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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:
26.02.-18.03.2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.42 (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:
solid

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Netherlands B.V. Postbus 6174 NL - 5960 AD Horst
- Age at study initiation: Pre-test: 9-10 weeks; Main test: 8 - 9 weeks
- Weight at study initiation: Pre-test: 20.5 g; Main test: 19.5+/- 1.5 g
- Housing: grouped per dose
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: day 1 To: day 6

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
10, 25 and 50 % (w/w)
No. of animals per dose:
5
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: 50% in acetone/olive oil (4+1, v/v)
- Irritation: slight erythema
- Lymph node proliferation response: -

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD 429
- Criteria used to consider a positive response: Stimulation index > 3

Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
Standard statistical methods have been applied for data processing.

Results and discussion

Positive control results:
Conc. SI
0%: 1.00
5% 1.8
10% 3.2
25% 5.8

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
0.84
Test group / Remarks:
Test Group: 10%
Key result
Parameter:
SI
Value:
0.74
Test group / Remarks:
Test Group: 25%
Key result
Parameter:
SI
Value:
0.77
Test group / Remarks:
Test Group: 50%

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was not a skin sensitiser under the test conditions of this study.
Executive summary:

In the study the test item formulated in acetone/olive oil was assessed for its possible skin sensitising potential. For this purpose a local lymph node assay was performed using test item concentrations of 10, 25 and 50% (w/w).

In this study Stimulation Indices (S.I.) of 0.84, 0.74 and 0.77 were determined with the test item at concentrations of 10, 25 and 50% (w/w) in acetone/olive oil, respectively.

The test item was not a skin sensitiser under the test conditions of this study.