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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
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.