Registration Dossier

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:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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

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.