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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, available as unpublished report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Adopted 24 February 1987
Deviations:
no
Remarks:
Non-GLP
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
8-azaspiro[4,5]decane-8-{4-[4''-(2'''-pyrimidinyl)-1''-piperazinyl]-butyne/2/-yl}-7,9-dione /E/-2-butenedionate
EC Number:
947-290-3
Cas Number:
118286-97-8
Molecular formula:
C21H27N5O2 × C4H4O4
IUPAC Name:
8-azaspiro[4,5]decane-8-{4-[4''-(2'''-pyrimidinyl)-1''-piperazinyl]-butyne/2/-yl}-7,9-dione /E/-2-butenedionate
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): Buspiron XI. fázistermék
- Physical state: white odourless powder
- Lot/batch No.: 1/1992
- Storage condition of test material: room temperature, protected from light

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Species: Rabbit
- Strain: New Zealand
- Sex of animals: male
- Number of animals: 3
- Source of animals: Mezőgazdasági Kombinát, Környe 2851
- Weight of study animals determined at the beginning of the study: 2700-3300 g

ENVIRONMENTAL CONDITIONS
- Housing conditions: Animals were kept in cages - 1 animal / cage
- Size of cages: 34 x 37 x 50 cm
- Temperature in the experimental animal room: 20ºC +/- 3ºC
- Relative humidity: 50-70%
- Lighting: artificial - sequence: 12 hours light, 12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Tested dose was 100 mg test material / eye.
Right eye of the test animals was treated with the test material.
Duration of treatment / exposure:
Single exposure.
Observation period (in vivo):
Observations following treatment were made daily for 7 consecutive days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 7 days

Any other information on results incl. tables

Mortality

 ID of the animal  Day 0 (day of the treatment)  Day 1  Day 2  Day 3  Day 4  Day 5 Day 6  Day 7 
 1142  -  -  -  -  -  - -  - 
 1143  -  -  -  -  - -  -  - 
 1144  -  -  -

 -

 -  -   -  -

Clinical signs

 ID of the animal  Day 0  Day 1  Day 2  Day 3  Day 4  Day 5  Day 6  Day 7
 1142 no no no no  no no   no  no
 1143 no no no no  no no   no  no
 1144 no no  no no  no  no  no  no

"no": test animal showed no clinical signs of toxicity

Results of eye examination - 1 hour after the treatment

  SCORE                    
 ID of the animal Chemosis Conjunctivae    Cornea    Iris
   left  right  right  left  right  left  right  left
 1142  2  0  1  0  0  0  1  0
 1143  2  0  1  0  0  0  2  0
 1144  1  0  0  0  0  0  1  0
 Average  1,67  0  0,67  0  0  0  1,33  0

Results of eye examination - 24 hours after the treatment

  SCORE                    
 ID of the animal Chemosis Conjunctivae    Cornea    Iris
   left  right  right  left  right  left  right  left
 1142  3  0  0  0  0  0  1  0
 1143  1  0  0  0  0  0  0  0
 1144  1  0  0  0  0  0  0  0
 Average  1,67  0  0  0  0  0  0,33  0

Results of eye examination - 48 hours after the treatment

  SCORE                    
 ID of the animal Chemosis Conjunctivae    Cornea    Iris
   left  right  right  left  right  left  right  left
 1142  1  0  0  0  0  0  0  0
 1143  1  0  0  0  0  0  0  0
 1144  2  0  0  0  0  0  0  0
 Average  1,33  0  0  0  0  0  0  0

Results of eye examination - 72 hours after the treatment

  SCORE                    
 ID of the animal Chemosis Conjunctivae    Cornea    Iris
   left  right  right  left  right  left  right  left
 1142  1  0  0  0  0  0  0  0
 1143  0  0  0  0  0  0  0  0
 1144  1  0  0  0  0  0  0  0
 Average  0,67  0  0  0  0  0  0  0

Results of eye examination - 7 days after the treatment

  SCORE                    
 ID of the animal Chemosis Conjunctivae    Cornea    Iris
   left  right  right  left  right  left  right  left
 1142  0  0  0  0  0  0  0  0
 1143  0  0  0  0  0  0  0  0
 1144  0  0  0  0  0  0  0  0
 Average 0  0  0  0  0  0  0  0

Assessment of the cornea using fluorsescein staining

  Time of observation
 ID of the animal  24 hours after treatment  48 hours after treatment  72 hours after treatment  7 days after treatment
 1142  +  +  +  -
 1143  -  -  -  -
 1144  -  -  -  -

+ : fluorescein staining of corneal cells have been observed

- : no stained areas have been observed

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The substance causes eye irritation (Eye Irritation, Category 2) according to classification criteria laid down in Regulation EC No 1272/2008.