Registration Dossier

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:
2000-02-22 to 2000-05-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Feb. 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Jan. 1997
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(R)-5-isopropyl-2-methylcyclohexa-1,3-diene
EC Number:
224-167-6
EC Name:
(R)-5-isopropyl-2-methylcyclohexa-1,3-diene
Cas Number:
4221-98-1
Molecular formula:
C10H16
IUPAC Name:
(5R)-2-methyl-5-(propan-2-yl)cyclohexa-1,3-diene

Test animals / tissue source

Species:
rabbit
Strain:
other: SPF albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: BI Pharma KG, 88397 Biberach
- Weight at study initiation: 2.7 - 3.3 kg
- Housing: Individually in PPO cages (floor area: 2576 sq.cm) with perforated floor
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 20°C +/- 3°C
- Humidity: 55% +/- 15%
- Air changes: 10 times/hour
- Photoperiod: 12 hours light/12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied : 0.1 mL

Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
4
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: 20 mL 0.9% sodium chloride solution
- Time after start of exposure: 24 hours (Fluorescein was instilled)

SCORING SYSTEM:

Cornea
Opacity-degree of density (area most dense taken for reading)
No ulceration or opacity: 0
Scattered or diffuse area of opacity (other than slight dulling of normal luster), details of iris clearly visible: 1
Easily discernible translucent areas, details of iris slightly obscured: 2
Nacreous areas, no details of iris visible, size of pupil barely discernible: 3
Complete corneal opacity, iris not discernible: 4

Iris
Normal: 0
Markedly deepened folds, congestion, swelling, moderate circumcorneal injection (any of these or combination of any thereof)
iris still reacting to light (sluggish reaction is positive): 1
No reaction to light, haemorrhage, gross destruction (any or all of these): 2

Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)

Vessels normal: 0
Some vessels definitely injected: 1
More diffuse, deeper crimson red, individual vessels not easily discernible: 2
Diffuse beefy red: 3

Chemosis
No swelling: 0
Any swelling above normal (includes nictitating membrane): 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids about half closed to completely closed: 4

TOOL USED TO ASSESS SCORE: hand-slit lamp with white and UV-light/ magnifying glass with 2 x magnification (biomicroscope) / fluorescein

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:
cornea opacity 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:
cornea opacity score
Basis:
animal #4
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:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is not irritating to the eye of rabbit.
Executive summary:

The acute eye irritation/corrosion study was conducted according to OECD guideline no. 405 and GLP.

The test substance was applied in one eye of four female albino rabbits. The eyes were examined and the changes were graded according to a numerical scale one hour, 24, 48 and 72 hours as well as 7 days after dosing.

Slight to well-defined signs of irritation were observed on the treated eyes.

All effects were fully reversible within 7 days.

For the four animals the mean scores after 24/48 and 72 hours was for cornea opacity: 0, 0, 0, 0; iris:0, 0, 0, 0; conjunctival redness: 1.0, 0.67, 0.67, 1.0; chemosis: 0.67, 0.33, 0.33, 0.33, all signs were fully reversible at 7 days.

Based on these results the test substance is not irritating to the eye of rabbit.