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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:
Apr 03 - May 02, 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

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:
solid: crystalline

In vivo test system

Test animals

Species:
mouse
Strain:
other: CBA/CaOlaHsd
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories B.V. Postbus 6174 5960 AD Horst / The Netherlands
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: -
- Age at study initiation: 9-10 weeks
- Weight at study initiation: (21.5 +/- 1.1) g
- Housing: group
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:
- Indication of any skin lesions:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 45 - 65
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

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:
According to guideline
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
one-way ANOVA

Results and discussion

Positive control results:
5% SI=1.6
10% SI=2.4
25% SI=5.9

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
1.6
Test group / Remarks:
10% Test group
Key result
Parameter:
SI
Value:
1.7
Test group / Remarks:
25% Test group
Key result
Parameter:
SI
Value:
1.3
Test group / Remarks:
50% Test group
Cellular proliferation data / Observations:
CELLULAR PROLIFERATION DATA

DETAILS ON STIMULATION INDEX CALCULATION

Group DPM SI
BG: 290.9 1.0
10% 508.9 1.8
25% 484.9 1.7
50% 378.5 1.3

EC3 CALCULATION
No EC3 calculation as all SIs are below 3.

CLINICAL OBSERVATIONS:
No deaths occurred during the study period.
No symptoms of local skin irritation at the ears of the animals and no signs of systemic toxicity were observed during the study period.

BODY WEIGHTS
The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age.

Applicant's summary and conclusion

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

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 429. The test material was not a skin sensitiser under the test conditions of this study.