1-bromo-3,4,5-trifluorobenzene

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

02-1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

not further specified

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1-bromo-3,4,5-trifluorobenzene

EC Number:

418-480-9

EC Name:

1-bromo-3,4,5-trifluorobenzene

Cas Number:

138526-69-9

Molecular formula:

Hill formula: C6H2BrF3 CAS formula: C6H2BrF3

IUPAC Name:

5-bromo-1,2,3-trifluorobenzene

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston, UK
- Age at study initiation: 12 – 16 weeks
- Weight at study initiation: 2.98 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 – 21
- Humidity (%): 56
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

Due to an initial severe pain reaction the study was terminated immediately after application of the test item.

Observation period (in vivo):

no (see above)

Number of animals or in vitro replicates:

1

Details on study design:

lmmediately before the start of the test, both eyes of the provisionally selected test rabbit were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. A volume of 0.1 mL of the test material was instilled into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after instillation, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. lmmediately after administration of the test material, an assessment of the initial pain reaction was made.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks on result:

not determinable

Results 2

Irritation parameter:

iris score

Remarks on result:

not determinable

Results 3

Irritation parameter:

conjunctivae score

Remarks on result:

not determinable

Results 4

Irritation parameter:

chemosis score

Remarks on result:

not determinable

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

The test material produced a severe initial pain reaction. However, as stated by the author of this study there is often no correlation between initial pain reaction and subsequent irritation.

Executive summary:

The purpose of this GLP study performed according to OECD TG 405 was to assess the eye irritancy potential of the test item in New Zealand White rabbits. The application of the test material to the non-irrigated eye of one rabbit produced an initial pain reaction of 4 (max = 5). Therefore, the study was terminated immediately and no further animals were treated. The test material produced a severe initial pain reaction. It was stated that there is often no correlation between initial pain reaction and subsequent irritation.