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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
yes
Remarks:
The observation after the first application of the pre-test was conducted after 19 hours and 20 minutes and not after 24+/- 4 hours. This deviation to the study plan does not affect the validity of this study.
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Specific details on test material used for the study:
Identity: Frutonile
Batch No.: VE00002027
Storage: At room temperature, light protected
Expiration date: October 19, 2009

In vivo test system

Test animals

Species:
mouse
Strain:
not specified
Sex:
female
Details on test animals and environmental conditions:
Test system: Mice
Rationale: Recognised as the recommended test system
Number of animals for pre-test: 2 females
Number of animals for main study: 20 females
Number of animals per test group: 5 females (nulliparous and non-pregnant)
Number of test groups: 3
Number of control (vehicle) groups: 1
Agre: 8-12 weeks (beginning of treatment)
Identification: The animals were distributed into the test groups at random. All animals belonging to the same experimental group were kept in one cage. In the main experiment, the animals were identified by tail tags. In the pre-experiment, animals were identified by cage number.
Acclimatisation: At least 5 days prior to the start of dosing under test conditions after health examination. Only animals without any visible signs of illness were used for the study.

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
25, 50 and 100% test concentrations
No. of animals per dose:
5 female mice per dose
Details on study design:
In order to study a possible allergenic potential of Frutonile, three groups of five female mice were treated with different concentrations of the test iten by topical application at the dorsum of each ear lobe (left and right) on three consecutive days. A control group of five mice was treated with the vehicle only. Five days after the first topical application, the mice were intravenously injected into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed and the draining auricular lymph nodes excised and pooled per animal. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a β-scintillation counter.

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
2.06
Test group / Remarks:
25%
Parameter:
SI
Value:
1.64
Test group / Remarks:
50%
Parameter:
SI
Value:
2.7
Test group / Remarks:
100%
Cellular proliferation data / Observations:
All treated animals survived the scheduled study period and no signs of toxicity were observed.
In this study the Slimulation Indicies of 2.06, 1.64 and 2.70 were determined with the test item at concentrations of 25, 50 and 100% in acetone:olive oil (4+1). The statistical significance of the increase observed for the low and high dose is biologically irrelevant, since the stimulation indicies are all below 3 and a dose response relationship does not exist.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item Frutonile is not a skin sensitiser under the described conditions.