Registration Dossier
Registration Dossier
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EC number: 616-466-9 | CAS number: 77501-63-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- The irritant/corrosive potential of Lactofen was studied on the skin of rabbits. The method used complied with the OECD - Guideline for Testing of Chemicals No. 404 -" Acute Dermal 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
- 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
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: shorn
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema 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 effects reported
Any other information on results incl. tables
Lactofen is not an irritant to the skin. There were no systemic intolerance reactions.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
The irritant/corrosive potential of Lactofen was studied on the skin of rabbits. The method used complied with the OECD - Guideline for Testing of Chemicals No. 404 -" Acute Dermal Irritation/Corrosion"; for reasons of animal welfare a sequential testing strategy was followed.
The degree of erythema/eschar formation and oedema formation was recorded as specified by DRAIZE and any serious lesions or toxic effects other than dermal irritation were also recorded and described.
The mean erythema score after 24, 48, and 72 hours was 0.2 and the edema score = 0.
Therefore Lactofen is not an irritant to the skin. There were no systemic intolerance reactions.
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