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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:
1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study and GLP

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl cyanoacetate
EC Number:
203-309-0
EC Name:
Ethyl cyanoacetate
Cas Number:
105-56-6
Molecular formula:
C5H7NO2
IUPAC Name:
ethyl 2-cyanoacetate
Details on test material:
Batch No. T 434
ID No. 3633/81 410

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 cm³ undiluted test material
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48, 72 hours, 6 and 8 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with warm isotonic solution of sodium chloride
- Time after start of exposure: 24 hours

SCORING SYSTEM:cornea score, conjunctivae score, iris score, chemosis score

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
1.22
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0.78
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0.11
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0.78
Reversibility:
fully reversible within: 8 days

Any other information on results incl. tables

Individuell results

    1h        24h        48h        72h        6d        8d     
animal 
conjunctivae score   
chemosis score 1 1 0  
iris score  
cornea score  
fluorescein test*            
exudation  x      x      x      x                
 - of substance                                    
 - white mucous  x      x      x      x                
conjunctivae, incl. nictitating membrane- with hemorrhage                                    
 iris                                    
 - reddened        x                            
- circumcomeal injection                                     

* the area of the brightening from the cornea surface after instillation of one trop fluorescein (0,1%) is denoted:

0 = no brightening

1 = punctual to 1/4

2 = 1/4 to 1/2

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification: irritating
The following mean scores were calculated from the individual examinations performed 24 h, 48 h and 72 h p.a.:
Cornea score: 0.78
Conjunctivae score: 1.22
Iris score: 0.11
Chemosis score: 0.78
Ocular lesions were reversible in all animals. A clearly hyperemia respectively a redness and a light swelling of the conjunctivae was observed in all
animals after one hour exposition.
Mean scores for conjunctivae, chemosis and cornea exceed the thresholds for classifying a test substance as "irritating" as set by the EC Guideline 93/21. Criteria for corrosion are not fulfilled.
Therefore the test substance ethyl cyanoacetate is an irritant according to the EC-guideline 93/21.
Executive summary:

Aim of the study

The aim of this study was to investigate possible irritating or corrosive effects of the undiluted test substance following a single administration into a conjunctival sac of rabbits.

Methods

Methods and investigations were performed in conformance with the OECD Guideline 405, 1987.

Administration of the test substance

The equivalent of 0.1 cm³ ethyl cyanoacetate was instilled into the conjunctival sac of one eye of each of 3 rabbits. The eyes were rinsed with warm isotonic solution of sodium chloride after 24 h.

Investigations

Eye examination: 1, 24,48, 72 h and 6,8, d after the administration

Results

General signs

No other than ocular lesions were noted.

Eye examination

A clearly hyperemia respectively a redness and a light swelling of the conjunctivae was observed in all animals after one hour exposition.

Cornea: 1 animal was normal at any time. In 2 animals diffuse opacity of the cornea was present from 48 h to 72 h p.a.

Iris: 2 animals were normal at any time. In one animal mild lesions were observed after 24 h p.a.

Conjunctivae: Pronounced redness was observed in all animals already 1 h p.a.

Chemosis: A light swelling was seen in all animals already 1 h p.a. In 1 animal a clearly swelling with a partial ecetropion of the lid was observed 24 h p.a.

The third animal was without findings after 48 h p.a., the other two animals were without findings after 8 d p.a.