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Toxicological information

Skin irritation / corrosion

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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:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
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.

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.