1-bromo-2,4-difluorobenzene

Eye irritation

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:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1-bromo-2,4-difluorobenzene

EC Number:

206-479-4

EC Name:

1-bromo-2,4-difluorobenzene

Cas Number:

348-57-2

Molecular formula:

C6H3BrF2

IUPAC Name:

1-bromo-2,4-difluorobenzene

Test material form:

gas under pressure: refrigerated liquefied gas

Details on test material:

Test item: Difluoro-bromo-benzene
CAS No.: 348-57-2
Batch No.: L39084N
Physical state: liquid
Colour: colourless
Active Ingredient Content (GC): 96.4 %
Storage: 2-8 °C, in a tightly closed container

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand Black

Details on test animals or tissues and environmental conditions:

Species and strain: New Zealand white rabbit
Source: S & K-LAP Kft.
Hygienic level during the study: good conventional
Number of animal: 3 males
Age of animals: adult rabbits, 11 weeks old
Body weight range at the beginning of the study: 2279 - 2721 g
Body weight range at the end of the study: 2310 - 2845 g
Acclimatisation time: 7 days in first animal, 8 days in second animal and 9 days in third animal
Animal 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 °C
Relative 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 of the test item was used for the study in pure state, 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 then 1 week 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 moderate irritant effect was observed 24 hours after treatment. The confirmatory test was conducted using a second animal. Slight irritant effects were observed 24 hour after treatment. Following treatment of the second animal, the second confirmatory test was conducted using a third animal.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

(opacity)

Basis:

mean

Time point:

other: 24h, 48h, 72h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24h, 48h, 72h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

other: redness (conjunctival)

Basis:

mean

Time point:

other: 24h, 48h, 72h

Score:

0.66 - 2

Max. score:

2

Reversibility:

fully reversible within: 1 week

Results 4

Irritation parameter:

chemosis score

Remarks:

(conjunctival)

Basis:

mean

Time point:

other: 24h, 48h, 72h

Score:

0.66 - 1

Max. score:

1

Reversibility:

fully reversible within: 1 week

Results 5

Irritation parameter:

other: conjunctival discharge

Basis:

mean

Time point:

other: 24h, 48h, 72h

Score:

0 - 1

Max. score:

1

Reversibility:

fully reversible within: 1 week

Irritant / corrosive response data:

Treated and control eyes were examined at 1, 24, 48 and 72 hours then 1 week after the application.
1 hour after the single application of test item into the eye of the rabbits, slight redness of the conjunctivae occurred.
24 hour after the treatment slight to moderate rednessof the conjunctivae, slight chemosis and discharge of the conjunctivae were detected.
1 week after the treatment all animals became free of symptoms, so the study was finished.

Applicant's summary and conclusion

Interpretation of results:

Category 2B (mildly irritating to eyes) based on GHS criteria

Remarks:

Migrated information

Conclusions:

In conclusion, test item DIFLUORO-BROMO-BENZENE (CAS 348-57-2) applied to the rabbits' eye mucosa, caused slight to moderate conjunctival irritant effects, fully reversible within 1 week. The test item can be classified into Category 2B.