohexylpropionate
EC Number:
220-292-5
EC Name:
Allyl 3-cyclohexylpropionate
Cas Number:
2705-87-5
Molecular formula:
C12H20O2
IUPAC Name:
allyl 3-cyclohexylpropanoate
Details on test material:
- Physical state: liquid
- Stability under test conditions: not reported
- Storage condition of test material: cool and dry

Test animals / tissue source

Species:
rabbit
Strain:
other: Mol:Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Four female SPF albino rabbits of the stock Mol:Russian
- Source: Möllegaard Breeding and Reasearch Centre A/S, Ejby, Lille-Skensved, Denmark
- Age at study initiation: not reported
- Weight at study initiation: 2.3 to 2.7
- Housing: individually in PPO cages (floor area 2580 cm2) with perforated floor in animal room no. 3
- Diet (e.g. ad libitum): pelleted complete rabbit diet Altromin 2123 from Altromin, Lage/Lippe, Germany ad libitum
- Water (e.g. ad libitum): domestic quality drinking water acidified with hydrochloric acid to pH 2.5 ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL of neat test substance
Duration of treatment / exposure:
single administration; after 24 hour reading Fluorescein was instilled and treated eye was washed with 20 mL 0.9% sodium chloride solution
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
4
Details on study design:
REMOVAL OF TEST SUBSTANCE
- substance was not removed from the treated eye

SCORING SYSTEM:
see section "Any other information on materials and methods"

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Fluorescein was instilled after 24 hours, eyes were rinsed with 20 mL 0.9% sodium chloride solution and were examined using UV light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean of ratings at 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean of ratings at 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean of ratings at 24, 48 and 72 hours
Score:
0.8
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean of ratings at 24, 48 and 72 hours
Score:
0.8
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
Some light response to exposure of the eyes to the substance was observed in all animals at the early timepoints of observation at 1 hour, 24 and 48 hours after instillation. After 72 hours three out of four animals were free of any signs of eye irritation while one animal stilled exhibited light signs of irritation. These had disappeared at the observation made 7 days after exposure.
Other effects:
No other effects were reported.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is non-irritating to the rabbit eye and does not need classification.
Executive summary:

The potential for eye irritation was tested for allyl 3-cyclohexxylproprionate in a GLP study according to OECD guideline No. 405. Four healthy SPF albino rabbits (Mol:Russian) weighing 2.3 to 2.7 kg were used in the study. The day before testing both eyes of the animals were examined before and after the instillation of Fluorescein to ensure there were no defects or irritation. The next day an aliquot of 0.1 mL of the neat substance was placed in the left eyes of the animals by gently pulling the lower lid away from the eyeball. The lids were then gently hold together for one second. The right eye remained untreated and served as control. The eyes were examined and the grade of ocular reaction was recorded 1 and 24 hours later. After a first reading at 24 hours Fluorescein was instilled and the treated eye was rinsed with 20 mL 0.9% sodium chloride solution. Then the eye was examined again using UV-light to detect possible corneal damage. Further gradings were done after 48 and 72 hours after treatment. All animals showed slight conjunctival effects at the examinations occurring 1, 24 and 48 hours after treatment. Three out of four animals did no show any signs of eye irritation at the 72 hours observation timepoint, while one animal exhibited some conjunctival vessels definitely injected and swelling above normal. All these effects were transient and no reactions in the treated eyes of all four animals were seen in the examinations after 7 days. On the basis of these observations it was concluded that the substance is non-irritating to the rabbit eye.