Registration Dossier
Registration Dossier
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EC number: 635-156-4 | CAS number: 109293-98-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-05-30 until 1995-06-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Scientifically reliable study, similar to current OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- sodium 2-{N-[(3,5-difluorophenyl)carbamoyl]ethanehydrazonoyl}nicotinate
- EC Number:
- 635-156-4
- Cas Number:
- 109293-98-3
- Molecular formula:
- C15 H12 F2 N4 O3 .Na
- IUPAC Name:
- sodium 2-{N-[(3,5-difluorophenyl)carbamoyl]ethanehydrazonoyl}nicotinate
- Reference substance name:
- Diflufenzopyr
- IUPAC Name:
- Diflufenzopyr
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
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: Froxfield (U.K.) Ltd., Petersfield, Hampshire. England
- Age at study initiation: 11 - 14 weeks
- Weight at study initiation: 2.5 to 3.4 kg
- Housing: housed individually in metal cages with perforated floors
- Diet: a standard laboratory diet SDS Stanrab (P) Rabbit, ad libitum
- Water: drinking water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 19°C
- Humidity: 30 - 70 %
- Air changes: approximately 19 air changes per hour
- Photoperiod: 12 hours of artificial light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The contralateral eye remained untreated as a control
- Amount / concentration applied:
- 50 mg of the test substance
- Duration of treatment / exposure:
- Until end of the observation period
- Observation period (in vivo):
- 1, 2, 3, 24, 48, 72 hours and 4 and 7 days after instillation
- Number of animals or in vitro replicates:
- 7 rabbits
- Details on study design:
- SCORING SYSTEM: Draize scoring
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (mean scores of animals 1-6)
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (mean scores of animals 1-6)
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- (mean scores of animals 1-6)
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.06
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (mean scores of animals 1-6)
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.05
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
Any other information on results incl. tables
One animal was not considered in the results/scores presented above (results of 6 animals presented instead of 7) as the animal was not treated as the rest of the animals (pre test). The treated eye of this animal was washed, in opposite to the other treated eyes of the other animals. No irritation/ corrosion effects were observed in the washed eye of this animal.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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