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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
hexafluoro-λ⁵-phosphanuide; tris({4-[(4-acetylphenyl)sulfanyl]phenyl})sulfanium
EC Number:
700-373-6
Cas Number:
953084-13-4
Molecular formula:
C42 H33 O3 S4 . F6 P
IUPAC Name:
hexafluoro-λ⁵-phosphanuide; tris({4-[(4-acetylphenyl)sulfanyl]phenyl})sulfanium

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sulzfeld
- Age at study initiation: 8 – 12 weeks
- Weight at study initiation: 19.1 g – 21.2 g
- Housing: single housed
- Diet (e.g. ad libitum): Kliba-Labordiät (Maus / Ratte Haltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 24
- Humidity (%): 30 – 70
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Study design: in vivo (LLNA)

Vehicle:
propylene glycol
Concentration:
40 % w/w preparation of the test substance in propylene glycol or with the vehicle alone
No. of animals per dose:
5
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: low water solubility
- Irritation: the results of a pretest with a 40% test-substance preparation in propylene glycol were considered, which did not show increased ear weights and lymph node weights as indication of ear irritation.
- Lymph node proliferation response: the results of a pretest with a 40% test-substance preparation in propylene glycol were considered, which did not show increased ear weights and lymph node weights.

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: radioactive Murine Local Lymph Node Assay
- Criteria used to consider a positive response: The parameters used to characterize the response are lymph node cell count, 3H-thymidine incorporation into the lymph node cells and to a certain extent lymph node weight. The increase SI of cell count by a factor of ≥ 1.5 and/or of 3H-thymidine incorporation by a factor of ≥ 3 as compared to the concurrent vehicle control group is generally considered as indicating a sensitizing potential of a test substance.

TREATMENT PREPARATION AND ADMINISTRATION:
- Form of application: Epicutaneous application is simulating dermal contact with the compound which is possible to occur under practical use conditions.
Concentration: As the 40 % test-substance preparation was the maximum technically applicable concentration, it was chosen for the main test, which was carried out as a limit test.
- Application volume: 25 μL per ear
- Site of application: Dorsal part of both ears
- Frequency of application: 3 consecutive applications (day 0 – day 2) to the same application site
- ³H-thymidine injection: On study day five (about 66 to 72 hours after the last application of test substance to the ears) the mice were injected intravenously with 20 μCi of 3H-thymidine in 250 μl of sterile saline into a tail vein.
- Terminal procedures: The animals were sacrificed on study day 5 about 5 hours after 3H-thymidine injection by cervical dislocation.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
The positive control induced positive responses in the auricular lymph nodes when applied as 3%, 10% or 30% preparations in acetone or methyl ethyl ketone.
lt is concluded that Alpha-Hexylcinnamaldehyde, techn. 85 % has a sensitizing effect in the Murine Local Lymph Node Assay under the test conditions chosen.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: control:1.00 test: 1.28 Calculation on basis of 4 animals due to irregularities during 3H-thymidine injection.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: control: 1052.1 test: 1343.7, Calculation on basis of 4 animals due to irregularities during 3H-thymidine injection.

Any other information on results incl. tables

Lymph node weight, Cell count, 3H-Thymidine incorporation and Ear weight: Stimulation indices (test group x / test group 1 (vehicle control))

Test

group

Treatment

 

Lymph node

Weight Index

Cell Count

Index

³H-thymidine inc. [DPM/lymph node pair] Index

Ear Weight
Index

1

2*

vehicle propylene glycol

40% in propylene glycol

1.00

1.05

1.00

1.23

1.00

1.28

1.00
0.99

* Calculation on basis of 4 animals due to irregularities during 3H-thymidine injection.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU