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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:
2003-09-29 to 2004-09-23
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:
2004
Report Date:
2004

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:
limited details on test item, test animals and environmental conditions
Qualifier:
according to
Guideline:
other: SPL Standard Test method 595.12
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 this study.
Type of study:
mouse local lymph node 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-119717-AAA (T001036)
- Physical state: solid
Specific details on test material used for the study:
No further details on test material next to T1036

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:
dimethyl sulphoxide
Concentration:
10%, 25% and 50% w/w in dimethyl sulphoxide
No. of animals per dose:
Four animals
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: no data
- Irritation: no data
- Lymph node proliferation response: no data
-There were no signs of systemic toxicity following a preliminary sighting test at a concentration of 50%.

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: SPL Standard Test Method 595.12
- Criteria used to consider a positive response: Test to control ratio greater than 3.0 indicates a ‘positive’ result.

TREATMENT PREPARATION AND ADMINISTRATION: Three groups, each of four animals, were treated with 50 uL of the test material (25 uL per ear) as asolution in dimethyl sulphoxide at concentrations of 10%, 25% and 50% w/w. A further group of four animals was treated with dimethyl sulphoxide alone.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
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:
0.92
Test group / Remarks:
10% w/w group
Parameter:
SI
Value:
1.25
Test group / Remarks:
25% w/w group
Parameter:
SI
Value:
4.05
Test group / Remarks:
50% w/w group
Parameter:
EC3
Value:
40.63
Cellular proliferation data / Observations:
CELLULAR PROLIFERATION DATA
no data

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
Using the data generated, an EC3 value of 40.63% was calculated.

CLINICAL OBSERVATIONS:
no signs of systemic toxicity in a preliminary sighting test. No data for the main study

BODY WEIGHTS
no data

Any other information on results incl. tables

Table 1: The Stimulation Index (SI) expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:

 Concentration (% w/w) in dimethyl sulphoxide  Stimulation Index (SI) b  Result
 10  0.92  Negative
 25  1.25  Negative
 50  4.05  Positive

Using the data generated, an EC3 value of 40.63% was calculated.

b = Test to control ratio greater than 3.0 indicates a ‘positive’ result

Table 2: Positive Control Local Lymph Node Assay in the Mouse (2003)

Start Date

Finish Date

Test Material

Concentration

Vehicle

Stimulation Indexa

Classificationb

13/03/2003

19/03/2003

α‑Hexylcinnamaldehyde, tech., 85%

5%, 10%, 25% v/v

acetone/olive oil 4:1

2.8, 2.3, 5.5

Positive

13/03/2003

19/03/2003

α‑Hexylcinnamaldehyde, tech., 85%

5%, 10%, 25% v/v

acetone/olive oil 4:1

2.0, 1.9, 6.8

Positive

10/10/2003

16/10/2003

α‑Hexylcinnamaldehyde, tech., 85%

5%, 10%, 25% v/v

acetone/olive oil 4:1

1.76, 2.78, 5.06

Positive

16/10/2003

22/10/2003

α‑Hexylcinnamaldehyde, tech., 85%

5%, 10%, 25% v/v

acetone/olive oil 4:1

1.49, 1.73, 5.26

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:
The test material was considered to be a sensitiser under the conditions of the test. Using the data generated, an EC3 value of 40.63% was calculated.