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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
Study period:
2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study performed according to OECD guideline and according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd. CH-4414 Füllinsdorf, Switzerland
- Age at study initiation: 8 - 12 weeks (beginning of acclimatization)
- Weight at study initiation: 16 g - 24 g (ordered)
- Housing: single
- Diet (e.g. ad libitum): pelleted standard diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: Under test conditions after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:
other: ethanol/water (7:3, v:v)
Concentration:
0, 25, 50 and 100 % (w/v) in ethanol/water (7:3, v:v)
No. of animals per dose:
4
Details on study design:
TREATMENT PREPARATION AND ADMINISTRATION:
Topical application to the dorsum of each ear lobe (left and right) for three consecutive days. A control group of four mice was treated with the vehicle only. Five days after first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine. Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. 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 radio-labelled thymidine measured in a scintillation counter.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
Results obtained (stimulation index S.I.) with the positive control: 2.4, 3.6 and 11.2 at concnetrations of 5, 10 and 25% (w/v) in acetone/olive oil (4:1, v/v).

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: 1.4, 2.1 and 1.9 at concentrations of 25, 50 and 100 % in ethanol/water (7:3, v:v).
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: 1609, 2249, 3321, and 3064 at concentrations of 0, 25, 50 and 100 % in ethanol/water (7:3, v:v).

Any other information on results incl. tables

All treated animals survived the scheduled study period.

No clinical signs were observed in any animals of the control group or group 2 (25%). About 3 hours after the first topical application, a slight ear erythema was observed at both dosing sites in all mice of group 4 (100%, undiluted), persisting for a total of four days. On the second application day, a slight ear erythema was observed at both dosing sites in all mice of group 3 (50%), persisting for a total of two days.

In this study Stimulation Indices (S.I.) of 1.4, 2.1, and 1.9 were determined with the test item at concentrations of 25, 50, and 100 % in ethanol/water (7:3, v:v), respectively.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
The test item was not a skin sensitiser under the described conditions.
Executive summary:

In this study the test item dissolved in ethanol/water (7:3, v:v) was assessed for its possible contact allergenic potential.

For this purpose a local lymph node assay was performed using test item concentrations of 25, 50 and 100 % by topical application to the dorsum of each ear lobe (left and right) for three consecutive days. A control group of four mice was treated with the vehicle only. Five days after first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine. Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. 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 radio-labelled thymidine measured in a scintillation counter.

All treated animals survived the scheduled study period.

No clinical signs were observed in any animals of the control group or group 2 (25%). About 3 hours after the first topical application, a slight ear erythema was observed at both dosing sites in all mice of group 4 (100%, undiluted), persisting for a total of four days. On the second application day, a slight ear erythema was observed at both dosing sites in all mice of group 3 (50%), persisting for a total of two days.

In this study Stimulation Indices (S.I.) of 1.4, 2.1, and 1.9 were determined with the test item at concentrations of 25, 50, and 100 % in ethanol/water (7:3, v:v), respectively.

The test item was not a skin sensitiser in this assay.