Registration Dossier
Registration Dossier
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EC number: 214-787-5 | CAS number: 1194-65-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 April 1983 to 02 May 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (three animals instead of six used)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- yes
- Remarks:
- (three animals instead of six used)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dichlobenil
- EC Number:
- 214-787-5
- EC Name:
- Dichlobenil
- Cas Number:
- 1194-65-6
- Molecular formula:
- C7H3Cl2N
- IUPAC Name:
- 2,6-dichlorobenzonitrile
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.5-3.0 kg
- Housing: individually in stainless steel wire cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-21 °C
- Humidity: 60-80 %
- Air changes (per hr): 16 times per hours
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 g
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
Cornea
A. Opacity-degree of density
No ulceration or opacity - 0
Scattered or diffuse areas; details if iris clearly visible - 1
Easily discernible translucent areas, details of iris slightly obscured - 2
Opalescent areas of opacity, no details of iris visible, size of pupil barely discernible - 3
Opaque, iris invisible -4
B. Area of cornea involved
No damaged cornea - 0
One quarter (or less) but not zero - 1
Greater than one quarter but less than one half - 2
Greater than one half less than three quarters - 3
Greater than three quarters up to whole area - 4
Iris
Normal - 0
Folds above normal, congestion, swelling, circumcorneal injection (any one or all of these or combination of any thereof), iris still reacting to light (sluggish reaction is positive) - 1
No reaction to light, haemorrhage, gross destruction (any one or all of these) - 2
Conjunctiva
A. Redness
Vessels normal - 0
Vessels definitely injected above normal - 1
More diffuse, deeper crimson read, individual vessels not easily discernible - 2
Diffuse beefy red - 3
B. Chemosis
No swelling - 0
Any swelling above normal - 1
Obvious swelling with partial eversion of the lids - 2
Swelling with lids about half closed - 3
Swelling with lids about half closed to completely closed - 4
C. Discharge
Normal - 0
Any amount different from normal (does not include small amount observed in inner canthus of normal animals) - 1
Discharge with moistening of the lids and hairs just adjacent to the lids - 2
Discharge with moistening of the lids and considerable area around the eye - 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No effects were observed on cornea, iris or conjunctiva.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the test, the test material was determined to be non-irritating.
- Executive summary:
In a GLP compliant eye irritation study conducted in line with standardised guidelines OECD 405 and EPA OPP 81-4, the eye irritation of the test material was determined.
Under the conditions of the test, the test material was determined to be non-irritating.
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