Registration Dossier
Registration Dossier
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EC number: 236-425-5 | CAS number: 13361-34-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-ethylhexyl cyanoacetate
- EC Number:
- 236-425-5
- EC Name:
- 2-ethylhexyl cyanoacetate
- Cas Number:
- 13361-34-7
- Molecular formula:
- C11H19NO2
- IUPAC Name:
- 2-ethylhexyl 2-cyanoacetate
- Reference substance name:
- 2-ethylhexyl-cyanoacetate
- IUPAC Name:
- 2-ethylhexyl-cyanoacetate
- Details on test material:
- - Name of test substance: 2-ethylhexyl-cyanoacetate
- Chemical name: cyanoacetic acid 2-ethylhexyl ester
- Substance number: 96/219
- Batch number: ABL.NR . 13-9844
- CAS number: 13361-34-7
- Degree of purity/content: 98.5 g/100 g (GC)
- Date of manufacturing: 27-DEC-1995
- Physical state/appearance: liquid, yellowish, clear
- Stability under test conditions: The stability of the TS over the study period has been proven by reanalysis.
- Storage conditions: room temperature
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: 2.48 - 2.74 kg
- Housing: single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm²
- Diet: Kliba-Labordiaet 341 (Klingenthalmuehle AG, Kaiseraugst, Switzerland), about 130 g per animal per day
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 ml
- Concentration: undiluted - Duration of treatment / exposure:
- The TS was washed out with tap water about 24 hours after application. The observation period was 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: with tap water
- Time after start of exposure: about 24 hours after application
SCORING SYSTEM: According to OECD guideline 405 (adopted Feb. 24, 1987) and EEC L 383A, B.5 (Dec. 29, 1992).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity, iris, conjunctivae redness and chemosis. The findings were reversible in all animals within 24 hours after application. Thus the study was terminated after 72 hours.
Any other information on results incl. tables
Irritant/corrosive response data for each individual animal at each observation time asa well as calculation of the means:
Animal |
Cornea |
Iris |
Conjunctivae |
||||
Opacity |
Area |
Redness |
Swelling |
Discharge |
|||
1 hour |
1 |
0 |
0 |
0 |
1 |
0 |
2 |
|
2 |
0 |
0 |
0 |
1 |
0 |
2 |
|
3 |
0 |
0 |
0 |
1 |
0 |
2 |
24 hours |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
48 hours |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
72 hours |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean (24 - 72 h) |
1 |
0.0 |
|
0.0 |
0.0 |
0.0 |
|
|
2 |
0.0 |
|
0.0 |
0.0 |
0.0 |
|
|
3 |
0.0 |
|
0.0 |
0.0 |
0.0 |
|
Total mean (24 – 72 h) |
|
0.0 |
|
0.0 |
0.0 |
0.0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Under the test conditions chosen and considering the described findings the TS does not give indication of an irritant property to the eye.
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