Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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:
other: Well documented study according to international accepted guidelines and GLP compliant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Test item: 4-chloro-4’-fluorobutyrophenoneCAS No.: 3874-54-2Batch No.: 2607Physical state: liquidColour: yellowish greenStorage: cool, dry place in a tightly closed container

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Species and strain: New Zealand white rabbitSource: S&K LAP Kft.Hygienic level during the study: good conventionalNumber of animal: 3 malesAge of animals: adult rabbits, 11 weeks oldBody weight range at the beginning of the study: 2520 - 3006 gBody weight range at the end of the study: 2638 - 3078 gAcclimatisation time: 5 days in first animal, 6 days in second and third animalAnimal health: Only animals in acceptable health condition were used for the test.Housing: Animals were housed individually in metal cage.Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.Temperature: 20 ± 3 °CRelative humidity: 30-70 %Ventilation: 10-15 air exchanges/hour by central air-condition system

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye served as control.
Amount / concentration applied:
0.1 ml test item was used for the study, as a single dose.
Duration of treatment / exposure:
The eyes of the test animals were not washed out 24 hour after test item application, because the test item had been removed from the eye of test animal by physiological mechanisms.
Observation period (in vivo):
The eyes were examined at 1, 24, 48 and 72 hours after the application.
Number of animals or in vitro replicates:
3 male
Details on study design:
In the first step an initial test was performed using one animal. The test item was placed into the conjunctival sac of the left eye. The eyelids were held closed gently for about one second to prevent any loss of the test item. The contralateral eye served as control.In the initial test no irritant effect was observed 24 hours after treatment. The confirmatory test was conducted using a second and third animal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Irritation parameter:
other: redness (conjunctival)
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24h
Irritation parameter:
chemosis score
Remarks:
(conjunctival)
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24h
Irritation parameter:
other: conjunctival discharge
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24h
Irritant / corrosive response data:
Treated and control eyes were examined at 1, 24, 48 and 72 hours after the application.1 hour after the single application of test item into the eye of the rabbits, slight redness, slight chemosis and slight discharge of the conjunctivae occurred, as well.24 hours after treatment all animals became free of symptoms.72 hours after the treatment the study was finished, because there was no any irritation symptom in animals.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
In conclusion, test item 4-Chloro-4’-fluorobutyrophenone (CAS 3874-54-2) applied to the rabbits' eye mucosa caused slight conjunctival irritant effects which were fully reversible within 24 hours. The test item cannot be classified into any hazard category for eye irritation.