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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:
2005-04-27 to 2005-05-12
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
yes
Remarks:
1) Insufficient information on the test substance, test animals and methodological details presented
Qualifier:
according to
Guideline:
other: SPL Standard Test method 595.12
Deviations:
not specified
GLP compliance:
no
Remarks:
The study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but no formal claim of GLP compliance is made for the study.
Type of study:
mouse local lymphnode assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): JNJ-16479489-AAA (T001159)
- Physical state: solid
- Appearance: off-white powder

In vivo test system

Test animals

Species:
mouse
Strain:
CBA/Ca
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS: no data

ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES: no data

Study design: in vivo (LLNA)

Vehicle:
dimethylformamide
Concentration:
5, 10 and 25% (w/w) in dimethylformamide
A further group of four animals was treated with dimethyl formamide alone.
No. of animals per dose:
4
Details on study design:
RANGE FINDING TESTS: no signs of systemic toxicity at a concentration of 25% w/w in a preliminary sighting test

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: A stimulation index of 3.0 or greater indicates a positive result.

TREATMENT PREPARATION AND ADMINISTRATION:
- These groups were treated with 50 µL (25 µL per ear) of the test substance as a solution in dimethylformamide.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
other: 2,4 Dinitrobenzene sulphonic acid, sodium salt (DNBS), at 1%, 10%, 20% v/v in 1% pluronic L92 in distilled water.
Statistics:
no data

Results and discussion

Positive control results:
see: any other information on results (here below)

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
1.86
Test group / Remarks:
5% w/w in dimethyl formamide
Parameter:
SI
Value:
1.65
Test group / Remarks:
10% w/w in dimethyl formamide
Parameter:
SI
Value:
1.86
Test group / Remarks:
25% w/w in dimethyl formamide
Cellular proliferation data / Observations:
CELLULAR PROLIFERATION DATA
Dpm/node obtained by dividing the Dpm valule by 8 (total number of lymph nodes)
vehicle control group, Dpm/node: 565.23
5% w/w group: Dpm/node: 1053.65
10% w/w group: Dpm/node: 933.70
25% w/w group: Dpm/node: 1049.38

DETAILS ON STIMULATION INDEX CALCULATION
The Stimulation Index (SI) was expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group

EC3 CALCULATION
no data

CLINICAL OBSERVATIONS:
No signs of systemic toxicity have been observed, no mortality observed
White residual test material on the ears observed in 10 and 25 %w/w groups 1 hour post dose on day 1 (only 25% w/w group) and days 2 and 3

BODY WEIGHTS
The mean body weight gain shown by the animals over the study period was considered to be normal.

Any other information on results incl. tables

Positive Control Local Lymph Node Assay in the Mouse (2005)

Start Date

Finish Date

Test Material

Concentration

Vehicle

Stimulation Indexa

Classificationb

04/03/2005

10/03/2005

α‑Hexylcinnamaldehyde, tech., 85%

5%, 10%, 25% v/v

acetone/olive oil 4:1

2.76, 3.34, 8.91

Positive

20/04/2005

26/04/2005

α‑Hexylcinnamaldehyde, tech., 85%

5%, 10%, 25% v/v

ethanol/distilled water
7:3

2.64, 8.36, 12.94

Positive

14/07/2005

20/07/2005

α‑Hexylcinnamaldehyde, tech., 85%

5%, 10%, 25% v/v

1% pluronic L92

in distilled water

0.86, 1.50, 6.17

Positive

14/07/2005

20/07/2005

2,4 Dinitrobenzene sulphonic acid, sodium salt (DNBS)

1%, 10%, 20% v/v

1% pluronic L92

in distilled water

1.16, 9.59, 20.71

Positive


a=        Ratio of test to control lymphocyte proliferation

b=        Stimulation index greater than 3.0 indicates a positive result

* =        Standard Test Method 595 (Pooled nodes)

·=        Standard Test Method 599 (Individual nodes)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was not considered a sensitiser under the conditions of the test as no SI value >= 3 has been observed when tested up to a concentration of 25% w/w.