1-bromo-3,4,5-trifluorobenzene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 24, 1991 to October 01, 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

not specified

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston, UK
- Age at study initiation: 12 – 16 weeks
- Weight at study initiation: 2.35 – 2.42 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 – 22
- Humidity (%): 57 – 64
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

Up to 72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: On the day before the test each of a group of three rabbits was clipped free of fur from the dorsal/flank area. Only animals with a healthy intact epidermis by gross observation were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5 mL of the test material was introduced under a 2.5 * 2.5 cm gauze patch and placed in position on the shorn skin
- Type of wrap: The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset.

REMOVAL OF TEST SUBSTANCE
- Washing: any residual test material removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4h

OBSERVATION TIME POINTS
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined far evidence of primary irritation

SCORING SYSTEM:
- Method of calculation: scored according to Draize (1959).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean score

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean score

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean score

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean score

Time point:

24/48/72 h

Score:

3.7

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean score

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean score

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

The observed effects were fully reversible within 7 days

Other effects:

Other adverse skin reactions noted were haemorrhages of the dermal capillaries, light brown discolouration of the epidermis and oedema extending ventrally below the treatment site. Crust formation was noted at all treated skin sites seven days after treatment.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test material produced a skin irritation to rabbit skin. No corrosive effects were noted.

Executive summary:

The purpose of this GLP study performed according to OECD TG 404 was to assess the irritancy potential of the test item to the skin of the New Zealand White rabbits. Well-defined erythema was noted at all treated skin sites one hour after patch removal, at the 24 and 48-hour observations and at two treated skin sites at the 72-hour observation. Moderate to severe erythema was noted at one treated skin site at the 72-hour observation. Haemorrhage of the dermal capillaries was noted at two treated skin sites one hour after patch removal. Light brown discolouration of the epidermis was noted at two treated skin sites at the 24 and 48-hour observations and at one treated skin site at the 72-hour observation. Crust formation was noted at all treated skin sites seven days after treatment. Severe oedema was noted at all treated skin sites one and 24 hours after patch removal with moderate to severe oedema at the 48-hour observation and slight to moderate oedema at the 72-hour observation. Oedema extended ventrally below the treatment sites of two animals at the 48-hour observation. In conclusion, the test material produced a skin irritation to rabbit skin. No corrosive effects were noted.