Registration Dossier
Registration Dossier
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EC number: 203-309-0 | CAS number: 105-56-6
Eye irritation
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:
- 1 992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- 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
- Test material form:
- gas under pressure: refrigerated liquefied gas
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
Test system
- Amount / concentration applied:
- 0.1 ml of ethyl cyanoacetate
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours and 6 and 8 days
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.22
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.78
- Max. score:
- 1.33
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.11
- Max. score:
- 0.33
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.78
- Max. score:
- 1.68
- Reversibility:
- fully reversible within: 8 days
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Classification: no irritating
The following scores were calculated from the individual examinations performed 24 h, 48 h and 72 h p.a.:
Cornea score: 1.67, 0.67, 0
Conjunctivae score: 2, 1.33, 0.33
Iris score: 0.33, 0, 0
Chemosis score: 1.33, 1, 0
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.
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