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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye 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

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 405 (Acute Eye 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 / tissue source

Species:
rabbit
Strain:
other: Japanese White
Details on test animals or tissues 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

Vehicle:
unchanged (no vehicle)
Controls:
other: identical animal, left eye
Amount / concentration applied:
undiluted
Amount applied: 0.1 g/animal
Duration of treatment / exposure:
singular exposure;
The treated eyes were rinsed with warm water after 24 hours.
Observation period (in vivo):
Eye irritation was evaluated at 1 hour, and 1, 2, 3, 4, 7, and 14 days after test material application. The degree of irritation was scored using Draize scale. Animals were observed daily for mortality and signs of morbidity.
Number of animals or in vitro replicates:
2 male and 2 female animals
Details on study design:
- Dose preparation and administration
One day prior to being dosed, 4 healthy rabbits were selected for the study. 0.1 g of the test substance was applied directly into the conjunctival sac of the right eye of each animal by gently pulling the lower lid away from the eyeball. Left eye served as control in evaluation of eye irritation. Then the lids were gently held together for about one second to prevent loss of the test material. The treated eyes were rinsed with warm water after 24 hours.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, and 78 hours
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: conjunctival redness was observed 1 hour after instillation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: conjunctival redness was observed 1 hour after instillation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: conjunctival redness was observed 1 hour after instillation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: conjunctival redness was observed 1 hour after instillation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: conjunctival chemosis was observed 1 hour after instillation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: conjunctival chemosis was observed 1 hour after instillation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: conjunctival chemosis was observed 1 hour after instillation
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: conjunctival chemosis was observed 1 hour after instillation
Irritant / corrosive response data:
AVERAGE Score (4 animals)
- Cornea: 0
- Iris: 0
- Conjunctivae (Redness): 0
- Conjunctivae (Chemosis): 0
Other effects:
Redness and chemosis were observed in all rabbits treated 1 hour after application. All rabbits returned to normal after 1 day.
No other toxicological effects were observed.

Any other information on results incl. tables

no further results

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 conditions of the study, bis(4-fluorophenyl) ketone is not irritating to eyes of 2 male and 2 female rabbits.
Executive summary:

The acute eye irritation properties of bis(4-fluorophenyl) ketone were estimated in a study similar to OECD TG 405. An amount of 0.1 ml of the undiluted test substance was instilled into the right eye of each of 2 male and 2 female rabbits, and the untreated left eye served as control. The treated eyes were rinsed with warm water after 24 hours. The animals were observed for 14 days after application. Mortility, clinical signs, or eye irritation were observed during the whole study period. Eye irritation index was assessed using Draize scale.

The test was evaluated as follows (average of evaluation at 24, 48, and 72 hours): cornea: 0, iris: 0, conjunctivae: redness: 0 and chemosis: 0 (mean scores on Draize scale). Therefore, bis(4-fluorophenyl) ketone is considered to be not irritating to eyes.