Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well performed guideline study, but only 54 mg (0.1 ml) test substance administered.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
:only 54 mg administered
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
9-ethylcarbazole
EC Number:
201-660-4
EC Name:
9-ethylcarbazole
Cas Number:
86-28-2
Molecular formula:
C14H13N
IUPAC Name:
9-ethyl-9H-carbazole

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.76 to 3.36 kg
- Housing: Individually in metal cages equipped with feed hoppers and drinking water bowls
- Diet: standard laboratory diet (rabbit diet, Preston Farmers Ltd) ad libitum
- Water : drinking water ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 14°- 22°C
- Humidity (%): 55 - 60 %
- Photoperiod (hrs dark / hrs light): 12/12
- Air changes: approx. 15 changes per hr

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
Test material was ground to a fine powder using a mortar and pestle immediately before use.
- Amount(s) applied (volume or weight with unit): 0.1 ml (approx. 54 mg)
Duration of treatment / exposure:
One administration 24 hours
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
3
Details on study design:
Application of the substance to the conjunctival sac of the right eye of each animal, the left eyes served as control respectively

TOOL USED TO ASSESS SCORE: light source from standard ophthalmoscope (Keeler)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of three animals
Time point:
other: after 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
iris score
Basis:
mean
Remarks:
of three animals
Time point:
other: after 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of three animals
Time point:
other: after 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: grade 1 and 2 chemosis was observed in all animals at 1 hour and was fully reversible within 24 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of three animals
Time point:
other: after 24, 48 and 72 hours
Score:
0.25
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
The score refers to redness of conjunctiva, which was evident in all animals 1 h after treatment (scores 1 and 2 in all 3 animals). The value of 0.25 is the mean (of the three assessments at 24, 48 and 72 h) for all animals combined. Other parameters examined (opacity of cornea, iris, chemosis of conjunctiva) showed scores of 0 after 24, 48 and 72h.

Any other information on results incl. tables

Animal no

Evaluation Interval

Cornea

Conjunctiva

Iris

Opacity

Redness

Chemosis

93 male

 

1 h

0

2

2

0

134 male

0

2

1

0

136 female

0

2

2

0

93 male

 

24 h

0

1

0

0

134 male

0

1

0

0

136 female

0

1

0

0

93 male

 

48 h

0

0

0

0

134 male

0

0

0

0

136 female

0

0

0

0

93 male

 

72 h

0

0

0

0

134 male

0

0

0

0

136 female

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
In a OECD guideline and GLP compliant primary eye irritation test in rabbits, the test item caused grade 1 chemosis after one hour and conjunctival reddening grade 2 after 1 hours and grade 1 after 24 hours. No effects were observed for these and other parameters at the other reading times up to 72 hours. Therefore, the test item can be regarded as not eye irritating.
Executive summary:

A study with the test item according to OECD Guideline 405 and EU Method B.5 was performed to investigate the irritation potential to the rabbit eye.

One hour after treatment the conjunctivae of the animals showed score 2 for conjunctiva redness and chemosis. 48 hours after treatment all signs of irritation were reversible.

Therefore the test item has not to be classified as eye irritating according to Regulation (EC) No 1272/2008.