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Registration Dossier
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EC number: 616-466-9 | CAS number: 77501-63-4
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:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- The irritant/corrosive effects of Lactofen were tested on the eye of rabbits. The method used complied with the OECD - Guideline for Testing of Chemicals No.405 -"Acute Eye Irritation/Corrosion"; for reasons of animal welfare a sequential testing strategy was followed.
- GLP compliance:
- yes
Test material
- Reference substance name:
- (2-ethoxy-1-methyl-2-oxoethyl)-5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoate
- EC Number:
- 616-466-9
- Cas Number:
- 77501-63-4
- Molecular formula:
- C19H15ClF3NO7
- IUPAC Name:
- (2-ethoxy-1-methyl-2-oxoethyl)-5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoate
- Reference substance name:
- 2-ethoxy-1-methyl-2-oxoethyl)-5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoate
- IUPAC Name:
- 2-ethoxy-1-methyl-2-oxoethyl)-5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoate
- Test material form:
- other: solid, high viscous
- Details on test material:
- Test compound: Lactofen
Chemical name: (2-ethoxy-I-methyl'-2-oxoethyl)-5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoate
CAS no.: 77501-63-4
Molar mass: 461.78 g/mol
Molecular formula: C19H15ClF3NO7
Appearance: solid, high viscosity, brown
Storage: room temperature
Content of test substance: 95.54 % (not used for calculations)
Confirmation of the identity of the test compound was performed.
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score = 0 at any time point
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable - score = 0 at any time point
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score = 0 at any time point
- Other effects:
- no other effects reported
Any other information on results incl. tables
Lactofen is not irritating to eyes. There were no systemic intolerance reactions.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
The irritant/corrosive effects of Lactofen were tested on the eye of rabbits. The method used complied with the OECD - Guideline for Testing of Chemicals No.405 -"Acute Eye Irritation/Corrosion"; for reasons of animal welfare a sequential testing strategy was followed.
Eye irritations were scored and recorded approximately at 1, 24, 48 and 72 hours post application.
The degree of ocular lesions was recorded as specified by DRAIZE and any serious lesions or toxic effects other than ocular lesions were also recorded and fully described.
The mean cormeal opacity score after 24, 48, and 72 hours was 0, the iris score = 0, the redness conjunctivae score = 0.3 and the chemosis conjunctivae score = 0.
Therefore Lactofen is not irritating to eyes. There were no systemic intolerance reactions.
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