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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:
2003-10-28 to 2003-11-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

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:
no
Qualifier:
according to
Guideline:
other: SPL Standard Test method 595.12
Deviations:
no
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 lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): T 836
- Substance type: no data
- Physical state: no data
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
- Other: no data
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: no data
- Expiration date of the lot/batch: no data
- Purity test date: no data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL: No data


TREATMENT OF TEST MATERIAL PRIOR TO TESTING: No data

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: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (deg C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Study design: in vivo (LLNA)

Vehicle:
other: ethanol/distilled water 4:1
Concentration:
5%, 10%, 25% w/w
No. of animals per dose:
4
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: no data
- Irritation: no systemic toxicity in a preliminary sightings test at 25%
- Lymph node proliferation response: no data


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:
-3 groups of 4 animals were treated with 50 uL test material (25 uL per ear), in a solution of ethanol/distilled water 4:1, at 5, 10 and 25 %.
- Another group was treated with ethanol/distilled water 4:1 alone.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
other: 2,4-dinitrobenzenesulfonic acid, sodium salt 1%, 10%, 20% v/v in 1% pluronic F-68 in distilled water
Statistics:
no data

Results and discussion

Positive control results:
no data

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
2.21
Test group / Remarks:
5 (% w/w)
Remarks on result:
other: Negative
Parameter:
SI
Value:
6.15
Test group / Remarks:
10 (% w/w)
Remarks on result:
other: Positive
Parameter:
SI
Value:
11.01
Test group / Remarks:
25 (% w/w)
Remarks on result:
other: Positive
Cellular proliferation data / Observations:
CELLULAR PROLIFERATION DATA: no data

DETAILS ON STIMULATION INDEX CALCULATION: see above

EC3 CALCULATION : 6%

CLINICAL OBSERVATIONS: no data

BODY WEIGHTS: no data

Any other information on results incl. tables

Positive Control Local Lymph Node Assay in the Mouse (2004)

Project Number

Start Date

Finish Date

Test Material

Concentration

Vehicle

Stimulation Indexa

Classificationb

039/687·

29/04/2004

05/05/2004

α‑Hexylcinnamaldehyde, tech., 85%

5%, 10%, 25% v/v

acetone/olive oil 4:1

1.40, 2.23, 6.09

Positive

039/688*

29/04/2004

05/05/2004

α‑Hexylcinnamaldehyde, tech., 85%

5%, 10%, 25% v/v

acetone/olive oil 4:1

1.74, 2.20, 8.89

Positive

039/719*

14/10/2004

26/10/2004

α‑Hexylcinnamaldehyde, tech., 85%

5%, 10%, 25% v/v

tetrahydrofuran

1.97, 3.71, 7.82

Positive

039/720*

29/09/2004

05/10/2004

2,4‑Dinitrobenzenesulfonic acid, sodium salt

1%, 10%, 20% v/v

1% pluronic F-68

in distilled water

1.03, 4.41, 13.55

Positive

039/723*

27/10/2004

02/11/2004

α‑Hexylcinnamaldehyde, tech., 85%

10%, 25%, 50% v/v

cottonseed oil

1.52, 2.63, 5.07

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:
Based upon the data generated, an EC3 value of 6% was calculated. Therefore, the test substance was considered to be a sensitizer under the conditions of the test. The test substance is classified as category 1 based on criteria of CLP Regulation.