Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Mar - xxx 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, Guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
Appearance: white crystalline powder.

Receipt: 2 samples of test item were received at the laboratory.
Immediately upon receipt, the test item was registered, then stored at ambient temperature and protected from light in accordance with tbe Study Monitor's instructions.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Sex: female.
Identification: animals were individually identified by an ear clip.
Body weight: individual body weights were taken at the beginning and at the end of the experiment: it was between 2.8 kg and 3.4 kg at the start of the experiment.
Age: between 12 and 16 weeks at the start of the experiment.

Acclimatisation: for at least 5 days before the treatment, in the area where the experiment took place.
Housing: animals were housed individually in cages of standard size. Excreta were removed by unrolling plasticised brown paper, previously placed under cages. These cages were placed in an air conditioned (17- 21 °C) animal house kept at between 45% and 65 % relative humidity (except during the cleaning slot) in which non-recycled filtered air was changed approximately ten times per hour.
The artificial day/night cycle was 12 hours light and 12 hours darkness with light on at 7.30 a.m.

Feeding: SDS/DIETEX STANRAB (P) SQC feed was distributed daily at fixed times. The criteria for acceptable levels of contaminants in the feed supplied were within the limits of the analytical specifications established by the dit manufacturer.
Drinking water: Drinking water was available ad libitum in polycarbonate feeder bottles with a stainless steel nipple. A specimen of water is sent every 6 months to the Laboratoire Départemental d' Analyse du Cher- 216 rue Louis Mallet, 18014 Bourges Cedex, France- for analysis. The criteria for acceptable levels of contaminants in the water supplied were within the lirnits of the analytical specifications.

Test system

Vehicle:
unchanged (no vehicle)
Remarks:
FEX0-07 was applied to the eye as supplied by the Study Monitor.
Controls:
other: The untreated right eye served as a control.
Amount / concentration applied:
0.1 g of FEX0-07 was introduced into the conjunctival sac of the left eye of each of the animals.
Duration of treatment / exposure:
FEX0-07 was instilled once only.
Eyelids were held closed for approximately 1 second in arder to avoid any loss of FEX0-07.
The eye may be washed 24 hours after instillation if this is deemed appropriate.
Observation period (in vivo):
1 hour, 24, 48 and 72 hours approximately after the instillation of FEX0-07.

The day of instillation will be taken as the first study day D1.

Number of animals or in vitro replicates:
3

Justification of the number of animals per group: the number of animals per group was the minimum number enabling an accurate assessment of the studied toxicological effect.
Details on study design:
The aim of the study was to determine any irritant property of FEX0-07 following a single ocular instillation in the rabbit.
Ocular irritation and/or corrosion following instillation of FEX0-07 in the eye of the rabbit were evaluated by grading of any ocular irritation reaction seen, using a predetermined scoring system.
Three animals were required for the complete test.
Animals were selected on the basis of their general conditions. In addition, both eyes of each animal selected far testing were examined immediately before testing starts.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: Mean indices calculated from results obtained for each rabbit at times 24, 48 and 72 hours
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: Mean indices calculated from results obtained for each rabbit at times 24, 48 and 72 hours
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: Mean indices calculated from results obtained for each rabbit at times 24, 48 and 72 hours
Score:
0
Irritation parameter:
other: redness
Basis:
mean
Time point:
other: 1 hour
Score:
0
Irritation parameter:
other: redness
Basis:
mean
Time point:
other: Mean indices calculated from results obtained for each rabbit at times 24, 48 and 72 hours
Score:
0
Irritant / corrosive response data:
No ocular irritation reaction was seen in the animals up to the end of the observation period.
Chemosis score: 0 (mean for the three tested animals and three trials)
Redness score: 0 (mean for the three tested animals and three trials)
Iris score: 0 (mean for the three tested animals and three trials)
Cornea score: 0 (mean for the three tested animals and three trials)

Any other information on results incl. tables

The application of the test item did not induce colouring of the application site and did not interfere with grading of any eye lesion.

The surface area of corneal opacity and the lacrimation were not taken into account in the calculation of mean index.

The results related to area of corneal opacity are

- 1 h (mean for the three animals): 0

- 24 h (mean for the three animals): 0

- 48 h (mean for the three animals): 0

- 72 h (mean for the three animals): 0

The results related to lacrimation are

- 1 h (mean for the three animals): 0

- 24 h (mean for the three animals): 0

- 48 h (mean for the three animals): 0

- 72 h (mean for the three animals): 0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions adopted, FEX0-07 (batch 0511049) was found to be non-irritant for the eye of the rabbit.
Executive summary:

Any irritant property and/or degree of corrosion of the test item FEX0-07 (batch 0511049) was evaluated following a single ocular instillation in the rabbit in accordance with the General Requirements of OECD Guideline N. 405 and method B5 of Commission Directive N. 92/69/EEC adapting to technical progress for the 17th time Council Directive N. 67/548/EEC and subsequent arrendments. Three animals were used far the study 0.1 g of FEX0-07 was introduced into the conjunctival sac of the left eye of each of the anirnals. The untreated right eye served as a control. The application of the test itern did not induce colouring of the application site and did not interfere with grading of any eye lesion. Any conjunctival, iris and corneal lesion was evaluated approximately one hour, 24 hours, 48 hours and 72 hours after instillation of FEX0-07. Mean indices were calculated from results obtained for each rabbit at times 24, 48 and 72 hours.

Results obtained were: Mean index (Mi) for chemosis, redness, iris and cornea for each animal tested was 0.00.

Under the experimental conditions adopted, FEX0-07 (batch 0511049) was found to be non-irritant for the eye of the rabbit.