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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:
2005-01-17 to 2005-02-10
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:
according to
Guideline:
other: SPL Standard Test Method 595.12
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
yes
Remarks:
limited details on test item, test animals and environmental conditions
GLP compliance:
no
Remarks:
The study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA unit. No formal claim of GLP compliance is made for this study.
Type of study:
mouse local lymphnode assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study reports): JNJ-7928531-AAA (T001481)
- Physical state: liquid
- Appearance: Colourless, light yellow to brown liquid

In vivo test system

Test animals

Species:
mouse
Strain:
CBA/Ca
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 17 to 20 g (Main Study)
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum):no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS: no data

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
Preliminary Screening Test: 50 and 100% v/v
Main Study: 10%, 25%, and 50 % v/v
No. of animals per dose:
Main Study: 4 per dose
Details on study design:
PRE-SCREEN TESTS:
- Compound solubility: no data
- Irritation: no data
- Systemic toxicity: No signs of systemic toxicity or weight loss at a concentration of 50% v/v in acetone/olive oil 4:1. A weight loss of 2 g was observed with a concentration of 100% v/v.
- Ear thickness measurements: no data
- Erythema scores: no data

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: Stimulation Index of greater than 3.0 indicates a 'positive' result.


TREATMENT PREPARATION AND ADMINISTRATION:
- Three groups, each of four animals, were treated with 50 µL (25 µL per ear) of the test substance as a solution in acetone/olive oil 4:1 at concentrations of 10%, 25%, and 50% v/v. A further group of four animals was treated with acetone/olive oil 4:1 alone.
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:
1.53
Test group / Remarks:
10% v/v
Parameter:
SI
Value:
1.43
Test group / Remarks:
25% v/v
Parameter:
SI
Value:
3.54
Test group / Remarks:
50% v/v
Cellular proliferation data / Observations:
CELLULAR PROLIFERATION DATA :
DPM/node obtained by dividing DPM value by 8 (total number of lymph nodes):
Vehicle: 591.85
10% v/v: 904.58
25% v/v: 843.95
50% v/v: 2092.83

DETAILS ON STIMULATION INDEX CALCULATION: see table above

EC3 CALCULATION : The EC3 of the test substance was found to be 43.5%.

CLINICAL OBSERVATIONS: No signs of systemic toxicity were observed in any of the animals tested.

BODY WEIGHTS: no abnormal body weight changes observed in the tested animals

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:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
Since there was indication that the test item elicited a SI ≥ 3 when tested up to 50%, T001481 was considered to be a skin sensitizer. As the EC3 value was > 2% (i.e. 43.5%), the substance is classified as skin sensitizer category 1B according to the criteria of the CLP Regulation (H317).