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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin sensitization:

In a Local Lymph Node Assay (LLNA) in CBA/Ca mice, according to a method equivalent to OECD 429, T002326 did not elicit a SI >=3 when tested up to 10% (Sanders, 2004). Therefore, the test item does not have to be classified as a skin sensitizer and has no obligatory labelling requirement for sensitization by skin contact according to the Regulation (EC) No. 1272/2008.

Respiratory sensitization:

No reliable respiratory sensitization study was available.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003-05-20 to 2003-06-11
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
not specified
Remarks:
not specified/limited data provided on methodology
Principles of method if other than guideline:
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 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)
Species:
mouse
Strain:
CBA/Ca
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS: no data

ENVIRONMENTAL CONDITIONS: no data
Vehicle:
dimethyl sulphoxide
Concentration:
2.5, 5, and 10% w/w
No. of animals per dose:
4
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: no data
- Irritation: Following a preliminary sighting test, no death or signs of systemic toxicity were observed at a concentration of 10% w/w in DMSO.
- Lymph node proliferation response: no data


MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: Test to control ratio for stimulation Index greater than 3.0 indicates a 'positive' result


TREATMENT PREPARATION AND ADMINISTRATION:
- three groups of four animals were treated with 25 µL per ear of 2.5, 5, and 10% test material in dimethyl sulfoxide. A further group of four animals was treated with dimethyl sulfoxide alone. Determination of lymphocyte proliferation was quantified by measuring the incorporation of radiolabelled thymidine in the dividing lymph node cells. The proliferation response of the lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node and as the ratio of ³HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index).
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Positive control results:
see: any other information on results (here below)
Parameter:
SI
Value:
2.05
Test group / Remarks:
2.5% w/w group
Parameter:
SI
Value:
1.67
Test group / Remarks:
5% w/w group
Parameter:
SI
Value:
1.95
Test group / Remarks:
10% w/w group
Cellular proliferation data / Observations:
CELLULAR PROLIFERATION DATA: no data

DETAILS ON STIMULATION INDEX CALCULATION: The Stimulation Index (SI) was expresssed 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 data

BODY WEIGHTS: no data

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)

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was not considered to be a skin sensitizer as the test to control ratio for the stimulation index didn't exceed 3.0 in all dose groups.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A local lymph node assay (LLNA) was performed to assess the skin sensitization potential of T002326 in the CBA/Ca strain of mouse (Sanders, 2004).

Following a preliminary sighting test at which there were no deaths or signs of systemic toxicity at a concentration of 10% w/w in dimethyl sulphoxide, three groups, each of four animals, were treated with 50 µl of the test material (25 µl per ear) as a solution in dimethyl sulphoxide at concentrations of 2.5%, 5% and 10% w/w. A further group of four animals was treated with dimethyl sulphoxide alone.

As T002326 did not elicit a stimulation index (SI) greater than or equal to 3 when tested up to 10%, it is not considered to be a skin sensitizer.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Skin sensitization:

As T002326 did not elicit a stimulation index (SI) greater than or equal to 3 when tested up to 10%, it is not considered to be a skin sensitizer and does not have to be classified and has no obligatory labelling requirements for skin sensitization by skin contact according to the Regulation (EC) No. 1272/2008.

Respiratory sensitization:

No data were available to decide on the classification for respiratory sensitization.