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Diss Factsheets

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
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:
-
EC Number:
428-100-3
EC Name:
-
Cas Number:
94239-04-0
Molecular formula:
C6H3NF4
IUPAC Name:
2-fluoro-6-(trifluoromethyl)pyridine
Details on test material:
-Purity: 99.7%
Specific details on test material used for the study:
Substance ID: F6TF
Lot #: 8922/16
Purity: 99.7%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adults
- Weight at study initiation: 3232-3420 g
- Housing: The rabbits were housed individually, in cages suitable for animals of this strain and the weight range expected during the course of the study.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 ± 3°C
- Humidity (%): 30 -70%
- Air changes (per hr): 15 changes/hour,
- Photoperiod (hrs dark / hrs light): Artificial, giving 12 hours light, 12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:
single instillation of test substance in the eye
Observation period (in vivo):
1 hour and 1, 2, and 3 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
0.7
Max. score:
110
Reversibility:
fully reversible within: 2 days
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
110
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
110
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
80
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
80
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
80
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
10
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
10
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
10
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
0.7
Max. score:
20
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
20
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
20
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
20
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
20
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
20
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Instillation into the eye caused slight initial pain (class 2 on a 0 -5 scale). There were no corneal or iridial effects. Conjunctival effects consisted of slight redness in one animal 1 day after instillation and a slight discharge in another animal approximately 1 hour after instillation. There were no additional signs of irritation.
Other effects:
There were no signs of ill-health in any animal during the study.

Any other information on results incl. tables

A modified form of the Kay and Calandra system was used to interpret and classify numerical scores.

Applicant's summary and conclusion

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

The test substance was evaluated for acute eye irritation potential in 3 young adult New Zealand white rabbits according to the guidelines OECD 405 and EU method B.5. An aliquot of 0.1 mL of the test substance was administered to 1 eye of each animal. The eyes remained unwashed following treatment. The untreated eye served as a control. The conjunctiva, iris, and cornea of each treated eye were evaluated and scored according to a numerical scale approximately 1, 24, 48, and 72 hours following administration.


 


There were no signs of ill-health in any animal during the study. Instillation into the eye caused slight initial pain (class 2 on a 0 -5 scale). There were no corneal or iridial effects. Conjunctival effects consisted of slight redness in one animal 1 day after instillation and a slight discharge in another animal approximately 1 hour after instillation. There were no additional signs of irritation. Under the conditions of this study, the test substance is practically a non-irritant (class 2 on a 1-8 scale) to the rabbit eye.