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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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): RPA 405217, product : Dimethyl Benzylidène Cyclo Pentanone
- Substance type: yellowish powder
- Analytical purity: 96.5 %
- The pH of the test substance in solution at 1% in 0.9% NaCl, measured at C.I.T. was 4.70.
- Purity test date: 13.01.1992
- Lot/batch No.: 07/W
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Cunicole du Val de Seile, 80160 Prouzel, France
- Weight at study initiation: 2.9 ± 0.3 kg
- Housing: The animals were individually housed in polystyrene cages (35 x 55 x 32 cm or 48.2 x 58 x 36.5 cm). Each cage was equipped with a food container and a water bottle
- Diet: During the study, the animals were fed ad libitum with a certified pellet diet (Rabbits sustenance ref. 112 C" (U.A.R., 91360 Villemoisson-sur-Orge, France). An analytical certificate of the quality of the food and the major food contaminants (pesticides, heavy metals, mycotoxins, etc.) was made available by the supplier und given for each batch
- Water: During the study, the animals had free access to tap water filtered by a 0.22 micron filter membrane and contained in water bottles. Bacteriological und chemical analyses of the water und detection of the major contaminants (pesticides, heavy metals und nitrosamines) were made periodically
- Acclimation period: Upon their arrival. at C.I.T., the animals were acclimatized to the experimental environment for at least 5 days during which they were observed daily. The animals received a preventive treatment for coccidiosis by administration of a Mucoxid solution at the dose level of 137.5 mg/kg bw/day at a volume of 10 ml/kg to their drinking water tor 5 days during the acclimatisation period.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity: 50 ± 20 % relative humidity
- Air : The air was non-recycled and filtered by absolute filters.
- Photoperiod (hrs dark / hrs light): 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye, which remained untreated, served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied : 100 mg of the test substance in its original form was placed into the conjunctival sac of the left eye


Duration of treatment / exposure:
- single introduction of 100 mg of the test substance
- lower and upper eyelids were held together for several seconds to avoid any loss of the test substance
- eyes were not rinsed after administration
Observation period (in vivo):
The single introduction was performed on the 10.12.91 (day 1). The animals were kept under observation until the 13.12.91 (day 4).
Number of animals or in vitro replicates:
- 3 male animals
Details on study design:
SCORING SYSTEM:

The ocular reactions were evaluated one hour, 24, 48 and 72 hours after introduction of the test substance according to the scoring system laid down in OECD Guideline 405.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
4
Remarks on result:
other: mean
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: mean
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
4
Remarks on result:
other: mean
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
3
Remarks on result:
other: mean
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Remarks on result:
other: mean
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
3
Remarks on result:
other: mean
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Remarks on result:
other: mean
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Remarks on result:
other: mean
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Remarks on result:
other: mean
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.7
Max. score:
4
Remarks on result:
other: mean
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: mean
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
4
Remarks on result:
other: mean
Irritant / corrosive response data:
One hour after introduction of the test substance, slight (score of 1 to2) conjunctival reactions (chemosis, discharge, enanthema) were observed
in the 3 animals. No iridic irritation or corneal opacity were noted.
After 24 hours, the conjunctival reactions remained slight in 2 animals and were associated with a slight (score of 1) corneal opacity on 3/4 at least of the surface of the cornea. A myosis was also noted in 2 animals.
No ocular reactions were observed in one animal.
After 48 hours, only a minimal corneal opacity persisted in one animal.
No other ocular reactions were noted after 72 hours.

Applicant's summary and conclusion

Executive summary:

In an eye irritation study according to OECD Guideline 405 a single introduction of 100 mg (E)-5[(4 - chlorophenyl)methylene]-2,2 - dimethylcyclopentanone

(95.6 %) was administered to the eyes of 3 male New Zealand White rabbits (Rhone-Poulenc, 1992). The eyes were not rinsed after introduction of the test substance. The ocular reactions were observed one hour, 24, 48 und 72 hours after the introduction according to the scoring system laid down in OECD Guideline No. 405.

One hour and 24 hours after introduction of the test substunce, slight conjunctival reactions (chemosis und redness) were observed. After 24 hours in 2 animals and after 48 hours in one animal, a slight corneal opacity was noted. A myosis appeared in 2 animals after 24 hours und then disappeared at the 48 -hour scoring period. After 72 hours, all ocular reactions were reversible in the 3 animals.

Thus, the test substance was considered as non-irritant when administered by ocular route in rabbits.