Bis(4-fluorophenyl) ketone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005-11-11 - 2005-12-30

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline comparable study; restriction: no controls

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2005

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis(4-fluorophenyl) ketone

EC Number:

206-466-3

EC Name:

Bis(4-fluorophenyl) ketone

Cas Number:

345-92-6

Molecular formula:

C13H8F2O

IUPAC Name:

bis(4-fluorophenyl)methanone

Constituent 2

Reference substance name:

4,4'-Difluorobenzophenone

IUPAC Name:

4,4'-Difluorobenzophenone

Details on test material:

bis(4-fluorophenyl) ketone,
purity: 99 %,
physical state: white powder,
storage conditions: test substance was stored in the refrigator of sample room and kept only in the original container

Test animals

Species:

rabbit

Strain:

other: Japanese White

Details on test animals or test system and environmental conditions:

TEST ORGANISMS: 
- Source: Qianmin Animals Raising Farm of Yuhong District, Shenyang
- Strain: Adult Japanese White rabbits
- Weight at study initiation: 1.8 - 2.2 kg
- Diet: ad libitum
- Water: ad libitum
- Temperature (°C): 20 °C +/- 2° C
- Humidity (%): 55 % +/- 10 %
- Illumination: natural lights
- Number of animals: 2 males and 2 females
- Housing: each in individual cage (32x32x50 cm); cages and feeders were changed and sanitized weekly

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: soybean oil

Controls:

no

Amount / concentration applied:

0.5 g (substance mixed with little soybean oil) per rabbit

Duration of treatment / exposure:

4 hours

Observation period:

- Post dose observation period: 14 days

Number of animals:

2 males and 2 females

Details on study design:

- Dose preparation and administration:
One day prior to being dosed, 4 healthy rabbits were selected for the study. At least 24 hours prior to application of the test substance, two areas (3x 3 cm2 each) on the back of each animal were shaved by using an electric clipper. Then the test substance mixed with a little soybean oil was applied (0.5 g per rabbit) to four layers of gauze (2.5 x 2.5 cm2) and smeared evenly, and then put to the shaved site on the left. The gauche patch was covered with one layer of plastic film and fixed with adhesive tape tightly to the animal. The animals were returned to their cages for observations. After four hours, the covering were removed and the application sites were rinsed completely with warm water.
- Observation and clinical signs:
Skin irritation was evaluated at 1 hr, and 1, 2, 3, 4, 7, and 14 days after test material application. The degree of irritation was scored. Animals were observed daily for mortality and signs of morbidity.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 4 hrs, 24 hrs, 48 hrs, 72 hrs

Score:

0

Max. score:

8

Remarks on result:

other: None of the animals showed any signs of erythema or edema.

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Irritant / corrosive response data:

AVERAGE SCORE
- Erythema: 0
- Edema: 0
REVERSIBILITY: not applicable

Other effects:

Under the described test conditions none of the two male and two female rabbits showed any test substance related changes.

Any other information on results incl. tables

no further information

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Under the present test conditions, none of the two male and two female rabbits exposed for 4 hours to 0.5 g bis(4-fluorophenyl) ketone per patch and animal (okklusive) showed any test item-related changes at the examination time-points 4 hours, 24, 48 and 72 hours after patch removal. Therefore, bis(4-fluorophenyl) ketone is not irritating to skin.

Executive summary:

The acute skin irritation properties of bis(4-fluorophenyl) ketone were estimated similar to OECD Guideline 404. A dose of 500 mg test item (in soybean oil) per animal was applied to the shaved, intact dorsal skin of 2 male and 2 female rabbits under occlusive conditions. After the 4 -hour exposure period the patch was removed and the resulting reactions were examined. The average scores at 4 hours, 24, 48 and 72 hours after patch removal are as follows: erythema/eschar: 0, edema: 0. Therefore, bis(4-fluorophenyl) ketone

is not irritating to skin.